83 FR 7304 - Trinity Pharmacy II; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 34 (February 20, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 34 (February 20, 2018)
| Page Range | 7304-7336 | |
| FR Document | 2018-03294 |
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)] [Notices] [Pages 7304-7336] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03294] [[Page 7303]] Vol. 83 Tuesday, No. 34 February 20, 2018 Part II Department of Justice ----------------------------------------------------------------------- Drug Enforcement Administration ----------------------------------------------------------------------- Trinity Pharmacy II; Decision and Order; Notice Federal Register / Vol. 83 , No. 34 / Tuesday, February 20, 2018 / Notices [[Page 7304]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15-28] Trinity Pharmacy II; Decision and Order On July 10, 2015, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Trinity Pharmacy II, Inc. (hereinafter ``Trinity II'' or Respondent), which proposed the revocation of its DEA Certificate of Registration FT0531586, pursuant to which Trinity II is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 1474 South Belcher Road, Clearwater, Florida. Administrative Law Judge Exhibit (ALJ Ex.) 1b, at 1. As grounds for the proposed action, the Show Cause Order alleged that Respondent's ``continued registration is inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f) and 824(a)(4)). More specifically, the Show Cause Order set forth seven independent reasons why Respondent's registration should be revoked. Id. at 2-17. First, the Show Cause Order charged that, between February 2012 and February 2014, Trinity II ``committed acts as would render its continued registration inconsistent with the public interest'' pursuant to 21 U.S.C. 824(a)(4) because Respondent (1) ``failed to comply with applicable federal and Florida state laws relating to controlled substances'' (citing 21 U.S.C. 823(f)(4)) and (2) ``exhibited negative experience in its dispensing of controlled substances'' (citing 21 U.S.C. 823(f)(2)). Id. at 1, 2. During this period, the Order alleged that pharmacists at Trinity II ``filled [prescriptions for] and dispensed controlled substances on numerous occasions outside the usual course of pharmacy practice and in contravention of their corresponding responsibility,'' and that such pharmacists did so even when such prescriptions ``contained one or more `red flags' [f]or drug abuse or diversion without resolving the red flag(s) and, in certain circumstances, w[h]ere the red flags were unresolvable.'' Id. at 2-3 (citing Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 FR 62316, 62321-22 (2012)). The Show Cause Order listed six red flags of diversion which Respondent's pharmacists allegedly failed to resolve before dispensing prescriptions, including: (1) ``[e]arly [f]ills,'' in which nine customers sought ``to fill a new controlled substance prescription or refill an existing controlled substance prescription well before the customer should have exhausted the supply . . . obtained from the previous prescription;'' (2) unusual distance traveled, in which six customers ``present[ed] a prescription bearing an address for the customer and doctor showing that the customer had travelled an unusual or suspicious route to obtain their prescriptions and fill them at Trinity II;'' (3) ``[c]ocktail prescriptions,'' in which eight customers ``present[ed] multiple prescriptions that provided the individual with the cocktail of an opioid, a benzodiazepine, and a muscle relaxer;'' (4) ``[d]uplicative drug therapies,'' whereby eight customers ``present[ed] multiple prescriptions which provided the person duplicative drug treatment;'' (5) ``[t]wo prescriptions for the same drug,'' in which 10 ``customers present[ed] two prescriptions for the same drug on the same date;'' and (6) ``pattern prescribing,'' or a lack of individualized drug therapy, in which two sets of ``two individuals present[ed] prescriptions on the same day for the same drugs that were issued by the same prescriber.'' Id. at 3-14. Second, the Show Cause Order charged Trinity II with violating federal law when it dispensed ``a Schedule II controlled substance outside the usual course of professional practice . . . and in contravention of its corresponding responsibility . . . [when it] filled a prescription for customer D.G.'' on November 8, 2013 for ``7 patches of Duragesic 50 mcg/hr (fentanyl).'' Id. at 14 (citing 21 CFR 1306.04(a), 1306.06). The Order alleged that Trinity II filled this prescription even though D.G. had 12 days left on a prescription issued by a different doctor and filled by Trinity II on October 21, 2013 for a ``thirty-day supply'' of fentanyl patches that should have lasted D.G. until November 20, 2013. Id. The Order further alleged that when Trinity II filled the second prescription for D.G. 12 days early, Trinity II ``ignored the bright red flags that D.G. was abusing and/or diverting the fentanyl by doctor-shopping and seeking an early fill of fentanyl.'' Id. Third and fourth, the Show Cause Order charged that Trinity II violated federal law when it twice dispensed to D.G. ``a Schedule II controlled substance without a valid prescription,'' ``outside the usual course of professional practice,'' ``and in contravention of its corresponding responsibility.'' Id. at 14, 15 (citing 21 U.S.C. 829; 21 CFR 1306.04(a), 1306.06, 1306.11(a)). In the third charge, the Order alleged that D.G. presented Trinity II with a prescription dated November 15, 2013 ``for 15 patches of Duragesic 50 mcg/hr (fentanyl), a Schedule II controlled substance,'' that also contained the following instruction from the prescribing practitioner: ``NO EXCEPTIONS DO NOT FILL UNTIL 12-06-2013.'' Id. at 14. The Order alleged that Trinity II nevertheless filled the prescription on November 20, 2013. Id. In the fourth charge, the Order alleged that D.G. presented Trinity II with a prescription in December 2013, also ``for 15 patches of Duragesic 50 mcg/hr (fentanyl), a Schedule II controlled substance,'' that also contained the following instruction from the prescribing practitioner: ``NO EXCEPTIONS DO NOT FILL UNTIL 1-05-2014.'' Id. at 15. The Order alleged that Trinity II nevertheless filled the prescription on December 18, 2013. Id. As a result, and with respect to each of these charges, the Order alleged that Trinity II ``filled and dispensed this controlled substance to D.G. approximately two weeks before the prescriber had authorized it to do so, and, thus, before the prescription was valid for filling.'' Id. at 15. Fifth, the Show Cause Order charged that, on eight occasions between July 12, 2012 and January 25, 2013, Trinity II violated federal law when it dispensed to J.T. ``a Schedule II controlled substance without a valid prescription'' and ``outside the usual course of professional practice.'' Id. (citing 21 U.S.C. 829; 21 CFR 1306.06, 1306.11(a)). Specifically, the Order alleged that Trinity II dispensed to J.T. ``a morphine sulfate solution'' ``that was five times more potent than the doctor had prescribed, and instructed J.T. to take a dosage amount that would result in him receiving five times the amount'' prescribed. Id. The Order further alleged that such prescriptions ``placed the health and safety of J.T. at risk and, thus, engaged in conduct that may have threatened the public health and safety'' pursuant to 21 U.S.C. 823(f)(5). Id. at 16. Sixth, the Show Cause Order charged that ``Trinity II unlawfully distributed controlled substances in violation of federal and Florida state law by utilizing non-pharmacists to fill controlled substances prescriptions on numerous occasions between February, 2012 and February, 2014.'' Id. The Order alleged that when Trinity II allowed its non-pharmacist ``pharmacy interns'' to fill a prescription, it was not filled by a pharmacist ``acting in the usual course of his professional practice,'' pursuant to 21 CFR 1306.06, nor were Trinity II's pharmacists properly exercising their ``corresponding responsibility'' under 21 CFR 1306.04(a). Id. The Order further [[Page 7305]] alleged that such prescriptions violated Florida law's requirement that ``[a] pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances.'' Id. (citing Fla. Stat., Ch. 893.04(1)). Seventh, and lastly, the Show Cause Order charged that, ``if Trinity II's pharmacists in fact filled the prescriptions referenced in [the sixth charge], then Trinity II violated federal and Florida state law on numerous occasions between February 2012 and February 2014 by failing to maintain accurate records of the controlled substances it dispensed because they do not identify a pharmacist who filled the controlled substance prescription.'' Id. at 16-17 (citing 21 CFR 1304.22(c), 1306.06; Fla. Stat., Ch. 893.04(1)(c)(6)). In a letter from its counsel dated August 12, 2015, Trinity II acknowledged receipt of the Show Cause Order and requested a hearing on the allegations. ALJ Ex. 2b. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ), who proceeded to conduct pre-hearing proceedings as follows.\1\ --------------------------------------------------------------------------- \1\ Respondent raised no objection to the adequacy of service. --------------------------------------------------------------------------- On August 13, 2015, the CALJ issued an Order for Prehearing Statements (hereinafter, Prehearing Order). See ALJ Ex. 3b. In the Prehearing Order, the CALJ directed the Government to file its Prehearing Statement no later than 2 p.m. on August 24, 2015, Respondent to file its Prehearing Statement no later than 2 p.m. on September 8, 2015, and scheduled a Prehearing Conference for 1:30 p.m. on September 9, 2015. Id. at 1-2. The Order also directed the parties to provide the ``[n]ames and current addresses of all witnesses whose testimony is to be presented,'' and that if the Respondent's corporate representative intends to testify, the representative ``must be listed as a witness, and a summary of his/her testimony as described below must be provided.'' Id. at 2. The CALJ's Order provided the following instruction regarding the summaries of testimony: Brief summary of the testimony of each witness (counsel for the Government to indicate clearly each and every act, omission or occurrence upon which it relies in seeking to revoke the Respondent's [Certificate of Registration]; counsel for Respondent to indicate clearly each and every matter as to which Respondent intends to introduce evidence in opposition). The summaries are to state what the testimony will be rather than merely listing the areas to be covered. The parties are reminded that testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing. Id. The Order further emphasized that ``[f]ailure to timely file a prehearing statement that complies with the directions provided above may be considered a waiver of hearing and an implied withdrawal of a request for hearing.'' Id. at 3. On August 21, 2015, the Government filed its Prehearing Statement. ALJ Ex. 4b. On August 24, 2015, the CALJ issued an ``Order Rescheduling Prehearing Conference'' moving the prehearing conference up to 10:30 a.m. on September 3, 2015 in light of Respondent's counsel's August 20, 2015 notice of a conflict with the scheduled hearing on October 26, 2015. ALJ Ex. 8b at 1.\2\ Although this Order stated that ``[a]ll other dates specified in the [Prehearing Order], including the filing date for the Respondent's Prehearing Statement, remain in effect,'' id. at 1 n.1, the CALJ (through his staff) later requested that Respondent file its Prehearing Statement early. ALJ Ex. 10 at 1 n.1 (``Upon my realization that the status conference was now scheduled several days prior to the date that the Respondents' prehearing statements were due under the terms of the [Prehearing Order], chambers staff (at my direction) reached out to Respondents' counsel and requested (but not directed) that, if it was possible to do so, their prehearing statements be filed prior to the commencement of the now-rescheduled Status Conference . . . with the assurance that (as is customary) both sides would be permitted to file supplemental prehearing statements''). --------------------------------------------------------------------------- \2\ According to the CALJ, ``[t]he hearing commencement date [was] continued on multiple occasions at the Respondents' request.'' ALJ Ex. 34, at 1 n.1. The hearing was ultimately noticed to begin on January 4, 2016. ALJ Ex. 27. --------------------------------------------------------------------------- Per the CALJ's request, Trinity II filed its ``Preliminary Prehearing Statement'' on September 3, 2015. ALJ Ex. 9b. Trinity II proposed to call 77 witnesses in addition to ``[a]ny and all witnesses identified in the Government's Prehearing Statement.'' Id. at 3-7. Trinity II then provided a ``Summary of Anticipated Testimony'' for nine of these witnesses, all of whom were the owners or employees of Trinity II. Id. at 7-14. Trinity II stated that it anticipated calling an expert witness but had not yet identified one ``given the preliminary nature of this statement.'' Id. at 14. Trinity II offered an identical one-sentence summary of the testimony for each of 39 ``patients,'' and a separate identical one-sentence summary of the testimony for each of 32 ``prescribing physicians.'' Id. at 14-15. Trinity II also proposed as documents for the hearing copies of ``all prescriptions, patient profiles and related documents maintained by Trinity Pharmacy II in connection with each patient described in the [Show Cause Order].'' Id. at 16. On September 3, 2015, the CALJ conducted an on-the-record prehearing conference. During that conference, the CALJ noted the Government's motion to consolidate the hearings for Trinity II and Trinity Pharmacy I \3\ (hereinafter, collectively, Respondents) and asked Respondents' counsel to file something confirming that Trinity I and Trinity II waive any potential conflict in having him represent them both at a consolidated hearing. Transcript (``Tr.'') 5; ALJ Ex. 10 n.4 (same).\4\ The CALJ also noted during the proceedings that the Government was seeking an ``Order of Protection'' to limit disclosure of personally identifiable information of patients and confirmed that Respondent had no objection to such an order. Tr. 55-56. Lastly, the CALJ accepted Respondents' counsel's representation that neither Trinity I nor Trinity II were the subject of pending state administrative cases or ``criminal parallel proceedings.'' Id. at 63. --------------------------------------------------------------------------- \3\ Trinity Pharmacy (``Trinity I''), located in Seminole, Florida, was served with a separate July 10, 2015 Order to Show Cause by the Government. ALJ Ex. 1a. Although the CALJ eventually ordered the consolidation of the evidentiary hearings for Trinity I and Trinity II, see ALJ Ex. 10 at 2, the CALJ wrote separate recommendations regarding each Respondent, and I therefore have written a separate Order regarding the disposition of the Show Cause Order directed at Trinity I. \4\ On November 13, 2017, Mr. Michael Stanton filed a ``Notice of Appearance on Behalf of Respondents'' in which he entered ``an appearance as co-counsel for Respondents, Trinity Pharmacy I and Trinity Pharmacy II, along with Dale Sisco of Sisco Law.'' ALJ Ex. 35b, at 2. Although both counsel maintained that they represented both Respondents, at the evidentiary hearing, Mr. Sisco stated that ``[f]or the purposes of this hearing, I will be representing Trinity I and questioning witnesses on behalf of that pharmacy,'' and Mr. Stanton stated that ``for purposes of this hearing and to avoid any duplication, I will be handling the objections and the questioning on behalf of Trinity II.'' Tr. 83-84. --------------------------------------------------------------------------- On September 4, 2015, the CALJ issued a ``Consolidation Order, Prehearing Ruling, and Protective Order'' (hereinafter ``Consolidation Order''). ALJ Ex. 10 at 2. In this Order, the CALJ granted the Government's request for the aforementioned protective order and the Government's motion to consolidate the hearings, and the CALJ directed all parties to file a consolidated exhibit and witness list by October 16, 2015. Id. at 2, 9-11. The Order noted that the parties would be able to cross-examine the others' witnesses and stated that the ``parties are also reminded that testimony not [[Page 7306]] summarized in prehearing statements, or supplements thereto, may be excluded at the hearing.'' Id. at 4. The Order also directed the parties to serve each other with all documents it intends to identify as exhibits no later than September 11, 2015, and directed Respondents to supply the identity and curriculum vitae of their proposed expert witness by September 18, 2015. Id. at 4, 8. The Order further directed the parties to file supplemental prehearing statements and any additional exhibits, as well as any motions seeking relief, by 2 p.m. on October 16, 2015, and any responsive filings by 2 p.m. on October 23, 2015. Id. at 8. Finally, the Order reminded the parties that ``documents not noticed in prehearing statements, or supplements thereto, or not timely supplied to the opposing party may (and likely will) be excluded at the hearing.'' Id. at 4. Although the Prehearing Order had directed Trinity II to supply a compliant prehearing statement by September 8, 2015, ALJ Ex. 3b at 1, and the Order Rescheduling Prehearing Conference iterated that Trinity II's prehearing statement filing deadline remained the same, ALJ Ex. 8b at 1 n.1, Trinity II failed to do so. On September 24, 2015, the Government filed a Motion to Compel Respondents' Compliance with the Prehearing Order and the Consolidation Order and a Motion Requesting a New Supplemental Prehearing Statement and Motion Deadline. ALJ Exs. 11a, 11b. On September 28, 2015, Respondents filed their response. ALJ Ex. 13. On the same day, the CALJ issued an Order that generally denied the Government's motions and stated that honoring the CALJ's request for an earlier prehearing statement may have caused Respondents to have had the: mistaken impression that compliant prehearing statements were no longer required until the filing of supplemental prehearing statements. To alleviate any remaining misunderstanding in this regard and to afford the Respondents the time and ability to file both a fulsome prehearing statement and a supplemental prehearing statement, it is ORDERED that Respondents are to file prehearing statements that comply with the terms of the [Prehearing Statement] no later than 2 p.m. on October 5, 2015. ALJ Ex. 14, at 3-4. On October 5, 2015, Trinity II filed its Prehearing Statement. ALJ Ex. 15b. Trinity II provided the names and address of 79 proposed witnesses, in addition to ``[a]ny and all witnesses identified in the Government's Prehearing Statement.'' Id. at 4-7. Trinity II also provided a ``Summary of Anticipated Testimony'' for nine witnesses who were either owners or employees of Trinity II, a putative expert, and short but similar descriptions of testimony for 39 patients and 32 prescribing physicians. Id. at 7-54.\5\ The Prehearing Statement also identified 70 documents ``intended to be used at the consolidated hearing regarding both Trinity Pharmacy I and Trinity Pharmacy II.'' Id. at 55-57, 55 n.2. On October 15, 2015, Respondents filed a ``Consolidated Witness and Exhibit List'' that listed 133 witnesses, in addition to ``[a]ny and all witnesses identified in the Government's Prehearing Statement,'' 69 exhibits of ``[d]ocuments and information related to'' various individuals, and one exhibit that would be the CV of their putative expert. ALJ Ex. 15e. --------------------------------------------------------------------------- \5\ For example, for patient S.B., Trinity II stated that it anticipated her testimony to be as follows: [S.B.] was a patient whose prescriptions are identified in the various categories of allegations contained in the July 10, 2015 Order to Show Cause issued to Trinity Pharmacy II. It is anticipated that [S.B.] will testify regarding the inquiry done by the pharmacists and the staff at Trinity II regarding verification of her prescriptions and for the resolution of any potential red flags. [S.B.] will further confirm the information obtained from her by Trinity Pharmacy II prior to any prescription being dispensed, including but not limited to explanations for any significant distances traveled, the type of payment they made for the prescriptions, the circumstances of any refills and physician authorization for same. ALJ Ex. 15b, at 29. The proposed testimony of most of the other patients used similar language. See id. at 27-43. Likewise, the physician summaries used language similar or identical to the following example: [J.M.], M.D. was a prescribing physician for one or more of the patients who tendered prescriptions to Trinity Pharmacy II. [J.M.], M.D. will confirm the prescriptions he authorized were for a legitimate medical purpose and issued in the usual course of professional practice to patients that were known to him. Further, [J.M.], M.D. will describe his interaction with the pharmacists and staff at Trinity Pharmacy II, the authorization of refills or early fills, if any, and explanations for any duplicative drug therapy, combinations of medications or alleged ``drug cocktails.'' Id. at 45. --------------------------------------------------------------------------- On October 16, 2015, the Government filed its ``Consolidated Supplemental Prehearing Statement.'' ALJ Ex. 16a. In this filing, the Government proposed two new witnesses, provided a summary of their testimony, and provided additional summaries for the testimony of the fact and expert witness identified in the Government's original Prehearing Statement. Id. at 6-10. Lastly, the Government supplemented its list of proposed Government exhibits with a list of additional documents that it intended to introduce as exhibits at the hearing. Id. at 10-12. The Government also filed its consolidated witness list and exhibit list. ALJ Exs. 16b, 16c. Trinity II did not file a supplemental prehearing statement or any other prehearing statement by October 16, 2015 as required by the CALJ's Consolidation Order. As a result, the Government filed a ``Motion in Limine to Exclude Certain Testimony.'' ALJ Ex. 28. In its Motion, the Government contended that Respondents had failed in their prehearing statements to follow the requirements set forth in the CALJ's prehearing orders; namely, to ``state what the testimony will be rather than merely listing areas to be covered'' for each proposed witness.'' Id. at 2 (internal citations omitted). For example, the Government noted that Respondents proposed 69 witnesses identified as patients and that ``nearly every single patient of the sixty-nine listed by the Respondents is expected to testify identically.'' Id. at 4. The Government contended that, not only did the proposed patient ``testimony fail to make clear exactly what `information' each patient will `confirm,' thus preventing the Government from determining what specific defense(s) Respondents allege; the [proposed] testimony also fails to provide any basis upon which the Government can evaluate [whether] such information is even relevant or material to this case.'' Id. at 4-5. Such proposed testimony, the Government argued, ``is nothing more than `merely areas to be covered,' rather than any substantive recitation of `what the testimony will be,' '' as the prehearing orders required, ``offering no facts that, if proven, would rebut the Government's prima facie case or offer credible evidence in mitigation. Id. Finally, the Government argued that ``it is unclear from the Respondents' Prehearing Statements how the purported testimony of these various patients related to each of the dispensing events charged in the [Show Cause Orders], and how it affected the pharmacist's compliance with the standard of care and exercise of his corresponding responsibility in each charged instance.'' Id. With respect to the prescribing physicians that Respondents had proposed as witnesses, the Government noted that Respondents ``intend to call fifty-nine doctors as witnesses, who, again, will each testify identically. . . . Other than to blithely forecast that the physicians will approve their own prescriptions, Respondent provides no facts which, if proven, would rebut the Government's prima facie case.'' Id. at 6. This too, the Government contended, violated the requirement of the prehearing orders that the parties set forth ``what the testimony will be'' [[Page 7307]] rather than ``areas to be covered.'' Id. The Government argued that the summary of the physicians' proposed testimony failed to disclose sufficient facts to allow the Government to determine what specific defenses Respondents allege, nor provide any basis upon which the Government can evaluate how such information is relevant to the charges in the Show Cause Order. Id. at 6-7. In its Motion, the Government also challenged the adequacy of Respondents' disclosure of the proposed testimony of its owners and employees, contending that it too set forth ``a generalized statement of `areas to be covered' '' rather than ``a summary of `what the testimony will be' for each witness.'' Id. at 9. These generalized statements, the Government contended, failed ``to reveal the specific `actions' each employee purportedly is going to `describe' '' or ``to provide the Government (or the ALJ) any information upon which it can discern the relevance and materiality of the `actions' to the issues to be litigated in this case.'' Id. Although Respondents stated in their prehearing statements that certain employees would testify to describe the ``process'' Trinity II used ``to verify prescriptions and resolve concerns, if any, regarding the validity of those prescriptions,'' the Government argued that the statements ``fail[ed] to provide any information about the `process' '' employed to verify prescriptions and resolve concerns. Id. at 9-10. Similarly, the Government observed that Respondents' offer of testimony from employees who would provide ``a description and demonstration of the computer software used by the pharmacy in this process'' was not matched by a proposed ``exhibit containing each pharmacy's computer software that each witness purportedly would demonstrate for the court.'' Id. And while Respondents proposed its co-owners would testify about their knowledge of both their customers' medical conditions and the treating physicians efforts to ``resolve[ ] any concerns,'' the Government further alleged that Respondents failed to disclose ``each customer's medical condition . . . , how it related to each dispensing activity, or how and when each pharmacy purportedly became `aware' of it.'' Id. at 11. In its Motion, the Government also sought to preclude Respondents' proposed expert, Mr. Sam Badawi, from rendering an opinion concerning whether the prescriptions referenced in the Show Cause Orders ``were filled in compliance with federal and/or state law requirements.'' Id. at 14. Specifically, the Government alleged that Respondents failed to give the Government ``notice [of] a proposed opinion from Mr. Badawi as to the lawfulness of each prescription alleged in each'' Show Cause Order. Id. at 17 (``Respondents have had multiple opportunities to provide a compliant disclosure, yet have repeatedly failed to do so.''). As a result of these alleged deficiencies, the Government requested that the CALJ exclude ``the non-conforming testimony'' set forth in its Motion because Respondents had only provided ``vague summaries of areas to be covered by the Respondent's witnesses'' that unduly prejudiced the Government. Id. at 18-19 (``Agency precedent favors exclusion of evidence when the names of witnesses and `an adequate summary of their testimony' has `not been previously disclosed as required by the ALJ's Order for Pre-Hearing Statements.' '') (citing East Main Street Pharmacy, 75 FR 66149, 66150 (2010)). On November 5, 2015, the CALJ issued an ``Order Granting the Government's Unopposed Motion in Limine to Exclude Certain Testimony.'' ALJ Ex. 29. After noting the Government's timely filed Motion and that Respondents' deadline to file a responsive pleading was October 23, 2015, the CALJ noted: Respondents never filed a response. Not even a late or unpersuasive response. Nothing. The language of the [Prehearing Order] about the nature of the required notice proffers is clear and unambiguous; yet, notwithstanding multiple opportunities to do so, the Respondents have elected not to comply. The [Prehearing Statement] plainly states that ``testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing.'' ALJ Ex. 29, at 2. Although the CALJ posited that Respondents' repeated failure to comply with his orders could constitute a waiver of a hearing request, the CALJ also noted that the Government ``does not seek (as it could have) the draconian remedy of hearing waiver, but asks for the lesser sanction of preemptive exclusion of a limited subset of the noticed evidence,'' and the CALJ deemed the Motion unopposed and granted it. Id. at 3-4. Specifically, the CALJ's Order precluded Respondents from offering the following: 1. ``testimony from sixty-nine patients identified as proposed witnesses;'' 2. ``testimony from fifty-nine physicians identified as proposed witnesses;'' 3. ``testimony from proposed witness Nina Ghobrial;'' 4. ``evidence regarding the actions of DEA personnel and the cooperation of pharmacy staff during the Administrative Inspection of both pharmacies;'' 5. ``evidence regarding the process the pharmacies used to verify prescriptions and resolve concerns, including a description and demonstration of the computer software utilized;'' 6. ``evidence regarding the medical condition of patients who received early refills;'' 7. ``evidence of the pharmacy's knowledge of cocktail prescription and duplicative drug therapy patients, their medical condition, and their treating physicians;'' 8. ``evidence regarding circumstances surrounding an early fill for patient T.B.;'' 9. ``evidence regarding circumstances surrounding an early fill for patient C.F.;'' 10. ``evidence regarding information that Trinity I allegedly possessed relating to an early fill for patient J.K.;'' 11. ``evidence regarding circumstances surrounding an early fill for patient G.S.;'' 12. ``evidence regarding distances traveled by patients who either commuted, lived, or worked close to both pharmacies;'' and 13. ``evidence from the Respondents' proposed expert, Sam Badawi, regarding the lawful or unlawful nature of the numerous prescriptions referenced in each of the [Show Cause Orders].'' Id. at 3-4 (citing ALJ Ex. 28 at 4-18). Over a month later, on December 7, 2015, Respondents filed their ``Motion for Reconsideration on Behalf of Respondents'' in which they ``request[ed] an order reconsidering [the CALJ's] order granting the Government's motion in limine, and allowing Respondents to provide [the CALJ] with the necessary evidence needed for [the] final determination.'' ALJ Ex. 32, at 1. Respondents stated that ``due process requires that Respondents be entitled to present testimony from its witnesses, which were properly disclosed.'' Id. at 3. Respondents also stated that they ``recognize that the physician and patient disclosures lack particularity'' because ``Respondents cannot exercise sufficient control over these witnesses without first having them under subpoena to provide more detail.'' Id. at 3 n.1. Respondents added that ``[n]either the Government nor the Respondents should fear the Court learning the full truth . . . even if there may not be a way for any party to control that message before the hearing.'' Id. Respondents also contended that ``those same deficiencies . . . do not apply'' to their employee, expert, and owner witness disclosures. Id. Indeed, Respondents argued that ``it is disingenuous for the Government to alleged [sic] that the [expert witness] disclosure fails to provide adequate notice to allow it to prepare for a cross-examination when its prehearing statements provide a comparable [[Page 7308]] opportunity for notice to Respondents.'' Id at 4-5. Respondents contend that their ``representatives and pharmacist'' witness disclosures were ``similarly robust and detailed,'' and that their ``remaining pharmacy employees['] [witness] disclosures are brief.'' Id. at 5. Finally, Respondents claim that ``an intermediate remedial order requiring supplementation or a limit to the testimony would have been more appropriate than granting the motion in limine in its entirety.'' Id. The Government filed its ``Opposition to Respondents' Motion for Reconsideration'' on December 10, 2015. ALJ Ex. 33. In its Opposition, the Government argued that, as a threshold matter, ``Respondents have not even provided a basis--not to mention a plausible one that would demonstrate good cause--upon which to reconsider the decision.'' Id. at 4 (Respondents gave no ``explanation or justification for their failure to file a timely response on October 23, 2015.''). Id. ``Respondents['] Reconsideration Motion is a request for the ALJ to reconsider his decision on a Motion that they did not see fit to oppose in the first place, and have not seen/did not see fit [ ] to oppose for the past month.'' Id. In response to Respondents' concession that their patient and physician witness disclosures lacked particularity because they lacked subpoena authority, the Government contended that ``Respondents are unable to explain why they needed a subpoena to talk to their own customers and the physicians about prescriptions Respondents contend were lawfully issued. Nor do Respondents indicate that they attempted to contact these individuals and were rebuffed.'' Id. And finally, with respect to Respondents' Due Process argument, the Government noted that, ``despite hav[ing] been given multiple opportunities to correct their mistakes and provide the Government the requisite notice it was due,'' Respondents were attempting ``to shift the blame'' by ``now claiming that the ALJ is denying them a fair hearing.'' Id. at 4-5. On December 10, 2015, the CALJ issued his ``Order Denying the Respondents' Motion for Reconsideration.'' ALJ Ex. 34. In this Order, the CALJ noted that Respondents ``filed neither a response to the Government's motion [in Limine] nor a motion for an extension of time to do so. Indeed, the Respondents filed nothing.'' Id. at 1. The CALJ also observed that he waited an additional 13 ``days after the responsive filing deadline'' before issuing his Order granting the Government's Motion in Limine, ``perhaps hoping in vain for even a late response.'' Id. Indeed, the CALJ emphasized that Respondents did not file their Motion for Reconsideration until ``over forty-five days from the date their motion response was due and less than a month prior to the . . . commencement of the hearing.'' Id. (Respondents ``do[ ] not even mention the fact that no response was filed, as if it never happened''). The CALJ noted that Respondents asked for another order to give Respondents additional opportunities to cure any alleged deficiencies in their disclosures ``[u]nder th[e] theory[ ] this new, additional order would somehow carry more force and would result in compliance where the other orders had failed. Enough.'' Id. at 2. The CALJ found that Respondents ``have tendered no explanation for their failure to answer the Government's motion and no basis upon which to base good cause for reconsideration, even if such relief was warranted--which it is not.'' Id. Accordingly, the CALJ denied Respondents' reconsideration motion. Id. at 3.\6\ --------------------------------------------------------------------------- \6\ On December 11, 2015, the CALJ granted Respondents' requests for subpoenas for their pharmacy employees and denied Respondents' requests vis-[agrave]-vis their proposed practitioner witnesses pursuant to the Order granting the Government's Motion in Limine. ALJ Ex. 36. --------------------------------------------------------------------------- The CALJ conducted an evidentiary hearing on January 4-8, 2016, in Arlington, Virginia, and on January 11-12, 2016, in Tampa, Florida. See Recommended Decision (R.D.), at 2. At the hearing, both parties elicited testimony from multiple witnesses, and the Government submitted various exhibits. Following the hearing, on February 26, 2016, both parties filed briefs containing their proposed findings of fact, conclusions of law, and argument. ALJ Exs. 40a, 41. On February 29, 2016, the CALJ issued an ``Order Regarding the Exhibit (and Appended Attachments) Included with the Government's Closing Brief'' noting that the Government's proposed findings of fact and conclusions of law had attached a declaration from the Government's lead attorney as well as six attachments thereto and asking Respondents if they intended ``to take a position on the Agency's consideration of factual matters set forth'' in the declaration and attachments. ALJ Ex. 40b, at 1. Respondents filed joint objections to the declaration and attachments. ALJ Ex. 40c. On March 4, 2016, the CALJ issued an Order sustaining Respondents' objections, ruling that the declaration and attachments are ``EXCLUDED from the record, and will not be considered as evidence in these matters'' and ``will not be considered by this tribunal in its recommended decision.'' ALJ Ex. 40d, at 1 & n.3. On May 12, 2016, the CALJ issued and served his Recommended Decision. Specifically, the CALJ found that the Government had ``supplied sufficient evidence to make out a prima facie case that maintaining the Respondent's [DEA Registration] would be contrary to the requirements of 21 U.S.C. 823 and 824'' based on the third, fourth, and fifth charges set forth in the Show Cause Order. R.D. at 51. The CALJ further held that the testimony of the Government's expert was ``insufficiently reliable to establish a breach of the Respondent pharmacy's corresponding responsibility regarding the dispensing of controlled substances'' pursuant to 21 CFR 1306.04 as set forth in the first two charges of the Order. Id. at 43.\7\ Although the CALJ acknowledged that his decision not ``to rely on the Government's expert witness dramatically pared down the number of noticed transgressions that could be and were established by a preponderance'' of the evidence, the CALJ concluded that ``the evidence demonstrates a culture in the Respondent pharmacy of ignoring regulations deemed inconvenient . . . this pharmacy is dangerous, and the owners have given not even the smallest indication to the Agency that there is any inclination to change.'' Id. at 53-54. The CALJ also concluded that the Respondent ``fail[ed] to accept responsibility.'' Id. at 54. Thus, the CALJ recommended that I revoke Respondent's registration and deny any pending applications for renewal. Id. On June 2, 2016, the Government and Respondents each filed Exceptions to the CALJ's Recommended Decision. Thereafter, the record was forwarded to me for final agency action. --------------------------------------------------------------------------- \7\ The CALJ also found that the Government failed to sustain the sixth and seventh charges of the Show Cause Order related to prescriptions filled by pharmacy interns. R.D. at 43-46. --------------------------------------------------------------------------- Having considered the record in its entirety, including the parties' Exceptions (which I discuss throughout this decision), I do agree with the CALJ's conclusions that the Government sustained the Order's third, fourth and fifth charges. I also agree with the CALJ's conclusions that the Government failed to sustain the Order's second, sixth and seventh charges. And I further agree with his legal conclusion that Trinity II has failed to accept responsibility for the misconduct which has been proven on the record of the proceeding. However, I disagree with the CALJ's conclusion that the [[Page 7309]] Government did not prove the first charge of the Show Cause Order alleging that Trinity II violated its corresponding responsibility pursuant to 21 CFR 1306.04(a).\8\ Accordingly, I agree with the ALJ's ultimate conclusion that Trinity II has committed acts which render its continued registration inconsistent with the public interest and will adopt his recommendation that I revoke Trinity II's registration and deny any pending applications. As the ultimate fact finder, I make the following findings of fact. --------------------------------------------------------------------------- \8\ Although I do not rely on the Government expert's testimony in making my ruling, as set forth infra, I also disagree with the CALJ's conclusion that the Government's expert was not reliable. --------------------------------------------------------------------------- Findings of Fact Trinity II is the holder of DEA Certificate of Registration FT0531586, pursuant to which it is authorized to dispense controlled substances in schedules II through V, as a retail pharmacy, at the registered location of 1474 Belcher Rd., Clearwater, Florida. Government Exhibit (``GX'') 34; Tr. 120, 685-86. Respondent's registration was due to expire on November 16, 2016, R.D. at 3; however, having reviewed the Agency's registration records, I take official notice that on October 3, 2016, Trinity II submitted a renewal application.\9\ Because Trinity II has timely submitted a renewal application, I find that Trinity II's registration has remained in effect pending the issuance of this Decision and Final Order. See 5 U.S.C. 558(c). No evidence was put forward as to Trinity II's current licensure status with the Florida Department of Health. --------------------------------------------------------------------------- \9\ In accordance with the Administrative Procedure Act (APA), an agency ``may take official notice of facts at any stage in a proceeding--even in the final decision.'' U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). --------------------------------------------------------------------------- The Investigation of Trinity II On February 10, 2014, DEA Investigators (``DI'' or ``DIs'') conducted inspections of Trinity II. Tr. 119-20, 684-86, 709. The Government called three DIs as witnesses in its case-in-chief. See id. The lead investigator testified that when the DIs arrived at Trinity II for the inspection, they asked to speak to Trinity II's pharmacist-in- charge (``PIC'') or owner and were greeted by Mr. Mark Abdelmaseeh, who identified himself as Trinity II's PIC. Id. at 124-26. The DIs presented Trinity II's PIC with a Notice of Inspection, and the PIC consented to the inspection after reviewing the Notice. Id. at 126. The lead investigator also testified that the DIs obtained, by consent from Trinity II, photocopies of the driver's licenses of the employees present when the investigators arrived and the original prescriptions for the two-year period of February 2012 to February 2014. Id. at 127- 32, 135-36.\10\ Another DI separately testified that his role during the inspection included identifying employees at the pharmacy and obtaining copies of their drivers' licenses. Id. at 686-88, 694. He also spoke with some of Trinity II's employees to obtain their job descriptions. Id. at 688-89. --------------------------------------------------------------------------- \10\ The lead investigator also testified that during the inspection of Trinity II, DIs reviewed DEA-222 order forms and the CSOS electronic ordering system. Tr. 134. He testified that CSOS, which stands for Controlled Substance Ordering System, provides an electronic version of the DEA-222 order form. Id. at 134-35. --------------------------------------------------------------------------- The lead investigator also testified that during the inspection at Trinity II, some employees represented to him that the pharmacy only dispensed controlled substances to patients with Florida addresses, that the pharmacist inspected each prescription for alteration or forgery, and that each physician's status was confirmed through the Florida Department of Health website. Id. at 577-78, 595-97. He also testified that someone at Trinity II claimed that its computer software ``automatically confirmed the prescriber's DEA registration.'' Id. at 578, 595-97. He further testified that the owners of the pharmacy, Mina and Emad Yousef, told him that they would call the doctor's office--a practice followed at Trinity I and Trinity II; however, the DI also testified that he did not recall either of them telling him that the owners called a doctor's office for every controlled substance prescription and exactly what they would discuss with the doctor. Id. at 126, 133, 579, 595-97, 666-67. He testified that the majority of prescriptions contained no evidence that anyone at Trinity II had called a doctor's office, and that neither the patient profiles nor the dispensing reports that he reviewed reflected such contacts. Id. at 666-68. He also testified that Yousef told him during the inspection that the pharmacist would check the patient profile for medication history. Id. at 597. The lead investigator testified that he reviewed the original prescriptions and ``looked for the red flags of diversion that we had been trained on,'' such as distances, drug cocktails, drug interactions, and short fills. Id. at 147. He also reviewed them to make sure that the prescriptions included all of the required information such as the doctor's signature, patient name, patient address, and drug strength. Id. He then identified any prescriptions that were of interest and copied such prescriptions for review by the expert. Id. at 147-48, 538. He testified that the investigators did not make a forensic image of Trinity II's computer system. Id at 137. In addition to the prescriptions obtained by DEA during the inspection of Trinity II, the DIs obtained dispensing reports \11\ in May 2014 pursuant to a DEA administrative subpoena issued to Trinity II by facsimile. Id. at 156-57, 543 (``global dispensing report''), 544- 45. The May 9, 2014 subpoena specifically asked for Trinity II to provide, for the time period of February 10, 2012 through February 10, 2014, ``[d]ispensing records of controlled substances in schedules II-V to include: Prescription number; patient's full name, date of birth, and address; drug name, strength, dosage form, quantity prescribed, and directions for use; prescriber's full name, address, and DEA number; method of payment; whether it is a new prescription or refill; and the pharmacist who filled [the] prescription.'' GX 95, at 4; Tr. 157-58, 201-02, 608. On May 21, 2014, counsel for Respondents Trinity I and Trinity II, Mr. Dale Sisco, emailed to the lead investigator Trinity II's response to the administrative subpoena, which included a Microsoft Excel spreadsheet of Trinity II's dispensing report (hereinafter, ``global dispensing report'') as an attachment to that email. GX 96; Tr. 158, 172-73, 175, 627, 643.\12\ The DI testified that after receiving this global dispensing report, he created individual dispensing reports for individual patients to see the dispensing history for certain patients, and then he matched the original prescriptions with the dispensing report. Tr. 180-81, 219, 227.\13\ He also noted that the global dispensing report included a ``Filled By'' column which either contained the initials ``EFY,'' ``MAG,'' or ``MIA.'' Id. at 271-72, 338, 344, 345. --------------------------------------------------------------------------- \11\ Because witnesses and counsel used the phrases ``dispensing report'' and ``dispensing log'' interchangeably throughout the hearing, I also use those phrases interchangeably in this decision. \12\ Government Exhibit 84 is a printed copy of the global dispensing report entered into evidence. Tr. 177-79. \13\ The lead investigator also testified that when he created the individual dispensing reports, using the global dispensing report, he did not alter any of the information in the global dispensing report, and that the individual dispensing reports are true and accurate representations of the information contained in the global dispensing report. Id. at 241, 247-48, 253, 256, 259, 264, 268, 278, 285, 291-92, 297, 303-04, 348-49. --------------------------------------------------------------------------- On October 16, 2014, two DIs and Government counsel met with Trinity II's counsel, Mr. Sisco, and the co-owners of Trinity II--Emad Yousef and [[Page 7310]] Mina Yousef \14\--at Mr. Sisco's office. Id. at 186-88. The purpose of the meeting was to ask the Yousefs about information contained on the fill stickers of the prescriptions. Id. at 188-89. Emad Yousef was asked what ``MAG'' stood for, and the lead investigator testified that Yousef responded that it stood for Mina Ghobrial, a pharmacist intern at Trinity II. Id. at 339, 446-47. The DI testified that he conducted a license verification on Florida's Department of Health license verification website and learned that Mina Ghobrial is a pharmacist intern in Florida. Id. at 339, 444. Another DI testified that he also conducted the same license verification search on August 20, 2015 that confirmed Mr. Ghobrial's status as a licensed pharmacy intern. Id. at 711; GX 78. The lead investigator also testified that ``EFY'' are the initials for Emad Yousef, and ``MIA'' are the initials for pharmacist Mark Abdelmaseeh. Tr. 271-72, 338, 345. --------------------------------------------------------------------------- \14\ The lead investigator testified that, during the inspection of Trinity II, he spoke with Emad Yousef, and that Yousef had stated that he and his brother, Mina Yousef, were co-owners of Trinity I and Trinity II. Tr. 128, 133. --------------------------------------------------------------------------- On December 4, 2014, the lead investigator issued an administrative subpoena to Trinity II asking that the pharmacy ``provide a copy of the complete patient profile your pharmacy maintained pursuant to Florida Administrative Rule 64B16-27.800 (`Requirement for Patient Records')'' for 23 specific patients. GX 98, at 2; Tr. 159, 548-49. The CALJ took official notice of the version of this Rule applicable between February 2012 and February 2014. ALJ Ex. 38. The Florida Board of Pharmacy adopted the Florida Administrative Rules pursuant to its authority under Chapters 465.022 and 465.0155 of the Florida Statutes. This Rule requires ``all pharmacies'' to ``maintain[ ]'' ``[a] patient record system . . . for patients to whom new or refill prescriptions are dispensed'' that ``shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing.'' ALJ Ex. 38, at 1 (Rule 64B16-27.800(1)). The Rule also states that the ``pharmacist shall ensure that a reasonable effort is made to obtain, record and maintain'' certain patient-related information, including ``[p]harmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.'' Id. (Rule 64B16- 27.800(1)(f)). This Rule further requires the pharmacist to ``record any related information indicated by a licensed health care practitioner.'' Id. (Rule 64B16-27.800(2)). Finally, this Rule requires pharmacists to maintain ``[a] patient record for a period of not less than two years from the date of the last entry in the profile record'' in ``hard copy or a computerized form.'' Id. (Rule 64B16-27.800(3)). The lead investigator testified that he requested the patient profiles because ``another place to resolve red flags, from my training and experience, was in the patient profiles,'' and ``a lot of pharmacists, instead of writing it on the prescription, they will actually type it into a note section in the patient profile in the computer.'' Tr. 182, 572-73. He further testified that the patient profile is generally ``part of the pharmacy's electronic system, where it will list out the prescriptions that the individual patient has received. It also contains note sections and other information regarding the patient.'' Id. at 159. On December 22, 2014, Mr. Sisco sent an email to the lead investigator stating that ``[e]nclosed please find documents responsive to the referenced subpoena.'' GX 98, at 1. Attached to this email were patient profiles stored in portable document format (``PDF''). Id.; Tr. 159-60, 175, 182-83. The lead investigator testified that he reviewed all the prescriptions, dispensing reports, and patient records obtained from Trinity II and received from its counsel. Tr. 183-84, 241, 247-48, 253- 54, 256, 259, 264, 268, 278, 285, 291, 297, 303, 572-73, 666-67. He testified that none of the patient records received in response to the December 4, 2014 administrative subpoena contained a ``notes and comment section'' or documentation of contact with a doctor's office. Id. at 183-84, 667-68. He also testified that the majority of the prescriptions did not contain evidence that a doctor's office had been called. Id. at 666-67. Finally, he testified that he created Google Maps printouts to show certain patient's travel. Id. at 238. Specifically, he testified that when he created these maps, he would use the patient's home address as the starting point, the physician's address as the next stop, the pharmacy as the stop after that, and sometimes the patient's home address as the final stop. Id. at 237. The CALJ found that the testimony of each of the DIs called by the Government ``was sufficiently detailed, plausible, consistent and cogent to be fully credited in this recommended decision.'' R.D. at 14. The Allegations of Dispensing Violations The lead investigator testified that DEA investigators provided the following information to Professor Paul Doering, M.S., the Expert for the Government: (1) Copies of the original prescriptions for certain patients flagged by the lead investigator, (2) a copy of all of the E- FORCSE \15\ data for the Respondent from February 2012 to February 2014, (3) the aforementioned individualized dispensing reports prepared by the lead investigator, (4) a copy of one of his DEA-6 \16\ forms, (5) the subpoenaed patients' profiles, and (6) maps for certain patients. Tr. 581, 589-90, 597-98, 601-02. Professor Doering testified that he also received an electronic copy of the ``master dispensing report'' for Trinity II. Id. at 861. He further testified that he relied on the following materials in forming his opinion in this case: ``the dispensing logs, the copies of the individual prescriptions, the patient profiles, and what could best be called as Google Maps and/or MapQuest indicators of distances between two spots.'' Id. at 863. --------------------------------------------------------------------------- \15\ E-FORCSE stands for ``Electronic-Florida Online Reporting of Controlled Substances Evaluation'' and is the prescription drug monitoring program in Florida. Tr. 553, 857. \16\ A DEA-6 is the form where DIs write their report of an investigation. Tr. 582. Pursuant to 21 CFR 1316.46(b)(4), the information contained in investigatory reports are not available for inspection as part of the administrative record. Thus, the CALJ properly precluded Respondents' counsel from asking the agent on cross-examination to reveal the contents of his DEA-6. Tr. 583 (``He can't be compelled to answer or reveal anything that's in his DEA- 6.''), 584 (``he can't be compelled to discuss the investigative contents of the DEA-6''). --------------------------------------------------------------------------- Professor Doering was retained by the Government to be its Expert and was tendered as such at the hearing. Tr. 147, 834. Professor Doering has taught the practice of pharmacy in Florida for 40 years and at one time also worked in a retail pharmacy. Id. at 812-13, 824, 830- 31; GX 32. His teaching has included courses related to the standards of pharmacy practice in the State of Florida. Tr. 814-15. He has also conducted research and published extensively regarding the standards of pharmacy practice in Florida. Id. at 816-17; GX 32. Professor Doering was also the one professor to have ever been given the honorary title of Distinguished Service Professor Emeritus in the 95-year history of the University of Florida's School of Pharmacy, a status he received in 2011.\17\ Tr. 811-12. [[Page 7311]] Professor Doering testified that he keeps current on the latest developments in pharmacy practice. Id. at 817. --------------------------------------------------------------------------- \17\ According to his CV, he was ``[a]warded `Emeritus' status upon official retirement on January 31, 2011. Despite retirement, [he] continues to teach the same course as before retirement, except on a volunteer basis. [He e]ngages in special projects for the College of Pharmacy, Shands Hospital, and other agencies and organizations.'' GX 32, at 1. --------------------------------------------------------------------------- At the hearing, the CALJ accepted Professor Doering as an expert in the practice of pharmacy in the State of Florida and in the standard of care for pharmacists in the dispensing of controlled substances in Florida. Id. at 843-844. In his Recommended Decision, the CALJ also stated that Professor Doering ``has decades of experience in academia with honors and numerous publications'' and that ``[h]is credentials are extremely impressive, and the pride and commitment he displayed toward the field of pharmacy were undeniable and palpable in his testimony.'' R.D. at 14. In that capacity, Professor Doering testified that he sought to ``identify[ ] individual patients that might demonstrate some of the activities and issues that have come to be called red flags'' or ``indicators.'' Id. at 864. In his opinion, a red flag is ``anything that raises concern.'' Id. ``In the area of pharmacy it's a term that's come to be used to give examples to pharmacies of things that might indicate or suggest that prescriptions were filled outside the usual course of pharmacy practice.'' Id. He also testified that a red flag ``could be indicative of abuse or misuse,'' ``over or under compliance,'' ``drug-drug interactions,'' or a ``forged'' or ``altered'' prescription. Id. at 869. He further testified that these issues would be reviewed and resolved by a pharmacist ``before filling any prescription'' as part of the ``prospective drug utilization review, or prospective drug use review.'' See id. Resolution of red flags, he continued, ``would be documented on the face of the prescription, on the rear of the prescription, or in the patient profile.'' Id. at 882. Professor Doering testified that the standard of practice in Florida regarding the contents of such documentation is that it has to include ``a reason that makes sense that, to the average pharmacist, is understandable how a person could find themselves in that predicament,'' and the standard of practice also requires documentation of ``potentially reasonable removals of red flags'' and some link back to the prescribing physician. Id. at 1169-70. He further testified that ``if it's not written down[,] you didn't do it.'' Id. at 1353. Professor Doering testified that the standard of care for a prospective drug utilization review (also referred to as a prospective drug use review) is already ``specified in the Florida Administrative Code,'' which requires pharmacists to perform a prospective drug utilization review before dispensing a medication. Id. at 869-70 (``It says, pharmacists shall, before dispensing a medication, perform what [is] called . . . prospective drug utilization review.''), 958-59 (``it's crystal clear what it says, the pharmacist shall before dispensing any prescription do a drug utilization review''). The CALJ took official notice of (and entered into evidence) the applicable version of Florida Administrative Code Rule 64B16-27.810, entitled ``Prospective Drug Use Review,'' which states that ``[a] pharmacist shall review the patient record and each new and refill prescription presented for dispensing in order to promote therapeutic appropriateness by identifying: (a) Over-utilization [ ]; (b) Therapeutic duplication; . . . (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; . . . (g) Clinical abuse/misuse.'' ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)); Tr. 946, 1852. This Rule also states that, ``[u]pon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the potential problems which shall, if necessary, include consultation with the prescriber.'' Id. (Fla. Admin. Code Rule 64B16-27.810(2)). This prospective drug use review, according to Professor Doering, applies to all prescription drugs, including prescriptions for controlled substances and narcotics.\18\ See Tr. 870. --------------------------------------------------------------------------- \18\ Professor Doering testified that ``[n]arcotics prescriptions . . . are referred to as high alert medications'' that ``have a higher than ordinary potential to cause harm if used inappropriately.'' Tr. 865, 867-68. --------------------------------------------------------------------------- Professor Doering testified that the drug utilization review process ``begins when the prescription is presented'' and should be ``performed at the time the information is given to the pharmacist.'' Id. at 873. He also stated that the standard of care in Florida requires pharmacists to use the notes and comments fields in a patient profile to document the resolution of issues identified during the drug utilization review process. Id. at 1015-16. In the absence of notes resolving such issues in the patient profile, Professor Doering testified that he would also look to the front and back of the prescription to determine whether a pharmacist had resolved a red flag. Id. at 1055, 1101. He further testified that he did not find any notes and comments section in any of the patient profiles he reviewed.\19\ Id. at 1054, 2087. --------------------------------------------------------------------------- \19\ Professor Doering testified that he also reviewed dispensing logs, which are typically ``spreadsheet[s] that contain[ ] information regarding drugs that were dispensed by the pharmacy,'' and that the data in the dispensing log should ``correspond'' to the patient profile's data. Tr. 1018-19. --------------------------------------------------------------------------- Professor Doering testified that only after the pharmacist has identified, resolved, and documented his/her resolution of red flags of diversion and other issues identified during the drug utilization review process can the pharmacist fill the prescription. Id. at 873-74, 1093-94, 1099-1100. If the pharmacist cannot resolve the issue, then the standard of care calls for pharmacists not to fill the prescription. E.g., id. at 879. Professor Doering also explained some specific issues, or red flags, that pharmacists must look for as part of the prospective drug review process pursuant to Rule 64B16-27.810. For instance, he testified that the term ``over-utilization'' in this Rule is a red flag, and he explained that it ``can be two things. So it can be taking more of the medication at a single administration. Or it could be obtaining more medication than the physician had desired, and using it in a time span that is less than the medication was supposed to last.'' ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(a)); Tr. 872, 876. He offered the following example: ``So if it's a 30-day supply of medicine, having lasted only 15 days is suggestive of one of two things. One, is taking too much of it. Or two, might be distributing it to other persons. That would be over[-] utilization.'' Id. at 872. He testified that when a pharmacist identifies an over-utilization issue when a patient presents a prescription, the pharmacist must resolve that issue (and document that resolution) before filling the prescription. Id. at 873-74, 879. Professor Doering also explained that the term ``therapeutic duplication,'' as set forth in Rule 64B16-27.810(1)(b), ``is the presenting of two prescriptions, either for the identical drug, or drugs that are so closely allied that they would be overlapping in their actions in the body.'' Id. at 884-85, 1520 (therapeutic duplication'' occurs when ``two drugs with the same action [are] being prescribed under the same circumstances''), 1541 (``Essentially two drugs with the same net effect.''). ``[F]rom a pharmacist's standpoint, [that] is duplication of therapy.'' Id. at 885. Professor Doering testified that therapeutic duplication is a red flag. Id. at 886. ``Therapeutic duplication signifies that there are two or more [[Page 7312]] drugs that appear to be essentially doing the same thing, that together might pose the issue of adverse drug-drug interactions.'' Id. at 883; see ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(b), (d)). ``[I]t also may involve intentional duplication of drugs.'' Tr. 883. In this way, he added that a prescription raising a ``therapeutic duplication'' concern might lead to another issue for the pharmacist to resolve regarding drug-drug interactions. Id. at 883-84. As a result, Professor Doering stated that therapeutic duplication raises many concerns, including the ``safety of the patient. But it could also indicate an attempt to obtain more medication for over[-]utilization, which touches upon some of the other issues, which means clinical use or abuse, or diversion to some other use.'' Id. at 885-86. As with other red flags, he reiterated that the standard of care requires pharmacists receiving a prescription raising the red flag of therapeutic duplication to resolve that issue (and document such resolution) before filling the prescription. Id. at 886-91. Professor Doering next explained the term ``[d]rug-drug interactions.'' ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(d)). He testified that this ``refers to the fact that two drugs, when given together, can have outcomes that are not what was intended initially by either one or the other drug together.'' Tr. 893. He testified that when presented with prescriptions presenting potentially harmful drug- drug interactions, the standard of care requires the pharmacist to either (1) resolve this red flag and document the resolution once the pharmacist is satisfied that it is in the best interest of the patient, or (2) not fill the prescriptions. Id. at 1419-20. Professor Doering also testified, however, that drug cocktails that include an opioid, benzodiazepine, and a muscle relaxer present red flags that must be resolved. See, e.g., id. at 1413-16, 1427. ``[F]or example, oxycodone, or some other potent narcotic, along with a tranquilizer drug, such as alprazolam or Xanax, combined with a muscle relaxant, say for example, Soma,'' also known as carisoprodol. Id. at 894. ``[T]hose three drugs, which have been come to be called the unholy trinity, or . . . cocktail prescriptions, whatever you want to call them, are symbolic of drug interactions that might cause harms to the patient.'' Id.; see also id. at 1416-17. According to Professor Doering's testimony, these drugs ``have added central nervous system depressant properties and can present a real and present danger to the patient.'' Id. at 1417. Moreover, he testified that this combination of drugs ``constitute what I would call drugs with abuse potential, serious abuse potential'' and ``are often diverted to non-medical or recreational use.'' Id. at 1416.\20\ During the prospective drug utilization review process, pharmacists, ``check for drug/drug interactions. And this would be subject to, in my opinion, very severe drug/drug interactions.'' Id. at 1418. --------------------------------------------------------------------------- \20\ He also testified that ``[t]he nature of the drug combination, a potent narcotic analgesic, along with a potent anxiolytic medicine, along with a potent muscle relaxant . . . It's just come to be associated with a high potential for abuse.'' Tr. 1417. --------------------------------------------------------------------------- Professor Doering testified to what a pharmacist would look for in identifying ``[c]linical abuse/misuse'' as part of the prospective drug use review. ALJ Ex. 38 (Fla. Admin. Code Rule 64B16-27.810(1)(g)). He defined clinical abuse or misuse as ``recreational use'' or ``drug abuse'' which ``typically involves taking more of the prescribed drug or focusing on certain drugs that have [ ] mood altering properties . . . that individuals . . . will use for other than medical purposes.'' Tr. 952, 953 (it is ``any time you use the drug outside the conditions for which it could be prescribed''). To identify such clinical abuse/ misuse as part of the drug utilization review process, Professor Doering testified that a pharmacist ``would look for quantities of drugs that are being sought beyond those which were authorized by the prescriber or they might look for certain combinations of drugs that are known to be used frequently for non-medical reasons.'' Id. at 953. Again, as with the other red flags that may arise during a prospective drug use review (i.e., the drug utilization review process), if the pharmacist cannot resolve the clinical abuse/misuse red flag, then he or she must not fill the prescription. Id.at 955. Professor Doering also offered testimony regarding patient address information that appears on a prescription and the distance a patient travels to a pharmacy to fill a prescription. He testified that both Florida and federal law require a patient's address to appear on prescriptions ``so that the pharmacist has some idea of where this patient resides and that can be useful for a couple of different reasons . . . it's also useful to know what geographic area this patient lives in because that may become important information as the prospective drug use review takes place.'' Id. at 973. In the same vein, he testified that a physician's address must also appear on the prescription to indicate where the patient met with the practitioner. Id. at 970. ``Typically you would look to patients that are in the same geographic area [as the pharmacy]. I would say within the same county or geographic area.'' Id. at 1692. ``[W]hen the distances are very great, it raises . . . a question of why is somebody needing to travel this far to get this prescription filled.'' Id. Professor Doering also explained what type of information is generated after a pharmacist has decided to fill a prescription. ``When the computer prints out the information there are different versions of the [fill sticker]. One version of it doesn't contain necessarily all this information, but that's the one that gets applied to the prescription vial. Th[e other version] is the one for pharmacists' record keeping purposes. It has additional info that the one on the vial does not.'' Id. at 978. Significantly, he testified that the fill sticker is generated after the drug utilization review process has been completed, and that the date appearing on the fill sticker represents the date when the pharmacy filled the prescription. Id. at 979-80. He explained that the fill sticker is ``generated one step before the prescription label is actually applied to the vial . . . by the pharmacist. The significance of that is that the prescription has gone through all the proper steps and its certified ready for dispensing to the patient.'' Id. at 979. Professor Doering further testified that, in his opinion, the date on the fill sticker also represents when the prescription is dispensed. Id. at 1186. Respondents did not proffer an expert witness at the hearing, and I find that Professor Doering's testimony was credible.\21\ --------------------------------------------------------------------------- \21\ Although the CALJ expressly declined to offer a view of Professor Doering's credibility, he nonetheless disregarded his opinions as ``insufficiently reliable to form the basis of a sanction under the APA.'' R.D., at 33 (``To be clear, however, this is not an issue of credibility, and no credibility determination is entered here.''). As I discuss infra, I disagree with the CALJ's assessment of the expert's reliability. --------------------------------------------------------------------------- The Prescription Evidence At the hearing, the Government introduced into evidence copies of dispensing logs, patient profiles, and the front and back of prescriptions for controlled substances which it alleged Trinity II filled in violation of 21 CFR 1306.04(a) and 1306.06 because they presented red flags of diversion that Trinity II failed to resolve as set forth in the first two charges of the Show Cause Order. As already noted, the first charge of the Show Cause Order outlined six different categories of red flags of diversion that the Government alleged [[Page 7313]] that Trinity II failed to resolve before filling the pertinent prescriptions. When taken together, the Government alleged that Trinity II's failure to resolve these red flags before filling these prescriptions demonstrated that Trinity II knowingly filled prescriptions for controlled substances in contravention of its corresponding responsibility and outside the usual course of pharmacy practice. Early Fills The Government introduced prescription evidence to show that Trinity II failed to resolve the first alleged red flag of diversion, ``early fills,'' with respect to at least four of its customers identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena.\22\ For one such customer, J.T., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early at least nine prescriptions issued to J.T. for oxycodone 30 milligrams (hereinafter, ``mg''), a schedule II controlled substance, under the brand name Roxicodone. GX 35; Tr. 1198-1234. Specifically, the Government introduced evidence that on February 23, 2012, Trinity II filled a prescription issued by physician W.F. to customer J.T. for 336 pills of ``Roxicodone 30 mg,'' and with directions from the prescribing physician for J.T. to take up to eight pills per day. GX 35, at 1, 3, 10, 11; Tr. 1199-1202. Although the fill sticker and patient profile both state that the prescription was for a 30-day supply, in fact, the 336 pills prescribed to be taken at the rate of eight pills per day constitutes a 42-day supply that should have lasted J.T. until at least April 6, 2012. Id. Nevertheless, on March 22, 2012, Trinity II then filled another prescription (from the same prescriber) for another 336 pills of Roxicodone 30 mg with instructions to take up to eight pills per day. GX 35, at 1, 3, 16, 17; Tr. 1202-05. Thus, I find that when Trinity II filled this second prescription on March 22, 2012, Trinity II filled it 15 days early. Accord Tr. 1205.\23\ I also find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription early. GX 35, at 1, 3, 15, 16; Tr. 1198, 1199, 1205-06. --------------------------------------------------------------------------- \22\ For reasons I discuss infra, and as it relates to the first and second charges of the Show Cause Order only, I limit my fact findings to evidence related to those patients discussed at the hearing who were also identified in the December 4, 2014 subpoena. \23\ Notably, the CALJ failed to make recommended fact findings related to the alleged early fills, or most of the other allegations set forth in paragraphs 7-8 of the Show Cause Order (i.e., the first two charges of the Order) because of his concerns related to Professor Doering's reliability as an expert. R.D., at 43. However, as discussed further infra, this concern, even if well-founded, does not categorically relieve the Agency from making fact findings on allegations about Trinity II's filling conduct that can be decided without expert opinion. Accordingly, I will make such ultimate fact findings, even where the CALJ chose not to recommend any. --------------------------------------------------------------------------- Professor Doering testified that, in Florida, whereas a fill (or refill) that is 2-3 days early may not signify a problem, a fill that is more than two-to-three days early is a red flag that a pharmacist is expected to resolve during the drug utilization review process ``to avoid overuse or misuse.'' See Tr. 989-91, 1009. ``If someone is coming back fifteen days early, then that signifies a problem.'' Id. at 990. In the case of J.T.'s presentation of the aforementioned March 22, 2012 Roxicodone 30 mg prescription 15 days early, the evidence established that there are no notes or comments--much less any evidence that Trinity II resolved this red flag--reflected in J.T.'s patient profile, dispensing log, or the front-and-back of this prescription. GX 35, at 1, 3, 15, 16; Tr. 1198-99, 1205-06. As a result, Professor Doering testified that this prescription was inconsistent with Florida's standard of care, not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1206. In each of the next eight months, J.T. presented prescriptions to Trinity II for Roxicodone 30 mg in the same quantities and with the same dosing instructions; and in each instance, I find that Trinity II filled those prescriptions 14, 15, or 16 days early. GX 35, at 1, 3, 16, 17, 20, 21; Tr. 1208-09 (prescription for 42-day supply that Trinity II filled 15 days early on April 19, 2012); GX 35, at 1, 3, 20, 21, 30, 31; Tr. 1209-12 (prescription for 42-day supply that Trinity II filled 15 days early on May 17, 2012); GX 35, at 1, 3, 30, 31, 36, 37; Tr. 1213-17 (prescription for 42-day supply that Trinity II filled 15 days early on June 14, 2012); GX 35, at 1, 3, 36, 37, 44, 45; Tr. 1220- 23 (prescription for 42-day supply that Trinity II filled 15 days early on July 12, 2012); GX 35, at 1, 3, 44, 45, 50, 51; Tr. 1223-25 (prescription for 42-day supply that Trinity II filled 16 days early on August 8, 2012); GX 35, at 1, 3, 50, 51, 54, 55; Tr. 1225-28 (prescription for 42-day supply that Trinity II filled 14 days early on September 6, 2012); GX 35, at 1, 3, 54, 55, 62, 63; Tr. 1228-31 (prescription for 42-day supply that Trinity II filled 16 days early on October 3, 2012); GX 35, at 1, 3, 62, 63, 70, 71; Tr. 1231-34 (prescription for 42-day supply that Trinity II filled 14 days early on November 1, 2012). When considering the cumulative effect of these consecutive monthly early fills from March-November 2012, I find that Trinity II filled prescriptions for J.T. that resulted in the filling of 135 days of extra oxycodone 30 mg. And as with the earlier prescription that Trinity II filled for J.T. on March 22, 2012, I find that the prescriptions (front or back), patient profile, and dispensing log do not reflect any notes or comments, much less documentation, explaining how Trinity II resolved the early refill red flag presented by these prescriptions over the eight subsequent months. See GX 35, at 1, 3, 16, 17, 20, 21, 30, 31, 36, 37, 44, 45, 50, 51, 54, 55, 62, 63, 70, 71; Tr. 1198-99, 1205-06, 1212, 1216, 1218, 1222, 1225, 1228, 1230, 1234. And in each instance, Professor Doering testified that, because all of these early fills were well beyond 3 days early, Trinity II should have identified these early fills as red flags during the drug utilization review process to avoid drug abuse, overuse or misuse. Tr. 1208-09, 1211-12, 1215-17, 1222-25, 1227-28, 1230-31, 1234. He further testified that Trinity II's decision to fill these prescriptions without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility. Id. For a second customer, M.A., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early at least 8 prescriptions issued to M.A. for hydromorphone 8 mg, a schedule II controlled substance, under the brand name Dilaudid. GX 36; Tr. 1237-68. The Government introduced evidence that on May 2, 2013, Trinity II filled a prescription issued by physician R.A. at the Genesis Medical Clinic to customer M.A. for 165 pills of ``Dilaudid Oral Tablet 8 MG,'' with directions from the prescribing physician for M.A. to ``[t]ake one tablet every 5 to 6 hours for 30 days.'' GX 36, at 1-2, 4-5; Tr. 1237- 42. Although the prescription and the fill sticker both stated that the prescription was for a 30-day supply, in fact, the 165 pills prescribed to be taken at the rate [[Page 7314]] of five pills \24\ per day constitutes a 33-day supply that should have lasted M.A. until at least June 4, 2013. Id. Nevertheless, on May 28, 2013, Trinity II then filled another prescription (from another prescriber, J.S., at the same practice group--Genesis Medical Clinic) for another 165 pills of Dilaudid 8 mg with instructions to take one tablet every five to six hours for 30 days. GX 36, at 1-2, 4-7; Tr. 1242-45. Thus, I find that when Trinity II filled this second prescription on May 28, 2013, Trinity II filled it seven days early. I also find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription early. GX 36, at 1-2, 6-7; Tr. 1236, 1237, 1245. --------------------------------------------------------------------------- \24\ If M.A. took the tablets every six hours as instructed, then the daily tablet dosage would be four tablets/day; if M.A. took the tablets every five hours as alternatively instructed, then the daily dosage would be 4.8 tablets per day. Accord Tr. 1239-40. For purposes of this early fill fact-finding, I will round up to and use the rate of five tablets/day--a calculation that offers Trinity II the greatest lenity for purposes of calculating an early fill. --------------------------------------------------------------------------- In each of the next seven months, M.A. presented to Trinity II prescriptions from the same Genesis Medical Clinic for Dilaudid 8 mg in the same quantities and with the same dosing instructions; and in each instance, I find that Trinity II filled those prescriptions six days early. GX 36, at 1-2, 6-9; Tr. 1245-49 (prescription for 33-day supply that Trinity II filled six days early on June 25, 2013); GX 36, at 1-2, 8-10; Tr. 1249-51 (prescription for 33-day supply that Trinity II filled six days early on July 23, 2013); GX 36, at 1-2, 10-11; Tr. 1251-54 (prescription for 33-day supply that Trinity II filled six days early on August 20, 2013); GX 36, at 1-2, 11, 13-14; Tr. 1254-55 (prescription for 33-day supply that Trinity II filled six days early on September 17, 2013); GX 36, at 1-3, 13-16; Tr. 1256-58 (prescription for 33-day supply that Trinity II filled six days early on October 15, 2013); GX 36, at 1, 3, 15-18; Tr. 1259-61 (prescription for 33-day supply that Trinity II filled six days early on November 12, 2013); GX 36, at 1, 3, 17-20; Tr. 1262-64 (prescription for 33-day supply that Trinity II filled six days early on December 10, 2013). When considering the cumulative effect of these consecutive monthly early fills from May 2013 to December 2013, I find that Trinity II filled prescriptions for M.A. that resulted in the filling of 50 days of extra hydromorphone 8 mg. As with the earlier prescription that Trinity II filled for M.A. on May 28, 2013, I find that the prescriptions (front or back), patient profile, and dispensing log do not reflect any notes or comments, much less documentation, explaining how Trinity II resolved these early refill red flags over the seven subsequent months. See GX 36, at 1-3, 4-11, 13-20; Tr. 1236-37, 1245, 1248, 1251, 1253, 1255, 1258, 1261, 1263. Professor Doering testified that, because all of these early fills were well beyond three days early, Trinity II should have identified these early fills as red flags during the drug utilization review process to avoid drug abuse, overuse or misuse. Tr. 1240-41, 1245, 1248-49, 1251, 1253-54, 1255, 1256, 1258, 1261, 1263-64. He further testified that Trinity II's decision to fill these prescriptions without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility. Id. For a third customer, J.G., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early or refilled early prescriptions issued to J.G. at least seven times--one time for a prescription of lorazepam 2 mg, and six times for prescriptions of alprazolam 2 mg, both of which are schedule IV controlled substances. GX 39; Tr. 1364- 84. Regarding the lorazepam prescription, the Government introduced evidence that on May 29, 2012, Trinity II filled a prescription issued by physician G.C. to customer J.G. for 30 pills of lorazepam 2 mg, and with directions from the prescribing physician for J.G. to ``[t]ake \1/ 2\ [one-half of one] tablet(s) . . ., 2 times per day, for 30 days.'' GX 39, at 1-2, 4; Tr. 1365-66. Hence, the 30 pills prescribed to be taken at the rate of one pill per day constitute a 30-day supply that should have lasted J.G. until at least June 28, 2012. Id. Nevertheless, on June 19, 2012, Trinity II then filled another prescription from the same prescribing physician for another 30 pills of lorazepam 2 mg with the same instructions--one pill per day. GX 39, at 1-2, 4-5; Tr. 1366- 70. Thus, I find that when Trinity II filled this second prescription on June 19, 2012, Trinity II filled it nine days early. Accord Tr. 1367. I also find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription early. GX 39, at 1-2, 5; Tr. 1364- 65, 1369. With respect to the alprazolam prescriptions for J.G., the Government introduced evidence that on September 18, 2012, Trinity II filled a prescription issued by physician G.C. to customer J.G. for 30 pills of Xanax 2 mg, which is the brand name for alprazolam 2 mg, that could be refilled twice and with directions from the prescribing physician for J.G. to ``[t]ake \1/2\ [one-half of one] tablet(s) . . ., 2 times per day, for 30 days, as needed for anxiety.'' GX 39, at 1-2, 6; Tr. 1370-71. Hence, the 30 pills prescribed to be taken at the rate of one pill per day constitute a 30-day supply that should have lasted J.G. until at least October 18, 2012 (assuming J.G. needed to take it every day for 30 days). Id. Nevertheless, the dispensing log and patient profile show that on October 10, 2012, Trinity II then refilled the prescription for another 30 pills of alprazolam 2 mg. GX 39, at 1- 2, 6; Tr. 1371-73. Thus, I find that when Trinity II refilled this prescription on October 10, 2012, Trinity II refilled it eight days early. Accord Tr. 1372. The dispensing log and patient profile also establish that on October 29, 2012, Trinity II refilled the prescription again for another 30 pills of alprazolam 2 mg. GX 39, at 1-2, 6; Tr. 1373. Thus, I find that when Trinity II refilled this prescription on October 29, 2012, Trinity II refilled it 10 days early because the earlier refill should have lasted until November 8, 2012. Accord Tr. 1374. I also find that the front of the original prescription, the back of the original prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II refilled the prescription early on October 10 and October 29, 2012. GX 39, at 1-2, 6; Tr. 1373. On February 26, 2013, Trinity II filled another prescription issued by physician G.C. to customer J.G. for 30 pills of alprazolam 2 mg (a 30-day supply), even though the dispensing log and J.G.'s patient profile show that Trinity II had already filled a 30-day supply of alprazolam 2 mg for J.G. on February 14, 2013.\25\ GX 39, at 1-2, 8-9; Tr. 1375-77. I find that when Trinity II filled the February 26, 2013 prescription, Trinity II filled it at least 17 days early because the February 14, 2013 refill should have lasted J.G. until at least March 15, 2013. Accord Tr. 1377. Over the next two months, Trinity II then refilled this prescription twice (on March 18, 2013 and on April 12, [[Page 7315]] 2013), and in each instance I find that Trinity II refilled it 10 and five days early, respectively. GX 39, at 1-2, 9; Tr. 1377-79 (prescription for 30-day supply that Trinity II filled 10 days early on March 18, 2013); GX 39, at 1-2; Tr. 1377-79 (prescription for 30-day supply that Trinity II filled five days early on April 12, 2013). I find that the front of the original prescription, the back of the original prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the February 26, 2013 prescription early, and twice refilled that prescription early on March 18 and April 12, 2013. GX 39, at 1-2, 8-9; Tr. 1373, 1379. --------------------------------------------------------------------------- \25\ The February 14, 2013 filling by Trinity II was the second refill of a December 18, 2012 prescription (also issued by physician G.C.) that J.G. had filled at Trinity II on December 18, 2012. See GX 39, at 1-2, 8. --------------------------------------------------------------------------- In addition, even though Trinity II filled a new prescription for a 30-day supply of alprazolam 2 mg issued by physician G.C. to J.G. on May 14, 2013 that should have lasted J.G. until at least June 12, 2013, Trinity II refilled this prescription with another 30-day supply of alprazolam 2 mg on June 6, 2013. GX 39, at 1, 3, 10; Tr. 1380-83. Thus, I find that the June 6, 2013 refill by Trinity II was six days early. Accord Tr. 1383. As with the other prescriptions and early fills and refills related to J.G., I find that the front of the original prescription, the back of the original prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled and refilled the prescription early. GX 39, at 1, 3, 10; Tr. 1383. With respect to all the early fills and refills by Trinity II with respect to lorazepam 2 mg and alprazolam 2 mg prescriptions issued by physician G.C. to J.G., Professor Doering testified that, because all of these early fills and early refills were well beyond three days early, Trinity II should have identified them as red flags during the drug utilization review process to avoid drug abuse, overuse or misuse. Tr. 1369, 1372, 1374, 1377, 1383. He further testified that Trinity II's decision to fill these prescriptions without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility. Id. at 1370, 1373-74, 1377, 1379, 1384. For a fourth customer, L.H., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled early at least 2 prescriptions issued to L.H. for hydromorphone 8 mg, a schedule II controlled substance, under the brand name Dilaudid. GX 40; Tr. 1384-94. The Government introduced evidence that on June 5, 2012, Trinity II filled a prescription issued by physician J.I. at the Creative Health Center to customer L.H. for 180 pills of ``Dilaudid Tablet 8 mg,'' and with directions from the prescribing physician for L.H. to take one tablet by mouth every four hours as needed. GX 40, at 1, 3, 12-13; Tr. 1387- 88. Hence, the 180 pills prescribed to be taken at the rate of six pills per day constitute a 30-day supply that should have lasted L.H. until at least July 5, 2012 (assuming L.H. needed to take every dose, every day). Accord Tr. 1392. Nevertheless, on June 28, 2012, Trinity II filled another prescription (dated June 18, 2012 from another prescriber, E.P. at Morton Plant Hospital) \26\ for another 84 pills of Dilaudid 8 mg with instructions to take one tablet every 4 hours for 14 days. GX 40, at 1, 4, 14-15; Tr. 1388-89, 1392. Thus, I find that when Trinity II filled this second prescription on June 28, 2012, Trinity II filled it at least seven days early. Accord Tr. 1389. On July 3, 2012, Trinity II filled a third prescription, this time from physician J.I. (who issued the June 5, 2012 prescription) to L.H., for another 96 pills of Dilaudid 8 mg with instructions to take one tablet every four hours for 16 days. GX 40, at 1, 4, 16-17; Tr. 1392-93. As a result, I find that when Trinity II filled this third prescription on July 3, 2012, Trinity II filled it nine days early because the June 28, 2012 fill should have lasted L.H. until July 12, 2012. Accord Tr. 1393. I also find that the front of these prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled these prescriptions early. GX 40, at 1-4, 12-17; Tr. 1391, 1393-94. --------------------------------------------------------------------------- \26\ The fact that the same patient, L.H., went to two different prescribers in the same month for the same schedule II drug also demonstrates the appearance of doctor shopping--another red flag of overuse or misuse. Professor Doering testified that this too should have been identified during the drug utilization process as indicative of overuse, misuse, or abuse. Tr. 1390. There is no evidence in the record that Trinity II attempted to resolve this red flag before filling the second of these prescriptions on June 28, 2012. Professor Doering also testified that Trinity II's decision to fill the June 18, 2012 prescription on June 28, 2012 without resolving these red flags was inconsistent with Florida's standard of care, not in the usual course of professional practice, and did not reflect the proper exercise of the pharmacist's corresponding responsibility. Id. at 1391. --------------------------------------------------------------------------- Therapeutic Duplication The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of ``therapeutic duplication'' with respect to one of its customers, R.H., identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena. The Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled two therapeutically duplicative prescriptions issued by physician J.I. for R.H. on December 2, 2013. The first prescription was for 120 tablets of hydromorphone 8 mg, an immediate release opioid under the Dilaudid brand name, with directions to ``Take 1 Tablet by Mouth Every 6 Hours As Needed.'' GX 63, at 1, 4-6; Tr. 1560-61. The second prescription was for 120 tablets of oxycodone 30 mg, another immediate-release opiate, with the same directions to take one tablet every six hours as needed. GX 63, at 1, 4, 7-8; Tr. 1561-63. I find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled these two schedule II opiate prescriptions on December 2, 2013. GX 63, at 1, 4-8; accord Tr. 1563- 64. According to Professor Doering, when a Florida pharmacist receives two prescriptions from the same individual for two different opioids, both with the same or similar directions for use, and those two are immediate release dosage forms, the standard of care requires the pharmacist to identify that as a red flag and to initiate steps to resolve that red flag. Tr. at 2111. However, Professor Doering also testified that, in his opinion, the therapeutic duplication of hydromorphone and oxycodone with respect to R.H., or any other pharmacy customer, is not a resolvable flag. Id. at 1520, 1563. ``[P]harmacists would fall below the standard of care to dispense these two [opioids] together because of the inherent dangers that go along with giving both of these very potent narcotic analgesics . . . [t]hat could in fact be used together, at the same time.'' Id. at 1520. He also testified that therapeutic duplication should be identified during the drug utilization review process. Id. at 1526, 1541-42. Professor Doering testified that Trinity II's filling of these prescriptions for R.H. were inconsistent with the standard of care, not filled in the usual course of professional practice, and inconsistent with the proper exercise of the pharmacist's corresponding responsibility. Id. at 1563- 64. [[Page 7316]] Two Prescriptions for the Same Drug on the Same Date The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of receiving two prescriptions for the same drug on the same date from the same customer (J.K.)--another form of ``therapeutic duplication.'' The customer, J.K., was identified in the first charge of the Show Cause Order, and the Government had requested his patient records pursuant to its December 4, 2014 subpoena. The Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that Trinity II filled two prescriptions issued by physician M.L. for J.K. on the same day--December 4, 2013. The first prescription was for 100 tablets of hydromorphone 8 mg, under the Dilaudid brand name, with instructions that the patient take one tablet every four to six hours-- a 16-day supply. GX 69, at 1, 3-5; Tr. 1584-86. The second prescription was for 50 tablets of Dilaudid 8 mg with the same directions for use-- an eight-day supply. GX 69, at 1, 3, 6-7; Tr. 1584-86. The dispensing log also shows that J.K. paid ``cash'' for these two prescriptions, just as he had for every other prescription that Trinity II had filled for J.K. between March 5, 2012 and February 3, 2014. GX 69, at 1. According to Professor Doering, two prescriptions for the same medication filled on the same date for the same customer is an unresolvable red flag of diversion that should have been identified during the drug utilization process. Tr. 1568, 1586-87. Regardless of whether it is resolvable, I find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled these two prescriptions for the same drug and for the same customer (J.K.) on December 4, 2013. GX 69, at 1, 3-7; accord Tr. 1584-85, 1587. Distances The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of customers who had allegedly travelled unusually long distances and/or had taken suspicious routes for the purpose of obtaining, presenting, and filling prescriptions for controlled substances. Specifically, the Government introduced evidence exhibiting this red flag with respect to four of Trinity II's customers identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena. For one such customer, S.S., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on June 5, 2013, Trinity II filled a prescription for S.S. for 150 tablets of hydromorphone 8 mg, with instructions to take one tablet every four hours as needed for breakthrough pain. GX 44, at 1, 2, 8-9; Tr. 1676-80. Although the front of the prescription did not include S.S.'s address,\27\ the other prescription evidence--the fill sticker attached to the back of the prescription, the dispensing log, and the patient profile--all show S.S.'s address to be in Orange Park, Florida, which is a city located near Jacksonville, Florida. GX 44, at 1, 2, 9; Tr. 1680. --------------------------------------------------------------------------- \27\ See GX 44, at 8. The Show Cause Order alleges that Trinity II's filling of this prescription also constitutes an independent violation of 21 CFR 1306.05, which requires, inter alia, all prescriptions for controlled substances to bear the full name and address of the patient and imposes a corresponding liability ``upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.'' Id. at Sec. 1306.05(a), (f). As set forth more fully infra, I agree. --------------------------------------------------------------------------- It is undisputed that Trinity II is located in Clearwater, Florida, and that both the front of the prescription and Trinity II's dispensing log show that the prescribing physician's address was in Tampa, Florida. GX 44, at 1, 8. The Government also introduced Google Maps evidence showing that S.S. would have traveled: (1) 175 miles from his home address to the prescribing physician, (2) about 23 miles from there to Trinity II, and then (3) 199 miles from Trinity II back to his home address. GX 44, at 4-7; Tr. 1681-83. Indeed, S.S. would have to travel across the entire state of Florida--from the Jacksonville area on the East Coast of Florida to the greater Tampa Bay area on the West Coast of Florida--to obtain and to fill this schedule II prescription. Thus, I find that S.S. would have to travel approximately 397 miles roundtrip to obtain the June 5, 2013 hydromorphone 8 mg prescription from his physician, and that S.S. would have to travel at least 198 miles after picking up his prescription to return home. See id. I also find that Trinity II knew the addresses of both S.S. and his prescribing physician. See GX 44, at 1, 2, 8-9. I further find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription given the unusual distances S.S. traveled to obtain and to fill this prescription. GX 44, at 1, 2, 8-9; accord Tr. 1676-77, 1685, 2113. Although Professor Doering testified that there is no magical ``distance cutoff'' in determining when a particular distance constitutes a red flag, Tr. 1692-93, in response to hypothetical questions, he did testify that when a pharmacist in Florida receives a prescription for a controlled substance from a customer whose address is, for example, 75 miles away, ``[t]he standard of care calls for the pharmacist to identify that as a red flag and to initiate steps that may resolve that red flag'' and to document any such resolution. Tr. 2112. He testified that this standard of care ``requires the pharmacist to find out the address of where the person resides'' and ``to ask the patient for that address information'' by, for instance, ``ask[ing] for identification.'' Tr. 2119-20; see also id. at 1684. He further testified that in his opinion the distance red flag for this prescription should have been identified as part of the drug utilization process, and the fact that S.S. also paid cash \28\ raised an additional red flag. Tr. 1684, 1686 (``patients paying cash for their prescriptions is a recognized red flag''), 1696. As a result, Professor Doering testified that filling this prescription was inconsistent with Florida's standard of care, that it was not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1701- 02.\29\ --------------------------------------------------------------------------- \28\ Trinity II's own dispensing report states that S.S. paid ``cash'' for the July 5, 2013 prescription, and I find that S.S. did indeed pay for this prescription (rather than a third-party payer). See GX 44, at 1. The prescription evidence also does not reflect that Trinity II ever attempted to resolve the ``paying cash'' red flag. Tr. 1686. \29\ As discussed infra in the context of cocktail prescriptions, on June 27, 2013 and July 23, 2013, Trinity II also filled prescriptions for S.S. on each date for carisoprodol 350 mg, hydromorphone 8 mg and Xanax 2 mg. GX 44, at 1, 2, 14-19, 22-27; Tr. 1697-98; 1703-05. I also find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments whatsoever explaining why Trinity II filled these prescriptions given the unusual distances S.S. traveled to obtain and to fill these prescriptions. GX 44, at 1, 2, 14-19, 22-27; accord Tr. 1700, 1705. Professor Doering also testified that filling the June 27, 2013 and July 23, 2013 prescriptions were inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice or in the proper exercise of the pharmacist's corresponding responsibility. Tr. 1701, 1705. --------------------------------------------------------------------------- For a second customer, D.W., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on March 8, 2012, Trinity II filled two prescriptions for D.W.--one for 120 tablets of oxycodone 30 mg with [[Page 7317]] ginger \30\ (with instructions to take one capsule four times daily) and the other for 30 tablets of carisoprodol 350 mg under the brand name Soma (with instructions to take one tablet every night). GX 45, at 1, 2, 8-11; Tr. 1710, 1713-14. --------------------------------------------------------------------------- \30\ Professor Doering testified that physicians will issue a prescription calling for compounding with ginger ``to deter one from injecting the drug intravenously'' because ginger will ``make it sting and burn if someone were to try to inject it intravenously.'' Tr. 1265. It is also a deterrent to ``nasal insufflation'' (snorting) of the drug because ``it would be [an] irritant to the lining of the nasal mucous membranes.'' Id. at 1558. --------------------------------------------------------------------------- According to the front of the oxycodone prescription,\31\ the fill sticker attached to the back of both prescriptions, the dispensing log, and the patient profile, D.W.'s address was in Wellborn, Florida. GX 45, at 1, 2, 8, 9, 11; Tr. 1708-09. It is undisputed that the front of both prescriptions and Trinity II's fill stickers show that the prescribing physician's address was in Tampa, Florida. GX 45, at 8-11; Tr. 1709-1712. The Government also introduced Google Maps evidence showing that D.W. would have traveled: (1) 184 miles from his home address to the prescribing physician, (2) about 18 miles from there to Trinity II, and then (3) 202 miles from Trinity II back to his home address. GX 45, at 4-7. --------------------------------------------------------------------------- \31\ The front of the second prescription for Soma did not bear the patient's address. See GX 45, at 10. --------------------------------------------------------------------------- Thus, I find that D.W. would have to travel approximately 404 miles roundtrip to obtain the March 8, 2012 oxycodone and Soma prescriptions from his prescribing physician, fill them at Trinity II, and then return home. See id. I also find that Trinity II knew the address of both D.W. and his prescribing physician. See GX 45, at 1, 2, 8-11. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescriptions given the unusual distances D.W. traveled to obtain and to fill these prescriptions. GX 45, at 1, 2, 8- 11; accord Tr. 1712. Professor Doering testified that in his opinion ``[t]he long distance between the patient's home and the doctor's office'' was a red flag that was presented by D.W.'s prescriptions and which Trinity II should have identified as part of the drug utilization process. Tr. 1712. As a result, Professor Doering testified that filling these prescriptions was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1712-13. On April 5, 2012 and on May 3, 2012, Trinity II also filled prescriptions for D.W. for 120 tablets of oxycodone 30 mg with ginger each time--with the same instructions and from the same prescribing physician as in the March 8, 2012 oxycodone prescription that Trinity II had filled for D.W. GX 45, at 1, 2, 12-13, 16-17; Tr. 1714-17. On April 19, 2012 and May 11, 2012, Trinity II filled prescriptions for D.W. for 30 tablets of Soma 350 mg each time--again, with the same instructions and from the prescribing physician as the Soma prescription that Trinity II had filled for D.W. on March 8, 2012. GX 45, at 1, 2, 14-15, 18-19; \32\ Tr. 1716, 1718. As with the March 8, 2012 prescriptions for oxycodone and Soma, I find that D.W. would have traveled approximately 404 miles roundtrip to obtain the April 5, 2012 and May 3, 2012 oxycodone prescriptions, as well as the April 19, 2012 and May 11, 2012 Soma prescriptions, from his prescribing physician, and that D.W. would have traveled at least 202 miles after picking up his prescription to return home. See GX 45, at 4-7. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescriptions given the unusual distances D.W. traveled to obtain and to fill these prescriptions. GX 45, at 1, 2, 12-19; accord Tr. 1715, 1717. --------------------------------------------------------------------------- \32\ And like the March 8, 2012 Soma prescription to D.W., the front of these Soma prescriptions lacked the patient's address. See id. --------------------------------------------------------------------------- Professor Doering testified that these four prescriptions also presented the same unusual distance red flag that Trinity II should have identified as part of the drug utilization process. See Tr. 1715- 18. He also testified that, unlike the March 8, 2012 oxycodone and Soma prescriptions that Trinity II had filled on the same day, the fact that D.W. had to make two separate trips in April and in May to get the same prescriptions further emphasized the significance of the distance red flag of diversion. See id. at 1716 (``it sort of adds emphasis to that long distance thing because that meant two trips instead of one''). As a result, Professor Doering testified that filling these prescriptions was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1715-19. For a third customer, C.V., the Government introduced a dispensing log, patient profile, and the front and back of a prescription to establish that on May 10, 2012, Trinity II filled a prescription for C.V. for 90 tablets of hydromorphone 8 mg, under the brand name Dilaudid, with instructions to take one tablet every eight hours. GX 46, at 1-2, 7-8; Tr. 1719-21. According to the front of the prescription, the fill sticker attached to the back of the prescription, the dispensing log, and the patient profile, C.V.'s address was in Port Charlotte, Florida. GX 46, at 1-2, 7-8; Tr. 1720- 21. It is undisputed that the front of the prescription and Trinity II's fill stickers show that the prescribing physician's address was in Tampa, Florida. GX 46, at 7-8; Tr. 1720-21. The Government also introduced Google Maps evidence showing that C.V. would have traveled: (1) 105 miles from his home address to the prescribing physician, (2) about 22 miles from there to Trinity II, and then (3) 97 miles from Trinity II back to his home address. GX 46, at 3-6. Thus, I find that C.V. would have to travel approximately 224 miles roundtrip to obtain the May 10, 2012 prescription from his prescribing physician, fill it at Trinity II, and then return to his home. See id. I also find that Trinity II knew the address of both C.V. and his prescribing physician, and that C.V. paid ``cash'' for the prescription. See GX 46, at 1-2, 7- 8. I further find that the front of the prescription, the back of the prescription bearing the fill sticker, the patient profile, and the dispensing log do not reflect any notes or comments whatsoever explaining why Trinity II filled the prescription given the unusual distances C.V. traveled to obtain and to fill this prescription (or the fact that C.V. paid ``cash'' to fill it). Id.; accord Tr. 1719, 1722. Professor Doering testified that this prescription presents ``the distance red flag'' that Trinity II should have identified as part of the drug utilization process. See Tr. 1722. As a result, he testified that filling this prescription was inconsistent with Florida's standard of care, that it was not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1722-23. For a fourth customer, D.E., the Government introduced a dispensing log, patient profile, and the front and back of a prescription to establish that on June 13, 2013 and on July 3, 2013, Trinity II filled two prescriptions for D.E. for 120 tablets of hydromorphone 8 mg for each prescription, both under the brand name Dilaudid, with the same [[Page 7318]] instructions to take one tablet every six hours for 30 days. GX 48, at 1-2, 8, 10-11; Tr. 1724-25, 1728. According to the front of the prescriptions, the fill stickers attached to the back of the prescriptions, the dispensing log, and the patient profile, D.E.'s address was in Brooksville, Florida. GX 48, at 1-2, 8; Tr. 1724, 1728- 29. It is undisputed that the front of the prescriptions show that the prescribing physician's address was in Tampa, Florida. GX 48, at 8, 10; Tr. 1725. The Government also introduced Google Maps evidence showing that D.E. would have traveled: (1) 44 miles from his home address to the prescribing physician,\33\ (2) about 20 miles from there to Trinity II, and then (3) 55 miles from Trinity II back to his home address. GX 48, at 3-7. Thus, I find that D.E. would have to travel approximately 119 miles roundtrip to obtain the June 13, 2013 prescription from his prescribing physician, fill it at Trinity II, and then return to his home. See id. I also find that Trinity II knew the address of both D.E. and his prescribing physician, and that D.E. paid ``cash'' for the prescription. See GX 46, at 1-2, 8, 10. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled the prescription given the unusual distances D.E. traveled to obtain and to fill this prescription (or the fact that D.E. paid ``cash'' to fill it). Id.; accord Tr. 1727, 1732. --------------------------------------------------------------------------- \33\ The street address of the prescribing physician reflected on the front of the prescriptions was different from what was shown on Trinity II's dispensing report and fill sticker; however, the identity and the city (Tampa, Florida) of the physician was the same in every address. Compare GX 46, at 1 with id. at 8, 10. Although the distance calculation from the same city (Tampa) would have been very similar using either Tampa address, I find that the address on the prescriptions themselves is the most reliable evidence of the prescribing physician's address because it came directly from the physician. I find that the calculation of the distances to and from D.E.'s prescribing physician--as reflected in the Government's Google Maps evidence--is based, appropriately, on the street address reflected on the front of the June 13, 2013 and July 3, 2013 prescriptions. Id. at 4. --------------------------------------------------------------------------- Moreover, I find that when Trinity II filled D.E.'s Dilaudid prescription on July 3, 2013, Trinity II filled that prescription early--yet another red flag. Specifically, D.E.'s prescription that Trinity II filled on June 13, 2013 was for 120 tablets of Dilaudid 8 mg and instructions for D.E. to take one tablet every six hours for 30 days. GX 48, at 1-2, 8; Tr. 1729-30. Hence, the 120 pills prescribed to be taken at the rate of four pills per day constitute a 30-day supply that should have lasted D.E. until at least July 12, 2013. Nevertheless, on July 3, 2013, Trinity II filled another prescription for another 120 pills of Dilaudid 8 mg with instructions to take one tablet every 6 hours for 30 days. GX 48, at 1-2, 10-11; Tr. 1731. Thus, I find that when Trinity II filled this second prescription on July 3, 2013, Trinity II filled it 9 days early. Accord Tr. 1731. I also find that the front of these prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this prescription early. GX 48, at 1-2, 8, 10-11; Tr. 1731-32. Professor Doering testified that this prescription presents ``[t]he combination of the red flags. It's too early and the distance red flag.'' Tr. 1731, 1727 (``the distance is a long ways. Which in the judgment of my opinion, the pharmacist, it should raise a red flag.''). As a result, he testified that filling these prescriptions was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1727- 28, 1732. Cocktail Prescriptions The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of ``cocktail prescriptions,'' which the Government alleged occurs when a customer presents multiple prescriptions that would provide the same patient an opioid, a benzodiazepine, and a muscle relaxer. Specifically, the Government introduced evidence exhibiting this red flag with respect to three of Trinity II's customers identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena. For one such customer, S.S., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on June 27, 2013, Trinity II filled three prescriptions issued by the same prescribing physician for him: (1) 150 tablets of hydromorphone 8 mg (with instructions to take one tablet ``every 4 hours as needed [for] breakthrough pain''); (2) 60 tablets of carisoprodol 350 mg, under the brand name Soma (with instructions to take one tablet ``twice daily as needed''); and (3) 45 tablets of alprazolam 2 mg, under the brand name Xanax (with instructions to take half of a tablet ``three times daily as needed for anxiety'') . GX 44, at 1, 2, 14-19; Tr. 1697-98. On July 23, 2013, Trinity II filled for S.S. the same three prescriptions from the same prescribing physician for hydromorphone 8 mg, carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with the same dosage instructions as for the June 27, 2013 prescriptions. GX 44, at 1, 2, 22-27; Tr. 1703-05. Thus, I find that the evidence establishes that Trinity II twice (on June 27, 2013 and on July 23, 2013) filled prescriptions for S.S. for the same combination of controlled substances--an opioid (hydromorphone), a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 44, at 1, 2, 14-19, 22-27. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this combination, or cocktail, of prescriptions. Id.; accord Tr. 1700, 1705. For a second customer, J.Ha., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on March 7, 2012, Trinity II filled three prescriptions issued by the same prescribing physician for her: (1) 120 tablets of oxycodone 30 mg (with instructions to take 1 tablet every 6 hours as needed); (2) 30 tablets of carisoprodol 350 mg, under the brand name Soma (with instructions to take 1 tablet every night); and (3) 30 tablets of alprazolam 2 mg, under the brand name Xanax (with instructions to take one tablet daily). GX 73, at 1, 2, 4-9; Tr. 1594- 98. On May 3, 2012 and May 31, 2012, Trinity II filled for J.Ha. prescriptions from the same prescribing physician for oxycodone 30 mg, carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with the same dosage instructions \34\ as for the March 7, 2012 prescriptions. GX 73, 1-2, 10-21; Tr. at 1605-12. Thus, I find that the evidence establishes that on three separate occasions Trinity II filled for J.Ha. prescriptions for the following combination of controlled substances--an opioid (oxycodone), a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 73, at 1, 2, 4-21. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this [[Page 7319]] combination, or cocktail, of prescriptions. Id.; accord Tr. 1594, 1597, 1604, 1608, 1612. --------------------------------------------------------------------------- \34\ The fill sticker for the May 31, 2012 oxycodone 30 mg prescription for J.Ha. reflected the additional phrase ``for pain'' to the otherwise identical instruction that J.Ha. had received on the March 7, 2012 and May 3, 2012 prescriptions to take one tablet of oxycodone 30 mg every six hours as needed. GX 73, at 17. --------------------------------------------------------------------------- For a third customer, R.Ha., the Government introduced a dispensing log, patient profile, and the front and back of prescriptions to establish that on March 7, 2012, Trinity II filled the following three prescriptions issued by the same prescribing physician for him: (1) 180 tablets of oxycodone 30 mg (with instructions to take one tablet every four to six hours as needed); (2) 60 tablets of carisoprodol 350 mg, under the brand name Soma (with instructions to take one tablet twice daily); and (3) 30 tablets of alprazolam 1 mg, under the brand name Xanax (with instructions to take one tablet every night). GX 74, at 1, 2, 4-9; Tr. 1598-1600. On May 3, 2012 and May 31, 2012, Trinity II filled for R.Ha. the same three prescriptions from the same prescribing physician for oxycodone 30 mg, carisoprodol 350 mg, and alprazolam 2 mg in the same amounts and with the same dosage instructions \35\ as for the March 7, 2012 prescriptions. GX 74, 1-2, 10-21; Tr. at 1606-08, 1611-12. Thus, I find that the evidence establishes that on three separate occasions Trinity II filled for R.Ha. prescriptions for the following combination of controlled substances--an opioid (oxycodone), a benzodiazepine (alprazolam), and a muscle relaxant (carisoprodol). GX 74, at 1, 2, 4-21. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this combination, or cocktail, of prescriptions. Id.; accord Tr. 1597, 1604, 1608, 1612. --------------------------------------------------------------------------- \35\ The fill sticker for the May 3, 2012 and May 31 2012 alprazolam 1 mg prescriptions instructed R.Ha. to take one-half to 1 tablet every day as needed, which is slightly different from the instruction in the March 7, 2012 prescription to take one tablet every night. Compare GX 74, at 7 with id. at 13, 19. Professor Doering testified that, in his opinion, this was a labeling error. Tr. 1601-02. --------------------------------------------------------------------------- Professor Doering testified that the combination of these three drugs that Trinity II filled for customers like S.S., J.Ha., and R.Ha. constituted ``the unholy trinity'' or ``cocktail prescriptions'' that present a ``drug-drug interaction'' red flag because they are ``symbolic of drug interactions that might cause harm to the patient.'' Tr. 894-96. He emphasized that this ``combination of drugs'' risks harm to the patient because they ``have additive central nervous system depressant properties.'' Id. at 1698, see also id. at 1603 (``that's also the red flag of the so called accumulative additive effects of drugs with CNS depressant properties''). In his opinion, this is a red flag that Trinity II should have identified and resolved during the drug utilization review process with respect to customers S.S., J.Ha., and R.Ha. Id. at 1446, 1448.\36\ As a result, he testified that filling these cocktail prescriptions without resolving the drug-drug interaction red flag was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1604-05, 1609, 1612-13, 1701, 1705. --------------------------------------------------------------------------- \36\ Professor Doering also testified that the fact that Trinity II filled the cocktail prescriptions for S.S. 14 days after the prescriptions were issued presented another red flag because patients who are legitimately ``in pain and or having symptoms that might require these medications[ ] will get the prescriptions filled soon after they're written.'' Tr. 1700; compare GX 44, at 14, 16, 18 (prescriptions dated June 13, 2013) with id. at 15, 17, 19 (corresponding fill stickers dated June 27, 2013). I find that the front of these prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II filled this combination, or cocktail, of prescriptions 14 days after the prescriptions were issued. Id.; accord Tr. 1700. --------------------------------------------------------------------------- Pattern Prescribing to Patients With the Same Last Name and Address The Government introduced prescription evidence at the hearing to show that Trinity II failed to resolve the red flag of ``pattern prescribing'' reflecting a lack of individualized drug therapy, and which the Government alleges occurs whenever two related individuals present prescriptions issued (1) by the same prescribing physician, (2) on the same day, and (3) for the same drugs. Specifically, the Government introduced evidence exhibiting this red flag with respect to two sets of Trinity II's customers, in which each set of two customers shared a last name and home address, and who were also identified in the first charge of the Show Cause Order and whose patient records the Government had requested pursuant to its December 4, 2014 subpoena. For the first set of customers, J.Ha. and R.Ha., and as noted above in the ``cocktail prescription'' fact findings, the Government introduced dispensing logs, patient profiles, and the front and back of prescriptions to establish that on March 7, 2012, May 3, 2012, and May 31, 2012, J.Ha. and R.Ha. presented and Trinity II filled three prescriptions for the same controlled substances on each date: (1) Oxycodone, (2) carisoprodol, and (3) alprazolam. GX 73, at 1, 2, 4-21; GX 74, 1, 2, 4-21. The same evidence also shows that J.Ha. and R.Ha. share the same: (1) Home address in Clearwater, Florida; (2) last name; and (3) prescribing physician. Id. As a result, I find that on three separate occasions, the same prescribing physician issued prescriptions for the same combination of drugs (oxycodone, carisoprodol, and alprazolam) to J.Ha. and R.Ha. on the same dates. GX 73, at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20; GX 74, at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20. In addition, I find that on March 7, 2012, May 3, 2012, and May 31, 2012, Trinity II filled each of these prescriptions even though Trinity II knew that they came: (1) From the same prescribing physician; (2) for the same combination of drugs; and (3) for patients with the same last name and same home address. GX 73, at 1, 2, 5, 7, 9, 11, 13, 15, 19, 21; GX 74, at 1, 2, 5, 7, 9, 11, 13, 15, 19, 21. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments explaining why Trinity II nonetheless filled these prescriptions. Id.; accord Tr. 1594, 1597, 1604, 1608, 1612. For the second set of customers, M.W. and J.W., the Government introduced dispensing logs, patient profiles, and the front and back of prescriptions to establish that on November 20, 2013 and on December 18, 2013, M.W. and J.W. presented and Trinity II filled identical prescriptions for 150 capsules of oxycodone 30 mg compounded with ginger, with the same dosage instructions to take one capsule every four to six hours for pain.\37\ GX 75, at 1, 3, 4-7; GX 76, at 1, 3, 4- 7. The same evidence also shows that M.W. and J.W. share the same: (1) Home address in Clearwater, Florida; (2) last name; and (3) prescribing physician. Id. As a result, I find that on two separate occasions, the same prescribing physician issued prescriptions for the same controlled substance (oxycodone) to M.W. and J.W. on November 20, 2013 and on December 18, 2013. GX 75, at 1, 3, 4, 6; GX 76, at 1, 3, 4, 6. In addition, I find that on those same dates Trinity II filled each of these prescriptions, even though Trinity II knew that they came: (1) From the same prescribing physician; (2) for the same controlled substance; and (3) for patients with the same last name and home address. GX 75, at 1, 3, 5, 7; GX 76, at 1, 3, 5, 7. I further find that the front of the prescriptions, the back of the prescriptions bearing the fill stickers, the patient profile, and the dispensing log do not reflect any notes or comments whatsoever explaining why Trinity II nonetheless filled these [[Page 7320]] prescriptions. Id.; accord Tr. 1616, 1619-21, 1623. --------------------------------------------------------------------------- \37\ M.W.'s prescriptions also instructed a ``LIMIT [of] 5 [capsules] per day.'' GX 75, at 4, 6. --------------------------------------------------------------------------- Professor Doering testified that when two patients with the same last name and address, like J.Ha. and R.Ha. or M.W. and J.W., present prescriptions on the same day from the same prescribing physician for the same controlled substance and with the same dosage instructions, ``it's what some have come to call pattern prescribing.'' Tr. 1602-03; see also id. at 1608, 1612, 1620, 1623. In his opinion, this is a red flag that Trinity II should have identified and resolved during the drug utilization review process ``[b]y contacting the prescriber and/or discussing it with the patient'' before filling. See id. at 1603. As a result, he testified that filling these prescriptions without resolving the pattern prescription red flag was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Id. at 1604-05, 1609, 1612- 13, 1620-21, 1623-24. Controlled Substances Filled Before Authorized Date At the hearing, the Government introduced into evidence copies of a dispensing log and the front and back of two prescriptions for controlled substances that the Government alleged Trinity II twice filled for customer D.G. before the date authorized by the prescribing physician and in violation of 21 CFR 1306.04(a), 1306.06, 1306.11, and 21 U.S.C. 829 as set forth in the third and fourth charges of the Show Cause Order. For example, the Government introduced a dispensing log and the front and back of a prescription dated November 15, 2013 showing that Trinity II filled a prescription for D.G. on November 20, 2013 for 7 patches of fentanyl-50 mcg/hr, a schedule II controlled substance, under the brand name Duragesic. GX 77, at 1, 6, 7; Tr. 1508- 09, 1513-15. The front of the prescription, however, expressly instructed ``NO EXCEPTIONS DO NOT FILL UNTIL 12-06-2013.'' GX 77, at 6; Tr. 1514. Although the CALJ did not recommend findings of fact related to the Government's allegations that Trinity II filled prescriptions early as set forth in the first two charges of the Show Cause Order, for this (third) charge of the Order, the CALJ did choose to recommend findings of fact. Specifically, he recommended that I find that Trinity II filled a prescription for a schedule II controlled substance for D.G. early because it was filled on November 20, 2013--contrary to the prescription's instruction that the prescription not be filled until December 6, 2013. R.D. at 48-49. I agree and make this finding of fact. Similarly, the Government introduced the front and back of a prescription dated December 16, 2013 showing that Trinity II filled a prescription for D.G. on December 18, 2013 for 15 patches of fentanyl- 50 mcg/hr under the brand name Duragesic. GX 77, at 8, 9; Tr. 1508-11. The Government also introduced a dispensing log showing that Trinity II filled the prescription on December 23, 2013. GX 77, at 1; Tr. 1511. The front of the prescription, however, expressly instructed ``NO EXCEPTIONS DO NOT FILL UNTIL 1-5-2014.'' GX 77, at 8; Tr. 1511-12. The CALJ recommended for this (fourth) charge of the Show Cause Order that I find that, regardless of whether Trinity II filled this prescription on December 18 or December 23, 2013, Trinity II nonetheless filled the prescription contrary to the prescribing physician's express instruction that the prescription not be filled until January 5, 2014. R.D. 48-49, 48 n. 114. I agree and make this finding of fact. With respect to these two prescriptions filled by Trinity II, Professor Doering testified that filling these prescriptions before the date set forth in a ``DO NOT FILL UNTIL'' instruction was inconsistent with Florida's standard of care, that they were not filled in the usual course of professional practice, nor filled in the proper exercise of the pharmacist's corresponding responsibility. Tr. 1512, 1515-16. Controlled Substances Filled in Stronger Concentration Than Authorized At the hearing, the Government introduced into evidence copies of a dispensing log, patient profile, and the front and back of seven prescriptions for controlled substances that the Government alleged Trinity II filled for customer J.T. at dosages that were no less than five times stronger than authorized by the prescribing physician and in violation of 21 CFR 1306.06 and 1306.11 as set forth in the fifth charge of the Show Cause Order. For example, the Government introduced the front of a prescription dated July 11, 2013 showing that the prescribing physician issued to J.T. a prescription for 20 mg/5 ml of morphine liquid, which is a liquid dosage of morphine and a schedule II controlled substance, with instructions to take five milliliters every six hours for rescue pain. GX 35, at 40; Tr. 1394-96, 1412. However, the Government also introduced a dispensing log, patient profile, and the back of the same prescription to show that when Trinity II filled this prescription for J.T. on July 12, 2012, Trinity II filled the prescription for 20 mg/ml of morphine liquid--a concentration that is five times stronger than what the prescribing physician had authorized--and restating the same dosage directions to take five milliliters every six hours for pain. GX 35, at 1, 3, 41; Tr. 1396-98. The CALJ recommended that I find that, in fact, on July 12, 2013, Trinity II filled a prescription for J.T. for 20 mg/ml that was five times stronger than the authorized dosage. R.D. at 50. I agree and make this finding of fact. The Government also introduced evidence at the hearing showing that Trinity II repeatedly filled prescriptions for J.T. for morphine liquid at the same concentration (20 mg/ml) that was either five or 15 times the prescribed concentration (20 mg/5 ml or 20 mg/15 ml) \38\ on six other occasions--August 8, 2012, September 6, 2012, October 3, 2012, November 1, 2012, December 27, 2012, and January 25, 2012. GX 35, 1, 3, 52-53, 58-59, 66-67, 76-77, 84-87. The CALJ recommended that I find that, in fact, on each of these occasions Trinity II filled prescriptions for J.T. for 20 mg/ml and that this dosage was either five times or 15 times stronger than the authorized dosage.\39\ R.D. at 50. I agree and make these fact findings. --------------------------------------------------------------------------- \38\ I agree with the CALJ that the prescribing physician's handwriting regarding the dosages for these prescriptions is not always clear because they appear to state either 20 mg/5 ml or 20 mg/15 ml. R.D. at 50. In the Show Cause Order, the Government alleged that the dosage for each of these prescriptions were for 20 mg/5 ml. ALJ Ex. 1b, at 15-16. However, in its Proposed Findings of Fact, the Government asked that the Agency find that all the prescriptions reflect a dosage instruction of 20 mg/5 ml except for the October 3, 2012 and November 1, 2012, prescriptions, which the Government claimed reflect a dosage instruction of 20 mg/15 ml. ALJ Ex. 40a, at 56-57. In any event, I agree with the CALJ's recommendation that for each of these prescriptions, the prescribed dosage strengths are either for 20 mg/5 ml or 20 mg/15 ml. R.D. at 50 n.120. \39\ The CALJ also recommended that I find that on November 29, 2012, Trinity II filled a prescription issued to J.T. for morphine liquid for 20 mg/ml when the dosage instruction on the corresponding prescription was for 20 mg/5 ml. R.D. at 50 & n.119 (citing GX 35, at 1, 80-81). Although this particular prescription was not the subject of testimony at the hearing nor included in the Government's Proposed Findings of Fact, the Show Cause Order does allege that on November 20, 2012, Trinity II received a prescription issued to J.T. for 20 mg/5 ml of morphine liquid but nonetheless filled it at the dosage strength of 20 mg/ml. ALJ Ex. 1b at 16. The CALJ acknowledged that the date in the Show Cause Order (November 20, 2012) does not match the date on the fill sticker (November 29, 2012), but he recommended this fact-finding anyway and implied that the discrepancy was the result of a scrivener's error in the Show Cause Order. R.D. at 50 & n.119. Because neither the dispensing log nor the patient profile for J.T. show that Trinity II filled any prescriptions for J.T. on November 20, 2012 (much less one corresponding to the morphine liquid prescription described in the Show Cause Order), GX 35, at 1, 3, I find that this mistake in the Show Cause Order was merely a scrivener's error. Thus, I agree that the Government intended to state in the Order that Trinity II filled this prescription on November 29, 2012. And I agree with the CALJ's recommendation that I find (and I do so find) that Trinity II filled this prescription on November 29, 2012 at a dosage that was five times stronger than the prescribing physician had instructed. --------------------------------------------------------------------------- [[Page 7321]] Professor Doering testified that the filling of these prescriptions at dosages that were at least ``five times more potent that it was supposed to be'' constituted ``a misfill.'' Tr. 1398. ``This issue has been communicated to pharmacists. Be careful when you fill liquid morphine solutions, because it's a very concentrated form of the drug.'' Id. He testified that the issue ``should have been identified in the global dispensing process.'' Id. at 1400. He further testified that these prescriptions were not filled consistent with the standard of care in Florida nor filled in the usual course of pharmacy practice. Id. at 1399, 1402, 1404, 1406-07, 1409, 1411-12. Prescriptions Filled by Pharmacy Interns The Government introduced prescription evidence at the hearing for the purpose of showing that Trinity II unlawfully allowed pharmacist interns, instead of pharmacists, to fill controlled substances prescriptions. The Government specifically alleged that Mina A. Ghobrial, a pharmacist intern at Trinity II, filled such prescriptions based on the presence of the initials ``MAG'' or ``MG'' in the ``filled by'' field of the fill stickers. See, e.g., GX 79-82; see also Tr. 339, 452. The CALJ recommended that I find that the Government failed to present evidence to suggest that Ghobrial was not supervised by a registered pharmacist. R.D. at 46. I agree and make this finding of fact. Respondent's Case Respondent presented the testimony of Mark Abdelmaseeh, a pharmacist at Trinity II.\40\ T. 2340-42. Abdelmaseeh testified that he worked two days per week as a pharmacist at Trinity II. Id. at 2342. He testified that, although technicians and interns worked with the pharmacists at Trinity II, pharmacy interns and technicians did not dispense any prescriptions. Id. at 2342-43. He further testified that his role included ``overlook[ing] and supervis[ing] what's going on in the pharmacy'' and ``keep[ing] open communication with the doctors to make sure that all prescriptions are legitimate and needed for the patient.'' Id. at 2355-56. ``I check to see if there are any contraindications or interactions, if the patient has allergies. I look to see if the prescription is valid or not. I look to see if the prescription is being filled early or not. I look to see if the prescription has any mistakes on it, and I call and verify with the doctor on every prescription that I fill.'' Id. at 2356. --------------------------------------------------------------------------- \40\ Although Respondents presented the testimony of one other witness, Kristen Quinette, a former pharmacy technician at Trinity I, the CALJ did not consider her testimony in his Recommended Decision. After testifying that she had worked at one time at Trinity II, the CALJ sustained the Government's objection to her testimony since she was not noticed as a witness against Trinity II. Tr. 2232, 2247-49. --------------------------------------------------------------------------- Abdelmaseeh testified that Trinity II maintains ``records, notes and all types of other information other than just the plain prescription information'' and that ``[i]t's all documented in the computer system.'' Id. at 2345. He specifically testified that Trinity II ``maintain[ed] documentation regarding patient allergies'' and ``interactions with the physicians.'' Id. at 2360-61. He also testified that ``[w]hen the customer does pick up the medication they sign off for it that they picked up and that they do not have any questions in regards to the prescription that was picked up. . . . [a]t the point of sale.'' Id. at 2357. Specifically, he testified that the customer signs an electronic pad at the register confirming pick up and that the customer has no questions for the pharmacist. Id. at 2357-58. He further testified that he can access that information ``[a]t the register in the computer system.'' Id. at 2359. The CALJ noted that Abdelmaseeh has some built-in bias because he was still an employee of Trinity II when he testified, giving him ``some stake in the proceedings.'' R.D. at 34. The CALJ found that this bias was reflected in the fact that Abdelmaseeh ``affirmatively and deliberately disregarded Respondent's counsel's . . . efforts to elicit testimony that stood within the bounds of the in Limine Order when there was no question pending in order to provide information that was directly the subject of the Government's objections.'' Id. at 34-35. The CALJ believed that this was Abdelmaseeh's ``effort to cram in as much objectionable testimony as possible'' to get around the terms of his in Limine Order. Id. at 35. As a result, the CALJ concluded that ``it is difficult to afford this witness's testimony the full weight that it otherwise might have received in this recommended decision.'' Id. The CALJ sustained the Government's objections to Respondent's attempts to have Abdelmaseeh testify about evidence regarding the process the pharmacies used to verify prescriptions and resolve concerns, including a description and demonstration of the computer software utilized, because such testimony was excluded by the in Limine Order. See generally Tr. 2344-66. However, the CALJ nonetheless allowed Respondent's counsel to proffer how the witness would have testified on that topic. Id. at 2366-2372. Counsel proffered that Trinity II used computer software that requires a pharmacist to sign-in and approve prescriptions. Id. at 2367. Respondent's counsel also proffered ``that the software comes with a particular screen and tab for printing what is commonly referred to and has been referred to by Professor Doering as a patient profile which includes dispensing history, and it's limited to the dispensing history. It's a pre-programmed function of that software.'' Id. at 2368, 2370 (``It's an F-11 tab to print a profile.''). He also proffered that ``other fields that are maintained or other screens that are maintained'' by Trinity II's software ``include an area for notes on each prescription and that that information is maintained at the pharmacy in that . . . software.'' Id. at 2369, 2370-71 (``It has a tab for prescription notes, RX notes, and it operates not only by the tab but by a function key, F-3, and patient information tab that uses a function key, F-4'' and includes ``a date and time stamp entry so you can determine on which date those entries were made.''). According to counsel, Trinity II's pharmacists ``used this software as a mechanism to assist them . . . with identifying red flags and then documenting the resolution of those.'' Id. at 2371-72. The proffered facts related to Trinity II's computerized record- keeping and prescription verification process are only relevant to the Show Cause Order's first two charges related to the identification and resolution of red flags of diversion. The CALJ properly stated that he would not consider the proffer as evidence in making his recommendation, but he allowed Respondent's counsel to make the proffer to preserve the issue for review. See id. at 2352. Based principally on this proffer and the Government's failure to image Trinity II's computers, Trinity II contends that DEA cannot prove that it failed to document resolution of such red flags because ``DEA failed to request or obtain Respondent's records where such notes and comments were stored.'' Trinity II's Closing Submission and Proposed Findings of Fact and [[Page 7322]] Conclusions of Law (hereinafter ``Trinity II's Post-Hearing Brief''), AJL Ex. 41, at 6. This general argument has some merit (again, assuming the proffered facts are true) regarding Trinity II's customers for whom the Government never requested ``records where such notes and comments were stored.'' Id. However, Trinity II's argument does not account for the fact that the Government's December 4, 2014 subpoena required Trinity II to produce the complete patient profile that Trinity II maintained for 23 customers as required by Florida Administrative Rule 64B16-27.800, entitled ``Requirement for Patient Records.'' GX 98, at 2 (``For each of the following patients, please provide a copy of the complete patient profile your pharmacy maintained pursuant to Florida Administrative Rule 64B16-27.800''). As already noted, this rule expressly required Trinity II to maintain in its ``patient record system'' a record of every entry ``in the profile record'' for each patient for two years, including ``[p]harmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.'' ALJ Ex. 38; Fla. Admin. R. 64B16- 27.800. This Rule also mandated that Trinity II ``obtain from the patient . . . and shall record'' patient information ``which may relate to prospective drug review. The pharmacist shall record any related information indicated by a licensed health care practitioner.'' Id. at 64B16-27.800(2). In short, and as discussed more fully infra, Rule 64B16-27.800 required Trinity II to maintain patient records that included copies of any notes and comments reflecting their pharmacists' resolution of any red flags of diversion. I find that when the Government requested the complete patient profile Trinity II maintained pursuant to Rule 64B16- 27.800 related to the 23 customers in the December 4, 2014 subpoena, the Government did in fact request all patient records maintained by Trinity II for those customers pursuant to that Rule--including the pharmacists' notes and comments for those customers. Thus, I reject Trinity II's contention that the Government failed to request records including Trinity II's notes and comments.\41\ --------------------------------------------------------------------------- \41\ And it is also for this reason that I have limited my fact findings, supra, regarding the Show Cause Order's first two charges relating to violations of Trinity II's corresponding responsibility to allegations involving those 23 patients. --------------------------------------------------------------------------- Most significantly, Respondent's counsel never stated in his proffer that Trinity II did in fact maintain notes and comments resolving the alleged red flags for the 23 customers whose records were subpoenaed in this case. Although it is possible that Trinity II deliberately withheld this evidence in response to the December 4, 2014 subpoena,\42\ I find that it is more likely than not that, in fact, Trinity II failed to produce notes and comments reflecting Trinity II's resolution of the red flags in response to the Government's subpoena because Trinity II did not actually resolve them and hence had no notes or comments reflecting any such resolution. Respondent's counsel was careful never to aver during cross-examination of the Government's witnesses that Trinity II actually had notes or comments regarding the 23 patients identified in the subpoena. The CALJ gave Respondent's counsel's more than enough latitude to make this claim during his proffer or during cross-examination, yet he chose not to do so. Respondent's counsel also chose not to impeach Government witnesses during cross-examination by using actual notes and comments (or any other information) reflecting Trinity II's resolution of red flags for any customer discussed at the hearing. Although the in Limine Order precluded Trinity II from, inter alia, offering such information as evidence in its case-in-chief (ALJ Ex. 29, at 3), nothing in that Order precluded Trinity II from using this information to impeach the Government's witnesses.\43\ Indeed, it was in Trinity II's self- interest to use such notes and comments (if they existed) during cross- examination of the Government's witnesses because it would have been an effective way to impeach Government witnesses' testimony that they saw no evidence that Trinity II resolved any red flags of diversion. It would be a remarkable oversight for Respondent's counsel not to use such information during cross-examination if it did exist. As already noted, I find that it did not.\44\ --------------------------------------------------------------------------- \42\ During Respondent's counsel's cross-examination of Professor Doering regarding the scope of the Government's December 4, 2014 subpoena request for 23 customers' patient profiles maintained pursuant to Rule 64B16-27.800, Respondent's counsel asked ``Is the word `profile' anywhere in that Florida administrative code provision?'' (Tr. 2174), expecting the witness to confirm counsel's own understanding regarding the rule. Professor Doering then validated that (mis)understanding by stating that the word ``profile'' ``does not appear'' to him as he quickly read the rule on the stand. Tr. 2176. This reading, of course, is incorrect--Rule 64B16-27.800(3) expressly references patient profiles. Government counsel immediately corrected this error on re-direct by asking Professor Doering to read that provision into the record: ``A patient record shall be maintained for a period of not less than two years from the date of the last entry in the profile record. This record may be a hard copy or a computerized form.'' Tr. 2207 (emphasis added). Although this exchange raises the possibility that Respondent's counsel advised his clients not to produce the notes and comments regarding the 23 customers referenced in the subpoena based on this misunderstanding of the rule, I find (for the reasons set forth in the text above) that it is more likely than not that Trinity II did not produce any notes or comments regarding these customers because they do not exist. \43\ In fact, the CALJ lacks the authority to preclude a respondent from using relevant information to impeach a witness during cross-examination. See Farmacia Yani, 80 FR 29053, 29063 n.25 (2015) (finding that it was prejudicial error to preclude a respondent from using a document to impeach a witness on cross- examination, even where respondent had failed to present the document to the Government in advance of the hearing). Moreover, the APA and our regulations preserve a respondent's right to present information on cross-examination for the purpose of impeaching the Government's witnesses. See 5 U.S.C. 556(d) (``A party is entitled . . . to conduct such cross-examination as may be required for a full and true disclosure of the facts.''); 21 CFR 1316.60. \44\ For the same reason, I reject Trinity II's Exception that the CALJ's in Limine Order ``did not permit the Respondents to present relevant evidence to the charges set forth in the show cause order. As a result, the Respondents were limited in their ability to explain the computer system used by the Respondents, which would have clarified the record keeping questions.'' Respondents Trinity Pharmacy (I)'s and Trinity Pharmacy (II)'s Exceptions to the Recommended Decision of the Administrative Law Judge (``Resp. Except.''), at 7. Although the CALJ did limit Trinity II's ability to present evidence as part of its case-in-chief, as already noted, the CALJ (1) gave Trinity II multiple opportunities to comply with his prehearing orders, (2) did not (and could not) limit its ability to present information during cross-examination of the Government's witnesses, and (3) even gave Trinity II the opportunity to provide an attorney proffer at the hearing in which Trinity II's counsel could have at least proffered facts which, if true, would have rebutted the Government's case. Again, as already noted, Trinity II chose not to do so. Accordingly, I find that the CALJ acted within his discretion when he issued his in Limine Order and denied Trinity II's reconsideration motion, and I reject Trinity II's Exception to the CALJ's in Limine Order. Trinity II also raised in this Exception that the CALJ's in Limine Order precluded it from introducing evidence that ``would have corroborated Kristen Quinette that pharmacy technicians were not permitted to dispense prescriptions.'' Id. at 7. None of the allegations in the Show Cause Order relate to pharmacy technicians, and the CALJ limited her testimony's relevance to Trinity I. R.D. at 33 n. 86. In any event, and assuming Trinity II intended to state in its Exceptions that it would provide testimony related to pharmacy interns, I find that this Exception is moot because I find infra for Trinity II on the charges related to pharmacy interns. --------------------------------------------------------------------------- Discussion Before proceeding to analyze the evidence under the public interest factors, it is necessary to review the CALJ's discussion of two issues raised in the Government's Exceptions to the CALJ's Recommended Decision: (1) Whether the Government should have provided DEA-6s to Respondent that DEA had provided to its expert and (2) whether the expert's testimony was sufficiently ``reliable'' under the Administrative Procedure Act (``APA'') [[Page 7323]] to be given weight in my decision. See ``Government Exceptions'' (hereinafter ``Gov. Except.'') at 13-54. Requirement To Produce Documents Relied Upon by the Expert In his Recommendation, the CALJ included a discussion of whether the Government should have produced to Respondent copies of a DEA-6 related to Trinity II that DEA had provided \45\ to the Government's expert witness, Professor Doering. R.D. at 27-28, 28 nn. 78-79.\46\ In that discussion, the CALJ stated his belief that the DEA's intent in providing documents to an expert is relevant to determining whether the expert relied upon these documents in forming his opinion. R.D. at 28 n. 78 (``Like the other documents forwarded by DEA to Professor Doering, DEA-6s were furnished to him to assist him in formulating his expert opinion on the Government's theory of the case.''), id. at 28 (``The proposition that the Government would supply DEA-6s (or any other form) to an expert with the expectation that those documents would play no role `whatsoever' is dubious at best. Professor Doering was sent DEA-6s so he would read, analyze, and utilize them in forming his expert opinion''). Contrary to the CALJ's belief, the Government's purported ``expectation'' that Professor Doering would rely on DEA-6s provided to him is both factually unsupported and legally irrelevant to the question at bar. --------------------------------------------------------------------------- \45\ The Government also raised a separate Exception related to the CALJ's statement in his Recommended Decision that ``[i]t is unfathomable that the Agency counsel would gratuitously release a document as closely held by the Agency as a DEA-6 with no expectation that it would be used by that person for any purpose.'' Govt. Except. at 69 (emphasis omitted) (citing R.D. at 28 n. 78). The CALJ failed to indicate where the record indicates that Government counsel produced, much less ``gratuitously released,'' a DEA-6 to anyone. In fact, the record contradicts the CALJ's rendition of the facts. As Trinity II's counsel established during cross-examination of the lead DI at the hearing, it was the DIs, not ``Agency counsel,'' who provided a DEA-6 to Professor Doering. [Mr. Sisco:] All right. Would you describe for me all of the information that you initially provided to Professor Doering? [DI:] I believe we provided photocopies of the original prescriptions. I believe a copy of the E-FORCSE, the dispensing report. What else? And a copy of one of my 6s. Q When you say a 6, you're talking about a DEA-6. It's your report of an investigation? A Yes. Tr. 581-82. Elsewhere in his Recommended Decision, the CALJ himself noted and accepted this same testimony. R.D. at 12 (accepting DI's testimony that he had ``provided . . . a copy of one of his DEA-6 forms . . . to Professor Paul Doering, the Government's expert witness. Tr. 581, 589-90''). Professor Doering corroborated the DI's response during his own testimony on direct and cross- examination, stating that he received DEA-6s from the DIs who had retained him on behalf of DEA and before he had made first contact with Government counsel regarding the case. Id. at 855-59, 1783-84, 1786-89, 1800-01. As the Government observed, ``[e]veryone is entitled to his own opinion, but not to his own facts.'' Govt. Except. at 1. I expect all the ALJs working for DEA to ensure that that the statements in their Recommended Decisions are well-grounded in fact, especially before making statements disparaging counsel who appear before them. \46\ This issue arose when, for the first time at the hearing, Respondent requested production of the DEA-6s that the Government had provided to its expert. R.D. at 28 n.79; see Tr. 586, 805-07. The Government responded at the hearing that Respondent's request was untimely because Government counsel had already notified Respondent's counsel by letter months before the hearing that DEA had previously provided DEA-6s to Professor Doering and that they would not be produced pursuant to T.J. McNichol. Tr. 807-08. The Government also proffered a copy of the contents of its unsigned expert discovery letter at the hearing. Id. The Government subsequently raised an Exception seeking a finding that it had provided notice to Respondent's counsel prior to the hearing, and the Government attached to its Exceptions an affidavit and a copy of the signed expert discovery letter addressed to Respondent's counsel consistent with its representation at the hearing. Gov. Except. at 64-69 & Attachment 1. In his Recommendation, the CALJ decided that ruling on whether this discovery request was timely was ``unnecessary'' because ``the Respondent has not sought to develop the record regarding the timeliness of the request or even asked for the testimony to be stricken as unavailable to constitute substantial evidence.'' R.D. at 28 n.79. I agree that Trinity II failed to carry its burden to prove that its request for production of the DEA-6s was timely. In any event, as discussed infra, I find that Professor Doering did not rely on any DEA-6 as the basis for his expert opinion, thereby obviating any putative production requirement. --------------------------------------------------------------------------- As a threshold matter, the record does not support the CALJ's statement that DEA expected Professor Doering to rely on the DEA-6s. The CALJ's opinion on this supposed expectation is based solely on the fact that the Government provided them to him. See R.D. at 27-28. However, the Government may provide an expert with any number of documents for reasons that have nothing to do with formulating the substantive basis of an expert opinion--such as an index or a table of contents. In his Recommended Decision, the CALJ failed to indicate where in in the almost 2,400-page transcript and more than 90 exhibits in the case there are facts establishing that DEA's ``expectation'' was that Professor Doering use the DEA-6s ``in formulating his expert opinion on the Government's theory of the case.'' Id. at 28 n.78. Thus, I find that the mere fact that the DIs provided a DEA-6 to Professor Doering regarding Trinity II is insufficient to establish that DEA did so with the intent that he rely upon it in forming his opinion. More importantly, even if the record did support the CALJ's belief that DEA expected Professor Doering to rely on the DEA-6s in forming his opinion, it is legally irrelevant to the question of whether the Government should have produced the DEA-6s to Trinity II. ``DEA precedent has already made clear that where an expert relies on data or documents in forming his opinions, the failure of the sponsoring party to produce the data or documents denies the other party a meaningful opportunity to cross-examine the expert and show that his opinions are unfounded'' and ``runs the very substantial risk that the expert's conclusions will be rejected.'' \47\ T.J. McNichol, M.D., 77 FR 57133, 57146 n.18 (2012). Thus, the only fact that matters is whether Professor Doering actually relied on the DEA-6 in forming the substantive basis for his expert opinion. Accordingly, I find that, as a matter of law, the CALJ's unsupported belief that DEA expected Professor Doering to rely on the DEA-6s is irrelevant to the question of whether the Government was required to produce them to Trinity II because that legal question depends solely on whether Professor Doering, in fact, relied on the DEA-6 in forming the substantive basis for his opinion. See T.J. McNichol, M.D., 77 FR at 57146 n. 18; CBS Wholesale, 74 FR at 36749. --------------------------------------------------------------------------- \47\ The CALJ cited to an earlier case, CBS Wholesale Distributors, 74 FR 36746, 36749 (2009), where the Agency found that expert testimony about whether a respondent was selling ``excessive quantities of combination ephedrine products'' was unreliable because the expert was unable to produce the data on which he, in turn, relied in forming his opinion of what the average monthly sales figure calculation was for such products. Id. at 28 n.79. Notably, nowhere in that case or in T.J. McNichol (or in any other case) has the Agency held that the sponsoring party must produce to the other party data or documents that had been provided to the expert based on the sponsoring party's ``expectation'' that the expert would rely on the information. Rather, as already noted, both cases set forth the same requirement: The sponsoring party must produce to the other party all information upon which the expert actually relied in forming the substantive basis for his/her opinion. --------------------------------------------------------------------------- The CALJ also contends that Professor Doering, in fact, relied on the DEA-6s in forming his expert opinion based on his response to the following question during direct examination: Q . . . What role did [the DEA-6s] play in your forming of the opinion as to the dispensings and fillings that you formed the opinion on in this case? A None whatsoever ultimately. I used the DEA Form 6 as what I would call, like a beacon or flashlight to help me understand where I might find that documentation, so I could peer upon that with my own two eyes, and not have to rely on or depend on other people's impressions or thoughts. I never rely on DEA Form 6s, because I think it's risky to do that. Id. at 859-60. The CALJ found that, ``by his own account, [Professor Doering] used the investigative reports as a [[Page 7324]] framework to examine other potential evidence.'' R.D. at 27. The CALJ concluded that this testimony ``leaves little doubt that the DEA-6s supplied to Professor Doering constituted underlying data that supported his conclusion, his assertions.'' Id. at 28 n.79. Once again, the CALJ cites to the wrong legal standard under Agency precedent. The test is not whether Professor Doering used the DEA-6s ``as a beacon or flashlight'' to find other documents that constituted underlying data necessary to form his opinion. The question is whether Professor Doering, in fact, relied upon the DEA-6s as a substantive basis for his expert opinion. See T.J. McNichol, M.D., 77 FR at 57146 n. 18; CBS Wholesale, 74 FR at 36749. Here, Professor Doering's testimony shows that he used the DEA-6 as a table of contents or an index ``to help [him] understand where [he] might find that documentation'' upon which he ultimately did rely upon in forming his opinion--dispensing reports, dispensing logs, copies of individual prescriptions, patient profiles, and Google Maps and MapQuest printouts of distances. Tr. 860, 862-63. He even went so far as to testify that he only used DEA-6s in this limited way so he would ``not have to rely on or depend on other people's impressions or thoughts'' reflected by or in the DEA-6. Id. at 860 (emphasis added). Simply put, if an expert uses a document like an index to ``find'' other ``documentation'' and nothing more, then the expert is not relying on that index in forming the substantive basis of an expert opinion. As a result, the other party could not use that document to show that the expert's opinion was unfounded, and the sponsoring party would not be required to produce it. Here, the above testimony demonstrates that Professor Doering relied on dispensing reports, dispensing logs, copies of individual prescriptions, patient profiles, and Google Maps and MapQuest printouts in forming his opinions, not the DEA-6s that accompanied them. Tr. 860, 862-63. Accordingly, pursuant to T.J. McNichol and CBS Wholesale, I find that the record establishes that Professor Doering did not rely upon the DEA-6s in forming his expert opinion in this case, and thus the Government had no obligation to produce them to Trinity II. Expert Opinions Must Be Supported by Reliable, Probative and Reliable Evidence Under the APA, final agency action imposing a sanction must be ``supported by and in accordance with the reliable, probative, and substantial evidence.'' 5 U.S.C. 556(d). Like other evidence, the Agency has also held that an expert's opinion must be ``supported by substantial and reliable evidence.'' CBS Wholesale, 74 FR at 36749 (citing id.). I agree with the CALJ's decision to overrule Trinity II's objections in the hearing and in its closing brief to admitting the expert testimony of Professor Doering into evidence.\48\ See R.D. at 15. After the CALJ evaluated ``the weight that should be accorded [to Professor Doering's] expert testimony in this matter,'' R.D. at 16 n. 51, he recommended that I give his testimony no weight because it was, in his view, ``insufficiently reliable to form the basis of a sanction under the APA.'' Id. at 33 (``To be clear, however, this is not an issue of credibility . . . There is no question that the Professor is an individual of impressive credentials . . . This aspect of this recommended decision addresses only the narrow issue of whether the expert opinions he rendered . . . are sufficiently reliable to support a sanction.''). Like the CALJ, I too do not need to rely upon Professor Doering's expert testimony to find that Trinity II's DEA registration must be revoked. However, unlike the CALJ, I do find that his testimony was nonetheless reliable under the APA and could have been accorded more evidentiary weight in his recommended fact findings.\49\ --------------------------------------------------------------------------- \48\ Trinity II objected to the admission of Professor Doering's expert testimony on the basis that ``[h]e does not currently have a license in effect in the State of Florida'' (Tr. 840) based on Professor Doering's testimony that his license had fallen into delinquent status for a couple of months as of the date of the hearing. Id. at 822-23, 1770. He stated that ``when the decks are cleared with this matter . . . I will clear up the delinquent status of my license, and it will revert to clear and active, before it goes to null and void.'' Id. at 844. He stated that this fact had no impact on his ability to work at the University of Florida's School of Pharmacy because he was only required to maintain an active pharmacist's license in one state, and he had an active license in North Carolina. Id. at 821-23. Even if Professor Doering had no license in any state, however, DEA regulations do not require an expert witness to be licensed in the state in which the alleged violations occurred, and Agency precedent authorizes ALJ's to admit expert testimony even where the expert was not licensed in the state where the violations were alleged to have occurred. 21 CFR 1316.59(b) (``Opinion testimony shall be admitted when the presiding officer is satisfied that the witness is properly qualified''); Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44093 n.73 (2012) (finding that the Government's expert, who was licensed in Ohio but not Kentucky was nonetheless permissible and ``generally reliable and probative of whether Respondents (and their pharmacists) violated their corresponding responsibility''). Thus, the CALJ properly accepted Professor Doering ``as an expert in the practice of pharmacy in the State of Florida and the standard of care in the dispensing of controlled substances in Florida'' based on his expertise and the fact that he stays current in this area of expertise. Id. at 843; R.D. at 14. For the same reasons, I find that the fact that Professor Doering's CV may not have been up-to-date regarding the status of his Florida license is an insufficient basis to find that his testimony was unreliable. See R.D. at 28-30. \49\ The CALJ states that ``the factual findings set forth in this recommended decision are entitled to significant deference.'' R.D. at 38 (citing Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951)). However, nowhere does Universal Camera (or the APA) support this standard of review for the CALJ's recommended fact findings. Rather, it is axiomatic that an ALJ's recommended decisions are subject to de novo review by the agency. See 5 U.S.C. 557(b) (``On appeal from or review of the initial decision, the agency has all the powers which it would have in making the initial decision except as it may limit the issues on notice or by rule.''); Universal Camera, 340 U.S. at 492, 493 (the ALJ's recommended fact findings become part of the administrative record, just ``as the complaint or the testimony'' is part of the record, for the Agency's consideration), 494 (the APA states ``that an agency which reviews an examiner's [e.g., ALJ's] report has `all the powers which it would have in making the initial decision''') (quoting 5 U.S.C. 557(b)); Vineland Fireworks v. ATF, 544 F.3d 509, 514 (3d Cir. 2008) (recognizing an agency's authority under the APA to ``exercise[ ] de novo review over the ALJ's decision''). ALJs are ``entirely subject to the agency on matters of law; they can be reversed by the agency on matters of fact, even where demeanor evidence is an important factor.'' Antonin Scalia, The ALJ Fiasco--A Reprise, 47 Univ. Chi. L. Rev. 57, 62 (1979). See Kay v. FCC, 396 F.3d 1184, 1189 (D.C. Cir. 2005) (the agency may disagree with an ALJ's factual findings, including credibility determinations); Tom C. Clark, Attorney General's Manual on the Administrative Procedure Act 83 (1947) (``In making its decision, whether following an initial or recommended decision, the agency is in no way bound by the decision of its subordinate officer; it retains complete freedom of decision--as though it had heard the evidence itself.''). --------------------------------------------------------------------------- The CALJ identified six \50\ reasons for his recommendation not to rely on Professor Doering's testimony, and the Government filed Exceptions in response to each of them. First, the CALJ believed that Professor Doering's supposed ``acknowledgment that the opinions he had rendered were not `based on sufficient facts or data' critically undermines the weight that can be attached to those opinions.'' \51\ [[Page 7325]] R.D. at 16. Specifically, the CALJ states that Professor Doering ``did not have all of the information that was necessary for him to render an expert opinion.'' Id. (citing Tr. 2186-87). In its Exceptions, the Government responds that a ``careful and thorough review'' of the hearing transcript ``shows that the Presiding Officer's \52\ finding is a mischaracterization of Professor Doering's testimony.'' Gov. Except. at 13. I agree. --------------------------------------------------------------------------- \50\ The CALJ raised two other reasons to challenge the expert's reliability, one of which was the issue of DEA-6s, which I addressed supra. The other related to the CALJ's disagreement with Professor Doering on the question of whether an early fill calculation relates to when the pharmacist fills the prescription or to when the customer ultimately obtains the controlled substance. R.D. at 24-26. I find that this is a legal question and not a question of witness reliability, and it is one that I address infra. \51\ R.D. at 16 (quoting Fed. R. Evid. 702(b)). Although the CALJ properly framed the issue of reliability under Sec. 556(d) as a question of how much weight to give to Professor Doering's expert opinions, the CALJ erroneously resorted to Federal Rule of Evidence 702 as the lens through which to make this determination. Id. at 14- 15, 16 n.51. The CALJ stated that the ``Agency has long authorized resort to the Federal Rules of Evidence `where they do not conflict with Agency regulations.'' Id. at 14-15 (citing Rosalind A. Cropper, M.D., 66 FR 41040, 41041 (2001)). In Cropper, the Agency expressly rejected the ALJ's evidentiary ruling that the Federal Rules of Evidence ``generally apply'' to DEA administrative hearings and found ``instead that the Federal Rules of Evidence (FRE) do not apply directly to these proceedings . . . but may be used for guidance, where they do not conflict with agency regulations.'' 66 FR at 41041 (citing Klinestiver v. Drug Enforcement Administration, 606 F.2d 1128, 1130 (D.C. Cir. 1979) (holding that ``nothing in 21 CFR 1316.59(a) requires DEA to limit admissible testimony to that which would be acceptable in a jury trial or under the Federal Rules of Evidence'')). If the CALJ wished to deny admission of Professor Doering's testimony and exclude it from evidence, the APA only authorizes exclusion of evidence that is ``irrelevant, immaterial, or unduly repetitious.'' 5 U.S.C. 556(d); Klinestiver, 606 F.2d at 1130 (``The history of [21 CFR 1316.59] convinces us that DEA never intended to bind itself to a higher standard of admissibility than that prescribed by . . . 5 U.S.C. 556(d)''); Cropper, 66 FR at 41041 (same) (``The sections governing these proceedings found in 21 Code of Federal Regulations contain no references to the FRE; and 21 CFR 1316.59 . . . requires only that admitted evidence be `competent, relevant, material, and not unduly repetitious.''). Although Rule 702 does use the words ``expert'' and ``reliable,'' that does not make the rule applicable here, even as guidance, to determine how much weight to give expert testimony. The CALJ concedes that Rule 702 only provides conditions for ``the admission of expert opinion testimony.'' R.D. at 15. Indeed, Rule 702 says nothing about how much weight to give an expert's opinion once it has been admitted. For this reason, the Agency adopted the CALJ's evidentiary recommendation in Howard N. Robinson, M.D., 79 FR 19356, 19361 n.39 (2014), to overrule the Government's objection based on Rule 702 to receiving an expert witness because ``the nature of the objection was framed entirely as an argument as to weight and raised no appreciable issue regarding the qualifications of the witness to present expert testimony.'' Here, and as already noted, the CALJ properly accepted admission of Professor Doering's expert opinion (Tr. 843-44) but gave it no weight because it was, in the CALJ's view, insufficiently reliable. Thus, Rule 702 has no bearing, and provides no guidance, on the question of how much weight the expert's testimony should receive. \52\ ``The term presiding officer means an administrative law judge qualified and appointed as provided in the'' APA. 21 CFR 1316.42(f) (citing 5 U.S.C. 556). The APA, in turn, characterizes an ALJ as a ``presiding or participating employee'' of the Agency. 5 U.S.C. 556(b). In this case, the presiding officer or employee of the Agency was the CALJ. --------------------------------------------------------------------------- During the portion of cross-examination cited by the CALJ, it is clear that when Professor Doering testified that he ``d[id]n't know that [he'd] been provided enough information . . . to render'' expert opinions under the Florida standard of care regarding Trinity II's resolution of red flags was limited to prescriptions and customers where he did not have a corresponding patient profile. Tr. 2186-87, 2187; accord Gov. Except. 14-15. The record is clear that Professor Doering testified that he did have sufficient information to render expert opinions related to the Government's charges pursuant to 21 CFR 1306.04(a) for the 23 patients that were the subject of the December 4, 2014 administrative subpoena and for whom he had the corresponding patient profile. See Tr. 1054-55, 2217, 2224.\53\ For this reason, and as noted supra, those are the only patients whose prescription evidence I have considered in evaluating the Government's charges pursuant to 21 CFR 1306.04(a). Accordingly, I reject the CALJ's recommended finding that Professor Doering lacked sufficient facts to render his opinions with respect to those patients. --------------------------------------------------------------------------- \53\ After reviewing prescription evidence and patient profiles for over 20 of Respondents' customers and testifying that he saw no notes or comments resolving red flags of diversion with respect to those customers, Professor Doering was asked ``How many more did you need to be able to see to determine whether or not [Respondents] kept the notes and comments?'' Tr. 2217. He responded: ``Well, technically speaking I'd have to look at each and every one to be sure that they exist. I think the logical conclusion is these profiles typically don't have such a section.'' Id. On this basis, the Government argues that a reasonable inference could be made that Trinity II never documented resolution of red flags of diversion-- even for customers for whom patient profiles were not produced. Govt. Except. at 17 & n.5. I need not make this inference here because, as set forth infra, the prescription evidence and patient profiles that are already part of the record in this case are more than sufficient to establish by a preponderance of the evidence that Trinity II violated its corresponding responsibility pursuant to 21 CFR 1306.04(a). --------------------------------------------------------------------------- Second, the CALJ believed that Professor Doering's expert opinions were not reliable because he had not ``reliably applied'' the relevant principles and methods to the facts of the case, particularly in the context of what constitutes a ``red flag.'' R.D. at 16-17. The CALJ stated that ``nothing in his definition of a `red flag' suggests that it is an indicator of an elevated risk of diversion, or what, if any, steps are required prior to dispensing when a red flag is present.'' Id. at 17 (citing Tr. 865). As a threshold matter, how Professor Doering, or any other expert, defines a red flag is irrelevant. It is the Agency, not an expert, that must decide whether facts in a particular case demonstrate that a pharmacist knowingly filled a prescription that was not issued for a legitimate medical purpose pursuant to 21 CFR 1306.04(a). In this context, the role of the expert is merely to render an opinion of whether a pharmacist's decision to fill a particular prescription given the facts of the case satisfied the state's standard of pharmacy practice--one of several factors the Agency can consider in determining whether a pharmacy violated its corresponding responsibility. And as already noted, the CALJ chose not to make any recommended fact findings related to the Government's charges that Trinity II violated its corresponding responsibility. In any event, the CALJ's characterization of Professor Doering's definition of red flags is at odds with Professor Doering's actual testimony. As noted supra, Professor Doering testified that a red flag is ``a term that's come to be used to give examples to pharmacies of things that might indicate or suggest that prescriptions were filled outside the usual course of pharmacy practice.'' Tr. 864. He also testified that a red flag ``could be indicative of abuse or misuse,'' ``over or under compliance,'' ``drug-drug interactions,'' or a ``forged'' or ``altered'' prescription. Id. at 869. All of these indicators reflect what the CALJ described as ``an elevated risk of diversion.'' Indeed, Professor Doering's testimony about red flags of diversion that pharmacists must look for was consistent with what the relevant Florida Administrative Rule requires pharmacists to look for as part of their prospective drug use review. See Florida Administrative Code Rule 64B16-27.810. In one example, he testified that red flags indicating ``over-utilization'' of a controlled substance ``touches upon some of the other issues, which means clinical use or abuse, or diversion to some other use.'' Tr. 885-86. ``Over[- ]utilization'' ``might be distributing it to other persons'' (i.e., diversion to others) or ``taking too much of it.'' Id. at 872. Thus, Professor Doering testified that the red flags can indicate both an increased risk of diversion to others, but also a risk of clinical abuse. As I noted supra, he testified about many examples of red flags of diversion in a wide variety of contexts, including those set forth in Rule 64B16-27.810. See Gov. Except. at 18-23. Also, as already noted, and contrary to the CALJ's characterization, Professor Doering repeatedly testified about what pharmacists should do when a red flag is present. For example, he testified that, ``before filling any prescription'' as part of the ``prospective drug utilization review, or prospective drug use review,'' pharmacists must resolve the red flags and document such resolution ``on the face of the prescription, on the rear of the prescription, or in the patient profile.'' E.g., id. at 882, 870-73, 881-83, 958-59.\54\ Most importantly, this [[Page 7326]] testimony is consistent with the Florida Administrative Rules that also require resolving red flags and documenting resolution of red flags, which Professor Doering also discussed at length. See Florida Administrative Code Rule 64B16-27.800; Tr. 870-71, 873-75, 881-82, 887- 89, 891, 895-96, 953-55, 957-59, 1015-16, 1169-70, 1353, 1419-20. The fact that his testimony closely tracks the Florida Administrative Rules supports, rather than undermines, the reliability of his expert opinion. As a result, I reject the CALJ's belief that (1) the expert's definition of a red flag is relevant and (2) in any event, that the expert failed to define a red flag as an indicator of an elevated risk of diversion and set forth the steps a pharmacist must follow prior to filling or dispensing. --------------------------------------------------------------------------- \54\ As the Government notes in its Exceptions, Professor Doering testified at length about the steps that a pharmacist must follow before filling a controlled substance prescription presenting a red flag of diversion. Govt. Except. at 25-26. He testified that resolving the red flag during ``[d]rug utilization review means using the knowledge, skill, judgment, and experience of the pharmacist to evaluate all the information that might be in front of them regarding the use of this particular prescription, under this particular prescription, in this particular patient.'' Tr. 870-71. He testified that this review ``would mean consulting the patient profile, which might have a list of other drugs that a patient may be on[,] . . . a list of allergies or other adverse effects that patients may have had from the drug. It may have other idiosyncrasies[,] . . . [it] might have important demographic information, such as [an] address . . . information indicating other doctors, who may have or are seeing this very patient. It would also have information on dates of fills or refills, looking for . . . perhaps over[-]utilization of the medication.'' Id. at 871. He also testified that pharmacists should resolve red flags by reviewing the notes and comments field of the patient profile, consulting with the patient and/or the prescribing physician, and consulting Florida's Prescription Drug Monitoring Program, ``E-FORCSE.'' Id. at 873-74, 887-89, 895-96, 953-55, 957, 1015-16, 1419-20. --------------------------------------------------------------------------- Third, the CALJ stated that Professor Doering was unreliable because the CALJ believed that Professor Doering stated that ``it is the (presumably subjective) judgment of each individual pharmacist that governs whether a red flag is adequately resolved.'' R.D. at 17. Aside from the fact that the transcript fails to reflect Professor Doering making this statement,\55\ the CALJ confuses the question of whose judgment should be used in filling a prescription with the question of whether Trinity II's pharmacists' decisions to fill certain prescriptions satisfied their corresponding responsibility.\56\ The notion that pharmacists must use their professional judgement when filling prescriptions is neither new nor remarkable. Agency precedent, federal law, and Florida law uniformly require pharmacists to use their professional judgment in deciding whether to fill a prescription and dispense controlled substances.\57\ Accordingly, I reject the CALJ's view that Professor Doering's testimony was unreliable simply because he testified that pharmacists must use their professional judgment--a statement that is consistent with Agency precedent.\58\ --------------------------------------------------------------------------- \55\ As the Government states, ``[t]he Presiding Officer simply read the word `subjective' into Professor Doering's testimony when it did not exist.'' Govt. Except. at 27. \56\ On the latter question, the CALJ also expressed confusion about whether Professor Doering was ``speaking from the shoes of the pharmacists'' or from his view of ``looking from the shoes of the expert'' in determining what the Florida standard of practice should be in resolving red flags. R.D. at 17 (quoting Tr. 881). However, the record is clear that Professor Doering testified that his opinion was that Florida law applicable to all pharmacists governs whether a pharmacist adequately resolved a red flag before filling a prescription. See, e.g., Tr. 868-79. \57\ See, e.g., Ralph J. Bertolino, 55 FR 4,729, 4,730 (1990) (``The statutory scheme plainly requires that pharmacists use common sense and professional judgment. Where [pharmacists'] suspicions are aroused as reasonable professionals . . . pharmacists are called upon to obey the law and refuse to dispense.''); id. (``When [pharmacists'] suspicions are aroused as reasonable professionals,'' they must at least verify the prescription's propriety, and if not satisfied by the answer they must ``refuse to dispense''); Medicine Shoppe-Jonesborough, 300 Fed. Appx. 409, 412 (6th Cir. 2008) (same) (quoting Bertolino); United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979) (``What is required by [a pharmacist] is the responsibility not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows that the issuing practitioner issued it outside the scope of medical practice''); Florida Bd. of Pharm. R. 64B16-27.810 (requiring a pharmacist ``upon recognizing any of the [issues]'' to ``take appropriate steps to avoid or resolve the potential problems which shall, if necessary, include consultation with the prescriber''). \58\ In its Exceptions, the Government also notes that ``the Presiding Officer's finding is largely immaterial in this case because the evidence established that Respondents' pharmacists did not exercise any judgment at all with respect to the prescriptions containing red flag(s).'' Govt. Except. at 29. Given that I have already found facts establishing that Trinity II failed to document or otherwise establish that its pharmacists resolved red flags of diversion before filling prescriptions, see infra, the Government's point is well-taken. --------------------------------------------------------------------------- Fourth, the CALJ stated his belief that ``Professor Doering's reliance upon the subjective judgment of individual pharmacists as a Florida state standard'' undermined the reliability of his testimony. R.D. at 19. The CALJ contended that Professor Doering ``conceded that pharmacists in Florida can and do disagree on whether particular red flags are resolvable,\59\ when a refill constitutes an `early refill,' when duplicative therapy is present, and whether a particular combination of medications constitutes a `drug cocktail.' '' Id. (citing Tr. 1828-29, 1967). This largely academic testimony (during cross-examination) about how reasonable pharmacists may differ on where to draw the line regarding certain red flags in the abstract is interesting but not relevant to the question that Professor Doering was actually called on as an expert to answer: Whether prescriptions like the ones in this case presented red flags of diversion. --------------------------------------------------------------------------- \59\ See also R.D. at 26-27. The CALJ's concern regarding Professor Doering's testimony about ``whether particular red flags are resolvable'' is particularly irrelevant where, as here, I have limited my fact findings to customers where the Government established by a preponderance of the evidence that Trinity II failed to document that it resolved any red flags of diversion. --------------------------------------------------------------------------- And regarding prescriptions like those in this case, Professor Doering's testimony about what the standard of practice for Florida pharmacists was regarding early fills, duplicative therapy, and ``drug cocktails'' was clear. For example, Professor Doering testified that ``early fills'' or ``early refills'' are red flags of over-utilization, and that when there is a fill or refill was more than 2-3 days early, that ``early fill'' or ``early refill'' would be a red flag. See Tr. 989-991, 992 (``when there is a pattern of early refills, it makes one very concerned that there is over-utilization''), 1009. Although reasonable pharmacists in Florida may disagree whether the line should be drawn at two or three days, those are not the early fills in this case. In this vein, Professor Doering testified that pharmacists would not disagree that prescriptions filled or refilled eight to 17 days early, as the prescription evidence shows Trinity II routinely did, were red flags of diversion that pharmacists in Florida must resolve before filling. E.g., Tr. 1004-05, 2106-2110. Professor Doering also testified that there would be no disagreement among reasonable pharmacists that when a patient simultaneously presents prescriptions for the ``drug cocktail'' of an opioid, a benzodiazepine, and a muscle relaxant, then this is a red flag that a Florida pharmacist must resolve. Id. at 2111. Likewise, he testified that when the same customer simultaneously presents two prescriptions for different immediate-release opioids with the same or similar instructions, this too is a red flag of duplicative therapy that a pharmacist must resolve before filling. Id. Notably, Professor Doering's testimony is consistent with the same standard of care requirements set forth in Florida Administrative Rule 64B16-27.810--a fact that bolsters the reliability of his expert opinion. See ALJ Ex. 38. Accordingly, I reject the CALJ's belief that Professor Doering's testimony about the prescriptions in this case was unreliable. Fifth, the CALJ found Professor Doering's testimony unreliable because he failed to take into account the ``E- [[Page 7327]] FORSCE'' printouts that the DIs had provided to him before rendering his opinions. R.D. at 22 (``although he testified that checking E- FORSCE is a necessary step in the process for the pharmacist, he rendered his opinions without taking into consideration any E-FORSCE printouts that were provided to him'' and would ``arguably have been relevant in reaching a determination as whether a bona fide red flag was actually present''). While the CALJ contends that E-FORSCE printouts for specific Trinity II customers would have ``arguably'' been relevant in identifying a red flag,\60\ the CALJ failed to identify any prescription in this case where it would have been relevant to identifying a red flag.\61\ --------------------------------------------------------------------------- \60\ The CALJ concedes that ``this aspect of the case certainly has no impact on whether the pharmacists' attempts at red flag resolution were adequately documented.'' R.D. at 22. In that vein, the Government observed that ``the issue the Presiding Officer should have focused on was the fact that Respondents' pharmacists were not checking E-FORSCE to resolve the red flags that were seen in the prescriptions themselves (as well as the patient profiles and dispensing reports), as evidenced by the lack of any documentation on the prescriptions and the patient profiles of E-FORSCE queries.'' Govt. Except. at 40 n.9. \61\ Indeed, even if Professor Doering had received E-FORSCE printouts for specific Trinity II customers, they would not have rendered red flags presented by the actual prescriptions less suspicious. On the contrary, if anything, they may have shown additional red flags--such as doctor-shopping--that may not have been presented by the prescription evidence already in the case. --------------------------------------------------------------------------- Moreover, the Government noted in its Exceptions that the CALJ failed to point out that Professor Doering never received E-FORSCE printouts for specific Trinity II customers--the printouts the CALJ opined would have been relevant to his opinions. Gov. Except. at 39; Tr. 553 (DI testified that he ``did not run a specific [E-FORSCE] query for each patient''). Instead, the DIs only provided Professor Doering with E-FORSCE printouts of the prescriptions filled by Trinity II, which was already reflected in (and hence redundant to) Trinity II's own prescriptions, dispensing reports, and patient profile. See Tr. 605 (DI testifying that ``[w]e try not to use E-FORSCE, we prefer to use the dispensing report because it's a more accurate reflection of the pharmacies. Because it's their records. It's what they have in their system.''). Thus, I reject the CALJ's belief that Professor Doering's failure to take into account the E-FORSCE printouts of the prescriptions filled by Trinity II made his testimony unreliable. He correctly based his opinions, instead, on the prescriptions, dispensing reports, and patient profiles on which those E-FORSCE printouts depend. Sixth, the Government objected to the CALJ's belief that Professor Doering was unreliable because ``he was consistently unable to accurately calculate the number of days between two filled prescriptions, even though supplied on the witness stand with a calendar, a pad, a pencil, as much time as he needed, and repeated prompting and re-prompting by the Government.'' R.D. at 23. Even assuming, arguendo, that the CALJ's belief is correct, the CALJ failed to explain why it has any bearing on whether Professor Doering's expert opinions are reliable. Professor Doering testified that his trouble in making these calculation by hand, on the stand, stems from the fact that today's pharmacists rely on a computer to make them automatically. Tr. 1368.\62\ More importantly, the calculation of ``the number of days between two filled prescriptions'' is a question of fact, not of expert opinion.\63\ Thus, even if Professor Doering had little trouble making these calculations, it would not have obviated the Agency's independent requirement to make or to verify them as fact. Cf. Gov. Except. at 40 (``the Administrator does not even need Professor Doering's calculations to ascertain whether the prescriptions were early''). As already noted, the CALJ failed to make any recommended fact findings regarding the early fill allegations in this case, much less findings that conflicted with those made by Professor Doering. Thus, I reject the CALJ's belief that Professor Doering was unreliable based on his early fill calculations at the hearing. --------------------------------------------------------------------------- \62\ The following exchange at the hearing makes this point clear: Judge Mulrooney: . . . Would you say that it's difficult to count up these days as a pharmacist, particularly if you're in a busy retail pharmacy? [Professor Doering]: It's not difficult at all. Number 1, the computer does it for you. Number 2, they're not under the bright lights, under the stress of what I am. Although I may appear to be calm and cool, this is a stressful thing for me. Tr. 1368. At this point, Professor Doering had already been testifying continuously for almost two days. In addition to the pressure of testifying on the stand, Professor Doering appeared to suffer from witness fatigue, having testified for several days in a row in response to a similar pattern of questions during direct examination over and over again. For this reason, it is not surprising that this fatigue caused him to misstate whether he had certain documents in one instance, and to respond in ``automatic mode'' in another instance. See R.D. at 30- 33. It is not uncommon for a witness who testifies for most of 5 days (as reflected in more than 1,400 pages of an almost 2,400-page transcript) to make an accidental misstatement. While the CALJ could reasonably find particular erroneous testimony unreliable based on such mistakes, it would not be reasonable to find the entirety of Professor Doering's testimony unreliable under the APA on this basis. \63\ In its Exceptions, the Government further noted that the fact that Professor Doering needed more than one attempt to make a particular calculation in the examples cited by the CALJ (R.D. at 23-24) does not change the Government's allegation that the prescriptions at issue ``were extremely early, in most instances anywhere from 8 to 15 days early, and Professor Doering reliably testified that they were each early.'' Govt. Except. at 40. I agree, and as I note infra, what is important is the fact that most (if not all) of the relevant fills and refills are so early that Trinity II should have resolved these red flags before filling the prescriptions. --------------------------------------------------------------------------- Finally, Trinity II contends that if the Agency were to find Professor Doering unreliable in this case, then it would call into question the CALJ's previous finding in Holiday CVS that his consistent expert testimony there was reliable and accorded evidentiary weight. E.g., ALJ Ex. 41, at 20 (``Holiday CVS and its progeny all find their basis in the testimony of Doering.''), 20 n.5 (``[I]n the event the Court finds Doering's testimony to be not credible or appropriate to rely upon, it likewise calls into question the validity of Holiday CVS due to its reliance on his testimony. The effect would be akin to removing a bottom floor card in a house of cards.'').\64\ In response, the CALJ states that the ``Agency's legal conclusions in its prior final orders stand unaffected by a decision regarding the weight that should be accorded expert testimony in this matter; likewise, expert testimony reflected in prior final orders has no place in an evaluation of the evidence in this matter.'' R.D. at 15-16 n.51. Insofar as the Agency's legal conclusions in prior final orders depend on expert testimony that is inconsistent with Professor Doering's testimony in this case, I agree with the CALJ that the legal conclusions in those cases are not called into question. --------------------------------------------------------------------------- \64\ Trinity II's argument implies that allowing the CALJ to find the same expert testimony reliable in one case (Holiday CVS), yet unreliable in this case, calls into question whether such findings are arbitrary and capricious. Although I agree with Trinity II and the Government that some of Professor Doering's testimony in Holiday CVS is consistent with his testimony in this case, I do not consider whether the CALJ's inconsistent reliability findings are arbitrary and capricious because I find, consistent with the CALJ's finding in Holiday CVS, that Professor Doering's testimony in this case is reliable. --------------------------------------------------------------------------- However, I disagree with the CALJ's claim that expert testimony accepted in prior final orders has no place in evaluating the weight to be given to expert testimony in this matter. Where Professor Doering's testimony in this case is consistent with expert testimony previously found reliable by the Agency, then I do find that prior consistent testimony relevant to an evaluation of the reliability of Professor Doering's testimony in this case. Here, for example, the Government contends that his ``testimony about the drug [[Page 7328]] utilization review obligations of a pharmacist'' regarding early fills ``was consistent with the expert testimony that has been credited by [the] Agency in previous final decisions.'' ALJ Ex. 40a, at 73 (citing Grider #1 & Grider #2 and East Main Street Pharmacy), 86 (Professor Doering's testimony regarding the early fills in this case ``was consistent with the testimony of other experts in Agency precedent'') (citing Grider #1 & Grider #2 and The Medicine Dropper), 104 (Professor Doering's testimony regarding therapeutic duplication ``was again consistent with the testimony of another pharmacist expert that was credited by the Agency in a previous decision'') (citing Grider #1 & Grider #2 and Medicine Shoppe Jonesborough). Given Trinity II's further claim that Professor Doering's testimony is consistent with his own accepted testimony in Holiday CVS ``and its progeny,'' the fact that Professor Doering's testimony in this case is consistent with accepted expert testimony in the Agency's prior decisions is not in dispute. I find that this undisputed fact bolsters the reliability of Professor Doering's expert testimony--further undermining the CALJ's determination that in this case his testimony is not reliable. Accordingly, for all the foregoing reasons, I find that Professor Doering's expert testimony in this case was reliable under the APA. The Public Interest Factors Under the Controlled Substances Act (``CSA''), ``[a] registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.'' 21 U.S.C. 824(a)(4). In the case of a retail pharmacy, which is deemed to be a practitioner, see id. Sec. 802(21), Congress directed the Attorney General to consider the following factors in making the public interest determination: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing or conducting research with respect to controlled substances. (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. Sec. 823(f). ``[T]hese factors are . . . considered in the disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I ``may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether'' to suspend or revoke an existing registration. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ``need not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482.\65\ --------------------------------------------------------------------------- \65\ In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's or applicant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, findings under a single factor can support the revocation of a registration or denial of an application. See MacKay, 664 F.3d at 821. --------------------------------------------------------------------------- Under the Agency's regulation, ``[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. [Sec. ]824(a) . . . are satisfied.'' 21 CFR 1301.44(e). In this matter, while I have considered all of the factors, the Government's evidence in support of its prima facie case is confined to factors two and four.\66\ I find that the record taken as a whole provides substantial evidence that Trinity II's pharmacists violated their corresponding responsibility pursuant to 21 CFR 1306.04(a) when they dispensed many of the prescriptions at issue. I also find that the Government has established by substantial evidence that Trinity II's pharmacists filled prescriptions outside the usual course of their professional practice in violation of 21 CFR 1306.06. --------------------------------------------------------------------------- \66\ As to factor one, there is no evidence that the Florida Department of Health has either made a recommendation to the Agency with respect to Trinity II, or taken any disciplinary action against it. See 21 U.S.C. 823(f)(1). However, even if true, this finding is not dispositive of the public interest inquiry. See Mortimer Levin, 57 FR 8680, 8681 (1992) (``[T]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.''). Accordingly, this factor is not dispositive either for, or against, the revocation of Trinity II's registration. Paul Weir Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (DC Cir. 2008)). As to factor three, there is no evidence that Respondent, its owner, its manager, or any of its pharmacists, has been convicted of an offense under either federal or Florida law ``relating to the manufacture, distribution or dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, ``the absence of such a conviction is of considerably less consequence in the public interest inquiry'' and is therefore not dispositive. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). The Government did allege, in the alternative in the Show Cause Order's eighth charge, misconduct with respect to factor five regarding Trinity II's filling and dispensing of a controlled substance in an amount that was at least five times the amount prescribed. Because I consider this evidence in evaluating factors two and four, I deem it unnecessary to separately address this misconduct under factor five. --------------------------------------------------------------------------- Accordingly, I conclude that the Government has established that Trinity II committed numerous acts which render its continued ``registration inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). Because I further agree with the ALJ's finding that Trinity II has not accepted responsibility for its misconduct, I also agree with the ALJ that it has not rebutted the Government's prima facie showing. Because I find that Trinity II's misconduct is egregious, I will order that Trinity II's registration be revoked and that any pending application be denied. Factors Two and Four--The Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances The Allegations Pursuant to 21 CFR 1306.04(a) ``Except as authorized by'' the CSA, it is ``unlawful for any person [to] knowingly or intentionally . . . manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance.'' 21 U.S.C. 841(a)(1). Under the Act, a pharmacy's registration authorizes it ``to dispense,'' id. Sec. 823(f), which ``means to deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of, a practitioner, including . . . the packaging, labeling, or compounding necessary to prepare the substance for such delivery.'' Id. Sec. 802(10). ``The terms `deliver' or `delivery' mean the actual, constructive, or attempted transfer of a controlled substance.'' Id. Sec. 802(8). Thus, a pharmacy dispenses a controlled substance when it attempts to transfer a controlled substance to an ultimate user pursuant to a lawful [[Page 7329]] prescription by packaging or labeling a controlled substance for such delivery. The CSA's implementing regulations set forth the standard for a lawful controlled substance prescription. 21 CFR 1306.04(a). Under the regulation, ``[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.'' Id. Thus, `` `a practitioner is unauthorized to dispense a controlled substance if the prescription either lacks a legitimate purpose or is outside the usual course of professional practice.' '' United States v. Bennett, 874 F.3d 236, 245 (5th Cir. 2017) (quoting United States v. Armstrong, 550 F.3d 382, 397 (5th Cir. 2008), overruled on other grounds by United States v. Balleza, 613 F.3d 432, 433 n.1 (5th Cir. 2010)). Continuing, the regulation provides that: [t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription . . . shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.\67\ --------------------------------------------------------------------------- \67\ As the Supreme Court has explained, ``the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, the provision also bars doctors from peddling to patients who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). Id. (emphasis added). Thus, 1306.04(a) distinguishes between ``prescribing and dispensing'' and ``filling'' controlled substances, and who has responsibility for each function. Under this regulation, prescribing physicians are responsible for the ``proper prescribing and dispensing of controlled substances,'' and pharmacists bear a corresponding responsibility for ``filling'' only lawful prescriptions issued for a legitimate medical purpose. As the Agency has made clear, to prove a violation of a pharmacist's corresponding responsibility, the Government must show that the pharmacist acted with the requisite degree of scienter, i.e., that the pharmacist ``knowingly'' filled a prescription that was not issued for a legitimate purpose. See JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 FR 28667, 28669 (2015). Thus, the Government can prove a violation by showing either that the pharmacist filled a prescription (1) notwithstanding his/her actual knowledge that the prescription lacked a legitimate medical purpose, or (2) being willfully blind to (or deliberately ignorant of) the fact that the prescription lacked a legitimate medical purpose. See id. at 28671-72. As to establishing that a pharmacist acted with ``willful blindness, proof is required that: `(1) the defendant must subjectively believe that there is a high probability that a fact exists and (2) the defendant must take deliberate actions to avoid learning of that fact.' '' Id. at 28672 (quoting Global-Tech Appliances, Inc., v. SEB S.A., 563 U.S. 754, 769 (2011)).\68\ --------------------------------------------------------------------------- \68\ Courts have long held that when prescriptions are clearly not issued for legitimate medical purposes, a pharmacist may not intentionally close his eyes and thereby deliberately avoid actual knowledge of the real purpose of the prescription, thereby filling them with impunity. See United States v. Kershman, 555 F.2d 198 (8th Cir. 1977). See also United States v. Lawson, 682 F.2d 480 (4th Cir. 1982) (``The key element of knowledge may be shown by proof that the defendant deliberately closed his eyes to the true nature of the prescription''). --------------------------------------------------------------------------- Here, the Government makes no claim that any of Trinity II's pharmacists dispensed the prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, relying primarily on Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 77 FR 62316, 62341 (2012), the Government argues that a pharmacist violates the corresponding responsibility rule when he/she fills a controlled substance prescription (1) in the face of ``red flags'' or circumstances that do or should raise a reasonable suspicion as to the validity of a prescription and (2) without taking steps to resolve the red flag and ensure that the prescription is valid. ALJ Ex. 40a, at 66- 68. In this case, the Government argues that Trinity II's pharmacists violated 21 CFR 1306.04(a) by filling prescriptions for drugs such as oxycodone and hydromorphone, even though Trinity II's pharmacists knew that these prescriptions presented various ``red flags'' of diversion which were never resolved. Id. at 68. Notably, Florida law requires pharmacists to identify and resolve certain red flags for every prescription presented to them during a prospective drug use review. Florida Administrative Code Rule 64B-16- 27.810, entitled ``Prospective Drug Use Review,'' requires pharmacists to ``review the patient record and each new and refill prescription presented for dispensing in order to promote therapeutic appropriateness.'' ALJ Ex. 38 (Fla Admin Code r. 64B16-27.810(1)). This rule further requires that a pharmacist identify such issues as: ``[o]ver-utilization,'' ``[t]herapeutic duplication,'' ``[d]rug-drug interactions,'' ``[i]ncorrect drug dosage or duration of drug treatment,'' and ``[c]linical abuse/misuse.'' Id. Importantly, ``[u]pon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the potential problems which shall, if necessary, include consultation with the prescriber.'' Id. at 64B16-27.810(2). Thus, Trinity II's pharmacists violate Florida law if they fail to identify and resolve the red flags that are part of the prospective drug use review set forth in Rule 64B16-27.810. And if they knowingly fill prescriptions without resolving these red flags during this review, then they violate their corresponding responsibility under 21 CFR 1306.04(a). See, e.g., Grider Drug #1 & Grider Drug #2, 77 FR at 44097-98, 44100 (pharmacies violated their corresponding responsibility because they ``did not do prospective DUR [drug utilization review] with respect to any of the six patients even though this is required by the Kentucky Board of Pharmacy's rules''); East Main Street Pharmacy, 75 FR at 66157 & n.31 (pharmacists required to recognize and consider red flags as part of the prospective drug utilization review ``before they dispense a prescription''). Moreover, at all times relevant to this case, Florida law also required pharmacists to document resolution of a red flag. Rule 64B16- 27.800 \69\ required that ``[a] patient record system . . . be maintained by all pharmacies for patients to whom new or refill prescriptions are dispensed'' and that the ``system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing.'' Fla. Admin. Code r. 64B-16-27.800. This rule also required that the pharmacy maintain ``[a] list of all new and refill prescriptions obtained by the patient at the pharmacy . . . during the two years immediately preceding the most recent entry'' and include the ``prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber.'' Id. at 64B-16-27.800(1)(e). --------------------------------------------------------------------------- \69\ Because the prescriptions at issue in this case are dated from February 2012-February 2014, I apply the version of Rule 64B16- 27.800 that applied prior to its amendment on March 18, 2015. --------------------------------------------------------------------------- Most significantly, the rule required that the record include the [[Page 7330]] ``[p]harmacist['s] comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.'' Id. at 64B-16-27.800(1)(f). And the rule also required that the pharmacist make ``a reasonable effort . . . to obtain from the patient . . . and record any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs . . . being used by the patient which may relate to prospective drug review,'' id. at 64B-16-27.800(2), which is the ``prospective drug use review'' for red flags required by 64B-16- 27.810. Finally, the rule required that ``[t]he pharmacist . . . record any related information indicated by a licensed health care practitioner.'' Id. at 64B-16-27.800(2). All of these ``patient record[s]'' must be ``maintained for a period of not less than two years from the date of the last entry in the profile record.'' Id. at 64B-16-27.800(4). Thus, Florida's laws specifically require a pharmacist to document in the patient record his/her comments relevant to the patient's drug therapy and ``other information peculiar to the patient'' or drug, as well as ``any related information'' provided by the patient's physician in the patient's ``profile record.'' Although such patient records provide relevant evidence in assessing whether a pharmacist resolved the suspicion created by the prescriptions at issue here, the Government only obtained and introduced patient profiles related to the 23 Trinity II customers identified in its December 4, 2014 subpoena. GX 98.\70\ As noted supra, the Government established by a preponderance of the evidence that Trinity II's pharmacists failed to resolve red flags regarding these patients because the prescriptions, dispensing logs, and patient profiles contained no documentation that Trinity II resolved the red flags of diversion presented by these customers' prescriptions. As a result, I further find that the Government established by a preponderance of the evidence that Trinity II's pharmacists filled at least some of the prescriptions knowing that they lacked a legitimate medical purpose. --------------------------------------------------------------------------- \70\ In Superior Pharmacy I and II, I found the Government's evidence, which was limited to the prescriptions (which contained no documentation that the red flags were resolved) and its Expert's testimony, insufficient to establish that the pharmacists violated their corresponding responsibility. 81 FR 31310 (2016). --------------------------------------------------------------------------- For example, the evidence shows that Trinity II knowingly filled controlled substances prescriptions well before the customer should have exhausted the supply obtained from a previous prescription filled by Trinity II. For one customer, J.T., Trinity II filled prescriptions for oxycodone 30 mg 14-16 days early on nine occasions in each of nine consecutive months--resulting in a cumulative effect of Trinity II filling and delivering \71\ 135 extra days of oxycodone 30 mg (the equivalent of 1,080 extra tablets) for J.T. from March 2012-November 2012. While it is conceivable that a single early fill of a customer's prescription could be an unwitting mistake (albeit, at 16 days, a significant one) by one of Trinity II's pharmacists, it is not remotely credible that Trinity II could innocently repeat the same mistake nine times in nine consecutive months without knowing that the prescriptions lacked a legitimate medical purpose. Trinity II's pharmacists made no notes or comments on the front or back of these prescriptions, in the dispensing log, or in the patient profile explaining why J.T. should receive 135 extra days of oxycodone 30 mg. This lack of any explanation further highlights Trinity II's willingness to ignore the fact that J.T.'s early prescriptions lacked a legitimate medical purpose. This evidence of diversion of 135 extra days of a schedule II drug like oxycodone is so egregious that I find that it is more than sufficient to establish by a preponderance of the evidence that Trinity II's pharmacists were willfully blind \72\ to the fact that J.T.'s prescriptions lacked a legitimate medical purpose when its pharmacists filled them 14-16 days early in each of nine consecutive months. On this basis alone, I find that Trinity II violated its corresponding responsibility under 21 CFR 1306.04(a). Indeed, the Agency has previously found violations of the corresponding responsibility when pharmacists knowingly filled prescriptions less than 15 days early.\73\ --------------------------------------------------------------------------- \71\ Given that J.T. came back on a monthly basis, it is a reasonable inference that the drugs were actually delivered to him. \72\ Moreover, this evidence would likely be sufficient to show that Trinity II had actual knowledge that these prescriptions lacked a legitimate medical purpose. However, the Government did not allege that Trinity II had such actual knowledge, making such a finding unnecessary. \73\ E.g., Grider Drug #1 and Grider Drug #2, 77 FR at 44098 (finding a violation of the corresponding responsibility where the refills for one patient were ``more than five days early, and some as much as nine to twelve days early''); East Main Street Pharmacy, 75 FR 66149, 66159 (2010) (accepting expert opinion that a refill of controlled substance ``two weeks early'' is a ``blatant example[ ] of abuse and diversion''); cf. Jeri Hassman, 75 FR 8194, 8201, 8229, 8231 (2010) (finding prescriptions were not for a legitimate medical purpose where approximately half of the controlled substance ``prescriptions were refilled five days early, with some being refilled as early as eight or nine days before the previous prescription would have run out''). --------------------------------------------------------------------------- Trinity II's pattern of early fills and refills was not limited to one customer. The evidence establishes that Trinity II filled prescriptions for customer M.A. for hydromorphone 8 mg six to seven days early on eight occasions in eight consecutive months--resulting in the cumulative effect of Trinity II filling and providing 50 extra days of hydromorphone 8 mg for M.A. from May 2013-December 2013. Trinity II also filled a prescription for customer J.G. for lorazepam 2 mg nine days early on May 28, 2013. In addition, Trinity II filled and refilled J.G.'s prescriptions for Xanax 2 mg early on six occasions between October 10, 2012 and June 12, 2013--five days early, six days early, eight days early, 10 days early (twice), and 17 days early. The evidence also establishes that Trinity II filled prescriptions for customer L.H. for hydromorphone 8 mg eight days early on June 28, 2012 and nine days early on July 3, 2012.\74\ As with customer J.T., Trinity II's failure to document anywhere on the relevant prescriptions, dispensing logs, or patient profiles why M.A., J.G., or L.H. should receive early fills and refills of these controlled substances further underscores Trinity II's pharmacists' knowledge that they were filling illegitimate prescriptions and violating their corresponding responsibility under 21 CFR 1306.04(a). --------------------------------------------------------------------------- \74\ These are only the most egregious examples of early filling of controlled substances by Trinity II in violation of its corresponding responsibility under Sec. 1306.04(a). As I described in my fact findings, Trinity II also filled a prescription for Dilaudid 8 mg nine days early for customer D.E. without explanation. --------------------------------------------------------------------------- In his Recommended Decision, the CALJ declined to find that Trinity II violated its corresponding responsibility under Sec. 1306.04(a) based on these early fills because of his belief that the determination of when a fill occurred must be based on ``the date when the customer picked up their medications,'' not when Trinity II filled the prescriptions. R.D. at 25. ``An early refill only logically bears upon this consideration [of over-utilization or under-utilization] at the moment the medication is being dispensed to the patient, not when a [fill] sticker is prepared by the pharmacy.'' Id. The CALJ offered the following explanation: While there may be some logical appeal to the principle that some or most of the steps required in a valid prospective drug use review should (and generally will) be completed prior to the preparation of the pharmacy fill sticker, no shred of that rationale could logically be applied to justify deeming the fill sticker preparation date as [[Page 7331]] equivalent to the date that a medication was dispensed (delivered/ transferred) to a patient for early refill purposes. Id. The CALJ cites to no authority (and I am aware of none) for the proposition that the date when the customer actually receives the controlled substance should be used to determine whether a pharmacy's early fill of a prescription violates its corresponding responsibility under 21 CFR 1306.04(a).\75\ --------------------------------------------------------------------------- \75\ Likewise, Trinity II contends that the date ``when the prescription was actually dispensed to the patient . . . and not the fill date, is the operative evidence of whether there was an improper dispensing event.'' Resp. Except. at 4; ALJ Ex. 41 at 16-17 (``Doering was basing his often incorrect counting on the date the prescription was filled, without having any knowledge as to when the customer actually picked up the prescription''). Trinity II claims that its ``electronic records included patient signature logs for when the prescription was actually dispensed to the patient,'' Resp. Except. at 4, and as a result of this claim, the CALJ averred that the Government's expert ``could not determine the date the patients picked up their medications because he had never been provided with the pharmacy's disbursement log.'' R.D. at 25. In fact, neither the CALJ nor Trinity II cite to any authority (and I am aware of none) supporting their position that the date when the customer actually receives the controlled substance should be used to measure whether a pharmacy lawfully filled a prescription early under 21 CFR 1306.04(a). To the extent that the CALJ and Trinity II rely on the definition of dispense, I discuss infra why such reliance is misplaced. Most importantly, the notion that the fill date is equivalent to the pick-up date is belied by Sec. 1306.04(a)'s plain language, which --------------------------------------------------------------------------- states in pertinent part: A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription . . . shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. Id. (emphasis added). Section 1306.04(a) expressly requires pharmacists to identify and resolve suspicions that a prescription is illegitimate (like a prescription presented too early) before ``knowingly filling such a purported prescription.'' It does not allow a pharmacist to delay completing a prospective drug use review to confirm a suspicious prescription's legitimacy until ``a medication was dispensed (delivered/transferred) to a patient''--an event that necessarily occurs after the pharmacist has ``filled'' the prescription and which may even occur without the pharmacist's involvement at all. See R.D. at 25.\76\ Such a rule would lead to the nonsensical result of allowing pharmacists to knowingly fill controlled substance prescriptions lacking a legitimate purpose so long as the pharmacist had not yet actually delivered them to the customer--directly contradicting Sec. 1306.04(a)'s express prohibition. --------------------------------------------------------------------------- \76\ The CALJ surmised that, unless the pharmacist's corresponding responsibility is delayed until ``the moment the medication is being dispensed to the patient,'' then ``any ethical Florida pharmacist who works ahead and prepares medications in advance of their eligibility to be picked up by the patient due to staffing or some other benign business-related issue would stand in unavoidable conflict with the standard of pharmacy practice in Florida merely by virtue of the date on the fill sticker.'' R.D. at 25. Aside from the fact that the record does not show that Trinity II routinely filled prescriptions ``in advance of their eligibility to be picked up,'' no Agency precedent supports the CALJ's hypothetical as some kind of exception to a pharmacist's corresponding responsibility. In fact, Sec. 1306.04(a) precludes the CALJ's hypothetical by imposing a corresponding responsibility on the pharmacist at the time of ``filling,'' not at some point after filling the prescription. Thus, to fulfill their corresponding responsibility under Sec. 1306.04(a), pharmacists must identify and resolve any red flags of diversion presented by controlled substance prescriptions (e.g., by completing the prospective drug use review that Florida law required Trinity II to do) before filling them in order to avoid ``knowingly filling'' illegitimate prescriptions. --------------------------------------------------------------------------- And to the extent the CALJ's view is based on the notion that ``fill'' means ``dispense,'' or that the two terms are otherwise interchangeable, Sec. 1306.04(a)'s plain language precludes that notion as well. Specifically, Sec. 1306.04(a) distinguishes a prescribing practitioner's ``responsibility for the proper prescribing and dispensing of controlled substances'' only for a legitimate medical purpose from the pharmacist's corresponding responsibility not to ``knowingly fill[ ]'' prescriptions that lack a legitimate medical purpose. Filling constitutes part of the process of dispensing, but the CALJ cites to no decision of the Agency (and I am aware of none) holding that filling encompasses every part of the dispensing process, including the actual delivery to the ultimate user. If ``dispensing'' and ``filling'' shared the same meaning, then the Agency would not have used two different terms in the same regulation to describe prescribing practitioners' and pharmacists' respective responsibilities. Instead, the Agency would have simply used the term ``dispense'' to apply to both practitioners and pharmacists throughout the regulation. Thus, I reject the notion that under Sec. 1306.04(a), the term ``fill'' is coextensive with the term ``dispense,'' which includes the delivery of a controlled substance. Just as the operative date for determining whether a prescribing practitioner has met his/her responsibility under Sec. 1306.04(a) is when the physician ``prescribe[s] and dispens[es]'' a controlled substance, the operative date for determining whether a pharmacist has met his/her corresponding responsibility is when the pharmacist ``fills the prescription.'' \77\ And as noted supra, the record establishes by a preponderance of the evidence that the date on Trinity II's fill stickers represent the date when Trinity II's pharmacists filled the prescriptions at issue in this case. Accordingly, Sec. 1306.04(a) required Trinity II to identify and to resolve any suspicions that a particular prescription lacked a legitimate medical purpose before knowingly filling the prescription. --------------------------------------------------------------------------- \77\ Furthermore, even if Sec. 1306.04(a) did impose on pharmacists a corresponding responsibility not to ``knowingly dispense'' an illegitimate prescription (rather than prohibiting them from ``knowingly filling such a purported prescription''), the calculation of an ``early fill'' would be the same. Under the CSA, `` `dispense' means to deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of, a practitioner, including . . . the packaging, labeling, or compounding necessary to prepare the substance for such delivery.'' 21 U.S.C. 802(10). ``The terms `deliver' or `delivery' mean the actual, constructive, or attempted transfer of a controlled substance.'' Id. Sec. 802(8). Thus, the situations in which a pharmacy ``dispenses'' a controlled substance includes when the pharmacy attempts to transfer a controlled substance to an ultimate user pursuant to a lawful prescription ``by packaging or labeling a controlled substance for such delivery''--i.e., before a customer actually receives the prescribed controlled substance. As the Government points out in its Exceptions, even under Florida's definition, ``dispensing'' occurs before the customer receives the prescription. Gov. Except. at 46 (noting that Florida's `dispense' definition in Ch. 465.003(6) unequivocally states that ``the actual sales transaction and delivery of such drug shall not be considered dispensing'') (quoting Fla. Stat. Sec. 465.003(6)). In this case, when Trinity II filled a bottle with a prescribed controlled substance and then affixed a fill label or sticker to the bottle or ``packaging'' containing the controlled substance, Trinity II ``dispensed'' the prescription under the CSA (and arguably Florida law) by ``labeling . . . the substance for'' ``delivery to an ultimate user.'' The record reflects that the date on the fill sticker represents the date when Trinity II packaged or labeled a prescribed controlled substance. And as the CALJ concedes, ``the date on the fill sticker'' is also what the Government used to calculate the date when Trinity II ``filled'' the prescriptions at issue in the case. See R.D. at 25. Accordingly, even under the theory that ``fill'' in Sec. 1306.04(a) really means ``dispense,'' the date on the fill sticker in this case reflects both the ``fill'' date and the ``dispense'' date. --------------------------------------------------------------------------- As noted supra, the evidence of Trinity II's improper early fills alone is sufficient to prove that Trinity II knowingly filled illegitimate prescriptions in violation of its corresponding responsibility under Sec. 1306.04(a). However, there are other [[Page 7332]] examples of suspicious prescriptions nonetheless filled by Trinity II that further prove that Trinity II knowingly filled prescriptions lacking a legitimate medical purpose. For instance, the evidence established that on December 2, 2013, Trinity II knowingly filled two therapeutically duplicative prescriptions for customer R.H.--one for 120 tablets of hydromorphone 8 mg and a second for 120 tablets of oxycodone 30 mg. Each immediate-release opiate prescription had the same dosage instruction to take one tablet every six hours. The Agency has previously found that therapeutically duplicative prescriptions raise a strong suspicion of diversion, and a pharmacist who fails to resolve this suspicion before knowingly filling the prescription violates his/her corresponding responsibility under Sec. 1306.04(a). See The Medicine Shoppe, 79 FR 59504, 59507 & n. 10 (2014) (finding that prescriptions for ``duplicative narcotics'' is evidence of diversion, and knowingly filling such prescriptions without resolving this strong suspicion violates Sec. 1306.04(a)). Here, Trinity II's pharmacists offered no notes or comments on the front or back of these prescriptions, the dispensing log, or in the patient profile explaining why R.H. should have received these two therapeutically duplicative prescriptions. Thus, I find that Trinity II's pharmacist's decision to fill R.H.'s therapeutically duplicative prescriptions without explanation, combined with the early fill evidence already described, also shows that Trinity II knowingly filled prescriptions that lacked a legitimate medical purpose. In addition, the evidence shows that Trinity II knowingly and routinely filled controlled substance prescriptions presented by customers who had traveled great distances to fill them, even though the Agency has previously held that prescriptions by such customers should cause pharmacists to suspect that the prescriptions are not legitimate.\78\ For example, on June 5, 2013, customer S.S. traveled across the entire state of Florida--and approximately 397 miles roundtrip--to obtain from his physician in Tampa and to fill at Trinity II in Clearwater his prescription for 150 tablets of hydromorphone 8 mg. On May 10, 2012, customer C.V. traveled from his home in Port Charlotte, Florida--an approximately 224 miles roundtrip--to obtain from his physician in Tampa and to fill at Trinity II his prescription for 120 tablets of hydromorphone 8 mg. On June 13, 2013 and on July 3, 2013, customer D.E. traveled from his home in Brooksville, Florida--an approximately 119 miles roundtrip--to obtain from his physician in Tampa and to fill at Trinity II identical prescriptions for hydromorphone 8 mg. As already noted, Trinity II also filled the July 3, 2013 prescription nine days early--adding to the suspiciousness of this particular prescription's legitimacy. Nevertheless, even though Trinity II knew the addresses of S.S.,\79\ C.V., D.E., and their respective physicians, the evidence shows that Trinity II failed to document why it nonetheless filled the schedule II controlled substance prescriptions for these customers. --------------------------------------------------------------------------- \78\ E.g., East Main Street Pharmacy, 75 FR 66,149, 66,153 & n. 16, 66,163-66,164 (2010) (finding that traveling nearly 100 miles to pharmacy ``provided further reason to know that the prescriptions were not legitimate'' and that customers traveling 90 miles from their residence to the pharmacy constituted ``travelling great distances to fill their prescriptions'' and concluding ``the fact that the patients were driving so far to get their prescriptions filled `would be a major red flag for any pharmacist'''). \79\ The fill sticker that Trinity II generated and attached to the back of the prescription, the dispensing log, and the patient profile all show S.S.'s address to be in Orange Park, Florida, which is a city located near Jacksonville, Florida. GX 44, at 1, 2, 9; Tr. 1680. However, as noted supra, the front of the prescription lacked S.S.'s address. As a result, the Government alleged that Trinity II's filling of this prescription constitutes an independent violation of 21 CFR 1306.05, which requires, inter alia, all prescriptions for controlled substances to bear the full name and address of the patient and imposes a corresponding liability ``upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.'' Id. at Sec. 1306.05(a), (f). The CALJ also recommended that I find that Trinity II violated 21 CFR 1306.05. See R.D. at 46. At the time these prescriptions were issued, the Agency had made a public pronouncement that, if missing, pharmacists could add a patient's address if state law allowed it. See Superior I and II, 81 FR at 31336 n.58. Here, the Government has produced no evidence that Florida law, the Board of Pharmacy's regulations, or the Board's policy prohibited Trinity II's pharmacists from adding the patient's address to the prescriptions. --------------------------------------------------------------------------- The travel of customer D.W. deserves special mention. He traveled all the way from Wellborn, Florida--an approximately 404 miles roundtrip--to obtain from his physician in Tampa and to fill at Trinity II controlled substance prescriptions for oxycodone 30 mg with ginger and carisoprodol 350 mg on three separate occasions in March, April, and May of 2012. Moreover, D.W. endured the added inconvenience of traveling on different dates to fill his second and third prescriptions of each of these controlled substances--filling two prescriptions for oxycodone with ginger on April 5, 2012 and on May 3, 2012, and two prescriptions of carisoprodol on April 19, 2012 and on May 11, 2012. The fact that D.W. was willing to travel these distances so frequently, and inefficiently, just to fill these controlled substances prescriptions at Trinity II should have highlighted for its pharmacists just how unlikely it was that these prescriptions were filled for a legitimate medical purpose. Nevertheless, even though Trinity II knew how far away D.W. lived, Trinity II failed to document why it still filled D.W.'s highly suspicious controlled substance prescriptions. Accordingly, Trinity II's pharmacists' knowledge of the great distances traveled by these customers, combined with their failure to document why their prescriptions should nonetheless be filled, shows that Trinity II's pharmacists knew that these prescriptions lacked a legitimate medical purpose. The evidence further shows that Trinity II routinely filled ``cocktail prescriptions'' in which customers simultaneously presented multiple prescriptions that would provide the same customer an opioid, a benzodiazepine, and carisoprodol (a muscle relaxant). Trinity II routinely filled these ``cocktail prescriptions'' even though the Agency has identified this combination of drugs in several final decisions as being highly abused prior to the events at issue here. See Paul Volkman, 73 FR 30630, 30637 (2008); see also East Main Street Pharmacy, 75 FR at 66157-58. Nevertheless, on June 27, 2013 and July 23, 2013, Trinity II filled for customer S.S. prescriptions for the same combination of controlled substances--an opioid (hydromorphone 8 mg), a benzodiazepine (alprazolam 2 mg), and carisoprodol 350 mg--on each date. This is also the same customer who had traveled across the entire state of Florida to obtain these prescriptions--further highlighting the suspicious nature of his prescriptions. See supra. Trinity II's pharmacists provided no notes or comments explaining why they knowingly filled these ``cocktail'' prescriptions. Id. Thus, I find that Trinity II's pharmacists' knowledge that these prescriptions reflected a well-established suspicious ``cocktail'' of controlled substances for a customer who they also knew had traveled across the entire state of Florida established that Trinity II's pharmacists knew that these prescriptions lacked a legitimate purpose. Likewise, the record shows that on March 7, 2012, May 3, 2012, and May 31, 2012, Trinity II filled prescriptions for the same ``cocktail'' of controlled substances--an opioid (oxycodone 30 mg), a benzodiazepine (alprazolam 2 mg), and carisoprodol--issued by the same prescribing physician to customers J.Ha. and R.Ha. on each date. And yet, [[Page 7333]] Trinity II's pharmacists never explained why they filled these highly suspicious prescriptions. The suspiciousness of these ``cocktail prescriptions'' was further compounded by the fact that these prescriptions also reflected ``pattern prescribing'' and a lack of individualized drug therapy. Specifically, Trinity II knew that J.Ha. and R.Ha. shared a last name and home address and that their prescriptions were issued (1) by the same prescribing physician, (2) on the same day, and (3) for the same drugs.\80\ Trinity II's pharmacists provided no notes or comments explaining why they knowingly filled these prescriptions. See supra. Thus, I find that the fact that Trinity II's pharmacists' knew that these prescriptions reflected a well- established suspicious ``cocktail'' of controlled substances for two customers who also shared the same last name, address, and prescribing physician, established that Trinity II's pharmacists knew that these prescriptions lacked a legitimate purpose. --------------------------------------------------------------------------- \80\ See East Main Street Pharmacy, 75 FR at 66,157 (noting red flags such as ``lack of indivdua[liza]tion of therapy, certain patterns from physicians of seeing the same types of controlled substances over, and over, and over, again''). This is not the only example of Trinity II filling prescriptions presenting this type of ``pattern prescribing.'' On two occasions--November 20, 2013 and December 18, 2013--Trinity II filled prescriptions for customers M.W. and J.W. for the same controlled substance (oxycodone 30 mg with ginger), even though Trinity II knew that these customers shared the same last name, address and prescribing physician. Trinity II's pharmacists never explained why they nonetheless filled these prescriptions. As a result, I find that it is highly probable that Trinity II's pharmacists knew that these prescriptions also lacked a legitimate medical purpose. --------------------------------------------------------------------------- Accordingly, and in light of the very substantial weight of the evidence of diversion presented by the suspicious prescriptions in this case--early fills, therapeutic duplication, customers traveling great distances, ``cocktail prescriptions,'' and ``pattern prescribing''--I find that Trinity II's pharmacists violated their corresponding responsibility by knowingly filling prescriptions that lacked a legitimate medical purpose. The Allegations Pursuant to 21 CFR 1306.06 Under 21 CFR 1306.06, ``[a] prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice.'' Pharmacists fill prescriptions for controlled substances in the usual course of their professional practice, for example, when pharmacists follow the prescribing physician's instructions for a prescription issued for a legitimate medical purpose. When pharmacists knowingly fail to follow such instructions in filling otherwise valid prescriptions, they are not ``acting in the usual course of [their] professional practice'' and therefore violate 21 CFR 1306.06. Here, Trinity II filled prescriptions without following the prescribing physician's instructions with respect three of the Show Cause Order's charges. Specifically, in the third and fourth charges of the Show Cause Order, the Government charged Trinity II with twice filling prescriptions for customer D.G. for fentanyl patches on dates prior to the prescribing physician's explicit ``No Exceptions Do Not Fill Until'' instructions on each prescription. As noted supra, I have found that the Government proved these facts by a preponderance of the evidence.\81\ Although he did not rely on 21 CFR 1306.06,\82\ the CALJ recommended that I sustain the Government's third and fourth charges. I do sustain those charges, but only on the basis that Trinity II violated 21 CFR 1306.06 \83\ when it filled \84\ these prescriptions [[Page 7334]] before the prescribing physician's ``Do Not Fill'' instructions. --------------------------------------------------------------------------- \81\ In addition, I find that there is no evidence establishing that the ``Do Not Fill'' prescriptions underlying the Show Cause Order's third and fourth charges were invalid under 21 CFR 1306.04(a) and 1306.11(a). For this reason, I deny the Government's allegation that Trinity II also (1) violated their corresponding responsibility under 21 CFR 1306.04(a) when they filled these two prescriptions and (2) filled a prescription without a valid prescription in violation of 21 CFR 1306.11(a) regarding these prescriptions. See ALJ Ex. 1b, at 14-15. It is also for this reason that I disagree with the CALJ's statement that, ``[b]ecause the scrip[t] was not valid until the date articulated by the practitioner, . . . the Respondent filled these two prescriptions without a lawful order from a practitioner.'' R.D. at 49. As the CALJ himself noted in recommending that I reject the Government's claim of a Sec. 1306.11(a) violation regarding the Show Cause Order's fifth charge, ``because there was a (seemingly) valid scrip[t] presented for each of these dispensing events,'' Trinity II's conduct should not be reviewed ``as if it were dispensed with no [valid] order from the practitioner.'' Id. at 49 n.116. I agree. In the Show Cause Order's third, fourth, and fifth charges, customers presented apparently valid prescriptions to Trinity II, but its pharmacists ignored (repeatedly) the same instructions when filling them. Thus, I agree with the CALJ's argument regarding the fifth charge, and I apply the same argument in rejecting his rationale regarding the third and fourth charges. \82\ The CALJ criticized the Government for not relying on 21 CFR 1306.12 and 21 CFR 1306.14 as a basis for the third and fourth charges. R.D. at 47 n.111 (``It is difficult to imagine why the Government did not cite to these regulatory sections, which speak directly to the violations at issue in OSC ]] 9 and 10.''). However, the CALJ's own analysis supplies a good explanation for why the Government did not pursue charges on that basis. The CALJ conceded that ``those regulatory sections specifically pertain to the situation where a practitioner issues multiple prescriptions, presumably on the same date.'' Id. at 47. He further referenced DEA's ``notice of final rule implementing the regulation,'' in which ``DEA noted that the rule `did not address whether a single prescription with ``Do not fill before [date]'' instructions is permissible' '' and that ``no `existing provision of the CSA or DEA regulations address[es] this type of prescribing.' '' Id. at 47-48 (quoting ``Issuance of Multiple Prescriptions for Schedule II Controlled Substances,'' 72 FR 64,921-64,924 (2007)). Here, the ``Do Not Fill'' prescriptions underlying the Show Cause Order's third and fourth charges were not issued on the same date and hence are not ``multiple prescriptions'' on the same date within the meaning of 21 CFR 1306.12(b). \83\ Federal courts have suggested that the identical phrase-- ``usual course of his professional practice''--found in 21 CFR 1306.04(a) essentially includes a knowingly requirement in criminal cases. See, e.g., Bennett, 874 F.3d at 245 (finding that a prescribing physician violates Sec. 1306.04(a) when the practitioner ``knowingly distribut[es] prescriptions outside the usual course of professional practice'') (internal citations and quotations omitted). Assuming the ``knowingly'' scienter standard applies to the application of Sec. 1306.06 to this administrative proceeding, I find that the Government has met its burden to prove it. The Government's burden of proof in this proceeding is ``preponderance of the evidence,'' not ``beyond a reasonable doubt.'' In that vein, while it is conceivable that a Trinity II pharmacist may mistakenly fail to follow ``Do Not Fill Until'' instructions in good faith once, it is less credible that Trinity II's pharmacists would fail to follow such instructions for the same customer two months in a row without doing so knowingly. The CALJ apparently agreed. R.D. at 48-49 (``Despite the clear indication of the practitioner's limitation on the scrip[t]s, Respondent's employees blatantly ignored the instruction and filled the prescriptions before the practitioner had authorized them to be filled.''). When this pattern is combined with the broader pattern of Trinity II's pharmacists knowingly filling prescriptions in violation of their corresponding responsibility, see supra, I have little trouble finding that the Government has established by a preponderance of the evidence that Trinity II's pharmacists knowingly failed to follow the ``Do Not Fill Until'' instructions in D.G.'s prescriptions and hence filled prescriptions outside the pharmacists' usual course of their professional practice under 21 CFR 1306.06. In any event, even if the Government could not prove that this conduct violated Sec. 1306.06 or otherwise met Factors Two or Four under 21 U.S.C. 823(f), I find that a pharmacist blatantly and knowingly ignoring a physician's instructions on an otherwise valid prescription would constitute ``[s]uch other conduct which may threaten the public health and safety.'' 21 U.S.C. 823(f)(5). See R.D. at 48 (``To allow a pharmacy to fill a prescription at any time before a date specified by the issuing practitioner would completely undermine the practitioner's decision to issue the scrip[t] in that manner.''). \84\ In its Exceptions, Trinity II offered its conclusory argument that the date ``when the prescription was actually dispensed to the patient . . . and not the fill date, is the operative evidence of whether there was an improper dispensing event. Because the Government never requested'' ``the pharmacy's electronic records [which] included patient signature logs,'' ``there was insufficient evidence to meet the Government's burden of proof for this allegation.'' Resp. Except. at 4. I reject this Exception for the same two reasons that I rejected the same argument supra in the context of Trinity II's violations of 21 CFR 1306.04(a). Like Sec. 1306.04(a), 21 CFR 1306.06 expressly hinges on whether pharmacists ``filled'' controlled substance prescriptions in the usual course of their professional practice; it does not depend on ``when the prescription was actually dispensed to the patient'' as Trinity II claims. Thus, the ``operative evidence'' is the evidence of filling, and the CALJ properly reviewed the dates on the fill sticker, the front of the prescription, and the dispensing report to identify the fill date. Second, for the reasons I have already discussed supra, the dispensing date would ultimately have been the same as the fill date. --------------------------------------------------------------------------- In the Show Cause Order's fifth charge, the Government alleged, and as noted supra I have found, that Trinity II filled for customer J.T. seven consecutive prescriptions for a morphine sulfate solution that was at least five times, and sometimes 15 times, stronger than the dosages that the physician had prescribed. Although the Government charged that this conduct violated 21 CFR 1306.06 and 21 CFR 1306.11(a), I find that the conduct did not violate 21 CFR 1306.11(a) because I find that there is no proof that the prescriptions underlying the Show Cause Order's fifth charge were invalid. See R.D. at 49 n.116 (``there was a (seemingly) valid scrip[t] presented for each of these dispensing events''). For this reason, the CALJ recommended that I deny the Government's allegation that Trinity II filled prescriptions in the fifth charge without a valid prescription and in violation of 21 CFR 1306.11(a) regarding these prescriptions. See id. Although he did not rely on 21 CFR 1306.06,\85\ the CALJ nonetheless recommended that I sustain the Government's fifth charge. I do sustain this charge, but only on the basis that Trinity II violated 21 CFR 1306.06. As with D.G.'s prescriptions in the third and fourth charges, customer J.T. presented apparently valid prescriptions to Trinity II, but the Government proved the allegations in its fifth charge that Trinity II's pharmacists repeatedly ignored the prescriptions' instructions when filling them. While it is conceivable that a Trinity II pharmacist may have mistakenly failed to follow a prescription's dosage instructions in good faith once, it is not remotely credible that Trinity II's pharmacists would fail to follow such instructions for the same customer seven times in the span of six months without doing so knowingly. For this reason, I have little trouble finding that the Government has established by a preponderance of the evidence that Trinity II's pharmacists knowingly filled prescriptions with the incorrect dosage strength of a controlled substance seven times and hence filled prescriptions outside the pharmacists' usual course of their professional practice in violation of Sec. 1306.06. --------------------------------------------------------------------------- \85\ The CALJ recommended that I find that Trinity II's conduct in the Show Cause Order's fifth charge violated Trinity II's corresponding responsibility under 21 CFR 1306.04(a) because ``the regulation's plain language imposes a corresponding responsibility on the pharmacist `for the proper . . . dispensing' of the prescription. Dispensing a stronger concentration of a controlled substance than has been authorized by the practitioner is a violation of that corresponding responsibility.'' R.D. at 49. The CALJ's interpretation of Sec. 1306.04(a) is incorrect for at least two independent reasons. First, as noted supra, pharmacists violate their corresponding responsibility when they ``knowingly fill[ ]'' a prescription that lacks a legitimate purpose. The CALJ has already recommended that I find (and I have so found) that the underlying prescriptions at issue in the fifth charge were valid, R.D. at 49 n. 116 (``there was a (seemingly) valid scrip[t] presented for each of these dispensing events''), making impossible a finding that Trinity II's pharmacists knowingly filled illegitimate prescriptions in violation of Sec. 1306.04(a). Second, also as noted supra, the plain language of Sec. 1306.04(a) assigns`` [t]he responsibility for the proper prescribing and dispensing of controlled substances . . . upon the prescribing practitioner,'' not upon the pharmacists, whose corresponding responsibility expressly relates to filling, not dispensing. Indeed, it is likely for these reasons that the Government did not claim that Trinity II violated its corresponding responsibility in the Show Cause Order's fifth charge. --------------------------------------------------------------------------- The Allegations Regarding Prescriptions Filled by Non-Pharmacists In the Show Cause Order's final two charges, the Government alleged that Trinity II violated federal and Florida law when it allowed pharmacist interns to fill controlled substances prescriptions. Section 1306.06 provides that controlled substances prescriptions ``may only be filled by a pharmacist.'' Federal law states that a pharmacist ``means any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.'' 21 CFR 1300.01(b). In his Recommended Decision, the CALJ found that Florida law authorized pharmacy interns to dispense controlled substances. Specifically, the CALJ found that Florida defined a ``pharmacist'' as a person ``licensed pursuant to chapter 465 to practice the profession of pharmacy'' in Florida, and that Chapter 465 in turn defines the ``practice of the profession of pharmacy'' to include ``dispensing.'' R.D. at 44 (quoting Fla. Stat. Sec. Sec. 893.02(18), 465.003(13)). The CALJ also found that Florida law states that a ``person other than a licensed pharmacist or pharmacy intern may not engage in the practice of pharmacy.'' R.D. at 44 (quoting Fla. Stat. Sec. 465.014(1)). On this legal basis, the CALJ recommended that I find that ``both pharmacists and pharmacy interns are authorized under Florida law to `practice the profession of pharmacy,' which includes dispensing. Therefore, it is acceptable for pharmacy interns to dispense controlled substances under Florida law and under the DEA regulations.'' R.D. at 44. In its Exceptions, the Government took issue with the CALJ's characterization of Florida law and whether it authorized pharmacist interns to dispense controlled substances under the supervision of a licensed Florida pharmacist. The Government contended that Sec. 893.04(1) of Chapter 893 of Florida law states that controlled substance prescriptions may only be dispensed by ``a pharmacist, in good faith and in the course of professional practice''--making no reference to pharmacy interns. Gov. Except. at 78. The Government also argued that pharmacy interns are not ``licensed pursuant to Chapter 465 to practice the profession of Pharmacy'' as required under Sec. 893.02(18) but instead are ``registered with the'' state under Sec. 465.03(12). Gov. Except. at 79. For these reasons, the Government asked me to reject the CALJ's recommendation and find that pharmacy interns are essentially never authorized to dispense controlled substances prescriptions in Florida. Id. at 80. I find that both the CALJ and the Government have misinterpreted Florida law. Although Florida law is not as clear as federal law in this regard, Florida law neither permits all pharmacy interns to dispense controlled substances (as the CALJ recommended), nor prohibits all pharmacy interns from doing so (as the Government claims). Rather, Florida law permits pharmacy interns to dispense controlled substances only when they are under the statutorily prescribed supervision of a licensed pharmacist. For example, Florida statutes makes it unlawful for an intern registered in Florida to ``fill, compound, or dispense prescriptions or to dispense medicinal drugs'' if the intern is ``not acting under the direct and immediate personal supervision of a licensed pharmacist.'' Fla Stat. Sec. 465.015(2)(b). Florida law also authorizes disciplinary actions against pharmacists ``permitting a registered intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist, to fill, compound, or dispense any prescriptions in a pharmacy owned and operated by such pharmacists or in a pharmacy where such pharmacists are employed or on duty.'' Id. 465.016(1)(c) (emphasis added). In addition, Florida's Administrative Code states that ``[n]o intern shall perform any acts relating the filling, compounding, or dispensing of medicinal drugs unless it is done under the direct and immediate personal supervision of a person actively licensed to practice pharmacy [[Page 7335]] in this state.'' Fla. Admin. Code r. 64B16-26.400 (emphasis added). Thus, I find that it is lawful in Florida for a pharmacy intern, registered in Florida, to fill and to dispense prescriptions so long as it is under the statutorily prescribed supervision of a licensed Florida pharmacist. Here, even assuming arguendo as true the Government's allegations that Mina A. Ghobrial was a pharmacy intern who worked at Trinity II and filled controlled substances prescriptions during the alleged time period, I have already found that the Government failed to establish that Ghobrial was not supervised by a licensed Florida pharmacist when Ghobrial did so. See supra. Accordingly, I agree with the CALJ's recommendation that I find (and I do so find) that the Government has failed to carry its burden that Ghobrial was not properly supervised under Florida law, and I agree with the CALJ's recommendation that I reject (and I do so reject) the Show Cause Order's sixth and seventh charges. Summary of Factors Two and Four As found above, Trinity II's pharmacists knowingly filled dozens of controlled substance prescriptions for more than a dozen patients even though those prescriptions lacked a legitimate medical purpose. 21 CFR 1306.04(a). Moreover, Trinity II's pharmacists knowingly and repeatedly ignored the instructions set forth in legitimate prescriptions issued to two of its customers and thereby failed to fill them in the usual course of their professional practice. 21 CFR 1306.06. Thus, I conclude that Trinity II has engaged in egregious misconduct which supports the revocation of its registration. See Dewey C. MacKay, 75 FR 49956, 49997 (2010); Krishna-Iyer, 74 FR at 463; Alan H. Olefsky, 57 FR 928, 928-29 (1992). I therefore hold that the Government has clearly established its prima facie case that Trinity II's registration ``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). In its Exceptions, Trinity II argued that, ``[e]ven assuming that the DEA met its burden of proof, '' the CALJ ``erred in failing to balance the relatively de minimis problems that the ALJ found were supported by the preponderance of the evidence against the number of prescriptions during the [two-year] audit period in which there was no problem.'' Resp. Except. at 5 (citing Iyer v. DEA, 249 Fed. Appx. 159, 160 (11th Cir. 2007) (unpublished). Specifically, Trinity II claims that ``the sanction of revocation . . . is not supported'' because the CALJ found that ``approximately 0.07%'' of the prescriptions filled by Trinity II violated the law. Id. at 5-6. Trinity II's challenge to the CALJ's recommendation of revocation on the basis of the Iyer decision and the existence of prescriptions it filled ``in which there is no problem'' is unavailing for at least three reasons. First, as a threshold matter, I have already found that the scope of Trinity II's violations of federal law--particularly regarding Trinity II's egregious violations of its corresponding responsibility--far exceed the number that even the CALJ identified. In other words, some of the very prescriptions that Trinity II filled and claims in its Exceptions were ``no problem,'' were, in fact, highly problematic and illegal. Second, Trinity II's arguments based on the unpublished 11th Circuit opinion Iyer v. DEA are identical to those already rejected by the Agency in multiple final opinions, such as Wesley Pope, T.J. McNichol, and Dewey C. MacKay, and I incorporate the relevant portions of those final opinions herein. E.g., Wesley Pope, 82 FR 14944, 14981-14984 (2017); T.J. McNichol, 77 FR 57133, 57144-57146 (2012); Dewey C. MacKay, 75 FR at 49977. As I have pointed out previously (and repeat here for emphasis), the 11th Circuit has never chosen to publish the Iyer decision, and by local rule it is therefore not binding precedent for this case or for any other case. 11th Cir. R. 36-2 (``Unpublished opinions are not considered binding precedent''). In addition, no subsequent 11th Circuit panel has chosen to adopt it; on the contrary, they have affirmatively declined multiple opportunities to do so. See Pope, 82 FR at 14983 (identifying cases in which respondents have raised Iyer-based arguments identical to Trinity II's, and the 11th Circuit has nonetheless denied the petitions of review and affirmed the Agency's sanction). Moreover, the 10th Circuit, in a published opinion, flatly rejected the same argument Trinity II has made here. MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011). Third, and most significantly, even assuming arguendo that Trinity II legally filled every other controlled substance prescription presented to it between February 2012 and February 2014, and I consider them consistent with Iyer, I nevertheless find that the violations identified by the CALJ are sufficiently egregious to outweigh the remaining (and presumptively non-problematic) prescriptions. Thus, I find that the CALJ did not err in his recommendation that revoking Trinity II's registration is in the public interest. I therefore hold that the Government has established its prima facie case that Trinity II's registration ``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). Sanction Where, as here, ``the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must ` ``present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility carried by such a registration.'' ' '' Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for its actions and demonstrate that it will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an ``important factor[ ]'' in the public interest determination). The Agency has also held that `` `[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked.' '' Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504); see also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Moore, 76 FR at 45868. This is so, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of ``deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions''). Here, the CALJ recommended that I find that Trinity II ``has not accepted responsibility'' and that, as a result, ``evidence of remedial steps is irrelevant.'' R.D. at 52 (citing Hassman, 75 FR at 8236). The CALJ further recommended that I find that, ``[i]n any event, the Respondent provided no evidence of remedial steps in this case.'' Id. In its Exceptions, Trinity II claims that the CALJ ``failed to provide [[Page 7336]] Respondents' with the opportunity to present their evidence'' ``that it accepts responsibility for the established misconduct, and has taken appropriate steps to prevent such misconduct in the future.'' Resp. Except. at 4. Trinity II specifically claims that the CALJ did not consider as ``mitigating evidence'' that Trinity II allegedly ``voluntarily ceased dispensing schedule II controlled substances by March 1, 2014.'' Id. at 4-5. I agree with the CALJ that Trinity II has not accepted responsibility for its misconduct nor presented sufficient mitigating evidence to assure me that Trinity II can be entrusted with the responsibility carried by a DEA registration. The CALJ observed: There was no aspect of the evidentiary rulings issued during the prehearing proceedings in this case that would have limited [Trinity II's] ability to do so in any way. . . . the Respondent elected to proceed on a peculiar course where it presented no defense to these allegations, accepted no responsibility for them, and never indicated that it would act differently in the future. The registrant is essentially saying, it did it, it liked it, and it will continue to do it. . . . it has left the Agency little choice but to revoke its registration to ensure the safety of the public. R.D. at 54 n.124. Indeed, even in its Exceptions, Trinity II identifies no evidence of acceptance of responsibility, much less remorse, for its misconduct in this case. It did not even try to provide such evidence at the hearing. And it is difficult to overstate the significance of the misconduct that Trinity II has failed to accept. Trinity II's willingness to knowingly fill seemingly any prescription and any combination of prescriptions that its customers presented--no matter how obvious it was that the prescription lacked a legitimate purpose-- is alarming. Trinity II was apparently equally ready to provide controlled substances to an unscrupulous customer earlier, or at dramatically greater dosages, than the prescribing physician had instructed on the face of the prescriptions. I thus find that Trinity II has not adequately accepted responsibility for its misconduct. This finding provides reason alone to conclude that Respondent has not rebutted the Government's prima facie showing that it has committed acts which render its continued registration ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). And having found that Trinity II knowingly diverted controlled substances, there is no need to consider its remedial efforts \86\ as they are rendered irrelevant by its failure to acknowledge its misconduct. See The Medicine Shoppe, 79 FR 59504, 59510 (2014), pet. for rev. denied 626 Fed. Appx. 2 (Mem.) (D.C. Cir. 2015); Jayam Krishna-Iyer, 74 FR 459, 464 (2009) (``Because of the grave and increasing harm to public health and safety caused by the diversion of prescription controlled substances, even where the Agency's proof establishes that a practitioner has committed only a few acts of diversion, this Agency will not grant or continue the practitioner's registration unless he accepts responsibility for his misconduct.''). As the Tenth Circuit has recognized in the context of physician practitioners: --------------------------------------------------------------------------- \86\ Furthermore, the CALJ did not deny Trinity II, as it claims in its Exceptions, the opportunity to establish that it ceased dispensing schedule II controlled substances. Resp. Except. at 4-5. During the hearing, one of the DIs testified to his awareness that Trinity II stopped distributing schedule II controlled substances as of March 1, 2014. Tr. 527. However, Trinity II provided no evidence that this decision was intended to be remedial. More importantly, I have found that Trinity II's violation of its corresponding responsibility extended to other controlled substances, such as alprazolam, not regulated under schedule II. Thus, even if Trinity II had ceased distributing schedule II controlled substances as a remedial measure, it falls far short of what would have been necessary to mitigate Trinity II's misconduct. The DEA may properly consider whether a physician admits fault in determining if the physician's registration should be revoked. When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the [DEA] to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether continued --------------------------------------------------------------------------- registration is in the public interest. MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA, 419 F.3d at 483 (6th Cir. 2005)). See also Hoxie, 419 F.3d at 483 (``The DEA properly considers the candor of the physician . . . and admitting fault [to be] important factors in determining whether the physician's registration should be revoked.''). I further find that the misconduct proven on this record is egregious and supports the revocation of Respondent's registration. More specifically, my finding that Trinity II's pharmacists dispensed multiple prescriptions in violation of their corresponding responsibility and thereby knowingly diverted controlled substances is, by itself, sufficient to support the revocation of its registration. Revocation is also warranted by my finding that, even with respect to valid prescriptions, Trinity II's pharmacists repeatedly and knowingly failed to fill them consistent with the prescribing physicians' instructions. Cf. Medicine Shoppe-Jonesborough, 300 Fed. Appx. 409, 411-412 (6th Cir. 2008) (rejecting `` `human error' defense'' to dispensing ``the same drug in different concentrations'' because ``dispensing the right drug in the wrong strength `can have serious consequences for the health of patients' '') (internal citations omitted). I further find that the Agency's interest in deterring future misconduct both on the part of Trinity II as well as the community of pharmacy registrants supports revocation. As for the issue of specific deterrence, the revocation of Trinity II's registration is not a permanent bar. And regarding general deterrence, those members of the regulated community who contemplate using their registrations to divert controlled substances need to know that there will be serious consequences if they choose to do so. This interest would be compelling even if it was not the case that the nation faces an epidemic of opioid abuse. I therefore conclude that the revocation of Trinity II's registration is necessary to protect the public interest. And I will further order that any application of Trinity II to renew or modify its registration, or for any other registration, be denied. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration FT0531586 issued to Trinity Pharmacy II, Inc., be, and it hereby is, revoked. I further order that any application of Trinity Pharmacy II, Inc. to renew or modify its registration, or for any other registration, be, and it hereby is, denied. This order is effective immediately. Dated: February 6, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-03294 Filed 2-16-18; 8:45 am] BILLING CODE 4410-09-P
![7304 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
DEPARTMENT OF JUSTICE refill an existing controlled substance dated November 15, 2013 ‘‘for 15
prescription well before the customer patches of Duragesic 50 mcg/hr
Drug Enforcement Administration should have exhausted the supply . . . (fentanyl), a Schedule II controlled
[Docket No. 15–28] obtained from the previous substance,’’ that also contained the
prescription;’’ (2) unusual distance following instruction from the
Trinity Pharmacy II; Decision and traveled, in which six customers prescribing practitioner: ‘‘NO
Order ‘‘present[ed] a prescription bearing an EXCEPTIONS DO NOT FILL UNTIL
address for the customer and doctor 12–06–2013.’’ Id. at 14. The Order
On July 10, 2015, the Deputy showing that the customer had travelled alleged that Trinity II nevertheless filled
Assistant Administrator, Office of an unusual or suspicious route to obtain the prescription on November 20, 2013.
Diversion Control, Drug Enforcement their prescriptions and fill them at Id. In the fourth charge, the Order
Administration, issued an Order to Trinity II;’’ (3) ‘‘[c]ocktail alleged that D.G. presented Trinity II
Show Cause to Trinity Pharmacy II, Inc. prescriptions,’’ in which eight with a prescription in December 2013,
(hereinafter ‘‘Trinity II’’ or Respondent), customers ‘‘present[ed] multiple also ‘‘for 15 patches of Duragesic 50
which proposed the revocation of its prescriptions that provided the mcg/hr (fentanyl), a Schedule II
DEA Certificate of Registration individual with the cocktail of an controlled substance,’’ that also
FT0531586, pursuant to which Trinity II opioid, a benzodiazepine, and a muscle contained the following instruction
is authorized to dispense controlled relaxer;’’ (4) ‘‘[d]uplicative drug from the prescribing practitioner: ‘‘NO
substances in schedules II through V as therapies,’’ whereby eight customers EXCEPTIONS DO NOT FILL UNTIL
a retail pharmacy, at the registered ‘‘present[ed] multiple prescriptions 1–05–2014.’’ Id. at 15. The Order alleged
location of 1474 South Belcher Road, which provided the person duplicative that Trinity II nevertheless filled the
Clearwater, Florida. Administrative Law drug treatment;’’ (5) ‘‘[t]wo prescriptions prescription on December 18, 2013. Id.
Judge Exhibit (ALJ Ex.) 1b, at 1. As for the same drug,’’ in which 10 As a result, and with respect to each of
grounds for the proposed action, the ‘‘customers present[ed] two these charges, the Order alleged that
Show Cause Order alleged that prescriptions for the same drug on the Trinity II ‘‘filled and dispensed this
Respondent’s ‘‘continued registration is same date;’’ and (6) ‘‘pattern controlled substance to D.G.
inconsistent with the public interest.’’ prescribing,’’ or a lack of individualized approximately two weeks before the
Id. (citing 21 U.S.C. 823(f) and drug therapy, in which two sets of ‘‘two prescriber had authorized it to do so,
824(a)(4)). individuals present[ed] prescriptions on and, thus, before the prescription was
More specifically, the Show Cause the same day for the same drugs that valid for filling.’’ Id. at 15.
Order set forth seven independent were issued by the same prescriber.’’ Id. Fifth, the Show Cause Order charged
reasons why Respondent’s registration at 3–14. that, on eight occasions between July 12,
should be revoked. Id. at 2–17. First, the Second, the Show Cause Order 2012 and January 25, 2013, Trinity II
Show Cause Order charged that, charged Trinity II with violating federal violated federal law when it dispensed
between February 2012 and February law when it dispensed ‘‘a Schedule II to J.T. ‘‘a Schedule II controlled
2014, Trinity II ‘‘committed acts as controlled substance outside the usual substance without a valid prescription’’
would render its continued registration course of professional practice . . . and and ‘‘outside the usual course of
inconsistent with the public interest’’ in contravention of its corresponding professional practice.’’ Id. (citing 21
pursuant to 21 U.S.C. 824(a)(4) because responsibility . . . [when it] filled a U.S.C. 829; 21 CFR 1306.06, 1306.11(a)).
Respondent (1) ‘‘failed to comply with prescription for customer D.G.’’ on Specifically, the Order alleged that
applicable federal and Florida state laws November 8, 2013 for ‘‘7 patches of Trinity II dispensed to J.T. ‘‘a morphine
relating to controlled substances’’ (citing Duragesic 50 mcg/hr (fentanyl).’’ Id. at sulfate solution’’ ‘‘that was five times
21 U.S.C. 823(f)(4)) and (2) ‘‘exhibited 14 (citing 21 CFR 1306.04(a), 1306.06). more potent than the doctor had
negative experience in its dispensing of The Order alleged that Trinity II filled prescribed, and instructed J.T. to take a
controlled substances’’ (citing 21 U.S.C. this prescription even though D.G. had dosage amount that would result in him
823(f)(2)). Id. at 1, 2. During this period, 12 days left on a prescription issued by receiving five times the amount’’
the Order alleged that pharmacists at a different doctor and filled by Trinity prescribed. Id. The Order further alleged
Trinity II ‘‘filled [prescriptions for] and II on October 21, 2013 for a ‘‘thirty-day that such prescriptions ‘‘placed the
dispensed controlled substances on supply’’ of fentanyl patches that should health and safety of J.T. at risk and,
numerous occasions outside the usual have lasted D.G. until November 20, thus, engaged in conduct that may have
course of pharmacy practice and in 2013. Id. The Order further alleged that threatened the public health and safety’’
contravention of their corresponding when Trinity II filled the second pursuant to 21 U.S.C. 823(f)(5). Id. at 16.
responsibility,’’ and that such prescription for D.G. 12 days early, Sixth, the Show Cause Order charged
pharmacists did so even when such Trinity II ‘‘ignored the bright red flags that ‘‘Trinity II unlawfully distributed
prescriptions ‘‘contained one or more that D.G. was abusing and/or diverting controlled substances in violation of
‘red flags’ [f]or drug abuse or diversion the fentanyl by doctor-shopping and federal and Florida state law by utilizing
without resolving the red flag(s) and, in seeking an early fill of fentanyl.’’ Id. non-pharmacists to fill controlled
certain circumstances, w[h]ere the red Third and fourth, the Show Cause substances prescriptions on numerous
flags were unresolvable.’’ Id. at 2–3 Order charged that Trinity II violated occasions between February, 2012 and
(citing Holiday CVS, L.L.C., d/b/a CVS federal law when it twice dispensed to February, 2014.’’ Id. The Order alleged
Pharmacy Nos. 219 and 5195, 77 FR D.G. ‘‘a Schedule II controlled substance that when Trinity II allowed its non-
sradovich on DSK3GMQ082PROD with NOTICES2
62316, 62321–22 (2012)). without a valid prescription,’’ ‘‘outside pharmacist ‘‘pharmacy interns’’ to fill a
The Show Cause Order listed six red the usual course of professional prescription, it was not filled by a
flags of diversion which Respondent’s practice,’’ ‘‘and in contravention of its pharmacist ‘‘acting in the usual course
pharmacists allegedly failed to resolve corresponding responsibility.’’ Id. at 14, of his professional practice,’’ pursuant
before dispensing prescriptions, 15 (citing 21 U.S.C. 829; 21 CFR to 21 CFR 1306.06, nor were Trinity II’s
including: (1) ‘‘[e]arly [f]ills,’’ in which 1306.04(a), 1306.06, 1306.11(a)). In the pharmacists properly exercising their
nine customers sought ‘‘to fill a new third charge, the Order alleged that D.G. ‘‘corresponding responsibility’’ under
controlled substance prescription or presented Trinity II with a prescription 21 CFR 1306.04(a). Id. The Order further
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alleged that such prescriptions violated pursuant to subsequent rulings is likely to be physicians.’’ Id. at 14–15. Trinity II also
Florida law’s requirement that ‘‘[a] excluded at the hearing. proposed as documents for the hearing
pharmacist, in good faith and in the Id. The Order further emphasized that copies of ‘‘all prescriptions, patient
course of professional practice only, ‘‘[f]ailure to timely file a prehearing profiles and related documents
may dispense controlled substances.’’ statement that complies with the maintained by Trinity Pharmacy II in
Id. (citing Fla. Stat., Ch. 893.04(1)). directions provided above may be connection with each patient described
Seventh, and lastly, the Show Cause considered a waiver of hearing and an in the [Show Cause Order].’’ Id. at 16.
Order charged that, ‘‘if Trinity II’s implied withdrawal of a request for On September 3, 2015, the CALJ
pharmacists in fact filled the hearing.’’ Id. at 3. conducted an on-the-record prehearing
prescriptions referenced in [the sixth On August 21, 2015, the Government conference. During that conference, the
charge], then Trinity II violated federal filed its Prehearing Statement. ALJ Ex. CALJ noted the Government’s motion to
and Florida state law on numerous 4b. On August 24, 2015, the CALJ issued consolidate the hearings for Trinity II
occasions between February 2012 and an ‘‘Order Rescheduling Prehearing and Trinity Pharmacy I 3 (hereinafter,
February 2014 by failing to maintain Conference’’ moving the prehearing collectively, Respondents) and asked
accurate records of the controlled conference up to 10:30 a.m. on Respondents’ counsel to file something
substances it dispensed because they do September 3, 2015 in light of confirming that Trinity I and Trinity II
not identify a pharmacist who filled the Respondent’s counsel’s August 20, 2015 waive any potential conflict in having
controlled substance prescription.’’ Id. notice of a conflict with the scheduled him represent them both at a
at 16–17 (citing 21 CFR 1304.22(c), hearing on October 26, 2015. ALJ Ex. 8b consolidated hearing. Transcript (‘‘Tr.’’)
1306.06; Fla. Stat., Ch. 893.04(1)(c)(6)). at 1.2 Although this Order stated that 5; ALJ Ex. 10 n.4 (same).4 The CALJ also
In a letter from its counsel dated ‘‘[a]ll other dates specified in the noted during the proceedings that the
August 12, 2015, Trinity II [Prehearing Order], including the filing Government was seeking an ‘‘Order of
acknowledged receipt of the Show date for the Respondent’s Prehearing Protection’’ to limit disclosure of
Cause Order and requested a hearing on Statement, remain in effect,’’ id. at 1 n.1, personally identifiable information of
the allegations. ALJ Ex. 2b. The matter the CALJ (through his staff) later patients and confirmed that Respondent
was placed on the docket of the Office requested that Respondent file its had no objection to such an order. Tr.
of Administrative Law Judges and Prehearing Statement early. ALJ Ex. 10 55–56. Lastly, the CALJ accepted
assigned to Chief Administrative Law at 1 n.1 (‘‘Upon my realization that the Respondents’ counsel’s representation
Judge John J. Mulrooney, II (hereinafter, status conference was now scheduled that neither Trinity I nor Trinity II were
CALJ), who proceeded to conduct pre- several days prior to the date that the the subject of pending state
hearing proceedings as follows.1 Respondents’ prehearing statements administrative cases or ‘‘criminal
On August 13, 2015, the CALJ issued parallel proceedings.’’ Id. at 63.
were due under the terms of the
an Order for Prehearing Statements On September 4, 2015, the CALJ
[Prehearing Order], chambers staff (at
(hereinafter, Prehearing Order). See ALJ issued a ‘‘Consolidation Order,
my direction) reached out to
Ex. 3b. In the Prehearing Order, the Prehearing Ruling, and Protective
Respondents’ counsel and requested
CALJ directed the Government to file its Order’’ (hereinafter ‘‘Consolidation
(but not directed) that, if it was possible
Prehearing Statement no later than 2 Order’’). ALJ Ex. 10 at 2. In this Order,
to do so, their prehearing statements be
p.m. on August 24, 2015, Respondent to the CALJ granted the Government’s
filed prior to the commencement of the
file its Prehearing Statement no later request for the aforementioned
now-rescheduled Status Conference
than 2 p.m. on September 8, 2015, and protective order and the Government’s
. . . with the assurance that (as is
scheduled a Prehearing Conference for motion to consolidate the hearings, and
customary) both sides would be
1:30 p.m. on September 9, 2015. Id. at the CALJ directed all parties to file a
permitted to file supplemental
1–2. The Order also directed the parties consolidated exhibit and witness list by
prehearing statements’’).
to provide the ‘‘[n]ames and current Per the CALJ’s request, Trinity II filed October 16, 2015. Id. at 2, 9–11. The
addresses of all witnesses whose its ‘‘Preliminary Prehearing Statement’’ Order noted that the parties would be
testimony is to be presented,’’ and that on September 3, 2015. ALJ Ex. 9b. able to cross-examine the others’
if the Respondent’s corporate Trinity II proposed to call 77 witnesses witnesses and stated that the ‘‘parties
representative intends to testify, the in addition to ‘‘[a]ny and all witnesses are also reminded that testimony not
representative ‘‘must be listed as a identified in the Government’s
witness, and a summary of his/her Prehearing Statement.’’ Id. at 3–7.
3 Trinity Pharmacy (‘‘Trinity I’’), located in
testimony as described below must be Trinity II then provided a ‘‘Summary of
Seminole, Florida, was served with a separate July
provided.’’ Id. at 2. The CALJ’s Order 10, 2015 Order to Show Cause by the Government.
Anticipated Testimony’’ for nine of ALJ Ex. 1a. Although the CALJ eventually ordered
provided the following instruction these witnesses, all of whom were the the consolidation of the evidentiary hearings for
regarding the summaries of testimony: owners or employees of Trinity II. Id. at Trinity I and Trinity II, see ALJ Ex. 10 at 2, the CALJ
wrote separate recommendations regarding each
Brief summary of the testimony of each 7–14. Trinity II stated that it anticipated Respondent, and I therefore have written a separate
witness (counsel for the Government to calling an expert witness but had not yet Order regarding the disposition of the Show Cause
indicate clearly each and every act, omission identified one ‘‘given the preliminary Order directed at Trinity I.
or occurrence upon which it relies in seeking 4 On November 13, 2017, Mr. Michael Stanton
to revoke the Respondent’s [Certificate of nature of this statement.’’ Id. at 14.
filed a ‘‘Notice of Appearance on Behalf of
Registration]; counsel for Respondent to Trinity II offered an identical one- Respondents’’ in which he entered ‘‘an appearance
indicate clearly each and every matter as to sentence summary of the testimony for as co-counsel for Respondents, Trinity Pharmacy I
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which Respondent intends to introduce each of 39 ‘‘patients,’’ and a separate and Trinity Pharmacy II, along with Dale Sisco of
evidence in opposition). The summaries are identical one-sentence summary of the Sisco Law.’’ ALJ Ex. 35b, at 2. Although both
to state what the testimony will be rather counsel maintained that they represented both
testimony for each of 32 ‘‘prescribing Respondents, at the evidentiary hearing, Mr. Sisco
than merely listing the areas to be covered.
stated that ‘‘[f]or the purposes of this hearing, I will
The parties are reminded that testimony not 2 According to the CALJ, ‘‘[t]he hearing be representing Trinity I and questioning witnesses
disclosed in the prehearing statements or commencement date [was] continued on multiple on behalf of that pharmacy,’’ and Mr. Stanton stated
occasions at the Respondents’ request.’’ ALJ Ex. 34, that ‘‘for purposes of this hearing and to avoid any
1 Respondent raised no objection to the adequacy at 1 n.1. The hearing was ultimately noticed to duplication, I will be handling the objections and
of service. begin on January 4, 2016. ALJ Ex. 27. the questioning on behalf of Trinity II.’’ Tr. 83–84.
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summarized in prehearing statements, witnesses who were either owners or Trinity II did not file a supplemental
or supplements thereto, may be employees of Trinity II, a putative prehearing statement or any other
excluded at the hearing.’’ Id. at 4. The expert, and short but similar prehearing statement by October 16,
Order also directed the parties to serve descriptions of testimony for 39 patients 2015 as required by the CALJ’s
each other with all documents it intends and 32 prescribing physicians. Id. at 7– Consolidation Order. As a result, the
to identify as exhibits no later than 54.5 The Prehearing Statement also Government filed a ‘‘Motion in Limine
September 11, 2015, and directed identified 70 documents ‘‘intended to be to Exclude Certain Testimony.’’ ALJ Ex.
Respondents to supply the identity and used at the consolidated hearing 28. In its Motion, the Government
curriculum vitae of their proposed regarding both Trinity Pharmacy I and contended that Respondents had failed
expert witness by September 18, 2015. Trinity Pharmacy II.’’ Id. at 55–57, 55 in their prehearing statements to follow
Id. at 4, 8. The Order further directed n.2. On October 15, 2015, Respondents the requirements set forth in the CALJ’s
the parties to file supplemental filed a ‘‘Consolidated Witness and prehearing orders; namely, to ‘‘state
prehearing statements and any Exhibit List’’ that listed 133 witnesses, what the testimony will be rather than
additional exhibits, as well as any in addition to ‘‘[a]ny and all witnesses merely listing areas to be covered’’ for
motions seeking relief, by 2 p.m. on identified in the Government’s each proposed witness.’’ Id. at 2
October 16, 2015, and any responsive Prehearing Statement,’’ 69 exhibits of (internal citations omitted). For
filings by 2 p.m. on October 23, 2015. ‘‘[d]ocuments and information related example, the Government noted that
Id. at 8. Finally, the Order reminded the to’’ various individuals, and one exhibit Respondents proposed 69 witnesses
parties that ‘‘documents not noticed in that would be the CV of their putative identified as patients and that ‘‘nearly
prehearing statements, or supplements expert. ALJ Ex. 15e. every single patient of the sixty-nine
thereto, or not timely supplied to the listed by the Respondents is expected to
On October 16, 2015, the Government
opposing party may (and likely will) be testify identically.’’ Id. at 4. The
filed its ‘‘Consolidated Supplemental
excluded at the hearing.’’ Id. at 4. Government contended that, not only
Although the Prehearing Order had Prehearing Statement.’’ ALJ Ex. 16a. In
did the proposed patient ‘‘testimony fail
directed Trinity II to supply a compliant this filing, the Government proposed
to make clear exactly what ‘information’
prehearing statement by September 8, two new witnesses, provided a
each patient will ‘confirm,’ thus
2015, ALJ Ex. 3b at 1, and the Order summary of their testimony, and
preventing the Government from
Rescheduling Prehearing Conference provided additional summaries for the
determining what specific defense(s)
iterated that Trinity II’s prehearing testimony of the fact and expert witness
Respondents allege; the [proposed]
statement filing deadline remained the identified in the Government’s original
testimony also fails to provide any basis
same, ALJ Ex. 8b at 1 n.1, Trinity II Prehearing Statement. Id. at 6–10.
upon which the Government can
failed to do so. On September 24, 2015, Lastly, the Government supplemented
evaluate [whether] such information is
the Government filed a Motion to its list of proposed Government exhibits
even relevant or material to this case.’’
Compel Respondents’ Compliance with with a list of additional documents that
Id. at 4–5. Such proposed testimony, the
the Prehearing Order and the it intended to introduce as exhibits at
Government argued, ‘‘is nothing more
Consolidation Order and a Motion the hearing. Id. at 10–12. The
than ‘merely areas to be covered,’ rather
Requesting a New Supplemental Government also filed its consolidated
than any substantive recitation of ‘what
Prehearing Statement and Motion witness list and exhibit list. ALJ Exs.
the testimony will be,’ ’’ as the
Deadline. ALJ Exs. 11a, 11b. 16b, 16c.
prehearing orders required, ‘‘offering no
On September 28, 2015, Respondents facts that, if proven, would rebut the
5 For example, for patient S.B., Trinity II stated
filed their response. ALJ Ex. 13. On the Government’s prima facie case or offer
that it anticipated her testimony to be as follows:
same day, the CALJ issued an Order that credible evidence in mitigation. Id.
[S.B.] was a patient whose prescriptions are
generally denied the Government’s identified in the various categories of allegations Finally, the Government argued that ‘‘it
motions and stated that honoring the contained in the July 10, 2015 Order to Show Cause is unclear from the Respondents’
CALJ’s request for an earlier prehearing issued to Trinity Pharmacy II. It is anticipated that Prehearing Statements how the
statement may have caused [S.B.] will testify regarding the inquiry done by the
pharmacists and the staff at Trinity II regarding purported testimony of these various
Respondents to have had the: verification of her prescriptions and for the patients related to each of the
mistaken impression that compliant resolution of any potential red flags. [S.B.] will dispensing events charged in the [Show
prehearing statements were no longer further confirm the information obtained from her Cause Orders], and how it affected the
by Trinity Pharmacy II prior to any prescription
required until the filing of supplemental being dispensed, including but not limited to pharmacist’s compliance with the
prehearing statements. To alleviate any explanations for any significant distances traveled, standard of care and exercise of his
remaining misunderstanding in this regard the type of payment they made for the corresponding responsibility in each
and to afford the Respondents the time and prescriptions, the circumstances of any refills and charged instance.’’ Id.
ability to file both a fulsome prehearing physician authorization for same.
statement and a supplemental prehearing ALJ Ex. 15b, at 29. The proposed testimony of With respect to the prescribing
statement, it is ORDERED that Respondents most of the other patients used similar language. physicians that Respondents had
are to file prehearing statements that comply See id. at 27–43. Likewise, the physician summaries proposed as witnesses, the Government
with the terms of the [Prehearing Statement] used language similar or identical to the following
example:
noted that Respondents ‘‘intend to call
no later than 2 p.m. on October 5, 2015. fifty-nine doctors as witnesses, who,
[J.M.], M.D. was a prescribing physician for one
ALJ Ex. 14, at 3–4. or more of the patients who tendered prescriptions again, will each testify identically. . . .
On October 5, 2015, Trinity II filed its to Trinity Pharmacy II. [J.M.], M.D. will confirm the Other than to blithely forecast that the
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Prehearing Statement. ALJ Ex. 15b. prescriptions he authorized were for a legitimate physicians will approve their own
medical purpose and issued in the usual course of
Trinity II provided the names and professional practice to patients that were known to prescriptions, Respondent provides no
address of 79 proposed witnesses, in him. Further, [J.M.], M.D. will describe his facts which, if proven, would rebut the
addition to ‘‘[a]ny and all witnesses interaction with the pharmacists and staff at Trinity Government’s prima facie case.’’ Id. at 6.
identified in the Government’s Pharmacy II, the authorization of refills or early This too, the Government contended,
fills, if any, and explanations for any duplicative
Prehearing Statement.’’ Id. at 4–7. drug therapy, combinations of medications or violated the requirement of the
Trinity II also provided a ‘‘Summary of alleged ‘‘drug cocktails.’’ prehearing orders that the parties set
Anticipated Testimony’’ for nine Id. at 45. forth ‘‘what the testimony will be’’
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rather than ‘‘areas to be covered.’’ Id. Specifically, the Government alleged 4. ‘‘evidence regarding the actions of DEA
The Government argued that the that Respondents failed to give the personnel and the cooperation of pharmacy
summary of the physicians’ proposed Government ‘‘notice [of] a proposed staff during the Administrative Inspection of
both pharmacies;’’
testimony failed to disclose sufficient opinion from Mr. Badawi as to the 5. ‘‘evidence regarding the process the
facts to allow the Government to lawfulness of each prescription alleged pharmacies used to verify prescriptions and
determine what specific defenses in each’’ Show Cause Order. Id. at 17 resolve concerns, including a description and
Respondents allege, nor provide any (‘‘Respondents have had multiple demonstration of the computer software
basis upon which the Government can opportunities to provide a compliant utilized;’’
evaluate how such information is disclosure, yet have repeatedly failed to 6. ‘‘evidence regarding the medical
relevant to the charges in the Show do so.’’). condition of patients who received early
Cause Order. Id. at 6–7. As a result of these alleged refills;’’
In its Motion, the Government also 7. ‘‘evidence of the pharmacy’s knowledge
deficiencies, the Government requested of cocktail prescription and duplicative drug
challenged the adequacy of that the CALJ exclude ‘‘the non- therapy patients, their medical condition,
Respondents’ disclosure of the proposed conforming testimony’’ set forth in its and their treating physicians;’’
testimony of its owners and employees, Motion because Respondents had only 8. ‘‘evidence regarding circumstances
contending that it too set forth ‘‘a provided ‘‘vague summaries of areas to surrounding an early fill for patient T.B.;’’
generalized statement of ‘areas to be be covered by the Respondent’s 9. ‘‘evidence regarding circumstances
covered’ ’’ rather than ‘‘a summary of witnesses’’ that unduly prejudiced the surrounding an early fill for patient C.F.;’’
‘what the testimony will be’ for each 10. ‘‘evidence regarding information that
Government. Id. at 18–19 (‘‘Agency
witness.’’ Id. at 9. These generalized Trinity I allegedly possessed relating to an
precedent favors exclusion of evidence early fill for patient J.K.;’’
statements, the Government contended, when the names of witnesses and ‘an 11. ‘‘evidence regarding circumstances
failed ‘‘to reveal the specific ‘actions’ adequate summary of their testimony’ surrounding an early fill for patient G.S.;’’
each employee purportedly is going to has ‘not been previously disclosed as 12. ‘‘evidence regarding distances traveled
‘describe’ ’’ or ‘‘to provide the required by the ALJ’s Order for Pre- by patients who either commuted, lived, or
Government (or the ALJ) any Hearing Statements.’ ’’) (citing East Main worked close to both pharmacies;’’ and
information upon which it can discern Street Pharmacy, 75 FR 66149, 66150 13. ‘‘evidence from the Respondents’
the relevance and materiality of the proposed expert, Sam Badawi, regarding the
(2010)). lawful or unlawful nature of the numerous
‘actions’ to the issues to be litigated in On November 5, 2015, the CALJ prescriptions referenced in each of the [Show
this case.’’ Id. Although Respondents issued an ‘‘Order Granting the Cause Orders].’’
stated in their prehearing statements Government’s Unopposed Motion in
that certain employees would testify to Id. at 3–4 (citing ALJ Ex. 28 at 4–18).
Limine to Exclude Certain Testimony.’’ Over a month later, on December 7,
describe the ‘‘process’’ Trinity II used ALJ Ex. 29. After noting the
‘‘to verify prescriptions and resolve 2015, Respondents filed their ‘‘Motion
Government’s timely filed Motion and for Reconsideration on Behalf of
concerns, if any, regarding the validity that Respondents’ deadline to file a
of those prescriptions,’’ the Government Respondents’’ in which they
responsive pleading was October 23, ‘‘request[ed] an order reconsidering [the
argued that the statements ‘‘fail[ed] to 2015, the CALJ noted:
provide any information about the CALJ’s] order granting the Government’s
‘process’ ’’ employed to verify Respondents never filed a response. Not motion in limine, and allowing
even a late or unpersuasive response. Respondents to provide [the CALJ] with
prescriptions and resolve concerns. Id. Nothing. The language of the [Prehearing
at 9–10. Similarly, the Government the necessary evidence needed for [the]
Order] about the nature of the required notice final determination.’’ ALJ Ex. 32, at 1.
observed that Respondents’ offer of proffers is clear and unambiguous; yet,
testimony from employees who would Respondents stated that ‘‘due process
notwithstanding multiple opportunities to do
provide ‘‘a description and so, the Respondents have elected not to requires that Respondents be entitled to
demonstration of the computer software comply. The [Prehearing Statement] plainly present testimony from its witnesses,
used by the pharmacy in this process’’ states that ‘‘testimony not disclosed in the which were properly disclosed.’’ Id. at
was not matched by a proposed ‘‘exhibit prehearing statements or pursuant to 3. Respondents also stated that they
containing each pharmacy’s computer subsequent rulings is likely to be excluded at ‘‘recognize that the physician and
software that each witness purportedly the hearing.’’ patient disclosures lack particularity’’
would demonstrate for the court.’’ Id. ALJ Ex. 29, at 2. Although the CALJ because ‘‘Respondents cannot exercise
And while Respondents proposed its co- posited that Respondents’ repeated sufficient control over these witnesses
owners would testify about their failure to comply with his orders could without first having them under
knowledge of both their customers’ constitute a waiver of a hearing request, subpoena to provide more detail.’’ Id. at
medical conditions and the treating the CALJ also noted that the 3 n.1. Respondents added that ‘‘[n]either
physicians efforts to ‘‘resolve[ ] any Government ‘‘does not seek (as it could the Government nor the Respondents
concerns,’’ the Government further have) the draconian remedy of hearing should fear the Court learning the full
alleged that Respondents failed to waiver, but asks for the lesser sanction truth . . . even if there may not be a
disclose ‘‘each customer’s medical of preemptive exclusion of a limited way for any party to control that
condition . . . , how it related to each subset of the noticed evidence,’’ and the message before the hearing.’’ Id.
dispensing activity, or how and when CALJ deemed the Motion unopposed Respondents also contended that ‘‘those
each pharmacy purportedly became and granted it. Id. at 3–4. Specifically, same deficiencies . . . do not apply’’ to
‘aware’ of it.’’ Id. at 11. the CALJ’s Order precluded their employee, expert, and owner
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In its Motion, the Government also Respondents from offering the witness disclosures. Id. Indeed,
sought to preclude Respondents’ following: Respondents argued that ‘‘it is
proposed expert, Mr. Sam Badawi, from disingenuous for the Government to
1. ‘‘testimony from sixty-nine patients
rendering an opinion concerning identified as proposed witnesses;’’
alleged [sic] that the [expert witness]
whether the prescriptions referenced in 2. ‘‘testimony from fifty-nine physicians disclosure fails to provide adequate
the Show Cause Orders ‘‘were filled in identified as proposed witnesses;’’ notice to allow it to prepare for a cross-
compliance with federal and/or state 3. ‘‘testimony from proposed witness Nina examination when its prehearing
law requirements.’’ Id. at 14. Ghobrial;’’ statements provide a comparable
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opportunity for notice to Respondents.’’ ‘‘perhaps hoping in vain for even a late evidence in these matters’’ and ‘‘will not
Id at 4–5. Respondents contend that response.’’ Id. Indeed, the CALJ be considered by this tribunal in its
their ‘‘representatives and pharmacist’’ emphasized that Respondents did not recommended decision.’’ ALJ Ex. 40d, at
witness disclosures were ‘‘similarly file their Motion for Reconsideration 1 & n.3.
robust and detailed,’’ and that their until ‘‘over forty-five days from the date On May 12, 2016, the CALJ issued
‘‘remaining pharmacy employees[’] their motion response was due and less and served his Recommended Decision.
[witness] disclosures are brief.’’ Id. at 5. than a month prior to the . . . Specifically, the CALJ found that the
Finally, Respondents claim that ‘‘an commencement of the hearing.’’ Id. Government had ‘‘supplied sufficient
intermediate remedial order requiring (Respondents ‘‘do[ ] not even mention evidence to make out a prima facie case
supplementation or a limit to the the fact that no response was filed, as if that maintaining the Respondent’s [DEA
testimony would have been more it never happened’’). The CALJ noted Registration] would be contrary to the
appropriate than granting the motion in that Respondents asked for another requirements of 21 U.S.C. 823 and 824’’
limine in its entirety.’’ Id. order to give Respondents additional based on the third, fourth, and fifth
The Government filed its ‘‘Opposition opportunities to cure any alleged charges set forth in the Show Cause
to Respondents’ Motion for deficiencies in their disclosures Order. R.D. at 51. The CALJ further held
Reconsideration’’ on December 10, ‘‘[u]nder th[e] theory[ ] this new, that the testimony of the Government’s
2015. ALJ Ex. 33. In its Opposition, the additional order would somehow carry expert was ‘‘insufficiently reliable to
Government argued that, as a threshold more force and would result in establish a breach of the Respondent
matter, ‘‘Respondents have not even compliance where the other orders had pharmacy’s corresponding
provided a basis—not to mention a failed. Enough.’’ Id. at 2. The CALJ responsibility regarding the dispensing
plausible one that would demonstrate found that Respondents ‘‘have tendered of controlled substances’’ pursuant to 21
good cause—upon which to reconsider no explanation for their failure to CFR 1306.04 as set forth in the first two
the decision.’’ Id. at 4 (Respondents answer the Government’s motion and no charges of the Order. Id. at 43.7
gave no ‘‘explanation or justification for basis upon which to base good cause for Although the CALJ acknowledged that
their failure to file a timely response on reconsideration, even if such relief was his decision not ‘‘to rely on the
October 23, 2015.’’). Id. ‘‘Respondents[’] warranted—which it is not.’’ Id. Government’s expert witness
Reconsideration Motion is a request for Accordingly, the CALJ denied dramatically pared down the number of
the ALJ to reconsider his decision on a Respondents’ reconsideration motion. noticed transgressions that could be and
Motion that they did not see fit to Id. at 3.6 were established by a preponderance’’
oppose in the first place, and have not The CALJ conducted an evidentiary of the evidence, the CALJ concluded
seen/did not see fit [ ] to oppose for the hearing on January 4–8, 2016, in that ‘‘the evidence demonstrates a
past month.’’ Id. In response to Arlington, Virginia, and on January 11– culture in the Respondent pharmacy of
Respondents’ concession that their 12, 2016, in Tampa, Florida. See ignoring regulations deemed
patient and physician witness Recommended Decision (R.D.), at 2. At inconvenient . . . this pharmacy is
disclosures lacked particularity because the hearing, both parties elicited dangerous, and the owners have given
they lacked subpoena authority, the testimony from multiple witnesses, and not even the smallest indication to the
Government contended that the Government submitted various Agency that there is any inclination to
‘‘Respondents are unable to explain why exhibits. Following the hearing, on change.’’ Id. at 53–54. The CALJ also
they needed a subpoena to talk to their February 26, 2016, both parties filed concluded that the Respondent ‘‘fail[ed]
own customers and the physicians briefs containing their proposed to accept responsibility.’’ Id. at 54.
about prescriptions Respondents findings of fact, conclusions of law, and Thus, the CALJ recommended that I
contend were lawfully issued. Nor do argument. ALJ Exs. 40a, 41. On February revoke Respondent’s registration and
Respondents indicate that they 29, 2016, the CALJ issued an ‘‘Order deny any pending applications for
attempted to contact these individuals Regarding the Exhibit (and Appended renewal. Id. On June 2, 2016, the
and were rebuffed.’’ Id. And finally, Attachments) Included with the Government and Respondents each filed
with respect to Respondents’ Due Government’s Closing Brief’’ noting that Exceptions to the CALJ’s Recommended
Process argument, the Government the Government’s proposed findings of Decision. Thereafter, the record was
noted that, ‘‘despite hav[ing] been given fact and conclusions of law had
forwarded to me for final agency action.
multiple opportunities to correct their attached a declaration from the Having considered the record in its
mistakes and provide the Government Government’s lead attorney as well as entirety, including the parties’
the requisite notice it was due,’’ six attachments thereto and asking Exceptions (which I discuss throughout
Respondents were attempting ‘‘to shift Respondents if they intended ‘‘to take a this decision), I do agree with the
the blame’’ by ‘‘now claiming that the position on the Agency’s consideration CALJ’s conclusions that the Government
ALJ is denying them a fair hearing.’’ Id. of factual matters set forth’’ in the sustained the Order’s third, fourth and
at 4–5. declaration and attachments. ALJ Ex.
fifth charges. I also agree with the
On December 10, 2015, the CALJ 40b, at 1. Respondents filed joint
CALJ’s conclusions that the Government
issued his ‘‘Order Denying the objections to the declaration and
Respondents’ Motion for failed to sustain the Order’s second,
attachments. ALJ Ex. 40c. On March 4,
Reconsideration.’’ ALJ Ex. 34. In this sixth and seventh charges. And I further
2016, the CALJ issued an Order
Order, the CALJ noted that Respondents agree with his legal conclusion that
sustaining Respondents’ objections,
‘‘filed neither a response to the Trinity II has failed to accept
ruling that the declaration and
responsibility for the misconduct which
sradovich on DSK3GMQ082PROD with NOTICES2
Government’s motion [in Limine] nor a attachments are ‘‘EXCLUDED from the
motion for an extension of time to do so. has been proven on the record of the
record, and will not be considered as
Indeed, the Respondents filed nothing.’’ proceeding. However, I disagree with
Id. at 1. The CALJ also observed that he 6 On December 11, 2015, the CALJ granted the CALJ’s conclusion that the
waited an additional 13 ‘‘days after the Respondents’ requests for subpoenas for their
pharmacy employees and denied Respondents’ 7 The CALJ also found that the Government failed
responsive filing deadline’’ before requests vis-à-vis their proposed practitioner to sustain the sixth and seventh charges of the
issuing his Order granting the witnesses pursuant to the Order granting the Show Cause Order related to prescriptions filled by
Government’s Motion in Limine, Government’s Motion in Limine. ALJ Ex. 36. pharmacy interns. R.D. at 43–46.
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Government did not prove the first photocopies of the driver’s licenses of identified any prescriptions that were of
charge of the Show Cause Order alleging the employees present when the interest and copied such prescriptions
that Trinity II violated its corresponding investigators arrived and the original for review by the expert. Id. at 147–48,
responsibility pursuant to 21 CFR prescriptions for the two-year period of 538. He testified that the investigators
1306.04(a).8 Accordingly, I agree with February 2012 to February 2014. Id. at did not make a forensic image of Trinity
the ALJ’s ultimate conclusion that 127–32, 135–36.10 Another DI II’s computer system. Id at 137.
Trinity II has committed acts which separately testified that his role during In addition to the prescriptions
render its continued registration the inspection included identifying obtained by DEA during the inspection
inconsistent with the public interest and employees at the pharmacy and of Trinity II, the DIs obtained dispensing
will adopt his recommendation that I obtaining copies of their drivers’ reports 11 in May 2014 pursuant to a
revoke Trinity II’s registration and deny licenses. Id. at 686–88, 694. He also DEA administrative subpoena issued to
any pending applications. As the spoke with some of Trinity II’s Trinity II by facsimile. Id. at 156–57,
ultimate fact finder, I make the employees to obtain their job 543 (‘‘global dispensing report’’), 544–
following findings of fact. descriptions. Id. at 688–89. 45. The May 9, 2014 subpoena
The lead investigator also testified specifically asked for Trinity II to
Findings of Fact that during the inspection at Trinity II, provide, for the time period of February
Trinity II is the holder of DEA some employees represented to him that 10, 2012 through February 10, 2014,
Certificate of Registration FT0531586, the pharmacy only dispensed controlled ‘‘[d]ispensing records of controlled
pursuant to which it is authorized to substances to patients with Florida substances in schedules II–V to include:
dispense controlled substances in addresses, that the pharmacist inspected Prescription number; patient’s full
schedules II through V, as a retail each prescription for alteration or name, date of birth, and address; drug
pharmacy, at the registered location of forgery, and that each physician’s status name, strength, dosage form, quantity
1474 Belcher Rd., Clearwater, Florida. was confirmed through the Florida prescribed, and directions for use;
Government Exhibit (‘‘GX’’) 34; Tr. 120, Department of Health website. Id. at prescriber’s full name, address, and
685–86. Respondent’s registration was 577–78, 595–97. He also testified that DEA number; method of payment;
due to expire on November 16, 2016, someone at Trinity II claimed that its whether it is a new prescription or refill;
R.D. at 3; however, having reviewed the computer software ‘‘automatically and the pharmacist who filled [the]
Agency’s registration records, I take confirmed the prescriber’s DEA prescription.’’ GX 95, at 4; Tr. 157–58,
official notice that on October 3, 2016, registration.’’ Id. at 578, 595–97. He 201–02, 608. On May 21, 2014, counsel
Trinity II submitted a renewal further testified that the owners of the for Respondents Trinity I and Trinity II,
application.9 Because Trinity II has pharmacy, Mina and Emad Yousef, told Mr. Dale Sisco, emailed to the lead
timely submitted a renewal application, him that they would call the doctor’s investigator Trinity II’s response to the
I find that Trinity II’s registration has office—a practice followed at Trinity I administrative subpoena, which
remained in effect pending the issuance and Trinity II; however, the DI also included a Microsoft Excel spreadsheet
of this Decision and Final Order. See 5 testified that he did not recall either of of Trinity II’s dispensing report
U.S.C. 558(c). No evidence was put them telling him that the owners called (hereinafter, ‘‘global dispensing report’’)
forward as to Trinity II’s current a doctor’s office for every controlled as an attachment to that email. GX 96;
licensure status with the Florida substance prescription and exactly what Tr. 158, 172–73, 175, 627, 643.12 The DI
Department of Health. they would discuss with the doctor. Id.
testified that after receiving this global
The Investigation of Trinity II at 126, 133, 579, 595–97, 666–67. He
dispensing report, he created individual
testified that the majority of
On February 10, 2014, DEA dispensing reports for individual
prescriptions contained no evidence
Investigators (‘‘DI’’ or ‘‘DIs’’) conducted patients to see the dispensing history for
that anyone at Trinity II had called a
inspections of Trinity II. Tr. 119–20, certain patients, and then he matched
doctor’s office, and that neither the
684–86, 709. The Government called the original prescriptions with the
patient profiles nor the dispensing
three DIs as witnesses in its case-in- dispensing report. Tr. 180–81, 219,
reports that he reviewed reflected such
chief. See id. The lead investigator 227.13 He also noted that the global
contacts. Id. at 666–68. He also testified
testified that when the DIs arrived at dispensing report included a ‘‘Filled
that Yousef told him during the
Trinity II for the inspection, they asked By’’ column which either contained the
inspection that the pharmacist would
to speak to Trinity II’s pharmacist-in- initials ‘‘EFY,’’ ‘‘MAG,’’ or ‘‘MIA.’’ Id. at
check the patient profile for medication
charge (‘‘PIC’’) or owner and were 271–72, 338, 344, 345.
history. Id. at 597.
greeted by Mr. Mark Abdelmaseeh, who The lead investigator testified that he On October 16, 2014, two DIs and
identified himself as Trinity II’s PIC. Id. reviewed the original prescriptions and Government counsel met with Trinity
at 124–26. The DIs presented Trinity II’s ‘‘looked for the red flags of diversion II’s counsel, Mr. Sisco, and the co-
PIC with a Notice of Inspection, and the that we had been trained on,’’ such as owners of Trinity II—Emad Yousef and
PIC consented to the inspection after distances, drug cocktails, drug 11 Because witnesses and counsel used the
reviewing the Notice. Id. at 126. The interactions, and short fills. Id. at 147. phrases ‘‘dispensing report’’ and ‘‘dispensing log’’
lead investigator also testified that the He also reviewed them to make sure that interchangeably throughout the hearing, I also use
DIs obtained, by consent from Trinity II, the prescriptions included all of the those phrases interchangeably in this decision.
12 Government Exhibit 84 is a printed copy of the
required information such as the
8 Although I do not rely on the Government global dispensing report entered into evidence. Tr.
doctor’s signature, patient name, patient
sradovich on DSK3GMQ082PROD with NOTICES2
expert’s testimony in making my ruling, as set forth 177–79.
infra, I also disagree with the CALJ’s conclusion address, and drug strength. Id. He then 13 The lead investigator also testified that when
that the Government’s expert was not reliable. he created the individual dispensing reports, using
9 In accordance with the Administrative 10 The lead investigator also testified that during the global dispensing report, he did not alter any
Procedure Act (APA), an agency ‘‘may take official the inspection of Trinity II, DIs reviewed DEA–222 of the information in the global dispensing report,
notice of facts at any stage in a proceeding—even order forms and the CSOS electronic ordering and that the individual dispensing reports are true
in the final decision.’’ U.S. Dept. of Justice, system. Tr. 134. He testified that CSOS, which and accurate representations of the information
Attorney General’s Manual on the Administrative stands for Controlled Substance Ordering System, contained in the global dispensing report. Id. at 241,
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, provides an electronic version of the DEA–222 247–48, 253, 256, 259, 264, 268, 278, 285, 291–92,
Inc., Reprint 1979). order form. Id. at 134–35. 297, 303–04, 348–49.
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Mina Yousef 14—at Mr. Sisco’s office. Id. requires the pharmacist to ‘‘record any The Allegations of Dispensing
at 186–88. The purpose of the meeting related information indicated by a Violations
was to ask the Yousefs about licensed health care practitioner.’’ Id. The lead investigator testified that
information contained on the fill (Rule 64B16–27.800(2)). Finally, this DEA investigators provided the
stickers of the prescriptions. Id. at 188– Rule requires pharmacists to maintain following information to Professor Paul
89. Emad Yousef was asked what ‘‘[a] patient record for a period of not Doering, M.S., the Expert for the
‘‘MAG’’ stood for, and the lead less than two years from the date of the Government: (1) Copies of the original
investigator testified that Yousef last entry in the profile record’’ in ‘‘hard prescriptions for certain patients flagged
responded that it stood for Mina copy or a computerized form.’’ Id. (Rule by the lead investigator, (2) a copy of all
Ghobrial, a pharmacist intern at Trinity 64B16–27.800(3)). of the E–FORCSE 15 data for the
II. Id. at 339, 446–47. The DI testified The lead investigator testified that he Respondent from February 2012 to
that he conducted a license verification requested the patient profiles because February 2014, (3) the aforementioned
on Florida’s Department of Health ‘‘another place to resolve red flags, from individualized dispensing reports
license verification website and learned my training and experience, was in the prepared by the lead investigator, (4) a
that Mina Ghobrial is a pharmacist patient profiles,’’ and ‘‘a lot of copy of one of his DEA–6 16 forms, (5)
intern in Florida. Id. at 339, 444. the subpoenaed patients’ profiles, and
pharmacists, instead of writing it on the
Another DI testified that he also (6) maps for certain patients. Tr. 581,
prescription, they will actually type it
conducted the same license verification 589–90, 597–98, 601–02. Professor
into a note section in the patient profile
search on August 20, 2015 that Doering testified that he also received
in the computer.’’ Tr. 182, 572–73. He
confirmed Mr. Ghobrial’s status as a an electronic copy of the ‘‘master
further testified that the patient profile
licensed pharmacy intern. Id. at 711; GX dispensing report’’ for Trinity II. Id. at
is generally ‘‘part of the pharmacy’s
78. The lead investigator also testified 861. He further testified that he relied
electronic system, where it will list out
that ‘‘EFY’’ are the initials for Emad on the following materials in forming
the prescriptions that the individual
Yousef, and ‘‘MIA’’ are the initials for his opinion in this case: ‘‘the dispensing
patient has received. It also contains
pharmacist Mark Abdelmaseeh. Tr. 271– logs, the copies of the individual
note sections and other information
72, 338, 345. prescriptions, the patient profiles, and
On December 4, 2014, the lead regarding the patient.’’ Id. at 159. On
what could best be called as Google
investigator issued an administrative December 22, 2014, Mr. Sisco sent an
Maps and/or MapQuest indicators of
subpoena to Trinity II asking that the email to the lead investigator stating
distances between two spots.’’ Id. at
pharmacy ‘‘provide a copy of the that ‘‘[e]nclosed please find documents
863.
complete patient profile your pharmacy responsive to the referenced subpoena.’’ Professor Doering was retained by the
maintained pursuant to Florida GX 98, at 1. Attached to this email were Government to be its Expert and was
Administrative Rule 64B16–27.800 patient profiles stored in portable tendered as such at the hearing. Tr. 147,
(‘Requirement for Patient Records’)’’ for document format (‘‘PDF’’). Id.; Tr. 159– 834. Professor Doering has taught the
23 specific patients. GX 98, at 2; Tr. 159, 60, 175, 182–83. practice of pharmacy in Florida for 40
548–49. The CALJ took official notice of The lead investigator testified that he years and at one time also worked in a
the version of this Rule applicable reviewed all the prescriptions, retail pharmacy. Id. at 812–13, 824,
between February 2012 and February dispensing reports, and patient records 830–31; GX 32. His teaching has
2014. ALJ Ex. 38. The Florida Board of obtained from Trinity II and received included courses related to the
Pharmacy adopted the Florida from its counsel. Tr. 183–84, 241, 247– standards of pharmacy practice in the
Administrative Rules pursuant to its 48, 253–54, 256, 259, 264, 268, 278, 285, State of Florida. Tr. 814–15. He has also
authority under Chapters 465.022 and 291, 297, 303, 572–73, 666–67. He conducted research and published
465.0155 of the Florida Statutes. This testified that none of the patient records extensively regarding the standards of
Rule requires ‘‘all pharmacies’’ to received in response to the December 4, pharmacy practice in Florida. Id. at
‘‘maintain[ ]’’ ‘‘[a] patient record system 2014 administrative subpoena contained 816–17; GX 32. Professor Doering was
. . . for patients to whom new or refill a ‘‘notes and comment section’’ or also the one professor to have ever been
prescriptions are dispensed’’ that ‘‘shall documentation of contact with a given the honorary title of Distinguished
provide for the immediate retrieval of doctor’s office. Id. at 183–84, 667–68. Service Professor Emeritus in the 95-
information necessary for the He also testified that the majority of the year history of the University of
dispensing pharmacist to identify prescriptions did not contain evidence Florida’s School of Pharmacy, a status
previously dispensed drugs at the time that a doctor’s office had been called. Id. he received in 2011.17 Tr. 811–12.
a new or refill prescription is presented at 666–67.
15 E–FORCSE stands for ‘‘Electronic-Florida
for dispensing.’’ ALJ Ex. 38, at 1 (Rule Finally, he testified that he created Online Reporting of Controlled Substances
64B16–27.800(1)). The Rule also states Google Maps printouts to show certain Evaluation’’ and is the prescription drug monitoring
that the ‘‘pharmacist shall ensure that a patient’s travel. Id. at 238. Specifically, program in Florida. Tr. 553, 857.
reasonable effort is made to obtain, he testified that when he created these 16 A DEA–6 is the form where DIs write their
record and maintain’’ certain patient- maps, he would use the patient’s home report of an investigation. Tr. 582. Pursuant to 21
related information, including CFR 1316.46(b)(4), the information contained in
address as the starting point, the investigatory reports are not available for inspection
‘‘[p]harmacist comments relevant to the physician’s address as the next stop, the as part of the administrative record. Thus, the CALJ
individual’s drug therapy, including any pharmacy as the stop after that, and properly precluded Respondents’ counsel from
sradovich on DSK3GMQ082PROD with NOTICES2
other information peculiar to the sometimes the patient’s home address as asking the agent on cross-examination to reveal the
specific patient or drug.’’ Id. (Rule contents of his DEA–6. Tr. 583 (‘‘He can’t be
the final stop. Id. at 237. The CALJ compelled to answer or reveal anything that’s in his
64B16–27.800(1)(f)). This Rule further found that the testimony of each of the DEA–6.’’), 584 (‘‘he can’t be compelled to discuss
DIs called by the Government ‘‘was the investigative contents of the DEA–6’’).
14 The lead investigator testified that, during the 17 According to his CV, he was ‘‘[a]warded
sufficiently detailed, plausible,
inspection of Trinity II, he spoke with Emad ‘Emeritus’ status upon official retirement on
Yousef, and that Yousef had stated that he and his
consistent and cogent to be fully January 31, 2011. Despite retirement, [he] continues
brother, Mina Yousef, were co-owners of Trinity I credited in this recommended to teach the same course as before retirement,
and Trinity II. Tr. 128, 133. decision.’’ R.D. at 14. except on a volunteer basis. [He e]ngages in special
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Professor Doering testified that he keeps prospective drug use review) is already the patient profiles he reviewed.19 Id. at
current on the latest developments in ‘‘specified in the Florida Administrative 1054, 2087.
pharmacy practice. Id. at 817. Code,’’ which requires pharmacists to Professor Doering testified that only
At the hearing, the CALJ accepted perform a prospective drug utilization after the pharmacist has identified,
Professor Doering as an expert in the review before dispensing a medication. resolved, and documented his/her
practice of pharmacy in the State of Id. at 869–70 (‘‘It says, pharmacists resolution of red flags of diversion and
Florida and in the standard of care for shall, before dispensing a medication, other issues identified during the drug
pharmacists in the dispensing of perform what [is] called . . . utilization review process can the
controlled substances in Florida. Id. at prospective drug utilization review.’’), pharmacist fill the prescription. Id. at
843–844. In his Recommended 958–59 (‘‘it’s crystal clear what it says, 873–74, 1093–94, 1099–1100. If the
Decision, the CALJ also stated that the pharmacist shall before dispensing pharmacist cannot resolve the issue,
Professor Doering ‘‘has decades of any prescription do a drug utilization then the standard of care calls for
experience in academia with honors and review’’). The CALJ took official notice pharmacists not to fill the prescription.
numerous publications’’ and that ‘‘[h]is of (and entered into evidence) the E.g., id. at 879.
credentials are extremely impressive, applicable version of Florida Professor Doering also explained
and the pride and commitment he Administrative Code Rule 64B16– some specific issues, or red flags, that
displayed toward the field of pharmacy pharmacists must look for as part of the
27.810, entitled ‘‘Prospective Drug Use
were undeniable and palpable in his prospective drug review process
Review,’’ which states that ‘‘[a]
testimony.’’ R.D. at 14. pursuant to Rule 64B16–27.810. For
pharmacist shall review the patient
In that capacity, Professor Doering instance, he testified that the term
record and each new and refill
testified that he sought to ‘‘identify[ ] ‘‘over-utilization’’ in this Rule is a red
prescription presented for dispensing in
individual patients that might flag, and he explained that it ‘‘can be
order to promote therapeutic two things. So it can be taking more of
demonstrate some of the activities and
appropriateness by identifying: (a) Over- the medication at a single
issues that have come to be called red
utilization [ ]; (b) Therapeutic administration. Or it could be obtaining
flags’’ or ‘‘indicators.’’ Id. at 864. In his
duplication; . . . (d) Drug-drug more medication than the physician had
opinion, a red flag is ‘‘anything that
interactions; (e) Incorrect drug dosage or desired, and using it in a time span that
raises concern.’’ Id. ‘‘In the area of
duration of drug treatment; . . . (g) is less than the medication was
pharmacy it’s a term that’s come to be
Clinical abuse/misuse.’’ ALJ Ex. 38 (Fla. supposed to last.’’ ALJ Ex. 38 (Fla.
used to give examples to pharmacies of
Admin. Code Rule 64B16–27.810(1)); Admin. Code Rule 64B16–27.810(1)(a));
things that might indicate or suggest
that prescriptions were filled outside Tr. 946, 1852. This Rule also states that, Tr. 872, 876. He offered the following
the usual course of pharmacy practice.’’ ‘‘[u]pon recognizing any of the above, example: ‘‘So if it’s a 30-day supply of
Id. He also testified that a red flag the pharmacist shall take appropriate medicine, having lasted only 15 days is
‘‘could be indicative of abuse or steps to avoid or resolve the potential suggestive of one of two things. One, is
misuse,’’ ‘‘over or under compliance,’’ problems which shall, if necessary, taking too much of it. Or two, might be
‘‘drug-drug interactions,’’ or a ‘‘forged’’ include consultation with the distributing it to other persons. That
or ‘‘altered’’ prescription. Id. at 869. He prescriber.’’ Id. (Fla. Admin. Code Rule would be over[-] utilization.’’ Id. at 872.
further testified that these issues would 64B16–27.810(2)). This prospective drug He testified that when a pharmacist
be reviewed and resolved by a use review, according to Professor identifies an over-utilization issue when
pharmacist ‘‘before filling any Doering, applies to all prescription a patient presents a prescription, the
prescription’’ as part of the ‘‘prospective drugs, including prescriptions for pharmacist must resolve that issue (and
drug utilization review, or prospective controlled substances and document that resolution) before filling
drug use review.’’ See id. Resolution of narcotics.18 See Tr. 870. the prescription. Id. at 873–74, 879.
red flags, he continued, ‘‘would be Professor Doering testified that the Professor Doering also explained that
documented on the face of the drug utilization review process ‘‘begins the term ‘‘therapeutic duplication,’’ as
prescription, on the rear of the when the prescription is presented’’ and set forth in Rule 64B16–27.810(1)(b), ‘‘is
prescription, or in the patient profile.’’ should be ‘‘performed at the time the the presenting of two prescriptions,
Id. at 882. Professor Doering testified information is given to the pharmacist.’’ either for the identical drug, or drugs
that the standard of practice in Florida Id. at 873. He also stated that the that are so closely allied that they would
regarding the contents of such standard of care in Florida requires be overlapping in their actions in the
documentation is that it has to include pharmacists to use the notes and body.’’ Id. at 884–85, 1520 (therapeutic
‘‘a reason that makes sense that, to the comments fields in a patient profile to duplication’’ occurs when ‘‘two drugs
average pharmacist, is understandable document the resolution of issues with the same action [are] being
how a person could find themselves in identified during the drug utilization prescribed under the same
that predicament,’’ and the standard of review process. Id. at 1015–16. In the circumstances’’), 1541 (‘‘Essentially two
practice also requires documentation of absence of notes resolving such issues drugs with the same net effect.’’).
‘‘potentially reasonable removals of red in the patient profile, Professor Doering ‘‘[F]rom a pharmacist’s standpoint,
flags’’ and some link back to the testified that he would also look to the [that] is duplication of therapy.’’ Id. at
prescribing physician. Id. at 1169–70. front and back of the prescription to 885. Professor Doering testified that
He further testified that ‘‘if it’s not determine whether a pharmacist had therapeutic duplication is a red flag. Id.
written down[,] you didn’t do it.’’ Id. at at 886. ‘‘Therapeutic duplication
resolved a red flag. Id. at 1055, 1101. He
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1353. signifies that there are two or more
further testified that he did not find any
Professor Doering testified that the notes and comments section in any of 19 Professor Doering testified that he also
standard of care for a prospective drug
reviewed dispensing logs, which are typically
utilization review (also referred to as a 18 Professor Doering testified that ‘‘[n]arcotics ‘‘spreadsheet[s] that contain[ ] information
prescriptions . . . are referred to as high alert regarding drugs that were dispensed by the
projects for the College of Pharmacy, Shands medications’’ that ‘‘have a higher than ordinary pharmacy,’’ and that the data in the dispensing log
Hospital, and other agencies and organizations.’’ GX potential to cause harm if used inappropriately.’’ should ‘‘correspond’’ to the patient profile’s data.
32, at 1. Tr. 865, 867–68. Tr. 1018–19.
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drugs that appear to be essentially doing Id. at 1417. Moreover, he testified that would look to patients that are in the
the same thing, that together might pose this combination of drugs ‘‘constitute same geographic area [as the pharmacy].
the issue of adverse drug-drug what I would call drugs with abuse I would say within the same county or
interactions.’’ Id. at 883; see ALJ Ex. 38 potential, serious abuse potential’’ and geographic area.’’ Id. at 1692. ‘‘[W]hen
(Fla. Admin. Code Rule 64B16– ‘‘are often diverted to non-medical or the distances are very great, it raises
27.810(1)(b), (d)). ‘‘[I]t also may involve recreational use.’’ Id. at 1416.20 During . . . a question of why is somebody
intentional duplication of drugs.’’ Tr. the prospective drug utilization review needing to travel this far to get this
883. In this way, he added that a process, pharmacists, ‘‘check for drug/ prescription filled.’’ Id.
prescription raising a ‘‘therapeutic drug interactions. And this would be Professor Doering also explained what
duplication’’ concern might lead to subject to, in my opinion, very severe type of information is generated after a
another issue for the pharmacist to drug/drug interactions.’’ Id. at 1418. pharmacist has decided to fill a
resolve regarding drug-drug Professor Doering testified to what a prescription. ‘‘When the computer
interactions. Id. at 883–84. As a result, pharmacist would look for in prints out the information there are
Professor Doering stated that therapeutic identifying ‘‘[c]linical abuse/misuse’’ as different versions of the [fill sticker].
duplication raises many concerns, part of the prospective drug use review. One version of it doesn’t contain
including the ‘‘safety of the patient. But ALJ Ex. 38 (Fla. Admin. Code Rule necessarily all this information, but
it could also indicate an attempt to 64B16–27.810(1)(g)). He defined clinical that’s the one that gets applied to the
obtain more medication for abuse or misuse as ‘‘recreational use’’ or prescription vial. Th[e other version] is
over[-]utilization, which touches upon ‘‘drug abuse’’ which ‘‘typically involves the one for pharmacists’ record keeping
some of the other issues, which means taking more of the prescribed drug or purposes. It has additional info that the
clinical use or abuse, or diversion to focusing on certain drugs that have [ ] one on the vial does not.’’ Id. at 978.
some other use.’’ Id. at 885–86. As with mood altering properties . . . that Significantly, he testified that the fill
other red flags, he reiterated that the individuals . . . will use for other than sticker is generated after the drug
standard of care requires pharmacists medical purposes.’’ Tr. 952, 953 (it is utilization review process has been
receiving a prescription raising the red ‘‘any time you use the drug outside the completed, and that the date appearing
flag of therapeutic duplication to resolve conditions for which it could be on the fill sticker represents the date
that issue (and document such prescribed’’). To identify such clinical when the pharmacy filled the
resolution) before filling the abuse/misuse as part of the drug prescription. Id. at 979–80. He
prescription. Id. at 886–91. utilization review process, Professor explained that the fill sticker is
Professor Doering next explained the Doering testified that a pharmacist ‘‘generated one step before the
term ‘‘[d]rug-drug interactions.’’ ALJ Ex. ‘‘would look for quantities of drugs that prescription label is actually applied to
38 (Fla. Admin. Code Rule 64B16– are being sought beyond those which the vial . . . by the pharmacist. The
27.810(1)(d)). He testified that this were authorized by the prescriber or significance of that is that the
‘‘refers to the fact that two drugs, when they might look for certain prescription has gone through all the
given together, can have outcomes that combinations of drugs that are known to proper steps and its certified ready for
are not what was intended initially by be used frequently for non-medical dispensing to the patient.’’ Id. at 979.
either one or the other drug together.’’ reasons.’’ Id. at 953. Again, as with the Professor Doering further testified that,
Tr. 893. He testified that when other red flags that may arise during a in his opinion, the date on the fill
presented with prescriptions presenting prospective drug use review (i.e., the sticker also represents when the
potentially harmful drug-drug drug utilization review process), if the
prescription is dispensed. Id. at 1186.
interactions, the standard of care pharmacist cannot resolve the clinical
Respondents did not proffer an expert
requires the pharmacist to either (1) abuse/misuse red flag, then he or she
witness at the hearing, and I find that
resolve this red flag and document the must not fill the prescription. Id.at 955.
Professor Doering also offered Professor Doering’s testimony was
resolution once the pharmacist is
testimony regarding patient address credible.21
satisfied that it is in the best interest of
the patient, or (2) not fill the information that appears on a The Prescription Evidence
prescriptions. Id. at 1419–20. prescription and the distance a patient
At the hearing, the Government
Professor Doering also testified, travels to a pharmacy to fill a
introduced into evidence copies of
however, that drug cocktails that prescription. He testified that both
dispensing logs, patient profiles, and the
include an opioid, benzodiazepine, and Florida and federal law require a
front and back of prescriptions for
a muscle relaxer present red flags that patient’s address to appear on
must be resolved. See, e.g., id. at 1413– prescriptions ‘‘so that the pharmacist controlled substances which it alleged
16, 1427. ‘‘[F]or example, oxycodone, or has some idea of where this patient Trinity II filled in violation of 21 CFR
some other potent narcotic, along with resides and that can be useful for a 1306.04(a) and 1306.06 because they
a tranquilizer drug, such as alprazolam couple of different reasons . . . it’s also presented red flags of diversion that
or Xanax, combined with a muscle useful to know what geographic area Trinity II failed to resolve as set forth in
relaxant, say for example, Soma,’’ also this patient lives in because that may the first two charges of the Show Cause
known as carisoprodol. Id. at 894. become important information as the Order. As already noted, the first charge
‘‘[T]hose three drugs, which have been prospective drug use review takes of the Show Cause Order outlined six
come to be called the unholy trinity, or place.’’ Id. at 973. In the same vein, he different categories of red flags of
. . . cocktail prescriptions, whatever testified that a physician’s address must diversion that the Government alleged
sradovich on DSK3GMQ082PROD with NOTICES2
you want to call them, are symbolic of also appear on the prescription to 21 Although the CALJ expressly declined to offer
drug interactions that might cause indicate where the patient met with the a view of Professor Doering’s credibility, he
harms to the patient.’’ Id.; see also id. practitioner. Id. at 970. ‘‘Typically you nonetheless disregarded his opinions as
at 1416–17. According to Professor ‘‘insufficiently reliable to form the basis of a
Doering’s testimony, these drugs ‘‘have 20 He also testified that ‘‘[t]he nature of the drug sanction under the APA.’’ R.D., at 33 (‘‘To be clear,
combination, a potent narcotic analgesic, along with however, this is not an issue of credibility, and no
added central nervous system a potent anxiolytic medicine, along with a potent credibility determination is entered here.’’). As I
depressant properties and can present a muscle relaxant . . . It’s just come to be associated discuss infra, I disagree with the CALJ’s assessment
real and present danger to the patient.’’ with a high potential for abuse.’’ Tr. 1417. of the expert’s reliability.
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that Trinity II failed to resolve before that the front of the prescription, the Trinity II filled 14 days early on
filling the pertinent prescriptions. When back of the prescription bearing the fill September 6, 2012); GX 35, at 1, 3, 54,
taken together, the Government alleged sticker, the patient profile, and the 55, 62, 63; Tr. 1228–31 (prescription for
that Trinity II’s failure to resolve these dispensing log do not reflect any notes 42-day supply that Trinity II filled 16
red flags before filling these or comments explaining why Trinity II days early on October 3, 2012); GX 35,
prescriptions demonstrated that Trinity filled the prescription early. GX 35, at at 1, 3, 62, 63, 70, 71; Tr. 1231–34
II knowingly filled prescriptions for 1, 3, 15, 16; Tr. 1198, 1199, 1205–06. (prescription for 42-day supply that
controlled substances in contravention Professor Doering testified that, in Trinity II filled 14 days early on
of its corresponding responsibility and Florida, whereas a fill (or refill) that is November 1, 2012). When considering
outside the usual course of pharmacy 2–3 days early may not signify a the cumulative effect of these
practice. problem, a fill that is more than two-to- consecutive monthly early fills from
three days early is a red flag that a March–November 2012, I find that
Early Fills pharmacist is expected to resolve during Trinity II filled prescriptions for J.T. that
The Government introduced the drug utilization review process ‘‘to resulted in the filling of 135 days of
prescription evidence to show that avoid overuse or misuse.’’ See Tr. 989– extra oxycodone 30 mg.
Trinity II failed to resolve the first 91, 1009. ‘‘If someone is coming back
alleged red flag of diversion, ‘‘early fifteen days early, then that signifies a And as with the earlier prescription
fills,’’ with respect to at least four of its problem.’’ Id. at 990. In the case of J.T.’s that Trinity II filled for J.T. on March 22,
customers identified in the first charge presentation of the aforementioned 2012, I find that the prescriptions (front
of the Show Cause Order and whose March 22, 2012 Roxicodone 30 mg or back), patient profile, and dispensing
patient records the Government had prescription 15 days early, the evidence log do not reflect any notes or
requested pursuant to its December 4, established that there are no notes or comments, much less documentation,
2014 subpoena.22 For one such comments—much less any evidence explaining how Trinity II resolved the
customer, J.T., the Government that Trinity II resolved this red flag— early refill red flag presented by these
introduced a dispensing log, patient reflected in J.T.’s patient profile, prescriptions over the eight subsequent
profile, and the front and back of dispensing log, or the front-and-back of months. See GX 35, at 1, 3, 16, 17, 20,
prescriptions to establish that Trinity II this prescription. GX 35, at 1, 3, 15, 16; 21, 30, 31, 36, 37, 44, 45, 50, 51, 54, 55,
filled early at least nine prescriptions Tr. 1198–99, 1205–06. As a result, 62, 63, 70, 71; Tr. 1198–99, 1205–06,
issued to J.T. for oxycodone 30 Professor Doering testified that this 1212, 1216, 1218, 1222, 1225, 1228,
milligrams (hereinafter, ‘‘mg’’), a prescription was inconsistent with 1230, 1234. And in each instance,
schedule II controlled substance, under Florida’s standard of care, not filled in Professor Doering testified that, because
the brand name Roxicodone. GX 35; Tr. the usual course of professional all of these early fills were well beyond
1198–1234. Specifically, the practice, nor filled in the proper 3 days early, Trinity II should have
Government introduced evidence that exercise of the pharmacist’s identified these early fills as red flags
on February 23, 2012, Trinity II filled a corresponding responsibility. Id. at during the drug utilization review
prescription issued by physician W.F. to 1206. process to avoid drug abuse, overuse or
customer J.T. for 336 pills of In each of the next eight months, J.T. misuse. Tr. 1208–09, 1211–12, 1215–17,
‘‘Roxicodone 30 mg,’’ and with presented prescriptions to Trinity II for 1222–25, 1227–28, 1230–31, 1234. He
directions from the prescribing Roxicodone 30 mg in the same further testified that Trinity II’s decision
physician for J.T. to take up to eight quantities and with the same dosing to fill these prescriptions without
pills per day. GX 35, at 1, 3, 10, 11; Tr. instructions; and in each instance, I find resolving these red flags was
1199–1202. Although the fill sticker and that Trinity II filled those prescriptions inconsistent with Florida’s standard of
patient profile both state that the 14, 15, or 16 days early. GX 35, at 1, 3, care, not in the usual course of
prescription was for a 30-day supply, in 16, 17, 20, 21; Tr. 1208–09 (prescription professional practice, and did not reflect
fact, the 336 pills prescribed to be taken for 42-day supply that Trinity II filled the proper exercise of the pharmacist’s
at the rate of eight pills per day 15 days early on April 19, 2012); GX 35, corresponding responsibility. Id.
constitutes a 42-day supply that should at 1, 3, 20, 21, 30, 31; Tr. 1209–12
have lasted J.T. until at least April 6, For a second customer, M.A., the
(prescription for 42-day supply that Government introduced a dispensing
2012. Id. Nevertheless, on March 22, Trinity II filled 15 days early on May 17,
2012, Trinity II then filled another log, patient profile, and the front and
2012); GX 35, at 1, 3, 30, 31, 36, 37; Tr. back of prescriptions to establish that
prescription (from the same prescriber) 1213–17 (prescription for 42-day supply
for another 336 pills of Roxicodone 30 Trinity II filled early at least 8
that Trinity II filled 15 days early on prescriptions issued to M.A. for
mg with instructions to take up to eight June 14, 2012); GX 35, at 1, 3, 36, 37,
pills per day. GX 35, at 1, 3, 16, 17; Tr. hydromorphone 8 mg, a schedule II
44, 45; Tr. 1220–23 (prescription for 42- controlled substance, under the brand
1202–05. Thus, I find that when Trinity day supply that Trinity II filled 15 days
II filled this second prescription on name Dilaudid. GX 36; Tr. 1237–68. The
early on July 12, 2012); GX 35, at 1, 3, Government introduced evidence that
March 22, 2012, Trinity II filled it 15 44, 45, 50, 51; Tr. 1223–25 (prescription
days early. Accord Tr. 1205.23 I also find on May 2, 2013, Trinity II filled a
for 42-day supply that Trinity II filled prescription issued by physician R.A. at
16 days early on August 8, 2012); GX 35, the Genesis Medical Clinic to customer
22 For reasons I discuss infra, and as it relates to
the first and second charges of the Show Cause
at 1, 3, 50, 51, 54, 55; Tr. 1225–28 M.A. for 165 pills of ‘‘Dilaudid Oral
(prescription for 42-day supply that
sradovich on DSK3GMQ082PROD with NOTICES2
Order only, I limit my fact findings to evidence Tablet 8 MG,’’ with directions from the
related to those patients discussed at the hearing prescribing physician for M.A. to ‘‘[t]ake
who were also identified in the December 4, 2014 expert. R.D., at 43. However, as discussed further
subpoena. infra, this concern, even if well-founded, does not
one tablet every 5 to 6 hours for 30
23 Notably, the CALJ failed to make recommended categorically relieve the Agency from making fact days.’’ GX 36, at 1–2, 4–5; Tr. 1237–42.
fact findings related to the alleged early fills, or findings on allegations about Trinity II’s filling Although the prescription and the fill
most of the other allegations set forth in paragraphs conduct that can be decided without expert sticker both stated that the prescription
7–8 of the Show Cause Order (i.e., the first two opinion. Accordingly, I will make such ultimate
charges of the Order) because of his concerns fact findings, even where the CALJ chose not to
was for a 30-day supply, in fact, the 165
related to Professor Doering’s reliability as an recommend any. pills prescribed to be taken at the rate
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![7314 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
of five pills 24 per day constitutes a 33- 2013, I find that the prescriptions (front With respect to the alprazolam
day supply that should have lasted M.A. or back), patient profile, and dispensing prescriptions for J.G., the Government
until at least June 4, 2013. Id. log do not reflect any notes or introduced evidence that on September
Nevertheless, on May 28, 2013, Trinity comments, much less documentation, 18, 2012, Trinity II filled a prescription
II then filled another prescription (from explaining how Trinity II resolved these issued by physician G.C. to customer
another prescriber, J.S., at the same early refill red flags over the seven J.G. for 30 pills of Xanax 2 mg, which
practice group—Genesis Medical Clinic) subsequent months. See GX 36, at 1–3, is the brand name for alprazolam 2 mg,
for another 165 pills of Dilaudid 8 mg 4–11, 13–20; Tr. 1236–37, 1245, 1248, that could be refilled twice and with
with instructions to take one tablet 1251, 1253, 1255, 1258, 1261, 1263. directions from the prescribing
every five to six hours for 30 days. GX Professor Doering testified that, because physician for J.G. to ‘‘[t]ake 1⁄2 [one-half
36, at 1–2, 4–7; Tr. 1242–45. Thus, I find all of these early fills were well beyond of one] tablet(s) . . ., 2 times per day,
that when Trinity II filled this second three days early, Trinity II should have for 30 days, as needed for anxiety.’’ GX
prescription on May 28, 2013, Trinity II identified these early fills as red flags 39, at 1–2, 6; Tr. 1370–71. Hence, the 30
filled it seven days early. I also find that during the drug utilization review pills prescribed to be taken at the rate
the front of the prescription, the back of process to avoid drug abuse, overuse or of one pill per day constitute a 30-day
the prescription bearing the fill sticker, misuse. Tr. 1240–41, 1245, 1248–49, supply that should have lasted J.G. until
the patient profile, and the dispensing 1251, 1253–54, 1255, 1256, 1258, 1261, at least October 18, 2012 (assuming J.G.
log do not reflect any notes or comments 1263–64. He further testified that needed to take it every day for 30 days).
explaining why Trinity II filled the Trinity II’s decision to fill these Id. Nevertheless, the dispensing log and
prescription early. GX 36, at 1–2, 6–7; prescriptions without resolving these patient profile show that on October 10,
Tr. 1236, 1237, 1245. red flags was inconsistent with Florida’s 2012, Trinity II then refilled the
In each of the next seven months, standard of care, not in the usual course prescription for another 30 pills of
M.A. presented to Trinity II of professional practice, and did not alprazolam 2 mg. GX 39, at 1–2, 6; Tr.
prescriptions from the same Genesis reflect the proper exercise of the 1371–73. Thus, I find that when Trinity
Medical Clinic for Dilaudid 8 mg in the pharmacist’s corresponding II refilled this prescription on October
same quantities and with the same responsibility. Id. 10, 2012, Trinity II refilled it eight days
dosing instructions; and in each For a third customer, J.G., the early. Accord Tr. 1372. The dispensing
instance, I find that Trinity II filled Government introduced a dispensing log and patient profile also establish
those prescriptions six days early. GX log, patient profile, and the front and that on October 29, 2012, Trinity II
36, at 1–2, 6–9; Tr. 1245–49 back of prescriptions to establish that refilled the prescription again for
(prescription for 33-day supply that Trinity II filled early or refilled early another 30 pills of alprazolam 2 mg. GX
Trinity II filled six days early on June prescriptions issued to J.G. at least 39, at 1–2, 6; Tr. 1373. Thus, I find that
25, 2013); GX 36, at 1–2, 8–10; Tr. 1249– seven times—one time for a prescription when Trinity II refilled this prescription
51 (prescription for 33-day supply that of lorazepam 2 mg, and six times for on October 29, 2012, Trinity II refilled
Trinity II filled six days early on July 23, prescriptions of alprazolam 2 mg, both it 10 days early because the earlier refill
2013); GX 36, at 1–2, 10–11; Tr. 1251– of which are schedule IV controlled should have lasted until November 8,
54 (prescription for 33-day supply that substances. GX 39; Tr. 1364–84. 2012. Accord Tr. 1374. I also find that
Trinity II filled six days early on August Regarding the lorazepam prescription, the front of the original prescription, the
20, 2013); GX 36, at 1–2, 11, 13–14; Tr. the Government introduced evidence back of the original prescription bearing
1254–55 (prescription for 33-day supply that on May 29, 2012, Trinity II filled a the fill sticker, the patient profile, and
that Trinity II filled six days early on prescription issued by physician G.C. to the dispensing log do not reflect any
September 17, 2013); GX 36, at 1–3, 13– customer J.G. for 30 pills of lorazepam notes or comments explaining why
16; Tr. 1256–58 (prescription for 33-day 2 mg, and with directions from the Trinity II refilled the prescription early
supply that Trinity II filled six days prescribing physician for J.G. to ‘‘[t]ake on October 10 and October 29, 2012. GX
early on October 15, 2013); GX 36, at 1, 1⁄2 [one-half of one] tablet(s) . . ., 2 39, at 1–2, 6; Tr. 1373.
3, 15–18; Tr. 1259–61 (prescription for times per day, for 30 days.’’ GX 39, at On February 26, 2013, Trinity II filled
33-day supply that Trinity II filled six 1–2, 4; Tr. 1365–66. Hence, the 30 pills another prescription issued by
days early on November 12, 2013); GX prescribed to be taken at the rate of one physician G.C. to customer J.G. for 30
36, at 1, 3, 17–20; Tr. 1262–64 pill per day constitute a 30-day supply pills of alprazolam 2 mg (a 30-day
(prescription for 33-day supply that that should have lasted J.G. until at least supply), even though the dispensing log
Trinity II filled six days early on June 28, 2012. Id. Nevertheless, on June and J.G.’s patient profile show that
December 10, 2013). When considering 19, 2012, Trinity II then filled another Trinity II had already filled a 30-day
the cumulative effect of these prescription from the same prescribing supply of alprazolam 2 mg for J.G. on
consecutive monthly early fills from physician for another 30 pills of February 14, 2013.25 GX 39, at 1–2, 8–
May 2013 to December 2013, I find that lorazepam 2 mg with the same 9; Tr. 1375–77. I find that when Trinity
Trinity II filled prescriptions for M.A. instructions—one pill per day. GX 39, at II filled the February 26, 2013
that resulted in the filling of 50 days of 1–2, 4–5; Tr. 1366–70. Thus, I find that prescription, Trinity II filled it at least
extra hydromorphone 8 mg. when Trinity II filled this second 17 days early because the February 14,
As with the earlier prescription that prescription on June 19, 2012, Trinity II 2013 refill should have lasted J.G. until
Trinity II filled for M.A. on May 28, filled it nine days early. Accord Tr. at least March 15, 2013. Accord Tr.
sradovich on DSK3GMQ082PROD with NOTICES2
1367. I also find that the front of the 1377. Over the next two months, Trinity
24 If M.A. took the tablets every six hours as
prescription, the back of the II then refilled this prescription twice
instructed, then the daily tablet dosage would be
four tablets/day; if M.A. took the tablets every five prescription bearing the fill sticker, the (on March 18, 2013 and on April 12,
hours as alternatively instructed, then the daily patient profile, and the dispensing log
dosage would be 4.8 tablets per day. Accord Tr. do not reflect any notes or comments 25 The February 14, 2013 filling by Trinity II was
1239–40. For purposes of this early fill fact-finding, the second refill of a December 18, 2012
I will round up to and use the rate of five tablets/
explaining why Trinity II filled the prescription (also issued by physician G.C.) that J.G.
day—a calculation that offers Trinity II the greatest prescription early. GX 39, at 1–2, 5; Tr. had filled at Trinity II on December 18, 2012. See
lenity for purposes of calculating an early fill. 1364–65, 1369. GX 39, at 1–2, 8.
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![Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices 7315
2013), and in each instance I find that name Dilaudid. GX 40; Tr. 1384–94. The with respect to one of its customers,
Trinity II refilled it 10 and five days Government introduced evidence that R.H., identified in the first charge of the
early, respectively. GX 39, at 1–2, 9; Tr. on June 5, 2012, Trinity II filled a Show Cause Order and whose patient
1377–79 (prescription for 30-day supply prescription issued by physician J.I. at records the Government had requested
that Trinity II filled 10 days early on the Creative Health Center to customer pursuant to its December 4, 2014
March 18, 2013); GX 39, at 1–2; Tr. L.H. for 180 pills of ‘‘Dilaudid Tablet 8 subpoena. The Government introduced
1377–79 (prescription for 30-day supply mg,’’ and with directions from the a dispensing log, patient profile, and the
that Trinity II filled five days early on prescribing physician for L.H. to take front and back of prescriptions to
April 12, 2013). I find that the front of one tablet by mouth every four hours as establish that Trinity II filled two
the original prescription, the back of the needed. GX 40, at 1, 3, 12–13; Tr. 1387– therapeutically duplicative
original prescription bearing the fill 88. Hence, the 180 pills prescribed to be prescriptions issued by physician J.I. for
sticker, the patient profile, and the taken at the rate of six pills per day R.H. on December 2, 2013. The first
dispensing log do not reflect any notes constitute a 30-day supply that should
prescription was for 120 tablets of
or comments explaining why Trinity II have lasted L.H. until at least July 5,
hydromorphone 8 mg, an immediate
filled the February 26, 2013 prescription 2012 (assuming L.H. needed to take
early, and twice refilled that every dose, every day). Accord Tr. 1392. release opioid under the Dilaudid brand
prescription early on March 18 and Nevertheless, on June 28, 2012, Trinity name, with directions to ‘‘Take 1 Tablet
April 12, 2013. GX 39, at 1–2, 8–9; Tr. II filled another prescription (dated June by Mouth Every 6 Hours As Needed.’’
1373, 1379. 18, 2012 from another prescriber, E.P. at GX 63, at 1, 4–6; Tr. 1560–61. The
In addition, even though Trinity II Morton Plant Hospital) 26 for another 84 second prescription was for 120 tablets
filled a new prescription for a 30-day pills of Dilaudid 8 mg with instructions of oxycodone 30 mg, another
supply of alprazolam 2 mg issued by to take one tablet every 4 hours for 14 immediate-release opiate, with the same
physician G.C. to J.G. on May 14, 2013 days. GX 40, at 1, 4, 14–15; Tr. 1388– directions to take one tablet every six
that should have lasted J.G. until at least 89, 1392. Thus, I find that when Trinity hours as needed. GX 63, at 1, 4, 7–8; Tr.
June 12, 2013, Trinity II refilled this II filled this second prescription on June 1561–63. I find that the front of the
prescription with another 30-day supply 28, 2012, Trinity II filled it at least seven prescriptions, the back of the
of alprazolam 2 mg on June 6, 2013. GX days early. Accord Tr. 1389. On July 3, prescriptions bearing the fill stickers,
39, at 1, 3, 10; Tr. 1380–83. Thus, I find 2012, Trinity II filled a third the patient profile, and the dispensing
that the June 6, 2013 refill by Trinity II prescription, this time from physician log do not reflect any notes or comments
was six days early. Accord Tr. 1383. As J.I. (who issued the June 5, 2012 explaining why Trinity II filled these
with the other prescriptions and early prescription) to L.H., for another 96 pills two schedule II opiate prescriptions on
fills and refills related to J.G., I find that of Dilaudid 8 mg with instructions to December 2, 2013. GX 63, at 1, 4–8;
the front of the original prescription, the take one tablet every four hours for 16 accord Tr. 1563–64.
back of the original prescription bearing days. GX 40, at 1, 4, 16–17; Tr. 1392–
the fill sticker, the patient profile, and According to Professor Doering, when
93. As a result, I find that when Trinity a Florida pharmacist receives two
the dispensing log do not reflect any II filled this third prescription on July
notes or comments explaining why prescriptions from the same individual
3, 2012, Trinity II filled it nine days
Trinity II filled and refilled the for two different opioids, both with the
early because the June 28, 2012 fill
prescription early. GX 39, at 1, 3, 10; Tr. same or similar directions for use, and
should have lasted L.H. until July 12,
1383. those two are immediate release dosage
2012. Accord Tr. 1393. I also find that
With respect to all the early fills and the front of these prescriptions, the back forms, the standard of care requires the
refills by Trinity II with respect to of the prescriptions bearing the fill pharmacist to identify that as a red flag
lorazepam 2 mg and alprazolam 2 mg stickers, the patient profile, and the and to initiate steps to resolve that red
prescriptions issued by physician G.C. dispensing log do not reflect any notes flag. Tr. at 2111. However, Professor
to J.G., Professor Doering testified that, or comments explaining why Trinity II Doering also testified that, in his
because all of these early fills and early filled these prescriptions early. GX 40, opinion, the therapeutic duplication of
refills were well beyond three days at 1–4, 12–17; Tr. 1391, 1393–94. hydromorphone and oxycodone with
early, Trinity II should have identified respect to R.H., or any other pharmacy
them as red flags during the drug Therapeutic Duplication customer, is not a resolvable flag. Id. at
utilization review process to avoid drug The Government introduced 1520, 1563. ‘‘[P]harmacists would fall
abuse, overuse or misuse. Tr. 1369, prescription evidence at the hearing to below the standard of care to dispense
1372, 1374, 1377, 1383. He further show that Trinity II failed to resolve the these two [opioids] together because of
testified that Trinity II’s decision to fill red flag of ‘‘therapeutic duplication’’ the inherent dangers that go along with
these prescriptions without resolving
giving both of these very potent narcotic
these red flags was inconsistent with 26 The fact that the same patient, L.H., went to
analgesics . . . [t]hat could in fact be
Florida’s standard of care, not in the two different prescribers in the same month for the
usual course of professional practice, same schedule II drug also demonstrates the used together, at the same time.’’ Id. at
and did not reflect the proper exercise appearance of doctor shopping—another red flag of 1520. He also testified that therapeutic
of the pharmacist’s corresponding
overuse or misuse. Professor Doering testified that duplication should be identified during
this too should have been identified during the drug
responsibility. Id. at 1370, 1373–74, utilization process as indicative of overuse, misuse,
the drug utilization review process. Id.
1377, 1379, 1384. or abuse. Tr. 1390. There is no evidence in the at 1526, 1541–42. Professor Doering
sradovich on DSK3GMQ082PROD with NOTICES2
For a fourth customer, L.H., the record that Trinity II attempted to resolve this red testified that Trinity II’s filling of these
flag before filling the second of these prescriptions prescriptions for R.H. were inconsistent
Government introduced a dispensing on June 28, 2012. Professor Doering also testified
log, patient profile, and the front and that Trinity II’s decision to fill the June 18, 2012 with the standard of care, not filled in
back of prescriptions to establish that prescription on June 28, 2012 without resolving the usual course of professional
Trinity II filled early at least 2 these red flags was inconsistent with Florida’s practice, and inconsistent with the
standard of care, not in the usual course of proper exercise of the pharmacist’s
prescriptions issued to L.H. for professional practice, and did not reflect the proper
hydromorphone 8 mg, a schedule II exercise of the pharmacist’s corresponding corresponding responsibility. Id. at
controlled substance, under the brand responsibility. Id. at 1391. 1563–64.
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Two Prescriptions for the Same Drug on Government had requested pursuant to prescription. GX 44, at 1, 2, 8–9; accord
the Same Date its December 4, 2014 subpoena. Tr. 1676–77, 1685, 2113.
The Government introduced For one such customer, S.S., the Although Professor Doering testified
Government introduced a dispensing that there is no magical ‘‘distance
prescription evidence at the hearing to
log, patient profile, and the front and cutoff’’ in determining when a
show that Trinity II failed to resolve the
back of prescriptions to establish that on particular distance constitutes a red flag,
red flag of receiving two prescriptions
June 5, 2013, Trinity II filled a Tr. 1692–93, in response to hypothetical
for the same drug on the same date from
prescription for S.S. for 150 tablets of questions, he did testify that when a
the same customer (J.K.)—another form
hydromorphone 8 mg, with instructions pharmacist in Florida receives a
of ‘‘therapeutic duplication.’’ The
to take one tablet every four hours as prescription for a controlled substance
customer, J.K., was identified in the first
needed for breakthrough pain. GX 44, at from a customer whose address is, for
charge of the Show Cause Order, and
1, 2, 8–9; Tr. 1676–80. Although the example, 75 miles away, ‘‘[t]he standard
the Government had requested his
front of the prescription did not include of care calls for the pharmacist to
patient records pursuant to its December identify that as a red flag and to initiate
4, 2014 subpoena. The Government S.S.’s address,27 the other prescription
evidence—the fill sticker attached to the steps that may resolve that red flag’’ and
introduced a dispensing log, patient to document any such resolution. Tr.
profile, and the front and back of back of the prescription, the dispensing
log, and the patient profile—all show 2112. He testified that this standard of
prescriptions to establish that Trinity II care ‘‘requires the pharmacist to find out
filled two prescriptions issued by S.S.’s address to be in Orange Park,
Florida, which is a city located near the address of where the person resides’’
physician M.L. for J.K. on the same and ‘‘to ask the patient for that address
day—December 4, 2013. The first Jacksonville, Florida. GX 44, at 1, 2, 9;
Tr. 1680. information’’ by, for instance, ‘‘ask[ing]
prescription was for 100 tablets of for identification.’’ Tr. 2119–20; see also
hydromorphone 8 mg, under the It is undisputed that Trinity II is
located in Clearwater, Florida, and that id. at 1684. He further testified that in
Dilaudid brand name, with instructions his opinion the distance red flag for this
that the patient take one tablet every both the front of the prescription and
Trinity II’s dispensing log show that the prescription should have been
four to six hours—a 16-day supply. GX identified as part of the drug utilization
69, at 1, 3–5; Tr. 1584–86. The second prescribing physician’s address was in
Tampa, Florida. GX 44, at 1, 8. The process, and the fact that S.S. also paid
prescription was for 50 tablets of cash 28 raised an additional red flag. Tr.
Dilaudid 8 mg with the same directions Government also introduced Google
Maps evidence showing that S.S. would 1684, 1686 (‘‘patients paying cash for
for use—an eight-day supply. GX 69, at their prescriptions is a recognized red
1, 3, 6–7; Tr. 1584–86. The dispensing have traveled: (1) 175 miles from his
home address to the prescribing flag’’), 1696. As a result, Professor
log also shows that J.K. paid ‘‘cash’’ for Doering testified that filling this
these two prescriptions, just as he had physician, (2) about 23 miles from there
to Trinity II, and then (3) 199 miles from prescription was inconsistent with
for every other prescription that Trinity Florida’s standard of care, that it was
II had filled for J.K. between March 5, Trinity II back to his home address. GX
44, at 4–7; Tr. 1681–83. Indeed, S.S. not filled in the usual course of
2012 and February 3, 2014. GX 69, at 1. professional practice, nor filled in the
According to Professor Doering, two would have to travel across the entire
state of Florida—from the Jacksonville proper exercise of the pharmacist’s
prescriptions for the same medication corresponding responsibility. Id. at
filled on the same date for the same area on the East Coast of Florida to the
greater Tampa Bay area on the West 1701–02.29
customer is an unresolvable red flag of For a second customer, D.W., the
diversion that should have been Coast of Florida—to obtain and to fill
Government introduced a dispensing
identified during the drug utilization this schedule II prescription. Thus, I
log, patient profile, and the front and
process. Tr. 1568, 1586–87. Regardless find that S.S. would have to travel back of prescriptions to establish that on
of whether it is resolvable, I find that approximately 397 miles roundtrip to March 8, 2012, Trinity II filled two
the front of the prescriptions, the back obtain the June 5, 2013 hydromorphone prescriptions for D.W.—one for 120
of the prescriptions bearing the fill 8 mg prescription from his physician, tablets of oxycodone 30 mg with
stickers, the patient profile, and the and that S.S. would have to travel at
dispensing log do not reflect any notes least 198 miles after picking up his 28 Trinity II’s own dispensing report states that
or comments explaining why Trinity II prescription to return home. See id. I S.S. paid ‘‘cash’’ for the July 5, 2013 prescription,
filled these two prescriptions for the also find that Trinity II knew the and I find that S.S. did indeed pay for this
addresses of both S.S. and his prescription (rather than a third-party payer). See
same drug and for the same customer GX 44, at 1. The prescription evidence also does not
(J.K.) on December 4, 2013. GX 69, at 1, prescribing physician. See GX 44, at 1, reflect that Trinity II ever attempted to resolve the
3–7; accord Tr. 1584–85, 1587. 2, 8–9. I further find that the front of the ‘‘paying cash’’ red flag. Tr. 1686.
prescription, the back of the 29 As discussed infra in the context of cocktail
Distances prescription bearing the fill sticker, the prescriptions, on June 27, 2013 and July 23, 2013,
Trinity II also filled prescriptions for S.S. on each
The Government introduced patient profile, and the dispensing log date for carisoprodol 350 mg, hydromorphone 8 mg
prescription evidence at the hearing to do not reflect any notes or comments and Xanax 2 mg. GX 44, at 1, 2, 14–19, 22–27; Tr.
show that Trinity II failed to resolve the explaining why Trinity II filled the 1697–98; 1703–05. I also find that the front of the
prescription given the unusual distances prescriptions, the back of the prescriptions bearing
red flag of customers who had allegedly the fill stickers, the patient profile, and the
travelled unusually long distances and/ S.S. traveled to obtain and to fill this dispensing log do not reflect any notes or comments
or had taken suspicious routes for the whatsoever explaining why Trinity II filled these
sradovich on DSK3GMQ082PROD with NOTICES2
27 See GX 44, at 8. The Show Cause Order alleges prescriptions given the unusual distances S.S.
purpose of obtaining, presenting, and
that Trinity II’s filling of this prescription also traveled to obtain and to fill these prescriptions. GX
filling prescriptions for controlled constitutes an independent violation of 21 CFR 44, at 1, 2, 14–19, 22–27; accord Tr. 1700, 1705.
substances. Specifically, the 1306.05, which requires, inter alia, all prescriptions Professor Doering also testified that filling the June
Government introduced evidence for controlled substances to bear the full name and 27, 2013 and July 23, 2013 prescriptions were
exhibiting this red flag with respect to address of the patient and imposes a corresponding inconsistent with Florida’s standard of care, that
liability ‘‘upon the pharmacist . . . who fills a they were not filled in the usual course of
four of Trinity II’s customers identified prescription not prepared in the form prescribed by professional practice or in the proper exercise of the
in the first charge of the Show Cause DEA regulations.’’ Id. at § 1306.05(a), (f). As set pharmacist’s corresponding responsibility. Tr. 1701,
Order and whose patient records the forth more fully infra, I agree. 1705.
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ginger 30 (with instructions to take one pharmacist’s corresponding For a third customer, C.V., the
capsule four times daily) and the other responsibility. Id. at 1712–13. Government introduced a dispensing
for 30 tablets of carisoprodol 350 mg On April 5, 2012 and on May 3, 2012, log, patient profile, and the front and
under the brand name Soma (with Trinity II also filled prescriptions for back of a prescription to establish that
instructions to take one tablet every D.W. for 120 tablets of oxycodone 30 mg on May 10, 2012, Trinity II filled a
night). GX 45, at 1, 2, 8–11; Tr. 1710, with ginger each time—with the same prescription for C.V. for 90 tablets of
1713–14. instructions and from the same hydromorphone 8 mg, under the brand
According to the front of the prescribing physician as in the March 8, name Dilaudid, with instructions to take
oxycodone prescription,31 the fill 2012 oxycodone prescription that one tablet every eight hours. GX 46, at
sticker attached to the back of both Trinity II had filled for D.W. GX 45, at 1–2, 7–8; Tr. 1719–21. According to the
prescriptions, the dispensing log, and 1, 2, 12–13, 16–17; Tr. 1714–17. On front of the prescription, the fill sticker
the patient profile, D.W.’s address was April 19, 2012 and May 11, 2012, attached to the back of the prescription,
in Wellborn, Florida. GX 45, at 1, 2, 8, Trinity II filled prescriptions for D.W. the dispensing log, and the patient
9, 11; Tr. 1708–09. It is undisputed that for 30 tablets of Soma 350 mg each profile, C.V.’s address was in Port
the front of both prescriptions and time—again, with the same instructions Charlotte, Florida. GX 46, at 1–2, 7–8;
Trinity II’s fill stickers show that the and from the prescribing physician as Tr. 1720–21. It is undisputed that the
prescribing physician’s address was in the Soma prescription that Trinity II had front of the prescription and Trinity II’s
Tampa, Florida. GX 45, at 8–11; Tr. filled for D.W. on March 8, 2012. GX 45, fill stickers show that the prescribing
1709–1712. The Government also at 1, 2, 14–15, 18–19; 32 Tr. 1716, 1718. physician’s address was in Tampa,
introduced Google Maps evidence As with the March 8, 2012 prescriptions Florida. GX 46, at 7–8; Tr. 1720–21. The
showing that D.W. would have traveled: Government also introduced Google
for oxycodone and Soma, I find that
(1) 184 miles from his home address to Maps evidence showing that C.V. would
D.W. would have traveled
the prescribing physician, (2) about 18 have traveled: (1) 105 miles from his
approximately 404 miles roundtrip to
miles from there to Trinity II, and then home address to the prescribing
obtain the April 5, 2012 and May 3,
(3) 202 miles from Trinity II back to his physician, (2) about 22 miles from there
2012 oxycodone prescriptions, as well
home address. GX 45, at 4–7. to Trinity II, and then (3) 97 miles from
as the April 19, 2012 and May 11, 2012
Thus, I find that D.W. would have to Trinity II back to his home address. GX
Soma prescriptions, from his
travel approximately 404 miles 46, at 3–6. Thus, I find that C.V. would
prescribing physician, and that D.W.
roundtrip to obtain the March 8, 2012 have to travel approximately 224 miles
would have traveled at least 202 miles
oxycodone and Soma prescriptions from roundtrip to obtain the May 10, 2012
after picking up his prescription to prescription from his prescribing
his prescribing physician, fill them at return home. See GX 45, at 4–7. I further
Trinity II, and then return home. See id. physician, fill it at Trinity II, and then
find that the front of the prescriptions, return to his home. See id. I also find
I also find that Trinity II knew the the back of the prescriptions bearing the
address of both D.W. and his prescribing that Trinity II knew the address of both
fill sticker, the patient profile, and the C.V. and his prescribing physician, and
physician. See GX 45, at 1, 2, 8–11. I dispensing log do not reflect any notes
further find that the front of the that C.V. paid ‘‘cash’’ for the
or comments explaining why Trinity II prescription. See GX 46, at 1–2, 7–8. I
prescriptions, the back of the filled the prescriptions given the
prescriptions bearing the fill sticker, the further find that the front of the
unusual distances D.W. traveled to prescription, the back of the
patient profile, and the dispensing log obtain and to fill these prescriptions. GX
do not reflect any notes or comments prescription bearing the fill sticker, the
45, at 1, 2, 12–19; accord Tr. 1715, 1717. patient profile, and the dispensing log
explaining why Trinity II filled the
Professor Doering testified that these do not reflect any notes or comments
prescriptions given the unusual
four prescriptions also presented the whatsoever explaining why Trinity II
distances D.W. traveled to obtain and to
same unusual distance red flag that filled the prescription given the unusual
fill these prescriptions. GX 45, at 1, 2,
Trinity II should have identified as part distances C.V. traveled to obtain and to
8–11; accord Tr. 1712.
of the drug utilization process. See Tr. fill this prescription (or the fact that
Professor Doering testified that in his
1715–18. He also testified that, unlike C.V. paid ‘‘cash’’ to fill it). Id.; accord
opinion ‘‘[t]he long distance between
the March 8, 2012 oxycodone and Soma Tr. 1719, 1722.
the patient’s home and the doctor’s Professor Doering testified that this
prescriptions that Trinity II had filled
office’’ was a red flag that was presented prescription presents ‘‘the distance red
on the same day, the fact that D.W. had
by D.W.’s prescriptions and which flag’’ that Trinity II should have
to make two separate trips in April and
Trinity II should have identified as part identified as part of the drug utilization
in May to get the same prescriptions
of the drug utilization process. Tr. 1712. process. See Tr. 1722. As a result, he
further emphasized the significance of
As a result, Professor Doering testified testified that filling this prescription
the distance red flag of diversion. See id.
that filling these prescriptions was was inconsistent with Florida’s standard
at 1716 (‘‘it sort of adds emphasis to that
inconsistent with Florida’s standard of of care, that it was not filled in the usual
long distance thing because that meant
care, that they were not filled in the course of professional practice, nor
two trips instead of one’’). As a result,
usual course of professional practice, filled in the proper exercise of the
Professor Doering testified that filling
nor filled in the proper exercise of the pharmacist’s corresponding
these prescriptions was inconsistent
with Florida’s standard of care, that they responsibility. Id. at 1722–23.
30 Professor Doering testified that physicians will
were not filled in the usual course of For a fourth customer, D.E., the
sradovich on DSK3GMQ082PROD with NOTICES2
issue a prescription calling for compounding with
ginger ‘‘to deter one from injecting the drug professional practice, nor filled in the Government introduced a dispensing
intravenously’’ because ginger will ‘‘make it sting proper exercise of the pharmacist’s log, patient profile, and the front and
and burn if someone were to try to inject it corresponding responsibility. Id. at back of a prescription to establish that
intravenously.’’ Tr. 1265. It is also a deterrent to
1715–19. on June 13, 2013 and on July 3, 2013,
‘‘nasal insufflation’’ (snorting) of the drug because Trinity II filled two prescriptions for
‘‘it would be [an] irritant to the lining of the nasal
mucous membranes.’’ Id. at 1558. 32 And like the March 8, 2012 Soma prescription D.E. for 120 tablets of hydromorphone 8
31 The front of the second prescription for Soma to D.W., the front of these Soma prescriptions mg for each prescription, both under the
did not bear the patient’s address. See GX 45, at 10. lacked the patient’s address. See id. brand name Dilaudid, with the same
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instructions to take one tablet every six least July 12, 2013. Nevertheless, on July 1697–98. On July 23, 2013, Trinity II
hours for 30 days. GX 48, at 1–2, 8, 10– 3, 2013, Trinity II filled another filled for S.S. the same three
11; Tr. 1724–25, 1728. According to the prescription for another 120 pills of prescriptions from the same prescribing
front of the prescriptions, the fill Dilaudid 8 mg with instructions to take physician for hydromorphone 8 mg,
stickers attached to the back of the one tablet every 6 hours for 30 days. GX carisoprodol 350 mg, and alprazolam 2
prescriptions, the dispensing log, and 48, at 1–2, 10–11; Tr. 1731. Thus, I find mg in the same amounts and with the
the patient profile, D.E.’s address was in that when Trinity II filled this second same dosage instructions as for the June
Brooksville, Florida. GX 48, at 1–2, 8; prescription on July 3, 2013, Trinity II 27, 2013 prescriptions. GX 44, at 1, 2,
Tr. 1724, 1728–29. It is undisputed that filled it 9 days early. Accord Tr. 1731. 22–27; Tr. 1703–05. Thus, I find that the
the front of the prescriptions show that I also find that the front of these evidence establishes that Trinity II twice
the prescribing physician’s address was prescriptions, the back of the (on June 27, 2013 and on July 23, 2013)
in Tampa, Florida. GX 48, at 8, 10; Tr. prescriptions bearing the fill stickers, filled prescriptions for S.S. for the same
1725. The Government also introduced the patient profile, and the dispensing combination of controlled substances—
Google Maps evidence showing that log do not reflect any notes or comments an opioid (hydromorphone), a
D.E. would have traveled: (1) 44 miles explaining why Trinity II filled this benzodiazepine (alprazolam), and a
from his home address to the prescription early. GX 48, at 1–2, 8, 10– muscle relaxant (carisoprodol). GX 44,
prescribing physician,33 (2) about 20 11; Tr. 1731–32. at 1, 2, 14–19, 22–27. I further find that
miles from there to Trinity II, and then Professor Doering testified that this the front of the prescriptions, the back
(3) 55 miles from Trinity II back to his prescription presents ‘‘[t]he of the prescriptions bearing the fill
home address. GX 48, at 3–7. Thus, I combination of the red flags. It’s too stickers, the patient profile, and the
find that D.E. would have to travel early and the distance red flag.’’ Tr. dispensing log do not reflect any notes
approximately 119 miles roundtrip to 1731, 1727 (‘‘the distance is a long or comments explaining why Trinity II
obtain the June 13, 2013 prescription ways. Which in the judgment of my filled this combination, or cocktail, of
from his prescribing physician, fill it at opinion, the pharmacist, it should raise prescriptions. Id.; accord Tr. 1700, 1705.
Trinity II, and then return to his home. a red flag.’’). As a result, he testified that For a second customer, J.Ha., the
See id. I also find that Trinity II knew filling these prescriptions was Government introduced a dispensing
the address of both D.E. and his inconsistent with Florida’s standard of log, patient profile, and the front and
prescribing physician, and that D.E. care, that they were not filled in the back of prescriptions to establish that on
paid ‘‘cash’’ for the prescription. See GX usual course of professional practice, March 7, 2012, Trinity II filled three
46, at 1–2, 8, 10. I further find that the nor filled in the proper exercise of the prescriptions issued by the same
front of the prescriptions, the back of pharmacist’s corresponding prescribing physician for her: (1) 120
the prescriptions bearing the fill responsibility. Id. at 1727–28, 1732. tablets of oxycodone 30 mg (with
stickers, the patient profile, and the instructions to take 1 tablet every 6
Cocktail Prescriptions
dispensing log do not reflect any notes hours as needed); (2) 30 tablets of
or comments explaining why Trinity II The Government introduced carisoprodol 350 mg, under the brand
filled the prescription given the unusual prescription evidence at the hearing to name Soma (with instructions to take 1
distances D.E. traveled to obtain and to show that Trinity II failed to resolve the tablet every night); and (3) 30 tablets of
fill this prescription (or the fact that D.E. red flag of ‘‘cocktail prescriptions,’’ alprazolam 2 mg, under the brand name
paid ‘‘cash’’ to fill it). Id.; accord Tr. which the Government alleged occurs Xanax (with instructions to take one
1727, 1732. when a customer presents multiple tablet daily). GX 73, at 1, 2, 4–9; Tr.
Moreover, I find that when Trinity II prescriptions that would provide the 1594–98. On May 3, 2012 and May 31,
filled D.E.’s Dilaudid prescription on same patient an opioid, a 2012, Trinity II filled for J.Ha.
July 3, 2013, Trinity II filled that benzodiazepine, and a muscle relaxer. prescriptions from the same prescribing
prescription early—yet another red flag. Specifically, the Government physician for oxycodone 30 mg,
Specifically, D.E.’s prescription that introduced evidence exhibiting this red carisoprodol 350 mg, and alprazolam 2
Trinity II filled on June 13, 2013 was for flag with respect to three of Trinity II’s mg in the same amounts and with the
120 tablets of Dilaudid 8 mg and customers identified in the first charge same dosage instructions 34 as for the
instructions for D.E. to take one tablet of the Show Cause Order and whose March 7, 2012 prescriptions. GX 73, 1–
every six hours for 30 days. GX 48, at patient records the Government had 2, 10–21; Tr. at 1605–12. Thus, I find
1–2, 8; Tr. 1729–30. Hence, the 120 pills requested pursuant to its December 4, that the evidence establishes that on
prescribed to be taken at the rate of four 2014 subpoena. three separate occasions Trinity II filled
For one such customer, S.S., the for J.Ha. prescriptions for the following
pills per day constitute a 30-day supply
Government introduced a dispensing combination of controlled substances—
that should have lasted D.E. until at
log, patient profile, and the front and an opioid (oxycodone), a
33 The street address of the prescribing physician back of prescriptions to establish that on benzodiazepine (alprazolam), and a
reflected on the front of the prescriptions was June 27, 2013, Trinity II filled three muscle relaxant (carisoprodol). GX 73,
different from what was shown on Trinity II’s prescriptions issued by the same at 1, 2, 4–21. I further find that the front
dispensing report and fill sticker; however, the prescribing physician for him: (1) 150
identity and the city (Tampa, Florida) of the of the prescriptions, the back of the
physician was the same in every address. Compare
tablets of hydromorphone 8 mg (with prescriptions bearing the fill stickers,
GX 46, at 1 with id. at 8, 10. Although the distance instructions to take one tablet ‘‘every 4 the patient profile, and the dispensing
calculation from the same city (Tampa) would have hours as needed [for] breakthrough log do not reflect any notes or comments
sradovich on DSK3GMQ082PROD with NOTICES2
been very similar using either Tampa address, I find pain’’); (2) 60 tablets of carisoprodol 350
that the address on the prescriptions themselves is explaining why Trinity II filled this
the most reliable evidence of the prescribing
mg, under the brand name Soma (with
physician’s address because it came directly from instructions to take one tablet ‘‘twice 34 The fill sticker for the May 31, 2012 oxycodone
the physician. I find that the calculation of the daily as needed’’); and (3) 45 tablets of 30 mg prescription for J.Ha. reflected the additional
distances to and from D.E.’s prescribing physician— alprazolam 2 mg, under the brand name phrase ‘‘for pain’’ to the otherwise identical
as reflected in the Government’s Google Maps instruction that J.Ha. had received on the March 7,
evidence—is based, appropriately, on the street
Xanax (with instructions to take half of 2012 and May 3, 2012 prescriptions to take one
address reflected on the front of the June 13, 2013 a tablet ‘‘three times daily as needed for tablet of oxycodone 30 mg every six hours as
and July 3, 2013 prescriptions. Id. at 4. anxiety’’) . GX 44, at 1, 2, 14–19; Tr. needed. GX 73, at 17.
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combination, or cocktail, of effects of drugs with CNS depressant Clearwater, Florida; (2) last name; and
prescriptions. Id.; accord Tr. 1594, 1597, properties’’). In his opinion, this is a red (3) prescribing physician. Id. As a result,
1604, 1608, 1612. flag that Trinity II should have I find that on three separate occasions,
For a third customer, R.Ha., the identified and resolved during the drug the same prescribing physician issued
Government introduced a dispensing utilization review process with respect prescriptions for the same combination
log, patient profile, and the front and to customers S.S., J.Ha., and R.Ha. Id. at of drugs (oxycodone, carisoprodol, and
back of prescriptions to establish that on 1446, 1448.36 As a result, he testified alprazolam) to J.Ha. and R.Ha. on the
March 7, 2012, Trinity II filled the that filling these cocktail prescriptions same dates. GX 73, at 1, 2, 4, 6, 8, 10,
following three prescriptions issued by without resolving the drug-drug 12, 14, 16, 18, 20; GX 74, at 1, 2, 4, 6,
the same prescribing physician for him: interaction red flag was inconsistent 8, 10, 12, 14, 16, 18, 20. In addition, I
(1) 180 tablets of oxycodone 30 mg (with with Florida’s standard of care, that they find that on March 7, 2012, May 3, 2012,
instructions to take one tablet every four were not filled in the usual course of and May 31, 2012, Trinity II filled each
to six hours as needed); (2) 60 tablets of professional practice, nor filled in the of these prescriptions even though
carisoprodol 350 mg, under the brand proper exercise of the pharmacist’s Trinity II knew that they came: (1) From
name Soma (with instructions to take corresponding responsibility. Id. at the same prescribing physician; (2) for
one tablet twice daily); and (3) 30 tablets 1604–05, 1609, 1612–13, 1701, 1705. the same combination of drugs; and (3)
of alprazolam 1 mg, under the brand for patients with the same last name and
Pattern Prescribing to Patients With the
name Xanax (with instructions to take same home address. GX 73, at 1, 2, 5,
Same Last Name and Address
one tablet every night). GX 74, at 1, 2, 7, 9, 11, 13, 15, 19, 21; GX 74, at 1, 2,
4–9; Tr. 1598–1600. On May 3, 2012 and The Government introduced 5, 7, 9, 11, 13, 15, 19, 21. I further find
May 31, 2012, Trinity II filled for R.Ha. prescription evidence at the hearing to that the front of the prescriptions, the
the same three prescriptions from the show that Trinity II failed to resolve the back of the prescriptions bearing the fill
same prescribing physician for red flag of ‘‘pattern prescribing’’ stickers, the patient profile, and the
oxycodone 30 mg, carisoprodol 350 mg, reflecting a lack of individualized drug dispensing log do not reflect any notes
and alprazolam 2 mg in the same therapy, and which the Government or comments explaining why Trinity II
amounts and with the same dosage alleges occurs whenever two related nonetheless filled these prescriptions.
instructions 35 as for the March 7, 2012 individuals present prescriptions issued Id.; accord Tr. 1594, 1597, 1604, 1608,
prescriptions. GX 74, 1–2, 10–21; Tr. at (1) by the same prescribing physician, 1612.
1606–08, 1611–12. Thus, I find that the (2) on the same day, and (3) for the same For the second set of customers, M.W.
evidence establishes that on three drugs. Specifically, the Government and J.W., the Government introduced
separate occasions Trinity II filled for introduced evidence exhibiting this red dispensing logs, patient profiles, and the
R.Ha. prescriptions for the following flag with respect to two sets of Trinity front and back of prescriptions to
combination of controlled substances— II’s customers, in which each set of two establish that on November 20, 2013
an opioid (oxycodone), a customers shared a last name and home and on December 18, 2013, M.W. and
benzodiazepine (alprazolam), and a address, and who were also identified in J.W. presented and Trinity II filled
muscle relaxant (carisoprodol). GX 74, the first charge of the Show Cause Order identical prescriptions for 150 capsules
at 1, 2, 4–21. I further find that the front and whose patient records the of oxycodone 30 mg compounded with
of the prescriptions, the back of the Government had requested pursuant to ginger, with the same dosage
prescriptions bearing the fill stickers, its December 4, 2014 subpoena. instructions to take one capsule every
For the first set of customers, J.Ha. four to six hours for pain.37 GX 75, at
the patient profile, and the dispensing
and R.Ha., and as noted above in the 1, 3, 4–7; GX 76, at 1, 3, 4–7. The same
log do not reflect any notes or comments
‘‘cocktail prescription’’ fact findings, the evidence also shows that M.W. and J.W.
explaining why Trinity II filled this
Government introduced dispensing logs, share the same: (1) Home address in
combination, or cocktail, of
patient profiles, and the front and back Clearwater, Florida; (2) last name; and
prescriptions. Id.; accord Tr. 1597, 1604,
of prescriptions to establish that on (3) prescribing physician. Id. As a result,
1608, 1612.
Professor Doering testified that the March 7, 2012, May 3, 2012, and May I find that on two separate occasions,
combination of these three drugs that 31, 2012, J.Ha. and R.Ha. presented and the same prescribing physician issued
Trinity II filled for customers like S.S., Trinity II filled three prescriptions for prescriptions for the same controlled
J.Ha., and R.Ha. constituted ‘‘the unholy the same controlled substances on each substance (oxycodone) to M.W. and J.W.
trinity’’ or ‘‘cocktail prescriptions’’ that date: (1) Oxycodone, (2) carisoprodol, on November 20, 2013 and on December
present a ‘‘drug-drug interaction’’ red and (3) alprazolam. GX 73, at 1, 2, 4– 18, 2013. GX 75, at 1, 3, 4, 6; GX 76, at
flag because they are ‘‘symbolic of drug 21; GX 74, 1, 2, 4–21. The same 1, 3, 4, 6. In addition, I find that on
interactions that might cause harm to evidence also shows that J.Ha. and R.Ha. those same dates Trinity II filled each of
the patient.’’ Tr. 894–96. He emphasized share the same: (1) Home address in these prescriptions, even though Trinity
that this ‘‘combination of drugs’’ risks II knew that they came: (1) From the
harm to the patient because they ‘‘have
36 Professor Doering also testified that the fact that
same prescribing physician; (2) for the
Trinity II filled the cocktail prescriptions for S.S. 14 same controlled substance; and (3) for
additive central nervous system days after the prescriptions were issued presented
depressant properties.’’ Id. at 1698, see another red flag because patients who are patients with the same last name and
also id. at 1603 (‘‘that’s also the red flag legitimately ‘‘in pain and or having symptoms that home address. GX 75, at 1, 3, 5, 7; GX
of the so called accumulative additive
might require these medications[ ] will get the 76, at 1, 3, 5, 7. I further find that the
prescriptions filled soon after they’re written.’’ Tr. front of the prescriptions, the back of
sradovich on DSK3GMQ082PROD with NOTICES2
1700; compare GX 44, at 14, 16, 18 (prescriptions
35 The fill sticker for the May 3, 2012 and May dated June 13, 2013) with id. at 15, 17, 19 the prescriptions bearing the fill
31 2012 alprazolam 1 mg prescriptions instructed (corresponding fill stickers dated June 27, 2013). I stickers, the patient profile, and the
R.Ha. to take one-half to 1 tablet every day as find that the front of these prescriptions, the back dispensing log do not reflect any notes
needed, which is slightly different from the of the prescriptions bearing the fill stickers, the or comments whatsoever explaining
instruction in the March 7, 2012 prescription to patient profile, and the dispensing log do not reflect
take one tablet every night. Compare GX 74, at 7 any notes or comments explaining why Trinity II why Trinity II nonetheless filled these
with id. at 13, 19. Professor Doering testified that, filled this combination, or cocktail, of prescriptions
in his opinion, this was a labeling error. Tr. 1601– 14 days after the prescriptions were issued. Id.; 37 M.W.’s prescriptions also instructed a ‘‘LIMIT
02. accord Tr. 1700. [of] 5 [capsules] per day.’’ GX 75, at 4, 6.
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prescriptions. Id.; accord Tr. 1616, prescription’s instruction that the back of the same prescription to show
1619–21, 1623. prescription not be filled until that when Trinity II filled this
Professor Doering testified that when December 6, 2013. R.D. at 48–49. I agree prescription for J.T. on July 12, 2012,
two patients with the same last name and make this finding of fact. Trinity II filled the prescription for 20
and address, like J.Ha. and R.Ha. or Similarly, the Government introduced mg/ml of morphine liquid—a
M.W. and J.W., present prescriptions on the front and back of a prescription concentration that is five times stronger
the same day from the same prescribing dated December 16, 2013 showing that than what the prescribing physician had
physician for the same controlled Trinity II filled a prescription for D.G. authorized—and restating the same
substance and with the same dosage on December 18, 2013 for 15 patches of dosage directions to take five milliliters
instructions, ‘‘it’s what some have come fentanyl-50 mcg/hr under the brand every six hours for pain. GX 35, at 1, 3,
to call pattern prescribing.’’ Tr. 1602– name Duragesic. GX 77, at 8, 9; Tr. 41; Tr. 1396–98. The CALJ
03; see also id. at 1608, 1612, 1620, 1508–11. The Government also recommended that I find that, in fact, on
1623. In his opinion, this is a red flag introduced a dispensing log showing July 12, 2013, Trinity II filled a
that Trinity II should have identified that Trinity II filled the prescription on prescription for J.T. for 20 mg/ml that
and resolved during the drug utilization December 23, 2013. GX 77, at 1; Tr. was five times stronger than the
review process ‘‘[b]y contacting the 1511. The front of the prescription, authorized dosage. R.D. at 50. I agree
prescriber and/or discussing it with the however, expressly instructed ‘‘NO and make this finding of fact.
patient’’ before filling. See id. at 1603. EXCEPTIONS DO NOT FILL UNTIL 1– The Government also introduced
As a result, he testified that filling these 5–2014.’’ GX 77, at 8; Tr. 1511–12. The evidence at the hearing showing that
prescriptions without resolving the CALJ recommended for this (fourth) Trinity II repeatedly filled prescriptions
pattern prescription red flag was charge of the Show Cause Order that I for J.T. for morphine liquid at the same
inconsistent with Florida’s standard of find that, regardless of whether Trinity concentration (20 mg/ml) that was
care, that they were not filled in the II filled this prescription on December either five or 15 times the prescribed
usual course of professional practice, 18 or December 23, 2013, Trinity II concentration (20 mg/5 ml or 20 mg/15
nor filled in the proper exercise of the nonetheless filled the prescription ml) 38 on six other occasions—August 8,
pharmacist’s corresponding contrary to the prescribing physician’s 2012, September 6, 2012, October 3,
responsibility. Id. at 1604–05, 1609, express instruction that the prescription 2012, November 1, 2012, December 27,
1612–13, 1620–21, 1623–24. not be filled until January 5, 2014. R.D. 2012, and January 25, 2012. GX 35, 1,
48–49, 48 n. 114. I agree and make this 3, 52–53, 58–59, 66–67, 76–77, 84–87.
Controlled Substances Filled Before
finding of fact. The CALJ recommended that I find that,
Authorized Date With respect to these two in fact, on each of these occasions
At the hearing, the Government prescriptions filled by Trinity II, Trinity II filled prescriptions for J.T. for
introduced into evidence copies of a Professor Doering testified that filling 20 mg/ml and that this dosage was
dispensing log and the front and back of these prescriptions before the date set either five times or 15 times stronger
two prescriptions for controlled forth in a ‘‘DO NOT FILL UNTIL’’ than the authorized dosage.39 R.D. at 50.
substances that the Government alleged instruction was inconsistent with I agree and make these fact findings.
Trinity II twice filled for customer D.G. Florida’s standard of care, that they
before the date authorized by the were not filled in the usual course of 38 I agree with the CALJ that the prescribing
prescribing physician and in violation professional practice, nor filled in the physician’s handwriting regarding the dosages for
of 21 CFR 1306.04(a), 1306.06, 1306.11, proper exercise of the pharmacist’s these prescriptions is not always clear because they
and 21 U.S.C. 829 as set forth in the appear to state either 20 mg/5 ml or 20 mg/15 ml.
corresponding responsibility. Tr. 1512, R.D. at 50. In the Show Cause Order, the
third and fourth charges of the Show 1515–16. Government alleged that the dosage for each of
Cause Order. For example, the these prescriptions were for 20 mg/5 ml. ALJ Ex. 1b,
Government introduced a dispensing Controlled Substances Filled in Stronger at 15–16. However, in its Proposed Findings of Fact,
log and the front and back of a Concentration Than Authorized the Government asked that the Agency find that all
At the hearing, the Government the prescriptions reflect a dosage instruction of 20
prescription dated November 15, 2013 mg/5 ml except for the October 3, 2012 and
showing that Trinity II filled a introduced into evidence copies of a November 1, 2012, prescriptions, which the
prescription for D.G. on November 20, dispensing log, patient profile, and the Government claimed reflect a dosage instruction of
2013 for 7 patches of fentanyl-50 mcg/ front and back of seven prescriptions for 20 mg/15 ml. ALJ Ex. 40a, at 56–57. In any event,
controlled substances that the I agree with the CALJ’s recommendation that for
hr, a schedule II controlled substance, each of these prescriptions, the prescribed dosage
under the brand name Duragesic. GX 77, Government alleged Trinity II filled for strengths are either for 20 mg/5 ml or 20 mg/15 ml.
at 1, 6, 7; Tr. 1508–09, 1513–15. The customer J.T. at dosages that were no R.D. at 50 n.120.
front of the prescription, however, less than five times stronger than 39 The CALJ also recommended that I find that on
expressly instructed ‘‘NO EXCEPTIONS authorized by the prescribing physician November 29, 2012, Trinity II filled a prescription
issued to J.T. for morphine liquid for 20 mg/ml
DO NOT FILL UNTIL 12–06–2013.’’ GX and in violation of 21 CFR 1306.06 and when the dosage instruction on the corresponding
77, at 6; Tr. 1514. 1306.11 as set forth in the fifth charge prescription was for 20 mg/5 ml. R.D. at 50 & n.119
Although the CALJ did not of the Show Cause Order. For example, (citing GX 35, at 1, 80–81). Although this particular
recommend findings of fact related to the Government introduced the front of prescription was not the subject of testimony at the
hearing nor included in the Government’s Proposed
the Government’s allegations that a prescription dated July 11, 2013 Findings of Fact, the Show Cause Order does allege
Trinity II filled prescriptions early as set showing that the prescribing physician that on November 20, 2012, Trinity II received a
forth in the first two charges of the issued to J.T. a prescription for 20 mg/ prescription issued to J.T. for 20 mg/5 ml of
sradovich on DSK3GMQ082PROD with NOTICES2
Show Cause Order, for this (third) 5 ml of morphine liquid, which is a morphine liquid but nonetheless filled it at the
dosage strength of 20 mg/ml. ALJ Ex. 1b at 16. The
charge of the Order, the CALJ did liquid dosage of morphine and a CALJ acknowledged that the date in the Show
choose to recommend findings of fact. schedule II controlled substance, with Cause Order (November 20, 2012) does not match
Specifically, he recommended that I instructions to take five milliliters every the date on the fill sticker (November 29, 2012), but
find that Trinity II filled a prescription six hours for rescue pain. GX 35, at 40; he recommended this fact-finding anyway and
implied that the discrepancy was the result of a
for a schedule II controlled substance Tr. 1394–96, 1412. However, the scrivener’s error in the Show Cause Order. R.D. at
for D.G. early because it was filled on Government also introduced a 50 & n.119. Because neither the dispensing log nor
November 20, 2013—contrary to the dispensing log, patient profile, and the the patient profile for J.T. show that Trinity II filled
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Professor Doering testified that the interns and technicians did not have Abdelmaseeh testify about
filling of these prescriptions at dosages dispense any prescriptions. Id. at 2342– evidence regarding the process the
that were at least ‘‘five times more 43. He further testified that his role pharmacies used to verify prescriptions
potent that it was supposed to be’’ included ‘‘overlook[ing] and and resolve concerns, including a
constituted ‘‘a misfill.’’ Tr. 1398. ‘‘This supervis[ing] what’s going on in the description and demonstration of the
issue has been communicated to pharmacy’’ and ‘‘keep[ing] open computer software utilized, because
pharmacists. Be careful when you fill communication with the doctors to such testimony was excluded by the in
liquid morphine solutions, because it’s make sure that all prescriptions are Limine Order. See generally Tr. 2344–
a very concentrated form of the drug.’’ legitimate and needed for the patient.’’ 66. However, the CALJ nonetheless
Id. He testified that the issue ‘‘should Id. at 2355–56. ‘‘I check to see if there allowed Respondent’s counsel to proffer
have been identified in the global are any contraindications or how the witness would have testified on
dispensing process.’’ Id. at 1400. He interactions, if the patient has allergies. that topic. Id. at 2366–2372. Counsel
further testified that these prescriptions I look to see if the prescription is valid proffered that Trinity II used computer
were not filled consistent with the or not. I look to see if the prescription software that requires a pharmacist to
standard of care in Florida nor filled in is being filled early or not. I look to see sign-in and approve prescriptions. Id. at
the usual course of pharmacy practice. if the prescription has any mistakes on 2367. Respondent’s counsel also
Id. at 1399, 1402, 1404, 1406–07, 1409, it, and I call and verify with the doctor proffered ‘‘that the software comes with
1411–12. on every prescription that I fill.’’ Id. at a particular screen and tab for printing
2356. what is commonly referred to and has
Prescriptions Filled by Pharmacy Abdelmaseeh testified that Trinity II been referred to by Professor Doering as
Interns maintains ‘‘records, notes and all types a patient profile which includes
The Government introduced of other information other than just the dispensing history, and it’s limited to
prescription evidence at the hearing for plain prescription information’’ and that the dispensing history. It’s a pre-
the purpose of showing that Trinity II ‘‘[i]t’s all documented in the computer programmed function of that software.’’
unlawfully allowed pharmacist interns, system.’’ Id. at 2345. He specifically Id. at 2368, 2370 (‘‘It’s an F–11 tab to
instead of pharmacists, to fill controlled testified that Trinity II ‘‘maintain[ed] print a profile.’’). He also proffered that
substances prescriptions. The documentation regarding patient ‘‘other fields that are maintained or
Government specifically alleged that allergies’’ and ‘‘interactions with the other screens that are maintained’’ by
Mina A. Ghobrial, a pharmacist intern at physicians.’’ Id. at 2360–61. He also Trinity II’s software ‘‘include an area for
Trinity II, filled such prescriptions testified that ‘‘[w]hen the customer does notes on each prescription and that that
based on the presence of the initials pick up the medication they sign off for information is maintained at the
‘‘MAG’’ or ‘‘MG’’ in the ‘‘filled by’’ field it that they picked up and that they do pharmacy in that . . . software.’’ Id. at
of the fill stickers. See, e.g., GX 79–82; not have any questions in regards to the 2369, 2370–71 (‘‘It has a tab for
see also Tr. 339, 452. The CALJ prescription that was picked up. . . . prescription notes, RX notes, and it
recommended that I find that the [a]t the point of sale.’’ Id. at 2357. operates not only by the tab but by a
Government failed to present evidence Specifically, he testified that the function key, F–3, and patient
to suggest that Ghobrial was not customer signs an electronic pad at the information tab that uses a function key,
supervised by a registered pharmacist. register confirming pick up and that the F–4’’ and includes ‘‘a date and time
R.D. at 46. I agree and make this finding customer has no questions for the stamp entry so you can determine on
of fact. pharmacist. Id. at 2357–58. He further which date those entries were made.’’).
testified that he can access that According to counsel, Trinity II’s
Respondent’s Case
information ‘‘[a]t the register in the pharmacists ‘‘used this software as a
Respondent presented the testimony computer system.’’ Id. at 2359. mechanism to assist them . . . with
of Mark Abdelmaseeh, a pharmacist at The CALJ noted that Abdelmaseeh identifying red flags and then
Trinity II.40 T. 2340–42. Abdelmaseeh has some built-in bias because he was documenting the resolution of those.’’
testified that he worked two days per still an employee of Trinity II when he Id. at 2371–72.
week as a pharmacist at Trinity II. Id. at testified, giving him ‘‘some stake in the The proffered facts related to Trinity
2342. He testified that, although proceedings.’’ R.D. at 34. The CALJ II’s computerized record-keeping and
technicians and interns worked with the found that this bias was reflected in the prescription verification process are
pharmacists at Trinity II, pharmacy fact that Abdelmaseeh ‘‘affirmatively only relevant to the Show Cause Order’s
and deliberately disregarded first two charges related to the
any prescriptions for J.T. on November 20, 2012 Respondent’s counsel’s . . . efforts to identification and resolution of red flags
(much less one corresponding to the morphine elicit testimony that stood within the of diversion. The CALJ properly stated
liquid prescription described in the Show Cause
Order), GX 35, at 1, 3, I find that this mistake in
bounds of the in Limine Order when that he would not consider the proffer
the Show Cause Order was merely a scrivener’s there was no question pending in order as evidence in making his
error. Thus, I agree that the Government intended to provide information that was directly recommendation, but he allowed
to state in the Order that Trinity II filled this the subject of the Government’s Respondent’s counsel to make the
prescription on November 29, 2012. And I agree
with the CALJ’s recommendation that I find (and I
objections.’’ Id. at 34–35. The CALJ proffer to preserve the issue for review.
do so find) that Trinity II filled this prescription on believed that this was Abdelmaseeh’s See id. at 2352.
November 29, 2012 at a dosage that was five times ‘‘effort to cram in as much objectionable Based principally on this proffer and
stronger than the prescribing physician had testimony as possible’’ to get around the the Government’s failure to image
sradovich on DSK3GMQ082PROD with NOTICES2
instructed.
40 Although Respondents presented the testimony
terms of his in Limine Order. Id. at 35. Trinity II’s computers, Trinity II
of one other witness, Kristen Quinette, a former As a result, the CALJ concluded that ‘‘it contends that DEA cannot prove that it
pharmacy technician at Trinity I, the CALJ did not is difficult to afford this witness’s failed to document resolution of such
consider her testimony in his Recommended testimony the full weight that it red flags because ‘‘DEA failed to request
Decision. After testifying that she had worked at otherwise might have received in this or obtain Respondent’s records where
one time at Trinity II, the CALJ sustained the
Government’s objection to her testimony since she recommended decision.’’ Id. such notes and comments were stored.’’
was not noticed as a witness against Trinity II. Tr. The CALJ sustained the Government’s Trinity II’s Closing Submission and
2232, 2247–49. objections to Respondent’s attempts to Proposed Findings of Fact and
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Conclusions of Law (hereinafter comments resolving the alleged red flags was in Trinity II’s self-interest to use
‘‘Trinity II’s Post-Hearing Brief’’), AJL for the 23 customers whose records such notes and comments (if they
Ex. 41, at 6. This general argument has were subpoenaed in this case. Although existed) during cross-examination of the
some merit (again, assuming the it is possible that Trinity II deliberately Government’s witnesses because it
proffered facts are true) regarding withheld this evidence in response to would have been an effective way to
Trinity II’s customers for whom the the December 4, 2014 subpoena,42 I find impeach Government witnesses’
Government never requested ‘‘records that it is more likely than not that, in testimony that they saw no evidence
where such notes and comments were fact, Trinity II failed to produce notes that Trinity II resolved any red flags of
stored.’’ Id. and comments reflecting Trinity II’s diversion. It would be a remarkable
However, Trinity II’s argument does resolution of the red flags in response to oversight for Respondent’s counsel not
not account for the fact that the the Government’s subpoena because to use such information during cross-
Government’s December 4, 2014 Trinity II did not actually resolve them examination if it did exist. As already
subpoena required Trinity II to produce and hence had no notes or comments noted, I find that it did not.44
the complete patient profile that Trinity reflecting any such resolution.
II maintained for 23 customers as Discussion
Respondent’s counsel was careful never
required by Florida Administrative Rule to aver during cross-examination of the Before proceeding to analyze the
64B16–27.800, entitled ‘‘Requirement Government’s witnesses that Trinity II evidence under the public interest
for Patient Records.’’ GX 98, at 2 (‘‘For actually had notes or comments factors, it is necessary to review the
each of the following patients, please regarding the 23 patients identified in CALJ’s discussion of two issues raised
provide a copy of the complete patient the subpoena. The CALJ gave in the Government’s Exceptions to the
profile your pharmacy maintained Respondent’s counsel’s more than CALJ’s Recommended Decision: (1)
pursuant to Florida Administrative Rule enough latitude to make this claim Whether the Government should have
64B16–27.800’’). As already noted, this during his proffer or during cross- provided DEA–6s to Respondent that
rule expressly required Trinity II to examination, yet he chose not to do so. DEA had provided to its expert and (2)
maintain in its ‘‘patient record system’’ Respondent’s counsel also chose not to whether the expert’s testimony was
a record of every entry ‘‘in the profile impeach Government witnesses during sufficiently ‘‘reliable’’ under the
record’’ for each patient for two years, cross-examination by using actual notes Administrative Procedure Act (‘‘APA’’)
including ‘‘[p]harmacist comments and comments (or any other
relevant to the individual’s drug information) reflecting Trinity II’s witness on cross-examination, even where
respondent had failed to present the document to
therapy, including any other resolution of red flags for any customer the Government in advance of the hearing).
information peculiar to the specific discussed at the hearing. Although the Moreover, the APA and our regulations preserve a
patient or drug.’’ ALJ Ex. 38; Fla. in Limine Order precluded Trinity II respondent’s right to present information on cross-
Admin. R. 64B16–27.800. This Rule also from, inter alia, offering such examination for the purpose of impeaching the
Government’s witnesses. See 5 U.S.C. 556(d) (‘‘A
mandated that Trinity II ‘‘obtain from information as evidence in its case-in- party is entitled . . . to conduct such cross-
the patient . . . and shall record’’ chief (ALJ Ex. 29, at 3), nothing in that examination as may be required for a full and true
patient information ‘‘which may relate Order precluded Trinity II from using disclosure of the facts.’’); 21 CFR 1316.60.
to prospective drug review. The this information to impeach the 44 For the same reason, I reject Trinity II’s
pharmacist shall record any related Government’s witnesses.43 Indeed, it Exception that the CALJ’s in Limine Order ‘‘did not
permit the Respondents to present relevant
information indicated by a licensed evidence to the charges set forth in the show cause
health care practitioner.’’ Id. at 64B16– 42 During Respondent’s counsel’s cross-
order. As a result, the Respondents were limited in
27.800(2). examination of Professor Doering regarding the their ability to explain the computer system used
In short, and as discussed more fully scope of the Government’s December 4, 2014 by the Respondents, which would have clarified the
subpoena request for 23 customers’ patient profiles record keeping questions.’’ Respondents Trinity
infra, Rule 64B16–27.800 required maintained pursuant to Rule 64B16–27.800, Pharmacy (I)’s and Trinity Pharmacy (II)’s
Trinity II to maintain patient records Respondent’s counsel asked ‘‘Is the word ‘profile’ Exceptions to the Recommended Decision of the
that included copies of any notes and anywhere in that Florida administrative code Administrative Law Judge (‘‘Resp. Except.’’), at 7.
comments reflecting their pharmacists’ provision?’’ (Tr. 2174), expecting the witness to Although the CALJ did limit Trinity II’s ability to
confirm counsel’s own understanding regarding the present evidence as part of its case-in-chief, as
resolution of any red flags of diversion. rule. Professor Doering then validated that already noted, the CALJ (1) gave Trinity II multiple
I find that when the Government (mis)understanding by stating that the word opportunities to comply with his prehearing orders,
requested the complete patient profile ‘‘profile’’ ‘‘does not appear’’ to him as he quickly (2) did not (and could not) limit its ability to
Trinity II maintained pursuant to Rule read the rule on the stand. Tr. 2176. This reading, present information during cross-examination of the
of course, is incorrect—Rule 64B16–27.800(3) Government’s witnesses, and (3) even gave Trinity
64B16–27.800 related to the 23 expressly references patient profiles. Government II the opportunity to provide an attorney proffer at
customers in the December 4, 2014 counsel immediately corrected this error on re- the hearing in which Trinity II’s counsel could have
subpoena, the Government did in fact direct by asking Professor Doering to read that at least proffered facts which, if true, would have
request all patient records maintained provision into the record: ‘‘A patient record shall rebutted the Government’s case. Again, as already
be maintained for a period of not less than two noted, Trinity II chose not to do so. Accordingly,
by Trinity II for those customers years from the date of the last entry in the profile I find that the CALJ acted within his discretion
pursuant to that Rule—including the record. This record may be a hard copy or a when he issued his in Limine Order and denied
pharmacists’ notes and comments for computerized form.’’ Tr. 2207 (emphasis added). Trinity II’s reconsideration motion, and I reject
those customers. Thus, I reject Trinity Although this exchange raises the possibility that Trinity II’s Exception to the CALJ’s in Limine Order.
Respondent’s counsel advised his clients not to Trinity II also raised in this Exception that the
II’s contention that the Government produce the notes and comments regarding the 23 CALJ’s in Limine Order precluded it from
failed to request records including customers referenced in the subpoena based on this introducing evidence that ‘‘would have
Trinity II’s notes and comments.41 misunderstanding of the rule, I find (for the reasons corroborated Kristen Quinette that pharmacy
sradovich on DSK3GMQ082PROD with NOTICES2
Most significantly, Respondent’s set forth in the text above) that it is more likely than technicians were not permitted to dispense
not that Trinity II did not produce any notes or prescriptions.’’ Id. at 7. None of the allegations in
counsel never stated in his proffer that comments regarding these customers because they the Show Cause Order relate to pharmacy
Trinity II did in fact maintain notes and do not exist. technicians, and the CALJ limited her testimony’s
43 In fact, the CALJ lacks the authority to preclude
relevance to Trinity I. R.D. at 33 n. 86. In any event,
41 And it is also for this reason that I have limited a respondent from using relevant information to and assuming Trinity II intended to state in its
my fact findings, supra, regarding the Show Cause impeach a witness during cross-examination. See Exceptions that it would provide testimony related
Order’s first two charges relating to violations of Farmacia Yani, 80 FR 29053, 29063 n.25 (2015) to pharmacy interns, I find that this Exception is
Trinity II’s corresponding responsibility to (finding that it was prejudicial error to preclude a moot because I find infra for Trinity II on the
allegations involving those 23 patients. respondent from using a document to impeach a charges related to pharmacy interns.
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to be given weight in my decision. See stated his belief that the DEA’s intent in whether the Government should have
‘‘Government Exceptions’’ (hereinafter providing documents to an expert is produced the DEA–6s to Trinity II.
‘‘Gov. Except.’’) at 13–54. relevant to determining whether the ‘‘DEA precedent has already made clear
expert relied upon these documents in that where an expert relies on data or
Requirement To Produce Documents
forming his opinion. R.D. at 28 n. 78 documents in forming his opinions, the
Relied Upon by the Expert
(‘‘Like the other documents forwarded failure of the sponsoring party to
In his Recommendation, the CALJ by DEA to Professor Doering, DEA–6s produce the data or documents denies
included a discussion of whether the were furnished to him to assist him in the other party a meaningful
Government should have produced to formulating his expert opinion on the opportunity to cross-examine the expert
Respondent copies of a DEA–6 related Government’s theory of the case.’’), id. and show that his opinions are
to Trinity II that DEA had provided 45 to at 28 (‘‘The proposition that the unfounded’’ and ‘‘runs the very
the Government’s expert witness, Government would supply DEA–6s (or substantial risk that the expert’s
Professor Doering. R.D. at 27–28, 28 nn. any other form) to an expert with the conclusions will be rejected.’’ 47 T.J.
78–79.46 In that discussion, the CALJ expectation that those documents would McNichol, M.D., 77 FR 57133, 57146
play no role ‘whatsoever’ is dubious at n.18 (2012). Thus, the only fact that
45 The Government also raised a separate
best. Professor Doering was sent DEA– matters is whether Professor Doering
Exception related to the CALJ’s statement in his
Recommended Decision that ‘‘[i]t is unfathomable 6s so he would read, analyze, and actually relied on the DEA–6 in forming
that the Agency counsel would gratuitously release utilize them in forming his expert the substantive basis for his expert
a document as closely held by the Agency as a opinion’’). Contrary to the CALJ’s belief, opinion. Accordingly, I find that, as a
DEA–6 with no expectation that it would be used
by that person for any purpose.’’ Govt. Except. at
the Government’s purported matter of law, the CALJ’s unsupported
69 (emphasis omitted) (citing R.D. at 28 n. 78). The ‘‘expectation’’ that Professor Doering belief that DEA expected Professor
CALJ failed to indicate where the record indicates would rely on DEA–6s provided to him Doering to rely on the DEA–6s is
that Government counsel produced, much less is both factually unsupported and irrelevant to the question of whether the
‘‘gratuitously released,’’ a DEA–6 to anyone. In fact,
the record contradicts the CALJ’s rendition of the
legally irrelevant to the question at bar. Government was required to produce
facts. As Trinity II’s counsel established during As a threshold matter, the record does them to Trinity II because that legal
cross-examination of the lead DI at the hearing, it not support the CALJ’s statement that question depends solely on whether
was the DIs, not ‘‘Agency counsel,’’ who provided DEA expected Professor Doering to rely Professor Doering, in fact, relied on the
a DEA–6 to Professor Doering. on the DEA–6s. The CALJ’s opinion on DEA–6 in forming the substantive basis
[Mr. Sisco:] All right. Would you describe for me
all of the information that you initially provided to
this supposed expectation is based for his opinion. See T.J. McNichol, M.D.,
Professor Doering? solely on the fact that the Government 77 FR at 57146 n. 18; CBS Wholesale,
[DI:] I believe we provided photocopies of the provided them to him. See R.D. at 27– 74 FR at 36749.
original prescriptions. I believe a copy of the E– 28. However, the Government may The CALJ also contends that Professor
FORCSE, the dispensing report. What else? And a provide an expert with any number of Doering, in fact, relied on the DEA–6s
copy of one of my 6s.
Q When you say a 6, you’re talking about a DEA–
documents for reasons that have nothing in forming his expert opinion based on
6. It’s your report of an investigation? to do with formulating the substantive his response to the following question
A Yes. basis of an expert opinion—such as an during direct examination:
Tr. 581–82. Elsewhere in his Recommended index or a table of contents. In his Q . . . What role did [the DEA–6s] play in
Decision, the CALJ himself noted and accepted this Recommended Decision, the CALJ failed your forming of the opinion as to the
same testimony. R.D. at 12 (accepting DI’s
testimony that he had ‘‘provided . . . a copy of one
to indicate where in in the almost 2,400- dispensings and fillings that you formed the
of his DEA–6 forms . . . to Professor Paul Doering, page transcript and more than 90 opinion on in this case?
the Government’s expert witness. Tr. 581, 589–90’’). exhibits in the case there are facts A None whatsoever ultimately. I used the
Professor Doering corroborated the DI’s response establishing that DEA’s ‘‘expectation’’ DEA Form 6 as what I would call, like a
during his own testimony on direct and cross- beacon or flashlight to help me understand
examination, stating that he received DEA–6s from
was that Professor Doering use the where I might find that documentation, so I
the DIs who had retained him on behalf of DEA and DEA–6s ‘‘in formulating his expert could peer upon that with my own two eyes,
before he had made first contact with Government opinion on the Government’s theory of and not have to rely on or depend on other
counsel regarding the case. Id. at 855–59, 1783–84, the case.’’ Id. at 28 n.78. Thus, I find people’s impressions or thoughts. I never rely
1786–89, 1800–01. As the Government observed,
‘‘[e]veryone is entitled to his own opinion, but not
that the mere fact that the DIs provided on DEA Form 6s, because I think it’s risky
to his own facts.’’ Govt. Except. at 1. I expect all a DEA–6 to Professor Doering regarding to do that.
the ALJs working for DEA to ensure that that the Trinity II is insufficient to establish that Id. at 859–60. The CALJ found that, ‘‘by
statements in their Recommended Decisions are DEA did so with the intent that he rely
well-grounded in fact, especially before making
his own account, [Professor Doering]
statements disparaging counsel who appear before
upon it in forming his opinion. used the investigative reports as a
them. More importantly, even if the record
46 This issue arose when, for the first time at the did support the CALJ’s belief that DEA 47 The CALJ cited to an earlier case, CBS
hearing, Respondent requested production of the expected Professor Doering to rely on Wholesale Distributors, 74 FR 36746, 36749 (2009),
DEA–6s that the Government had provided to its the DEA–6s in forming his opinion, it is where the Agency found that expert testimony
expert. R.D. at 28 n.79; see Tr. 586, 805–07. The about whether a respondent was selling ‘‘excessive
Government responded at the hearing that legally irrelevant to the question of quantities of combination ephedrine products’’ was
Respondent’s request was untimely because unreliable because the expert was unable to
Government counsel had already notified hearing. Gov. Except. at 64–69 & Attachment 1. In produce the data on which he, in turn, relied in
Respondent’s counsel by letter months before the his Recommendation, the CALJ decided that ruling forming his opinion of what the average monthly
hearing that DEA had previously provided DEA–6s on whether this discovery request was timely was sales figure calculation was for such products. Id.
to Professor Doering and that they would not be ‘‘unnecessary’’ because ‘‘the Respondent has not at 28 n.79. Notably, nowhere in that case or in T.J.
sradovich on DSK3GMQ082PROD with NOTICES2
produced pursuant to T.J. McNichol. Tr. 807–08. sought to develop the record regarding the McNichol (or in any other case) has the Agency held
The Government also proffered a copy of the timeliness of the request or even asked for the that the sponsoring party must produce to the other
contents of its unsigned expert discovery letter at testimony to be stricken as unavailable to constitute party data or documents that had been provided to
the hearing. Id. The Government subsequently substantial evidence.’’ R.D. at 28 n.79. I agree that the expert based on the sponsoring party’s
raised an Exception seeking a finding that it had Trinity II failed to carry its burden to prove that its ‘‘expectation’’ that the expert would rely on the
provided notice to Respondent’s counsel prior to request for production of the DEA–6s was timely. information. Rather, as already noted, both cases set
the hearing, and the Government attached to its In any event, as discussed infra, I find that Professor forth the same requirement: The sponsoring party
Exceptions an affidavit and a copy of the signed Doering did not rely on any DEA–6 as the basis for must produce to the other party all information
expert discovery letter addressed to Respondent’s his expert opinion, thereby obviating any putative upon which the expert actually relied in forming
counsel consistent with its representation at the production requirement. the substantive basis for his/her opinion.
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framework to examine other potential U.S.C. 556(d). Like other evidence, the been accorded more evidentiary weight
evidence.’’ R.D. at 27. The CALJ Agency has also held that an expert’s in his recommended fact findings.49
concluded that this testimony ‘‘leaves opinion must be ‘‘supported by The CALJ identified six 50 reasons for
little doubt that the DEA–6s supplied to substantial and reliable evidence.’’ CBS his recommendation not to rely on
Professor Doering constituted Wholesale, 74 FR at 36749 (citing id.). Professor Doering’s testimony, and the
underlying data that supported his I agree with the CALJ’s decision to Government filed Exceptions in
conclusion, his assertions.’’ Id. at 28 overrule Trinity II’s objections in the response to each of them. First, the CALJ
n.79. hearing and in its closing brief to believed that Professor Doering’s
Once again, the CALJ cites to the admitting the expert testimony of supposed ‘‘acknowledgment that the
wrong legal standard under Agency Professor Doering into evidence.48 See opinions he had rendered were not
precedent. The test is not whether R.D. at 15. After the CALJ evaluated ‘based on sufficient facts or data’
Professor Doering used the DEA–6s ‘‘as ‘‘the weight that should be accorded [to critically undermines the weight that
a beacon or flashlight’’ to find other Professor Doering’s] expert testimony in can be attached to those opinions.’’ 51
documents that constituted underlying this matter,’’ R.D. at 16 n. 51, he
data necessary to form his opinion. The recommended that I give his testimony 49 The CALJ states that ‘‘the factual findings set
question is whether Professor Doering, no weight because it was, in his view, forth in this recommended decision are entitled to
significant deference.’’ R.D. at 38 (citing Universal
in fact, relied upon the DEA–6s as a ‘‘insufficiently reliable to form the basis Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951)).
substantive basis for his expert opinion. of a sanction under the APA.’’ Id. at 33 However, nowhere does Universal Camera (or the
See T.J. McNichol, M.D., 77 FR at 57146 (‘‘To be clear, however, this is not an APA) support this standard of review for the CALJ’s
n. 18; CBS Wholesale, 74 FR at 36749. issue of credibility . . . There is no recommended fact findings. Rather, it is axiomatic
that an ALJ’s recommended decisions are subject to
Here, Professor Doering’s testimony question that the Professor is an de novo review by the agency. See 5 U.S.C. 557(b)
shows that he used the DEA–6 as a table individual of impressive credentials (‘‘On appeal from or review of the initial decision,
of contents or an index ‘‘to help [him] . . . This aspect of this recommended the agency has all the powers which it would have
understand where [he] might find that decision addresses only the narrow in making the initial decision except as it may limit
the issues on notice or by rule.’’); Universal Camera,
documentation’’ upon which he issue of whether the expert opinions he 340 U.S. at 492, 493 (the ALJ’s recommended fact
ultimately did rely upon in forming his rendered . . . are sufficiently reliable to findings become part of the administrative record,
opinion—dispensing reports, dispensing support a sanction.’’). Like the CALJ, I just ‘‘as the complaint or the testimony’’ is part of
logs, copies of individual prescriptions, too do not need to rely upon Professor the record, for the Agency’s consideration), 494 (the
APA states ‘‘that an agency which reviews an
patient profiles, and Google Maps and Doering’s expert testimony to find that examiner’s [e.g., ALJ’s] report has ‘all the powers
MapQuest printouts of distances. Tr. Trinity II’s DEA registration must be which it would have in making the initial
860, 862–63. He even went so far as to revoked. However, unlike the CALJ, I do decision’’’) (quoting 5 U.S.C. 557(b)); Vineland
testify that he only used DEA–6s in this find that his testimony was nonetheless Fireworks v. ATF, 544 F.3d 509, 514 (3d Cir. 2008)
(recognizing an agency’s authority under the APA
limited way so he would ‘‘not have to reliable under the APA and could have to ‘‘exercise[ ] de novo review over the ALJ’s
rely on or depend on other people’s decision’’). ALJs are ‘‘entirely subject to the agency
impressions or thoughts’’ reflected by or 48 Trinity II objected to the admission of Professor on matters of law; they can be reversed by the
in the DEA–6. Id. at 860 (emphasis Doering’s expert testimony on the basis that ‘‘[h]e agency on matters of fact, even where demeanor
does not currently have a license in effect in the evidence is an important factor.’’ Antonin Scalia,
added). Simply put, if an expert uses a State of Florida’’ (Tr. 840) based on Professor The ALJ Fiasco—A Reprise, 47 Univ. Chi. L. Rev.
document like an index to ‘‘find’’ other Doering’s testimony that his license had fallen into 57, 62 (1979). See Kay v. FCC, 396 F.3d 1184, 1189
‘‘documentation’’ and nothing more, delinquent status for a couple of months as of the (D.C. Cir. 2005) (the agency may disagree with an
then the expert is not relying on that date of the hearing. Id. at 822–23, 1770. He stated ALJ’s factual findings, including credibility
that ‘‘when the decks are cleared with this matter determinations); Tom C. Clark, Attorney General’s
index in forming the substantive basis of Manual on the Administrative Procedure Act 83
. . . I will clear up the delinquent status of my
an expert opinion. As a result, the other license, and it will revert to clear and active, before (1947) (‘‘In making its decision, whether following
party could not use that document to it goes to null and void.’’ Id. at 844. He stated that an initial or recommended decision, the agency is
show that the expert’s opinion was this fact had no impact on his ability to work at the in no way bound by the decision of its subordinate
University of Florida’s School of Pharmacy because officer; it retains complete freedom of decision—as
unfounded, and the sponsoring party though it had heard the evidence itself.’’).
he was only required to maintain an active
would not be required to produce it. pharmacist’s license in one state, and he had an 50 The CALJ raised two other reasons to challenge
Here, the above testimony active license in North Carolina. Id. at 821–23. Even the expert’s reliability, one of which was the issue
demonstrates that Professor Doering if Professor Doering had no license in any state, of DEA–6s, which I addressed supra. The other
relied on dispensing reports, dispensing however, DEA regulations do not require an expert related to the CALJ’s disagreement with Professor
witness to be licensed in the state in which the Doering on the question of whether an early fill
logs, copies of individual prescriptions, alleged violations occurred, and Agency precedent calculation relates to when the pharmacist fills the
patient profiles, and Google Maps and authorizes ALJ’s to admit expert testimony even prescription or to when the customer ultimately
MapQuest printouts in forming his where the expert was not licensed in the state obtains the controlled substance. R.D. at 24–26. I
opinions, not the DEA–6s that where the violations were alleged to have occurred. find that this is a legal question and not a question
21 CFR 1316.59(b) (‘‘Opinion testimony shall be of witness reliability, and it is one that I address
accompanied them. Tr. 860, 862–63. admitted when the presiding officer is satisfied that infra.
Accordingly, pursuant to T.J. McNichol the witness is properly qualified’’); Grider Drug #1 51 R.D. at 16 (quoting Fed. R. Evid. 702(b)).
and CBS Wholesale, I find that the & Grider Drug #2, 77 FR 44070, 44093 n.73 (2012) Although the CALJ properly framed the issue of
record establishes that Professor Doering (finding that the Government’s expert, who was reliability under § 556(d) as a question of how much
licensed in Ohio but not Kentucky was nonetheless weight to give to Professor Doering’s expert
did not rely upon the DEA–6s in permissible and ‘‘generally reliable and probative of opinions, the CALJ erroneously resorted to Federal
forming his expert opinion in this case, whether Respondents (and their pharmacists) Rule of Evidence 702 as the lens through which to
and thus the Government had no violated their corresponding responsibility’’). Thus, make this determination. Id. at 14–15, 16 n.51. The
obligation to produce them to Trinity II. the CALJ properly accepted Professor Doering ‘‘as CALJ stated that the ‘‘Agency has long authorized
sradovich on DSK3GMQ082PROD with NOTICES2
an expert in the practice of pharmacy in the State resort to the Federal Rules of Evidence ‘where they
Expert Opinions Must Be Supported by of Florida and the standard of care in the do not conflict with Agency regulations.’’ Id. at 14–
Reliable, Probative and Reliable dispensing of controlled substances in Florida’’ 15 (citing Rosalind A. Cropper, M.D., 66 FR 41040,
based on his expertise and the fact that he stays 41041 (2001)). In Cropper, the Agency expressly
Evidence current in this area of expertise. Id. at 843; R.D. at rejected the ALJ’s evidentiary ruling that the
Under the APA, final agency action 14. For the same reasons, I find that the fact that Federal Rules of Evidence ‘‘generally apply’’ to DEA
Professor Doering’s CV may not have been up-to- administrative hearings and found ‘‘instead that the
imposing a sanction must be ‘‘supported date regarding the status of his Florida license is an Federal Rules of Evidence (FRE) do not apply
by and in accordance with the reliable, insufficient basis to find that his testimony was directly to these proceedings . . . but may be used
probative, and substantial evidence.’’ 5 unreliable. See R.D. at 28–30. for guidance, where they do not conflict with
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R.D. at 16. Specifically, the CALJ states Doering testified that he did have responsibility. And as already noted, the
that Professor Doering ‘‘did not have all sufficient information to render expert CALJ chose not to make any
of the information that was necessary opinions related to the Government’s recommended fact findings related to
for him to render an expert opinion.’’ Id. charges pursuant to 21 CFR 1306.04(a) the Government’s charges that Trinity II
(citing Tr. 2186–87). In its Exceptions, for the 23 patients that were the subject violated its corresponding
the Government responds that a ‘‘careful of the December 4, 2014 administrative responsibility.
and thorough review’’ of the hearing subpoena and for whom he had the In any event, the CALJ’s
transcript ‘‘shows that the Presiding corresponding patient profile. See Tr. characterization of Professor Doering’s
Officer’s 52 finding is a 1054–55, 2217, 2224.53 For this reason, definition of red flags is at odds with
mischaracterization of Professor and as noted supra, those are the only Professor Doering’s actual testimony. As
Doering’s testimony.’’ Gov. Except. at patients whose prescription evidence I noted supra, Professor Doering testified
13. I agree. have considered in evaluating the that a red flag is ‘‘a term that’s come to
During the portion of cross- Government’s charges pursuant to 21 be used to give examples to pharmacies
examination cited by the CALJ, it is CFR 1306.04(a). Accordingly, I reject the of things that might indicate or suggest
clear that when Professor Doering CALJ’s recommended finding that that prescriptions were filled outside
testified that he ‘‘d[id]n’t know that Professor Doering lacked sufficient facts the usual course of pharmacy practice.’’
[he’d] been provided enough to render his opinions with respect to Tr. 864. He also testified that a red flag
information . . . to render’’ expert those patients. ‘‘could be indicative of abuse or
opinions under the Florida standard of Second, the CALJ believed that misuse,’’ ‘‘over or under compliance,’’
care regarding Trinity II’s resolution of Professor Doering’s expert opinions ‘‘drug-drug interactions,’’ or a ‘‘forged’’
red flags was limited to prescriptions were not reliable because he had not or ‘‘altered’’ prescription. Id. at 869. All
and customers where he did not have a ‘‘reliably applied’’ the relevant of these indicators reflect what the CALJ
corresponding patient profile. Tr. 2186– principles and methods to the facts of described as ‘‘an elevated risk of
87, 2187; accord Gov. Except. 14–15. the case, particularly in the context of diversion.’’ Indeed, Professor Doering’s
The record is clear that Professor what constitutes a ‘‘red flag.’’ R.D. at testimony about red flags of diversion
16–17. The CALJ stated that ‘‘nothing in that pharmacists must look for was
agency regulations.’’ 66 FR at 41041 (citing his definition of a ‘red flag’ suggests that consistent with what the relevant
Klinestiver v. Drug Enforcement Administration,
606 F.2d 1128, 1130 (D.C. Cir. 1979) (holding that
it is an indicator of an elevated risk of Florida Administrative Rule requires
‘‘nothing in 21 CFR 1316.59(a) requires DEA to diversion, or what, if any, steps are pharmacists to look for as part of their
limit admissible testimony to that which would be required prior to dispensing when a red prospective drug use review. See
acceptable in a jury trial or under the Federal Rules flag is present.’’ Id. at 17 (citing Tr. 865).
of Evidence’’)). If the CALJ wished to deny
Florida Administrative Code Rule
admission of Professor Doering’s testimony and As a threshold matter, how Professor 64B16–27.810. In one example, he
exclude it from evidence, the APA only authorizes Doering, or any other expert, defines a testified that red flags indicating ‘‘over-
exclusion of evidence that is ‘‘irrelevant, red flag is irrelevant. It is the Agency, utilization’’ of a controlled substance
immaterial, or unduly repetitious.’’ 5 U.S.C. 556(d); not an expert, that must decide whether
Klinestiver, 606 F.2d at 1130 (‘‘The history of [21
‘‘touches upon some of the other issues,
CFR 1316.59] convinces us that DEA never facts in a particular case demonstrate which means clinical use or abuse, or
intended to bind itself to a higher standard of that a pharmacist knowingly filled a diversion to some other use.’’ Tr. 885–
admissibility than that prescribed by . . . 5 U.S.C. prescription that was not issued for a 86. ‘‘Over[-]utilization’’ ‘‘might be
556(d)’’); Cropper, 66 FR at 41041 (same) (‘‘The
sections governing these proceedings found in 21
legitimate medical purpose pursuant to distributing it to other persons’’ (i.e.,
Code of Federal Regulations contain no references 21 CFR 1306.04(a). In this context, the diversion to others) or ‘‘taking too much
to the FRE; and 21 CFR 1316.59 . . . requires only role of the expert is merely to render an of it.’’ Id. at 872. Thus, Professor
that admitted evidence be ‘competent, relevant, opinion of whether a pharmacist’s Doering testified that the red flags can
material, and not unduly repetitious.’’).
decision to fill a particular prescription indicate both an increased risk of
Although Rule 702 does use the words ‘‘expert’’
and ‘‘reliable,’’ that does not make the rule given the facts of the case satisfied the diversion to others, but also a risk of
applicable here, even as guidance, to determine state’s standard of pharmacy practice— clinical abuse. As I noted supra, he
how much weight to give expert testimony. The one of several factors the Agency can testified about many examples of red
CALJ concedes that Rule 702 only provides consider in determining whether a
conditions for ‘‘the admission of expert opinion
flags of diversion in a wide variety of
testimony.’’ R.D. at 15. Indeed, Rule 702 says pharmacy violated its corresponding contexts, including those set forth in
nothing about how much weight to give an expert’s Rule 64B16–27.810. See Gov. Except. at
opinion once it has been admitted. For this reason, 53 After reviewing prescription evidence and
18–23.
the Agency adopted the CALJ’s evidentiary patient profiles for over 20 of Respondents’
recommendation in Howard N. Robinson, M.D., 79
Also, as already noted, and contrary
customers and testifying that he saw no notes or
FR 19356, 19361 n.39 (2014), to overrule the comments resolving red flags of diversion with to the CALJ’s characterization, Professor
Government’s objection based on Rule 702 to respect to those customers, Professor Doering was Doering repeatedly testified about what
receiving an expert witness because ‘‘the nature of asked ‘‘How many more did you need to be able to pharmacists should do when a red flag
the objection was framed entirely as an argument see to determine whether or not [Respondents] kept
as to weight and raised no appreciable issue
is present. For example, he testified
the notes and comments?’’ Tr. 2217. He responded:
regarding the qualifications of the witness to ‘‘Well, technically speaking I’d have to look at each that, ‘‘before filling any prescription’’ as
present expert testimony.’’ Here, and as already and every one to be sure that they exist. I think the part of the ‘‘prospective drug utilization
noted, the CALJ properly accepted admission of logical conclusion is these profiles typically don’t review, or prospective drug use review,’’
Professor Doering’s expert opinion (Tr. 843–44) but have such a section.’’ Id. On this basis, the
gave it no weight because it was, in the CALJ’s
pharmacists must resolve the red flags
Government argues that a reasonable inference
view, insufficiently reliable. Thus, Rule 702 has no could be made that Trinity II never documented and document such resolution ‘‘on the
face of the prescription, on the rear of
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bearing, and provides no guidance, on the question resolution of red flags of diversion—even for
of how much weight the expert’s testimony should customers for whom patient profiles were not the prescription, or in the patient
receive. produced. Govt. Except. at 17 & n.5. I need not
52 ‘‘The term presiding officer means an
profile.’’ E.g., id. at 882, 870–73, 881–
make this inference here because, as set forth infra,
administrative law judge qualified and appointed as the prescription evidence and patient profiles that 83, 958–59.54 Most importantly, this
provided in the’’ APA. 21 CFR 1316.42(f) (citing 5 are already part of the record in this case are more
U.S.C. 556). The APA, in turn, characterizes an ALJ than sufficient to establish by a preponderance of 54 As the Government notes in its Exceptions,
as a ‘‘presiding or participating employee’’ of the the evidence that Trinity II violated its Professor Doering testified at length about the steps
Agency. 5 U.S.C. 556(b). In this case, the presiding corresponding responsibility pursuant to 21 CFR that a pharmacist must follow before filling a
officer or employee of the Agency was the CALJ. 1306.04(a). Continued
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testimony is consistent with the Florida notion that pharmacists must use their medications constitutes a ‘drug
Administrative Rules that also require professional judgement when filling cocktail.’ ’’ Id. (citing Tr. 1828–29,
resolving red flags and documenting prescriptions is neither new nor 1967). This largely academic testimony
resolution of red flags, which Professor remarkable. Agency precedent, federal (during cross-examination) about how
Doering also discussed at length. See law, and Florida law uniformly require reasonable pharmacists may differ on
Florida Administrative Code Rule pharmacists to use their professional where to draw the line regarding certain
64B16–27.800; Tr. 870–71, 873–75, 881– judgment in deciding whether to fill a red flags in the abstract is interesting but
82, 887–89, 891, 895–96, 953–55, 957– prescription and dispense controlled not relevant to the question that
59, 1015–16, 1169–70, 1353, 1419–20. substances.57 Accordingly, I reject the Professor Doering was actually called on
The fact that his testimony closely CALJ’s view that Professor Doering’s as an expert to answer: Whether
tracks the Florida Administrative Rules testimony was unreliable simply prescriptions like the ones in this case
supports, rather than undermines, the because he testified that pharmacists presented red flags of diversion.
reliability of his expert opinion. As a must use their professional judgment— And regarding prescriptions like those
result, I reject the CALJ’s belief that (1) a statement that is consistent with in this case, Professor Doering’s
the expert’s definition of a red flag is Agency precedent.58 testimony about what the standard of
relevant and (2) in any event, that the Fourth, the CALJ stated his belief that practice for Florida pharmacists was
expert failed to define a red flag as an ‘‘Professor Doering’s reliance upon the regarding early fills, duplicative
indicator of an elevated risk of diversion subjective judgment of individual therapy, and ‘‘drug cocktails’’ was clear.
and set forth the steps a pharmacist pharmacists as a Florida state standard’’ For example, Professor Doering testified
must follow prior to filling or undermined the reliability of his that ‘‘early fills’’ or ‘‘early refills’’ are
dispensing. testimony. R.D. at 19. The CALJ red flags of over-utilization, and that
Third, the CALJ stated that Professor contended that Professor Doering when there is a fill or refill was more
Doering was unreliable because the ‘‘conceded that pharmacists in Florida than 2–3 days early, that ‘‘early fill’’ or
CALJ believed that Professor Doering can and do disagree on whether ‘‘early refill’’ would be a red flag. See
stated that ‘‘it is the (presumably particular red flags are resolvable,59 Tr. 989–991, 992 (‘‘when there is a
subjective) judgment of each individual when a refill constitutes an ‘early refill,’ pattern of early refills, it makes one very
pharmacist that governs whether a red when duplicative therapy is present, concerned that there is over-
flag is adequately resolved.’’ R.D. at 17. and whether a particular combination of utilization’’), 1009. Although reasonable
Aside from the fact that the transcript pharmacists in Florida may disagree
fails to reflect Professor Doering making that Professor Doering testified that his opinion was whether the line should be drawn at two
this statement,55 the CALJ confuses the that Florida law applicable to all pharmacists or three days, those are not the early
governs whether a pharmacist adequately resolved
question of whose judgment should be a red flag before filling a prescription. See, e.g., Tr.
fills in this case. In this vein, Professor
used in filling a prescription with the 868–79. Doering testified that pharmacists
question of whether Trinity II’s 57 See, e.g., Ralph J. Bertolino, 55 FR 4,729, 4,730 would not disagree that prescriptions
pharmacists’ decisions to fill certain (1990) (‘‘The statutory scheme plainly requires that filled or refilled eight to 17 days early,
prescriptions satisfied their pharmacists use common sense and professional as the prescription evidence shows
judgment. Where [pharmacists’] suspicions are
corresponding responsibility.56 The aroused as reasonable professionals . . . Trinity II routinely did, were red flags
pharmacists are called upon to obey the law and of diversion that pharmacists in Florida
controlled substance prescription presenting a red refuse to dispense.’’); id. (‘‘When [pharmacists’] must resolve before filling. E.g., Tr.
flag of diversion. Govt. Except. at 25–26. He suspicions are aroused as reasonable professionals,’’ 1004–05, 2106–2110.
testified that resolving the red flag during ‘‘[d]rug they must at least verify the prescription’s
utilization review means using the knowledge, skill, propriety, and if not satisfied by the answer they Professor Doering also testified that
judgment, and experience of the pharmacist to must ‘‘refuse to dispense’’); Medicine Shoppe- there would be no disagreement among
evaluate all the information that might be in front Jonesborough, 300 Fed. Appx. 409, 412 (6th Cir. reasonable pharmacists that when a
of them regarding the use of this particular 2008) (same) (quoting Bertolino); United States v. patient simultaneously presents
prescription, under this particular prescription, in Hayes, 595 F.2d 258, 261 (5th Cir. 1979) (‘‘What is
this particular patient.’’ Tr. 870–71. He testified that required by [a pharmacist] is the responsibility not
prescriptions for the ‘‘drug cocktail’’ of
this review ‘‘would mean consulting the patient to fill an order that purports to be a prescription but an opioid, a benzodiazepine, and a
profile, which might have a list of other drugs that is not a prescription within the meaning of the muscle relaxant, then this is a red flag
a patient may be on[,] . . . a list of allergies or other statute because he knows that the issuing that a Florida pharmacist must resolve.
adverse effects that patients may have had from the practitioner issued it outside the scope of medical
drug. It may have other idiosyncrasies[,] . . . [it] practice’’); Florida Bd. of Pharm. R. 64B16–27.810
Id. at 2111. Likewise, he testified that
might have important demographic information, (requiring a pharmacist ‘‘upon recognizing any of when the same customer
such as [an] address . . . information indicating the [issues]’’ to ‘‘take appropriate steps to avoid or simultaneously presents two
other doctors, who may have or are seeing this very resolve the potential problems which shall, if prescriptions for different immediate-
patient. It would also have information on dates of necessary, include consultation with the release opioids with the same or similar
fills or refills, looking for . . . perhaps over[- prescriber’’).
]utilization of the medication.’’ Id. at 871. He also 58 In its Exceptions, the Government also notes instructions, this too is a red flag of
testified that pharmacists should resolve red flags that ‘‘the Presiding Officer’s finding is largely duplicative therapy that a pharmacist
by reviewing the notes and comments field of the immaterial in this case because the evidence must resolve before filling. Id. Notably,
patient profile, consulting with the patient and/or established that Respondents’ pharmacists did not Professor Doering’s testimony is
the prescribing physician, and consulting Florida’s exercise any judgment at all with respect to the
Prescription Drug Monitoring Program, ‘‘E- prescriptions containing red flag(s).’’ Govt. Except.
consistent with the same standard of
FORCSE.’’ Id. at 873–74, 887–89, 895–96, 953–55, at 29. Given that I have already found facts care requirements set forth in Florida
957, 1015–16, 1419–20. establishing that Trinity II failed to document or Administrative Rule 64B16–27.810—a
55 As the Government states, ‘‘[t]he Presiding otherwise establish that its pharmacists resolved fact that bolsters the reliability of his
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Officer simply read the word ‘subjective’ into red flags of diversion before filling prescriptions,
Professor Doering’s testimony when it did not see infra, the Government’s point is well-taken.
expert opinion. See ALJ Ex. 38.
exist.’’ Govt. Except. at 27. 59 See also R.D. at 26–27. The CALJ’s concern Accordingly, I reject the CALJ’s belief
56 On the latter question, the CALJ also expressed regarding Professor Doering’s testimony about that Professor Doering’s testimony about
confusion about whether Professor Doering was ‘‘whether particular red flags are resolvable’’ is the prescriptions in this case was
‘‘speaking from the shoes of the pharmacists’’ or particularly irrelevant where, as here, I have limited unreliable.
from his view of ‘‘looking from the shoes of the my fact findings to customers where the
expert’’ in determining what the Florida standard Government established by a preponderance of the
Fifth, the CALJ found Professor
of practice should be in resolving red flags. R.D. at evidence that Trinity II failed to document that it Doering’s testimony unreliable because
17 (quoting Tr. 881). However, the record is clear resolved any red flags of diversion. he failed to take into account the ‘‘E–
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FORSCE’’ printouts that the DIs had Sixth, the Government objected to the were early’’). As already noted, the CALJ
provided to him before rendering his CALJ’s belief that Professor Doering was failed to make any recommended fact
opinions. R.D. at 22 (‘‘although he unreliable because ‘‘he was consistently findings regarding the early fill
testified that checking E–FORSCE is a unable to accurately calculate the allegations in this case, much less
necessary step in the process for the number of days between two filled findings that conflicted with those made
pharmacist, he rendered his opinions prescriptions, even though supplied on by Professor Doering. Thus, I reject the
without taking into consideration any the witness stand with a calendar, a CALJ’s belief that Professor Doering was
E–FORSCE printouts that were provided pad, a pencil, as much time as he unreliable based on his early fill
to him’’ and would ‘‘arguably have been needed, and repeated prompting and re- calculations at the hearing.
relevant in reaching a determination as prompting by the Government.’’ R.D. at Finally, Trinity II contends that if the
whether a bona fide red flag was 23. Even assuming, arguendo, that the Agency were to find Professor Doering
actually present’’). While the CALJ CALJ’s belief is correct, the CALJ failed unreliable in this case, then it would
contends that E–FORSCE printouts for to explain why it has any bearing on call into question the CALJ’s previous
specific Trinity II customers would have whether Professor Doering’s expert finding in Holiday CVS that his
‘‘arguably’’ been relevant in identifying opinions are reliable. Professor Doering consistent expert testimony there was
a red flag,60 the CALJ failed to identify testified that his trouble in making these reliable and accorded evidentiary
any prescription in this case where it calculation by hand, on the stand, stems weight. E.g., ALJ Ex. 41, at 20 (‘‘Holiday
would have been relevant to identifying from the fact that today’s pharmacists CVS and its progeny all find their basis
a red flag.61 rely on a computer to make them in the testimony of Doering.’’), 20 n.5
Moreover, the Government noted in automatically. Tr. 1368.62 More (‘‘[I]n the event the Court finds
its Exceptions that the CALJ failed to importantly, the calculation of ‘‘the Doering’s testimony to be not credible or
point out that Professor Doering never number of days between two filled appropriate to rely upon, it likewise
received E–FORSCE printouts for prescriptions’’ is a question of fact, not calls into question the validity of
specific Trinity II customers—the of expert opinion.63 Thus, even if Holiday CVS due to its reliance on his
printouts the CALJ opined would have Professor Doering had little trouble testimony. The effect would be akin to
been relevant to his opinions. Gov. making these calculations, it would not removing a bottom floor card in a house
Except. at 39; Tr. 553 (DI testified that have obviated the Agency’s independent of cards.’’).64 In response, the CALJ
he ‘‘did not run a specific [E–FORSCE] requirement to make or to verify them states that the ‘‘Agency’s legal
query for each patient’’). Instead, the DIs as fact. Cf. Gov. Except. at 40 (‘‘the conclusions in its prior final orders
only provided Professor Doering with Administrator does not even need stand unaffected by a decision regarding
E–FORSCE printouts of the Professor Doering’s calculations to the weight that should be accorded
prescriptions filled by Trinity II, which ascertain whether the prescriptions expert testimony in this matter;
was already reflected in (and hence likewise, expert testimony reflected in
redundant to) Trinity II’s own
62 The following exchange at the hearing makes
prior final orders has no place in an
this point clear: evaluation of the evidence in this
prescriptions, dispensing reports, and Judge Mulrooney: . . . Would you say that it’s
patient profile. See Tr. 605 (DI testifying difficult to count up these days as a pharmacist,
matter.’’ R.D. at 15–16 n.51. Insofar as
that ‘‘[w]e try not to use E–FORSCE, we particularly if you’re in a busy retail pharmacy? the Agency’s legal conclusions in prior
prefer to use the dispensing report [Professor Doering]: It’s not difficult at all. final orders depend on expert testimony
Number 1, the computer does it for you. Number that is inconsistent with Professor
because it’s a more accurate reflection of 2, they’re not under the bright lights, under the
the pharmacies. Because it’s their stress of what I am. Although I may appear to be
Doering’s testimony in this case, I agree
records. It’s what they have in their calm and cool, this is a stressful thing for me. with the CALJ that the legal conclusions
system.’’). Thus, I reject the CALJ’s Tr. 1368. At this point, Professor Doering had in those cases are not called into
belief that Professor Doering’s failure to already been testifying continuously for almost two question.
days. However, I disagree with the CALJ’s
take into account the E–FORSCE In addition to the pressure of testifying on the
printouts of the prescriptions filled by stand, Professor Doering appeared to suffer from
claim that expert testimony accepted in
Trinity II made his testimony unreliable. witness fatigue, having testified for several days in prior final orders has no place in
He correctly based his opinions, instead, a row in response to a similar pattern of questions evaluating the weight to be given to
during direct examination over and over again. For expert testimony in this matter. Where
on the prescriptions, dispensing reports, this reason, it is not surprising that this fatigue
and patient profiles on which those E– caused him to misstate whether he had certain
Professor Doering’s testimony in this
FORSCE printouts depend. documents in one instance, and to respond in case is consistent with expert testimony
‘‘automatic mode’’ in another instance. See R.D. at previously found reliable by the
30–33. It is not uncommon for a witness who Agency, then I do find that prior
60 The CALJ concedes that ‘‘this aspect of the case
testifies for most of 5 days (as reflected in more than
certainly has no impact on whether the 1,400 pages of an almost 2,400-page transcript) to consistent testimony relevant to an
pharmacists’ attempts at red flag resolution were make an accidental misstatement. While the CALJ evaluation of the reliability of Professor
adequately documented.’’ R.D. at 22. In that vein, could reasonably find particular erroneous Doering’s testimony in this case. Here,
the Government observed that ‘‘the issue the testimony unreliable based on such mistakes, it
Presiding Officer should have focused on was the
for example, the Government contends
would not be reasonable to find the entirety of
fact that Respondents’ pharmacists were not Professor Doering’s testimony unreliable under the that his ‘‘testimony about the drug
checking E–FORSCE to resolve the red flags that APA on this basis.
were seen in the prescriptions themselves (as well 63 In its Exceptions, the Government further noted 64 Trinity II’s argument implies that allowing the
as the patient profiles and dispensing reports), as that the fact that Professor Doering needed more CALJ to find the same expert testimony reliable in
evidenced by the lack of any documentation on the than one attempt to make a particular calculation one case (Holiday CVS), yet unreliable in this case,
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prescriptions and the patient profiles of E–FORSCE in the examples cited by the CALJ (R.D. at 23–24) calls into question whether such findings are
queries.’’ Govt. Except. at 40 n.9. does not change the Government’s allegation that arbitrary and capricious. Although I agree with
61 Indeed, even if Professor Doering had received the prescriptions at issue ‘‘were extremely early, in Trinity II and the Government that some of
E–FORSCE printouts for specific Trinity II most instances anywhere from 8 to 15 days early, Professor Doering’s testimony in Holiday CVS is
customers, they would not have rendered red flags and Professor Doering reliably testified that they consistent with his testimony in this case, I do not
presented by the actual prescriptions less were each early.’’ Govt. Except. at 40. I agree, and consider whether the CALJ’s inconsistent reliability
suspicious. On the contrary, if anything, they may as I note infra, what is important is the fact that findings are arbitrary and capricious because I find,
have shown additional red flags—such as doctor- most (if not all) of the relevant fills and refills are consistent with the CALJ’s finding in Holiday CVS,
shopping—that may not have been presented by the so early that Trinity II should have resolved these that Professor Doering’s testimony in this case is
prescription evidence already in the case. red flags before filling the prescriptions. reliable.
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utilization review obligations of a (5) Such other conduct which may threaten that the record taken as a whole
pharmacist’’ regarding early fills ‘‘was the public health and safety. provides substantial evidence that
consistent with the expert testimony Id. § 823(f). Trinity II’s pharmacists violated their
that has been credited by [the] Agency ‘‘[T]hese factors are . . . considered corresponding responsibility pursuant
in previous final decisions.’’ ALJ Ex. in the disjunctive.’’ Robert A. Leslie, to 21 CFR 1306.04(a) when they
40a, at 73 (citing Grider #1 & Grider #2 M.D., 68 FR 15227, 15230 (2003). It is dispensed many of the prescriptions at
and East Main Street Pharmacy), 86 well settled that I ‘‘may rely on any one issue. I also find that the Government
(Professor Doering’s testimony regarding or a combination of factors, and may has established by substantial evidence
the early fills in this case ‘‘was give each factor the weight [I] deem[ ] that Trinity II’s pharmacists filled
consistent with the testimony of other appropriate in determining whether’’ to prescriptions outside the usual course of
experts in Agency precedent’’) (citing suspend or revoke an existing their professional practice in violation
Grider #1 & Grider #2 and The Medicine registration. Id.; see also MacKay v. of 21 CFR 1306.06.
Dropper), 104 (Professor Doering’s DEA, 664 F.3d 808, 816 (10th Cir. 2011); Accordingly, I conclude that the
testimony regarding therapeutic Volkman v. DEA, 567 F.3d 215, 222 (6th Government has established that Trinity
duplication ‘‘was again consistent with Cir. 2009); Hoxie v. DEA, 419 F.3d 477, II committed numerous acts which
the testimony of another pharmacist 482 (6th Cir. 2005). Moreover, while I render its continued ‘‘registration
expert that was credited by the Agency am required to consider each of the inconsistent with the public interest.’’
in a previous decision’’) (citing Grider factors, I ‘‘need not make explicit 21 U.S.C. 824(a)(4). Because I further
#1 & Grider #2 and Medicine Shoppe findings as to each one.’’ MacKay, 664 agree with the ALJ’s finding that Trinity
Jonesborough). Given Trinity II’s further F.3d at 816 (quoting Volkman, 567 F.3d II has not accepted responsibility for its
claim that Professor Doering’s testimony at 222); see also Hoxie, 419 F.3d at misconduct, I also agree with the ALJ
is consistent with his own accepted 482.65 that it has not rebutted the
testimony in Holiday CVS ‘‘and its Under the Agency’s regulation, ‘‘[a]t Government’s prima facie showing.
progeny,’’ the fact that Professor any hearing for the revocation or Because I find that Trinity II’s
Doering’s testimony in this case is suspension of a registration, the misconduct is egregious, I will order
consistent with accepted expert Administration shall have the burden of that Trinity II’s registration be revoked
testimony in the Agency’s prior proving that the requirements for such and that any pending application be
decisions is not in dispute. I find that revocation or suspension pursuant to denied.
this undisputed fact bolsters the . . . 21 U.S.C. [§ ]824(a) . . . are
reliability of Professor Doering’s expert Factors Two and Four—The
satisfied.’’ 21 CFR 1301.44(e). In this
testimony—further undermining the Respondent’s Experience in Dispensing
matter, while I have considered all of
CALJ’s determination that in this case Controlled Substances and Compliance
the factors, the Government’s evidence
his testimony is not reliable. With Applicable Laws Related to
in support of its prima facie case is
Accordingly, for all the foregoing Controlled Substances
confined to factors two and four.66 I find
reasons, I find that Professor Doering’s
expert testimony in this case was The Allegations Pursuant to 21 CFR
65 In short, this is not a contest in which score
reliable under the APA. 1306.04(a)
is kept; the Agency is not required to mechanically
The Public Interest Factors
count up the factors and determine how many favor ‘‘Except as authorized by’’ the CSA, it
the Government and how many favor the registrant. is ‘‘unlawful for any person [to]
Under the Controlled Substances Act Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness knowingly or intentionally . . .
(‘‘CSA’’), ‘‘[a] registration pursuant to of the registrant’s or applicant’s misconduct. Jayam manufacture, distribute, or dispense, or
section 823 of this title to manufacture, Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, possess with intent to manufacture,
distribute, or dispense a controlled findings under a single factor can support the distribute, or dispense, a controlled
substance . . . may be suspended or revocation of a registration or denial of an
application. See MacKay, 664 F.3d at 821. substance.’’ 21 U.S.C. 841(a)(1). Under
revoked by the Attorney General upon 66 As to factor one, there is no evidence that the the Act, a pharmacy’s registration
a finding that the registrant . . . has Florida Department of Health has either made a authorizes it ‘‘to dispense,’’ id. § 823(f),
committed such acts as would render recommendation to the Agency with respect to which ‘‘means to deliver a controlled
[its] registration under section 823 of Trinity II, or taken any disciplinary action against
substance to an ultimate user . . . by, or
this title inconsistent with the public it. See 21 U.S.C. 823(f)(1). However, even if true,
this finding is not dispositive of the public interest pursuant to the lawful order of, a
interest as determined under such inquiry. See Mortimer Levin, 57 FR 8680, 8681 practitioner, including . . . the
section.’’ 21 U.S.C. 824(a)(4). In the case (1992) (‘‘[T]he Controlled Substances Act requires packaging, labeling, or compounding
of a retail pharmacy, which is deemed that the Administrator . . . make an independent
necessary to prepare the substance for
to be a practitioner, see id. § 802(21), determination [from that made by state officials] as
to whether the granting of controlled substance such delivery.’’ Id. § 802(10). ‘‘The
Congress directed the Attorney General privileges would be in the public interest.’’). terms ‘deliver’ or ‘delivery’ mean the
to consider the following factors in Accordingly, this factor is not dispositive either for, actual, constructive, or attempted
making the public interest or against, the revocation of Trinity II’s registration.
transfer of a controlled substance.’’ Id.
determination: Paul Weir Battershell, 76 FR 44359, 44366 (2011)
(citing Edmund Chein, 72 FR 6580, 6590 (2007), § 802(8). Thus, a pharmacy dispenses a
(1) The recommendation of the appropriate pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (DC controlled substance when it attempts to
State licensing board or professional Cir. 2008)). transfer a controlled substance to an
disciplinary authority. As to factor three, there is no evidence that ultimate user pursuant to a lawful
(2) The applicant’s experience in Respondent, its owner, its manager, or any of its
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dispensing or conducting research with pharmacists, has been convicted of an offense under
respect to controlled substances. either federal or Florida law ‘‘relating to the The Government did allege, in the alternative in
(3) The applicant’s conviction record under manufacture, distribution or dispensing of the Show Cause Order’s eighth charge, misconduct
controlled substances.’’ 21 U.S.C. 823(f)(3). with respect to factor five regarding Trinity II’s
Federal or State laws relating to the However, ‘‘the absence of such a conviction is of filling and dispensing of a controlled substance in
manufacture, distribution, or dispensing of considerably less consequence in the public interest an amount that was at least five times the amount
controlled substances. inquiry’’ and is therefore not dispositive. Dewey C. prescribed. Because I consider this evidence in
(4) Compliance with applicable State, MacKay, 75 FR 49956, 49973 (2010), pet. for rev. evaluating factors two and four, I deem it
Federal, or local laws relating to controlled denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. unnecessary to separately address this misconduct
substances. 2011). under factor five.
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prescription by packaging or labeling a (2015). Thus, the Government can prove Admin Code r. 64B16–27.810(1)). This
controlled substance for such delivery. a violation by showing either that the rule further requires that a pharmacist
The CSA’s implementing regulations pharmacist filled a prescription (1) identify such issues as: ‘‘[o]ver-
set forth the standard for a lawful notwithstanding his/her actual utilization,’’ ‘‘[t]herapeutic
controlled substance prescription. 21 knowledge that the prescription lacked duplication,’’ ‘‘[d]rug-drug
CFR 1306.04(a). Under the regulation, a legitimate medical purpose, or (2) interactions,’’ ‘‘[i]ncorrect drug dosage
‘‘[a] prescription for a controlled being willfully blind to (or deliberately or duration of drug treatment,’’ and
substance to be effective must be issued ignorant of) the fact that the prescription ‘‘[c]linical abuse/misuse.’’ Id.
for a legitimate medical purpose by an lacked a legitimate medical purpose. Importantly, ‘‘[u]pon recognizing any
individual practitioner acting in the See id. at 28671–72. As to establishing of the above, the pharmacist shall take
usual course of his professional that a pharmacist acted with ‘‘willful appropriate steps to avoid or resolve the
practice.’’ Id. Thus, ‘‘ ‘a practitioner is blindness, proof is required that: ‘(1) the potential problems which shall, if
unauthorized to dispense a controlled defendant must subjectively believe that necessary, include consultation with the
substance if the prescription either lacks there is a high probability that a fact prescriber.’’ Id. at 64B16–27.810(2).
a legitimate purpose or is outside the exists and (2) the defendant must take Thus, Trinity II’s pharmacists violate
usual course of professional practice.’ ’’ deliberate actions to avoid learning of Florida law if they fail to identify and
United States v. Bennett, 874 F.3d 236, that fact.’ ’’ Id. at 28672 (quoting Global- resolve the red flags that are part of the
245 (5th Cir. 2017) (quoting United Tech Appliances, Inc., v. SEB S.A., 563 prospective drug use review set forth in
States v. Armstrong, 550 F.3d 382, 397 U.S. 754, 769 (2011)).68 Rule 64B16–27.810. And if they
(5th Cir. 2008), overruled on other Here, the Government makes no claim knowingly fill prescriptions without
grounds by United States v. Balleza, 613 that any of Trinity II’s pharmacists resolving these red flags during this
F.3d 432, 433 n.1 (5th Cir. 2010)). dispensed the prescriptions having review, then they violate their
Continuing, the regulation provides actual knowledge that the prescriptions corresponding responsibility under 21
that: lacked a legitimate medical purpose. CFR 1306.04(a). See, e.g., Grider Drug #1
Instead, relying primarily on Holiday & Grider Drug #2, 77 FR at 44097–98,
[t]he responsibility for the proper prescribing
and dispensing of controlled substances is CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 44100 (pharmacies violated their
upon the prescribing practitioner, but a 219 and 5195, 77 FR 62316, 62341 corresponding responsibility because
corresponding responsibility rests with the (2012), the Government argues that a they ‘‘did not do prospective DUR [drug
pharmacist who fills the prescription. An pharmacist violates the corresponding utilization review] with respect to any
order purporting to be a prescription issued responsibility rule when he/she fills a of the six patients even though this is
not in the usual course of professional controlled substance prescription (1) in
treatment . . . is not a prescription within required by the Kentucky Board of
the face of ‘‘red flags’’ or circumstances Pharmacy’s rules’’); East Main Street
the meaning and intent of section 309 of the that do or should raise a reasonable
Act (21 U.S.C. 829) and the person knowingly Pharmacy, 75 FR at 66157 & n.31
filling such a purported prescription . . . suspicion as to the validity of a (pharmacists required to recognize and
shall be subject to the penalties provided for prescription and (2) without taking consider red flags as part of the
violations of the provisions of law relating to steps to resolve the red flag and ensure prospective drug utilization review
controlled substances.67 that the prescription is valid. ALJ Ex. ‘‘before they dispense a prescription’’).
Id. (emphasis added). Thus, 1306.04(a) 40a, at 66–68. In this case, the Moreover, at all times relevant to this
distinguishes between ‘‘prescribing and Government argues that Trinity II’s case, Florida law also required
dispensing’’ and ‘‘filling’’ controlled pharmacists violated 21 CFR 1306.04(a) pharmacists to document resolution of a
substances, and who has responsibility by filling prescriptions for drugs such as red flag. Rule 64B16–27.800 69 required
for each function. Under this regulation, oxycodone and hydromorphone, even that ‘‘[a] patient record system . . . be
prescribing physicians are responsible though Trinity II’s pharmacists knew maintained by all pharmacies for
for the ‘‘proper prescribing and that these prescriptions presented patients to whom new or refill
dispensing of controlled substances,’’ various ‘‘red flags’’ of diversion which prescriptions are dispensed’’ and that
and pharmacists bear a corresponding were never resolved. Id. at 68. the ‘‘system shall provide for the
Notably, Florida law requires
responsibility for ‘‘filling’’ only lawful immediate retrieval of information
pharmacists to identify and resolve
prescriptions issued for a legitimate necessary for the dispensing pharmacist
certain red flags for every prescription
medical purpose. to identify previously dispensed drugs
As the Agency has made clear, to presented to them during a prospective
at the time a new or refill prescription
prove a violation of a pharmacist’s drug use review. Florida Administrative
is presented for dispensing.’’ Fla.
corresponding responsibility, the Code Rule 64B–16–27.810, entitled
Admin. Code r. 64B–16–27.800. This
Government must show that the ‘‘Prospective Drug Use Review,’’
rule also required that the pharmacy
pharmacist acted with the requisite requires pharmacists to ‘‘review the
maintain ‘‘[a] list of all new and refill
degree of scienter, i.e., that the patient record and each new and refill
prescriptions obtained by the patient at
pharmacist ‘‘knowingly’’ filled a prescription presented for dispensing in
the pharmacy . . . during the two years
prescription that was not issued for a order to promote therapeutic
immediately preceding the most recent
legitimate purpose. See JM Pharmacy appropriateness.’’ ALJ Ex. 38 (Fla
entry’’ and include the ‘‘prescription
Group, Inc., d/b/a Farmacia Nueva and 68 Courts have long held that when prescriptions
number, name and strength of the drug,
Best Pharma Corp., 80 FR 28667, 28669 are clearly not issued for legitimate medical the quantity and date received, and the
name of the prescriber.’’ Id. at 64B–16–
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purposes, a pharmacist may not intentionally close
67 As the Supreme Court has explained, ‘‘the his eyes and thereby deliberately avoid actual 27.800(1)(e).
prescription requirement . . . ensures patients use knowledge of the real purpose of the prescription, Most significantly, the rule required
controlled substances under the supervision of a thereby filling them with impunity. See United
doctor so as to prevent addiction and recreational States v. Kershman, 555 F.2d 198 (8th Cir. 1977). that the record include the
abuse. As a corollary, the provision also bars See also United States v. Lawson, 682 F.2d 480 (4th
doctors from peddling to patients who crave the Cir. 1982) (‘‘The key element of knowledge may be 69 Because the prescriptions at issue in this case
drugs for those prohibited uses.’’ Gonzales v. shown by proof that the defendant deliberately are dated from February 2012–February 2014, I
Oregon, 546 U.S. 243, 274 (2006) (citing United closed his eyes to the true nature of the apply the version of Rule 64B16–27.800 that
States v. Moore, 423 U.S. 122, 135, 143 (1975)). prescription’’). applied prior to its amendment on March 18, 2015.
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‘‘[p]harmacist[’s] comments relevant to supply obtained from a previous Trinity II’s pattern of early fills and
the individual’s drug therapy, including prescription filled by Trinity II. For one refills was not limited to one customer.
any other information peculiar to the customer, J.T., Trinity II filled The evidence establishes that Trinity II
specific patient or drug.’’ Id. at 64B–16– prescriptions for oxycodone 30 mg 14– filled prescriptions for customer M.A.
27.800(1)(f). And the rule also required 16 days early on nine occasions in each for hydromorphone 8 mg six to seven
that the pharmacist make ‘‘a reasonable of nine consecutive months—resulting days early on eight occasions in eight
effort . . . to obtain from the patient in a cumulative effect of Trinity II filling consecutive months—resulting in the
. . . and record any known allergies, and delivering 71 135 extra days of cumulative effect of Trinity II filling and
drug reactions, idiosyncrasies, and oxycodone 30 mg (the equivalent of providing 50 extra days of
chronic conditions or disease states of 1,080 extra tablets) for J.T. from March hydromorphone 8 mg for M.A. from
the patient and the identity of any other 2012–November 2012. While it is May 2013-December 2013. Trinity II
drugs . . . being used by the patient conceivable that a single early fill of a also filled a prescription for customer
which may relate to prospective drug customer’s prescription could be an J.G. for lorazepam 2 mg nine days early
review,’’ id. at 64B–16–27.800(2), which unwitting mistake (albeit, at 16 days, a on May 28, 2013. In addition, Trinity II
is the ‘‘prospective drug use review’’ for significant one) by one of Trinity II’s filled and refilled J.G.’s prescriptions for
red flags required by 64B–16–27.810. pharmacists, it is not remotely credible Xanax 2 mg early on six occasions
Finally, the rule required that ‘‘[t]he that Trinity II could innocently repeat between October 10, 2012 and June 12,
pharmacist . . . record any related the same mistake nine times in nine 2013—five days early, six days early,
information indicated by a licensed consecutive months without knowing eight days early, 10 days early (twice),
health care practitioner.’’ Id. at 64B–16– that the prescriptions lacked a and 17 days early. The evidence also
27.800(2). All of these ‘‘patient legitimate medical purpose. Trinity II’s establishes that Trinity II filled
record[s]’’ must be ‘‘maintained for a pharmacists made no notes or prescriptions for customer L.H. for
period of not less than two years from comments on the front or back of these hydromorphone 8 mg eight days early
the date of the last entry in the profile prescriptions, in the dispensing log, or on June 28, 2012 and nine days early on
record.’’ Id. at 64B–16–27.800(4). in the patient profile explaining why July 3, 2012.74 As with customer J.T.,
Thus, Florida’s laws specifically J.T. should receive 135 extra days of Trinity II’s failure to document
require a pharmacist to document in the oxycodone 30 mg. This lack of any anywhere on the relevant prescriptions,
patient record his/her comments explanation further highlights Trinity dispensing logs, or patient profiles why
relevant to the patient’s drug therapy II’s willingness to ignore the fact that M.A., J.G., or L.H. should receive early
and ‘‘other information peculiar to the J.T.’s early prescriptions lacked a fills and refills of these controlled
patient’’ or drug, as well as ‘‘any related legitimate medical purpose. This substances further underscores Trinity
information’’ provided by the patient’s evidence of diversion of 135 extra days II’s pharmacists’ knowledge that they
physician in the patient’s ‘‘profile of a schedule II drug like oxycodone is were filling illegitimate prescriptions
record.’’ Although such patient records so egregious that I find that it is more and violating their corresponding
provide relevant evidence in assessing than sufficient to establish by a responsibility under 21 CFR 1306.04(a).
whether a pharmacist resolved the preponderance of the evidence that In his Recommended Decision, the
suspicion created by the prescriptions at Trinity II’s pharmacists were willfully CALJ declined to find that Trinity II
issue here, the Government only blind 72 to the fact that J.T.’s violated its corresponding responsibility
obtained and introduced patient profiles prescriptions lacked a legitimate under § 1306.04(a) based on these early
related to the 23 Trinity II customers medical purpose when its pharmacists fills because of his belief that the
identified in its December 4, 2014 filled them 14–16 days early in each of determination of when a fill occurred
subpoena. GX 98.70 As noted supra, the nine consecutive months. On this basis must be based on ‘‘the date when the
Government established by a alone, I find that Trinity II violated its customer picked up their medications,’’
preponderance of the evidence that corresponding responsibility under 21 not when Trinity II filled the
Trinity II’s pharmacists failed to resolve CFR 1306.04(a). Indeed, the Agency has prescriptions. R.D. at 25. ‘‘An early refill
red flags regarding these patients previously found violations of the only logically bears upon this
because the prescriptions, dispensing corresponding responsibility when consideration [of over-utilization or
logs, and patient profiles contained no pharmacists knowingly filled under-utilization] at the moment the
documentation that Trinity II resolved prescriptions less than 15 days early.73 medication is being dispensed to the
the red flags of diversion presented by patient, not when a [fill] sticker is
these customers’ prescriptions. As a 71 Given that J.T. came back on a monthly basis,
prepared by the pharmacy.’’ Id. The
result, I further find that the it is a reasonable inference that the drugs were CALJ offered the following explanation:
actually delivered to him.
Government established by a 72 Moreover, this evidence would likely be While there may be some logical appeal to
preponderance of the evidence that sufficient to show that Trinity II had actual the principle that some or most of the steps
Trinity II’s pharmacists filled at least knowledge that these prescriptions lacked a required in a valid prospective drug use
some of the prescriptions knowing that legitimate medical purpose. However, the review should (and generally will) be
Government did not allege that Trinity II had such completed prior to the preparation of the
they lacked a legitimate medical actual knowledge, making such a finding
purpose. pharmacy fill sticker, no shred of that
unnecessary.
For example, the evidence shows that 73 E.g., Grider Drug #1 and Grider Drug #2, 77 FR
rationale could logically be applied to justify
deeming the fill sticker preparation date as
Trinity II knowingly filled controlled at 44098 (finding a violation of the corresponding
substances prescriptions well before the responsibility where the refills for one patient were
sradovich on DSK3GMQ082PROD with NOTICES2
‘‘more than five days early, and some as much as some being refilled as early as eight or nine days
customer should have exhausted the nine to twelve days early’’); East Main Street before the previous prescription would have run
Pharmacy, 75 FR 66149, 66159 (2010) (accepting out’’).
70 In Superior Pharmacy I and II, I found the expert opinion that a refill of controlled substance 74 These are only the most egregious examples of
Government’s evidence, which was limited to the ‘‘two weeks early’’ is a ‘‘blatant example[ ] of abuse early filling of controlled substances by Trinity II
prescriptions (which contained no documentation and diversion’’); cf. Jeri Hassman, 75 FR 8194, 8201, in violation of its corresponding responsibility
that the red flags were resolved) and its Expert’s 8229, 8231 (2010) (finding prescriptions were not under § 1306.04(a). As I described in my fact
testimony, insufficient to establish that the for a legitimate medical purpose where findings, Trinity II also filled a prescription for
pharmacists violated their corresponding approximately half of the controlled substance Dilaudid 8 mg nine days early for customer D.E.
responsibility. 81 FR 31310 (2016). ‘‘prescriptions were refilled five days early, with without explanation.
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equivalent to the date that a medication was pharmacist has ‘‘filled’’ the prescription ‘‘dispense,’’ which includes the delivery
dispensed (delivered/transferred) to a patient and which may even occur without the of a controlled substance.
for early refill purposes. pharmacist’s involvement at all. See Just as the operative date for
Id. The CALJ cites to no authority (and R.D. at 25.76 Such a rule would lead to determining whether a prescribing
I am aware of none) for the proposition the nonsensical result of allowing practitioner has met his/her
that the date when the customer pharmacists to knowingly fill controlled responsibility under § 1306.04(a) is
actually receives the controlled substance prescriptions lacking a when the physician ‘‘prescribe[s] and
substance should be used to determine legitimate purpose so long as the dispens[es]’’ a controlled substance, the
whether a pharmacy’s early fill of a pharmacist had not yet actually operative date for determining whether
prescription violates its corresponding delivered them to the customer— a pharmacist has met his/her
responsibility under 21 CFR directly contradicting § 1306.04(a)’s corresponding responsibility is when
1306.04(a).75 express prohibition. the pharmacist ‘‘fills the
Most importantly, the notion that the And to the extent the CALJ’s view is prescription.’’ 77 And as noted supra,
fill date is equivalent to the pick-up date based on the notion that ‘‘fill’’ means the record establishes by a
is belied by § 1306.04(a)’s plain ‘‘dispense,’’ or that the two terms are preponderance of the evidence that the
language, which states in pertinent part: otherwise interchangeable, date on Trinity II’s fill stickers represent
A prescription for a controlled substance to § 1306.04(a)’s plain language precludes the date when Trinity II’s pharmacists
be effective must be issued for a legitimate that notion as well. Specifically, filled the prescriptions at issue in this
medical purpose by an individual § 1306.04(a) distinguishes a prescribing case. Accordingly, § 1306.04(a) required
practitioner acting in the usual course of his practitioner’s ‘‘responsibility for the Trinity II to identify and to resolve any
professional practice. The responsibility for proper prescribing and dispensing of suspicions that a particular prescription
the proper prescribing and dispensing of controlled substances’’ only for a lacked a legitimate medical purpose
controlled substances is upon the prescribing legitimate medical purpose from the before knowingly filling the
practitioner, but a corresponding
responsibility rests with the pharmacist who
pharmacist’s corresponding prescription.
fills the prescription. An order purporting to responsibility not to ‘‘knowingly fill[ ]’’ As noted supra, the evidence of
be a prescription issued not in the usual prescriptions that lack a legitimate Trinity II’s improper early fills alone is
course of professional treatment . . . is not medical purpose. Filling constitutes part sufficient to prove that Trinity II
a prescription within the meaning and intent of the process of dispensing, but the knowingly filled illegitimate
of section 309 of the Act (21 U.S.C. 829) and CALJ cites to no decision of the Agency prescriptions in violation of its
the person knowingly filling such a purported (and I am aware of none) holding that corresponding responsibility under
prescription . . . shall be subject to the filling encompasses every part of the § 1306.04(a). However, there are other
penalties provided for violations of the
provisions of law relating to controlled
dispensing process, including the actual
substances. delivery to the ultimate user. If 77 Furthermore, even if § 1306.04(a) did impose
on pharmacists a corresponding responsibility not
‘‘dispensing’’ and ‘‘filling’’ shared the to ‘‘knowingly dispense’’ an illegitimate
Id. (emphasis added). Section 1306.04(a) same meaning, then the Agency would prescription (rather than prohibiting them from
expressly requires pharmacists to not have used two different terms in the ‘‘knowingly filling such a purported prescription’’),
identify and resolve suspicions that a same regulation to describe prescribing the calculation of an ‘‘early fill’’ would be the same.
prescription is illegitimate (like a practitioners’ and pharmacists’ Under the CSA, ‘‘ ‘dispense’ means to deliver a
prescription presented too early) before controlled substance to an ultimate user . . . by, or
respective responsibilities. Instead, the pursuant to the lawful order of, a practitioner,
‘‘knowingly filling such a purported Agency would have simply used the including . . . the packaging, labeling, or
prescription.’’ It does not allow a term ‘‘dispense’’ to apply to both compounding necessary to prepare the substance
pharmacist to delay completing a practitioners and pharmacists
for such delivery.’’ 21 U.S.C. 802(10). ‘‘The terms
prospective drug use review to confirm ‘deliver’ or ‘delivery’ mean the actual, constructive,
throughout the regulation. Thus, I reject or attempted transfer of a controlled substance.’’ Id.
a suspicious prescription’s legitimacy the notion that under § 1306.04(a), the § 802(8). Thus, the situations in which a pharmacy
until ‘‘a medication was dispensed term ‘‘fill’’ is coextensive with the term ‘‘dispenses’’ a controlled substance includes when
(delivered/transferred) to a patient’’—an the pharmacy attempts to transfer a controlled
event that necessarily occurs after the substance to an ultimate user pursuant to a lawful
76 The CALJ surmised that, unless the
prescription ‘‘by packaging or labeling a controlled
pharmacist’s corresponding responsibility is substance for such delivery’’—i.e., before a
75 Likewise, Trinity II contends that the date delayed until ‘‘the moment the medication is being customer actually receives the prescribed controlled
‘‘when the prescription was actually dispensed to dispensed to the patient,’’ then ‘‘any ethical Florida substance. As the Government points out in its
the patient . . . and not the fill date, is the pharmacist who works ahead and prepares Exceptions, even under Florida’s definition,
operative evidence of whether there was an medications in advance of their eligibility to be ‘‘dispensing’’ occurs before the customer receives
improper dispensing event.’’ Resp. Except. at 4; ALJ picked up by the patient due to staffing or some the prescription. Gov. Except. at 46 (noting that
Ex. 41 at 16–17 (‘‘Doering was basing his often other benign business-related issue would stand in Florida’s ‘dispense’ definition in Ch. 465.003(6)
incorrect counting on the date the prescription was unavoidable conflict with the standard of pharmacy unequivocally states that ‘‘the actual sales
filled, without having any knowledge as to when practice in Florida merely by virtue of the date on transaction and delivery of such drug shall not be
the customer actually picked up the prescription’’). the fill sticker.’’ R.D. at 25. Aside from the fact that considered dispensing’’) (quoting Fla. Stat.
Trinity II claims that its ‘‘electronic records the record does not show that Trinity II routinely § 465.003(6)). In this case, when Trinity II filled a
included patient signature logs for when the filled prescriptions ‘‘in advance of their eligibility bottle with a prescribed controlled substance and
prescription was actually dispensed to the patient,’’ to be picked up,’’ no Agency precedent supports the then affixed a fill label or sticker to the bottle or
Resp. Except. at 4, and as a result of this claim, the CALJ’s hypothetical as some kind of exception to ‘‘packaging’’ containing the controlled substance,
CALJ averred that the Government’s expert ‘‘could a pharmacist’s corresponding responsibility. In fact, Trinity II ‘‘dispensed’’ the prescription under the
not determine the date the patients picked up their § 1306.04(a) precludes the CALJ’s hypothetical by CSA (and arguably Florida law) by ‘‘labeling . . .
medications because he had never been provided imposing a corresponding responsibility on the the substance for’’ ‘‘delivery to an ultimate user.’’
sradovich on DSK3GMQ082PROD with NOTICES2
with the pharmacy’s disbursement log.’’ R.D. at 25. pharmacist at the time of ‘‘filling,’’ not at some The record reflects that the date on the fill sticker
In fact, neither the CALJ nor Trinity II cite to any point after filling the prescription. Thus, to fulfill represents the date when Trinity II packaged or
authority (and I am aware of none) supporting their their corresponding responsibility under labeled a prescribed controlled substance. And as
position that the date when the customer actually § 1306.04(a), pharmacists must identify and resolve the CALJ concedes, ‘‘the date on the fill sticker’’ is
receives the controlled substance should be used to any red flags of diversion presented by controlled also what the Government used to calculate the date
measure whether a pharmacy lawfully filled a substance prescriptions (e.g., by completing the when Trinity II ‘‘filled’’ the prescriptions at issue
prescription early under 21 CFR 1306.04(a). To the prospective drug use review that Florida law in the case. See R.D. at 25. Accordingly, even under
extent that the CALJ and Trinity II rely on the required Trinity II to do) before filling them in order the theory that ‘‘fill’’ in § 1306.04(a) really means
definition of dispense, I discuss infra why such to avoid ‘‘knowingly filling’’ illegitimate ‘‘dispense,’’ the date on the fill sticker in this case
reliance is misplaced. prescriptions. reflects both the ‘‘fill’’ date and the ‘‘dispense’’ date.
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Trinity II’s pharmacists never explained pharmacists knowingly fail to follow I sustain the Government’s third and
why they filled these highly suspicious such instructions in filling otherwise fourth charges. I do sustain those
prescriptions. The suspiciousness of valid prescriptions, they are not ‘‘acting charges, but only on the basis that
these ‘‘cocktail prescriptions’’ was in the usual course of [their] Trinity II violated 21 CFR 1306.06 83
further compounded by the fact that professional practice’’ and therefore when it filled 84 these prescriptions
these prescriptions also reflected violate 21 CFR 1306.06.
‘‘pattern prescribing’’ and a lack of Here, Trinity II filled prescriptions the ‘‘Do Not Fill’’ prescriptions underlying the
individualized drug therapy. without following the prescribing Show Cause Order’s third and fourth charges were
not issued on the same date and hence are not
Specifically, Trinity II knew that J.Ha. physician’s instructions with respect ‘‘multiple prescriptions’’ on the same date within
and R.Ha. shared a last name and home three of the Show Cause Order’s the meaning of 21 CFR 1306.12(b).
address and that their prescriptions charges. Specifically, in the third and 83 Federal courts have suggested that the identical
were issued (1) by the same prescribing fourth charges of the Show Cause Order, phrase—‘‘usual course of his professional
practice’’—found in 21 CFR 1306.04(a) essentially
physician, (2) on the same day, and (3) the Government charged Trinity II with includes a knowingly requirement in criminal
for the same drugs.80 Trinity II’s twice filling prescriptions for customer cases. See, e.g., Bennett, 874 F.3d at 245 (finding
pharmacists provided no notes or D.G. for fentanyl patches on dates prior that a prescribing physician violates § 1306.04(a)
comments explaining why they to the prescribing physician’s explicit when the practitioner ‘‘knowingly distribut[es]
prescriptions outside the usual course of
knowingly filled these prescriptions. ‘‘No Exceptions Do Not Fill Until’’ professional practice’’) (internal citations and
See supra. Thus, I find that the fact that instructions on each prescription. As quotations omitted). Assuming the ‘‘knowingly’’
Trinity II’s pharmacists’ knew that these noted supra, I have found that the scienter standard applies to the application of
prescriptions reflected a well- Government proved these facts by a § 1306.06 to this administrative proceeding, I find
that the Government has met its burden to prove it.
established suspicious ‘‘cocktail’’ of preponderance of the evidence.81 The Government’s burden of proof in this
controlled substances for two customers Although he did not rely on 21 CFR proceeding is ‘‘preponderance of the evidence,’’ not
who also shared the same last name, 1306.06,82 the CALJ recommended that ‘‘beyond a reasonable doubt.’’ In that vein, while it
address, and prescribing physician, is conceivable that a Trinity II pharmacist may
mistakenly fail to follow ‘‘Do Not Fill Until’’
established that Trinity II’s pharmacists 81 In addition, I find that there is no evidence
instructions in good faith once, it is less credible
knew that these prescriptions lacked a establishing that the ‘‘Do Not Fill’’ prescriptions
that Trinity II’s pharmacists would fail to follow
underlying the Show Cause Order’s third and fourth
legitimate purpose. such instructions for the same customer two
charges were invalid under 21 CFR 1306.04(a) and
Accordingly, and in light of the very months in a row without doing so knowingly. The
1306.11(a). For this reason, I deny the Government’s CALJ apparently agreed. R.D. at 48–49 (‘‘Despite the
substantial weight of the evidence of allegation that Trinity II also (1) violated their clear indication of the practitioner’s limitation on
diversion presented by the suspicious corresponding responsibility under 21 CFR the scrip[t]s, Respondent’s employees blatantly
1306.04(a) when they filled these two prescriptions
prescriptions in this case—early fills, and (2) filled a prescription without a valid
ignored the instruction and filled the prescriptions
before the practitioner had authorized them to be
therapeutic duplication, customers prescription in violation of 21 CFR 1306.11(a) filled.’’). When this pattern is combined with the
traveling great distances, ‘‘cocktail regarding these prescriptions. See ALJ Ex. 1b, at 14– broader pattern of Trinity II’s pharmacists
prescriptions,’’ and ‘‘pattern 15. knowingly filling prescriptions in violation of their
It is also for this reason that I disagree with the corresponding responsibility, see supra, I have little
prescribing’’—I find that Trinity II’s CALJ’s statement that, ‘‘[b]ecause the scrip[t] was trouble finding that the Government has established
pharmacists violated their not valid until the date articulated by the by a preponderance of the evidence that Trinity II’s
corresponding responsibility by practitioner, . . . the Respondent filled these two pharmacists knowingly failed to follow the ‘‘Do Not
knowingly filling prescriptions that prescriptions without a lawful order from a Fill Until’’ instructions in D.G.’s prescriptions and
practitioner.’’ R.D. at 49. As the CALJ himself noted hence filled prescriptions outside the pharmacists’
lacked a legitimate medical purpose. in recommending that I reject the Government’s usual course of their professional practice under 21
The Allegations Pursuant to 21 CFR claim of a § 1306.11(a) violation regarding the Show CFR 1306.06.
Cause Order’s fifth charge, ‘‘because there was a In any event, even if the Government could not
1306.06 (seemingly) valid scrip[t] presented for each of prove that this conduct violated § 1306.06 or
Under 21 CFR 1306.06, ‘‘[a] these dispensing events,’’ Trinity II’s conduct otherwise met Factors Two or Four under 21 U.S.C.
should not be reviewed ‘‘as if it were dispensed 823(f), I find that a pharmacist blatantly and
prescription for a controlled substance with no [valid] order from the practitioner.’’ Id. at knowingly ignoring a physician’s instructions on an
may only be filled by a pharmacist, 49 n.116. I agree. In the Show Cause Order’s third, otherwise valid prescription would constitute
acting in the usual course of his fourth, and fifth charges, customers presented ‘‘[s]uch other conduct which may threaten the
professional practice.’’ Pharmacists fill apparently valid prescriptions to Trinity II, but its public health and safety.’’ 21 U.S.C. 823(f)(5). See
pharmacists ignored (repeatedly) the same R.D. at 48 (‘‘To allow a pharmacy to fill a
prescriptions for controlled substances instructions when filling them. Thus, I agree with prescription at any time before a date specified by
in the usual course of their professional the CALJ’s argument regarding the fifth charge, and the issuing practitioner would completely
practice, for example, when pharmacists I apply the same argument in rejecting his rationale undermine the practitioner’s decision to issue the
follow the prescribing physician’s regarding the third and fourth charges. scrip[t] in that manner.’’).
82 The CALJ criticized the Government for not 84 In its Exceptions, Trinity II offered its
instructions for a prescription issued for
relying on 21 CFR 1306.12 and 21 CFR 1306.14 as conclusory argument that the date ‘‘when the
a legitimate medical purpose. When a basis for the third and fourth charges. R.D. at 47 prescription was actually dispensed to the patient
n.111 (‘‘It is difficult to imagine why the . . . and not the fill date, is the operative evidence
80 See East Main Street Pharmacy, 75 FR at 66,157 Government did not cite to these regulatory of whether there was an improper dispensing event.
(noting red flags such as ‘‘lack of indivdua[liza]tion sections, which speak directly to the violations at Because the Government never requested’’ ‘‘the
of therapy, certain patterns from physicians of issue in OSC ¶¶ 9 and 10.’’). However, the CALJ’s pharmacy’s electronic records [which] included
seeing the same types of controlled substances over, own analysis supplies a good explanation for why patient signature logs,’’ ‘‘there was insufficient
and over, and over, again’’). This is not the only the Government did not pursue charges on that evidence to meet the Government’s burden of proof
example of Trinity II filling prescriptions presenting basis. The CALJ conceded that ‘‘those regulatory for this allegation.’’ Resp. Except. at 4. I reject this
this type of ‘‘pattern prescribing.’’ On two sections specifically pertain to the situation where Exception for the same two reasons that I rejected
occasions—November 20, 2013 and December 18, a practitioner issues multiple prescriptions, the same argument supra in the context of Trinity
sradovich on DSK3GMQ082PROD with NOTICES2
2013—Trinity II filled prescriptions for customers presumably on the same date.’’ Id. at 47. He further II’s violations of 21 CFR 1306.04(a). Like
M.W. and J.W. for the same controlled substance referenced DEA’s ‘‘notice of final rule implementing § 1306.04(a), 21 CFR 1306.06 expressly hinges on
(oxycodone 30 mg with ginger), even though Trinity the regulation,’’ in which ‘‘DEA noted that the rule whether pharmacists ‘‘filled’’ controlled substance
II knew that these customers shared the same last ‘did not address whether a single prescription with prescriptions in the usual course of their
name, address and prescribing physician. Trinity ‘‘Do not fill before [date]’’ instructions is professional practice; it does not depend on ‘‘when
II’s pharmacists never explained why they permissible’ ’’ and that ‘‘no ‘existing provision of the prescription was actually dispensed to the
nonetheless filled these prescriptions. As a result, the CSA or DEA regulations address[es] this type of patient’’ as Trinity II claims. Thus, the ‘‘operative
I find that it is highly probable that Trinity II’s prescribing.’ ’’ Id. at 47–48 (quoting ‘‘Issuance of evidence’’ is the evidence of filling, and the CALJ
pharmacists knew that these prescriptions also Multiple Prescriptions for Schedule II Controlled properly reviewed the dates on the fill sticker, the
lacked a legitimate medical purpose. Substances,’’ 72 FR 64,921–64,924 (2007)). Here, Continued
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before the prescribing physician’s ‘‘Do presented apparently valid prescriptions Florida law and under the DEA
Not Fill’’ instructions. to Trinity II, but the Government proved regulations.’’ R.D. at 44.
In the Show Cause Order’s fifth the allegations in its fifth charge that In its Exceptions, the Government
charge, the Government alleged, and as Trinity II’s pharmacists repeatedly took issue with the CALJ’s
noted supra I have found, that Trinity ignored the prescriptions’ instructions characterization of Florida law and
II filled for customer J.T. seven when filling them. While it is whether it authorized pharmacist
consecutive prescriptions for a conceivable that a Trinity II pharmacist interns to dispense controlled
morphine sulfate solution that was at may have mistakenly failed to follow a substances under the supervision of a
least five times, and sometimes 15 prescription’s dosage instructions in licensed Florida pharmacist. The
times, stronger than the dosages that the good faith once, it is not remotely Government contended that § 893.04(1)
physician had prescribed. Although the credible that Trinity II’s pharmacists of Chapter 893 of Florida law states that
Government charged that this conduct would fail to follow such instructions controlled substance prescriptions may
violated 21 CFR 1306.06 and 21 CFR for the same customer seven times in only be dispensed by ‘‘a pharmacist, in
1306.11(a), I find that the conduct did the span of six months without doing so good faith and in the course of
not violate 21 CFR 1306.11(a) because I knowingly. For this reason, I have little professional practice’’—making no
find that there is no proof that the trouble finding that the Government has reference to pharmacy interns. Gov.
prescriptions underlying the Show established by a preponderance of the Except. at 78. The Government also
Cause Order’s fifth charge were invalid. evidence that Trinity II’s pharmacists argued that pharmacy interns are not
See R.D. at 49 n.116 (‘‘there was a knowingly filled prescriptions with the ‘‘licensed pursuant to Chapter 465 to
(seemingly) valid scrip[t] presented for incorrect dosage strength of a controlled practice the profession of Pharmacy’’ as
each of these dispensing events’’). For substance seven times and hence filled required under § 893.02(18) but instead
this reason, the CALJ recommended that prescriptions outside the pharmacists’ are ‘‘registered with the’’ state under
I deny the Government’s allegation that usual course of their professional § 465.03(12). Gov. Except. at 79. For
Trinity II filled prescriptions in the fifth practice in violation of § 1306.06. these reasons, the Government asked me
charge without a valid prescription and to reject the CALJ’s recommendation
in violation of 21 CFR 1306.11(a) The Allegations Regarding Prescriptions and find that pharmacy interns are
regarding these prescriptions. See id. Filled by Non-Pharmacists essentially never authorized to dispense
Although he did not rely on 21 CFR In the Show Cause Order’s final two controlled substances prescriptions in
1306.06,85 the CALJ nonetheless charges, the Government alleged that Florida. Id. at 80.
recommended that I sustain the I find that both the CALJ and the
Trinity II violated federal and Florida
Government’s fifth charge. I do sustain Government have misinterpreted
law when it allowed pharmacist interns
this charge, but only on the basis that Florida law. Although Florida law is not
to fill controlled substances
Trinity II violated 21 CFR 1306.06. As as clear as federal law in this regard,
prescriptions. Section 1306.06 provides
with D.G.’s prescriptions in the third Florida law neither permits all
that controlled substances prescriptions
and fourth charges, customer J.T. pharmacy interns to dispense controlled
‘‘may only be filled by a pharmacist.’’
substances (as the CALJ recommended),
Federal law states that a pharmacist nor prohibits all pharmacy interns from
front of the prescription, and the dispensing report ‘‘means any pharmacist licensed by a
to identify the fill date. Second, for the reasons I doing so (as the Government claims).
have already discussed supra, the dispensing date State to dispense controlled substances, Rather, Florida law permits pharmacy
would ultimately have been the same as the fill and shall include any other person (e.g., interns to dispense controlled
date. pharmacist intern) authorized by a State substances only when they are under
85 The CALJ recommended that I find that Trinity
to dispense controlled substances under the statutorily prescribed supervision of
II’s conduct in the Show Cause Order’s fifth charge
violated Trinity II’s corresponding responsibility
the supervision of a pharmacist licensed a licensed pharmacist. For example,
under 21 CFR 1306.04(a) because ‘‘the regulation’s by such State.’’ 21 CFR 1300.01(b). Florida statutes makes it unlawful for an
plain language imposes a corresponding In his Recommended Decision, the intern registered in Florida to ‘‘fill,
responsibility on the pharmacist ‘for the proper . . . CALJ found that Florida law authorized
dispensing’ of the prescription. Dispensing a compound, or dispense prescriptions or
stronger concentration of a controlled substance pharmacy interns to dispense controlled to dispense medicinal drugs’’ if the
than has been authorized by the practitioner is a substances. Specifically, the CALJ found intern is ‘‘not acting under the direct
violation of that corresponding responsibility.’’ R.D. that Florida defined a ‘‘pharmacist’’ as and immediate personal supervision of
at 49. a person ‘‘licensed pursuant to chapter
The CALJ’s interpretation of § 1306.04(a) is
a licensed pharmacist.’’ Fla Stat.
incorrect for at least two independent reasons. First,
465 to practice the profession of § 465.015(2)(b). Florida law also
as noted supra, pharmacists violate their pharmacy’’ in Florida, and that Chapter authorizes disciplinary actions against
corresponding responsibility when they 465 in turn defines the ‘‘practice of the pharmacists ‘‘permitting a registered
‘‘knowingly fill[ ]’’ a prescription that lacks a profession of pharmacy’’ to include intern who is not acting under the direct
legitimate purpose. The CALJ has already
recommended that I find (and I have so found) that
‘‘dispensing.’’ R.D. at 44 (quoting Fla. and immediate personal supervision of
the underlying prescriptions at issue in the fifth Stat. §§ 893.02(18), 465.003(13)). The a licensed pharmacist, to fill,
charge were valid, R.D. at 49 n. 116 (‘‘there was a CALJ also found that Florida law states compound, or dispense any
(seemingly) valid scrip[t] presented for each of that a ‘‘person other than a licensed prescriptions in a pharmacy owned and
these dispensing events’’), making impossible a
finding that Trinity II’s pharmacists knowingly
pharmacist or pharmacy intern may not operated by such pharmacists or in a
filled illegitimate prescriptions in violation of engage in the practice of pharmacy.’’ pharmacy where such pharmacists are
§ 1306.04(a). Second, also as noted supra, the plain R.D. at 44 (quoting Fla. Stat. employed or on duty.’’ Id. 465.016(1)(c)
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language of § 1306.04(a) assigns‘‘ [t]he § 465.014(1)). On this legal basis, the (emphasis added). In addition, Florida’s
responsibility for the proper prescribing and
dispensing of controlled substances . . . upon the
CALJ recommended that I find that Administrative Code states that ‘‘[n]o
prescribing practitioner,’’ not upon the pharmacists, ‘‘both pharmacists and pharmacy intern shall perform any acts relating
whose corresponding responsibility expressly interns are authorized under Florida law the filling, compounding, or dispensing
relates to filling, not dispensing. Indeed, it is likely to ‘practice the profession of pharmacy,’ of medicinal drugs unless it is done
for these reasons that the Government did not claim
that Trinity II violated its corresponding
which includes dispensing. Therefore, it under the direct and immediate
responsibility in the Show Cause Order’s fifth is acceptable for pharmacy interns to personal supervision of a person
charge. dispense controlled substances under actively licensed to practice pharmacy
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![Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices 7335
in this state.’’ Fla. Admin. Code r. prescriptions filled by Trinity II violated Trinity II’s registration ‘‘would be
64B16–26.400 (emphasis added). Thus, the law. Id. at 5–6. inconsistent with the public interest.’’
I find that it is lawful in Florida for a Trinity II’s challenge to the CALJ’s 21 U.S.C. 823(f).
pharmacy intern, registered in Florida, recommendation of revocation on the
basis of the Iyer decision and the Sanction
to fill and to dispense prescriptions so
long as it is under the statutorily existence of prescriptions it filled ‘‘in Where, as here, ‘‘the Government has
prescribed supervision of a licensed which there is no problem’’ is proved that a registrant has committed
Florida pharmacist. unavailing for at least three reasons. acts inconsistent with the public
Here, even assuming arguendo as true First, as a threshold matter, I have interest, a registrant must ‘ ‘‘present
the Government’s allegations that Mina already found that the scope of Trinity sufficient mitigating evidence to assure
A. Ghobrial was a pharmacy intern who II’s violations of federal law— the Administrator that it can be
worked at Trinity II and filled particularly regarding Trinity II’s entrusted with the responsibility carried
controlled substances prescriptions egregious violations of its corresponding by such a registration.’’ ’ ’’ Medicine
during the alleged time period, I have responsibility—far exceed the number Shoppe-Jonesborough, 73 FR 364, 387
already found that the Government that even the CALJ identified. In other (2008) (quoting Samuel S. Jackson, 72
failed to establish that Ghobrial was not words, some of the very prescriptions FR 23848, 23853 (2007) (quoting Leo R.
supervised by a licensed Florida that Trinity II filled and claims in its Miller, 53 FR 21931, 21932 (1988))).
pharmacist when Ghobrial did so. See Exceptions were ‘‘no problem,’’ were, in ‘‘Moreover, because ‘past performance is
supra. Accordingly, I agree with the fact, highly problematic and illegal. the best predictor of future
CALJ’s recommendation that I find (and Second, Trinity II’s arguments based on performance,’ ALRA Labs, Inc. v. DEA,
I do so find) that the Government has the unpublished 11th Circuit opinion 54 F.3d 450, 452 (7th Cir.1995), [DEA]
failed to carry its burden that Ghobrial Iyer v. DEA are identical to those has repeatedly held that where a
was not properly supervised under already rejected by the Agency in registrant has committed acts
Florida law, and I agree with the CALJ’s multiple final opinions, such as Wesley inconsistent with the public interest, the
recommendation that I reject (and I do Pope, T.J. McNichol, and Dewey C. registrant must accept responsibility for
so reject) the Show Cause Order’s sixth MacKay, and I incorporate the relevant its actions and demonstrate that it will
and seventh charges. portions of those final opinions herein. not engage in future misconduct.’’
E.g., Wesley Pope, 82 FR 14944, 14981– Medicine Shoppe, 73 FR at 387; see also
Summary of Factors Two and Four Jackson, 72 FR at 23853; John H.
14984 (2017); T.J. McNichol, 77 FR
As found above, Trinity II’s 57133, 57144–57146 (2012); Dewey C. Kennedy, 71 FR 35705, 35709 (2006);
pharmacists knowingly filled dozens of MacKay, 75 FR at 49977. As I have Prince George Daniels, 60 FR 62884,
controlled substance prescriptions for pointed out previously (and repeat here 62887 (1995). See also Hoxie v. DEA,
more than a dozen patients even though for emphasis), the 11th Circuit has never 419 F.3d at 483 (‘‘admitting fault’’ is
those prescriptions lacked a legitimate chosen to publish the Iyer decision, and ‘‘properly consider[ed]’’ by DEA to be
medical purpose. 21 CFR 1306.04(a). by local rule it is therefore not binding an ‘‘important factor[ ]’’ in the public
Moreover, Trinity II’s pharmacists precedent for this case or for any other interest determination).
knowingly and repeatedly ignored the case. 11th Cir. R. 36–2 (‘‘Unpublished The Agency has also held that
instructions set forth in legitimate opinions are not considered binding ‘‘ ‘[n]either Jackson, nor any other
prescriptions issued to two of its precedent’’). In addition, no subsequent agency decision, holds . . . that the
customers and thereby failed to fill them 11th Circuit panel has chosen to adopt Agency cannot consider the deterrent
in the usual course of their professional it; on the contrary, they have value of a sanction in deciding whether
practice. 21 CFR 1306.06. Thus, I affirmatively declined multiple a registration should be [suspended or]
conclude that Trinity II has engaged in opportunities to do so. See Pope, 82 FR revoked.’ ’’ Gaudio, 74 FR at 10094
egregious misconduct which supports at 14983 (identifying cases in which (quoting Southwood, 72 FR at 36504);
the revocation of its registration. See respondents have raised Iyer-based see also Robert Raymond Reppy, 76 FR
Dewey C. MacKay, 75 FR 49956, 49997 arguments identical to Trinity II’s, and 61154, 61158 (2011); Moore, 76 FR at
(2010); Krishna-Iyer, 74 FR at 463; Alan the 11th Circuit has nonetheless denied 45868. This is so, both with respect to
H. Olefsky, 57 FR 928, 928–29 (1992). I the petitions of review and affirmed the the respondent in a particular case and
therefore hold that the Government has Agency’s sanction). Moreover, the 10th the community of registrants. See
clearly established its prima facie case Circuit, in a published opinion, flatly Gaudio, 74 FR at 10095 (quoting
that Trinity II’s registration ‘‘would be rejected the same argument Trinity II Southwood, 71 FR at 36503). Cf.
inconsistent with the public interest.’’ has made here. MacKay v. DEA, 664 McCarthy v. SEC, 406 F.3d 179, 188–89
21 U.S.C. 823(f). F.3d 808, 819 (10th Cir. 2011). Third, (2d Cir. 2005) (upholding SEC’s express
In its Exceptions, Trinity II argued and most significantly, even assuming adoptions of ‘‘deterrence, both specific
that, ‘‘[e]ven assuming that the DEA met arguendo that Trinity II legally filled and general, as a component in
its burden of proof, ’’ the CALJ ‘‘erred every other controlled substance analyzing the remedial efficacy of
in failing to balance the relatively de prescription presented to it between sanctions’’).
minimis problems that the ALJ found February 2012 and February 2014, and Here, the CALJ recommended that I
were supported by the preponderance of I consider them consistent with Iyer, I find that Trinity II ‘‘has not accepted
the evidence against the number of nevertheless find that the violations responsibility’’ and that, as a result,
prescriptions during the [two-year] identified by the CALJ are sufficiently ‘‘evidence of remedial steps is
sradovich on DSK3GMQ082PROD with NOTICES2
audit period in which there was no egregious to outweigh the remaining irrelevant.’’ R.D. at 52 (citing Hassman,
problem.’’ Resp. Except. at 5 (citing Iyer (and presumptively non-problematic) 75 FR at 8236). The CALJ further
v. DEA, 249 Fed. Appx. 159, 160 (11th prescriptions. Thus, I find that the CALJ recommended that I find that, ‘‘[i]n any
Cir. 2007) (unpublished). Specifically, did not err in his recommendation that event, the Respondent provided no
Trinity II claims that ‘‘the sanction of revoking Trinity II’s registration is in the evidence of remedial steps in this case.’’
revocation . . . is not supported’’ public interest. Id.
because the CALJ found that I therefore hold that the Government In its Exceptions, Trinity II claims
‘‘approximately 0.07%’’ of the has established its prima facie case that that the CALJ ‘‘failed to provide
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![7336 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
Respondents’ with the opportunity to II knowingly diverted controlled diverted controlled substances is, by
present their evidence’’ ‘‘that it accepts substances, there is no need to consider itself, sufficient to support the
responsibility for the established its remedial efforts 86 as they are revocation of its registration. Revocation
misconduct, and has taken appropriate rendered irrelevant by its failure to is also warranted by my finding that,
steps to prevent such misconduct in the acknowledge its misconduct. See The even with respect to valid prescriptions,
future.’’ Resp. Except. at 4. Trinity II Medicine Shoppe, 79 FR 59504, 59510 Trinity II’s pharmacists repeatedly and
specifically claims that the CALJ did not (2014), pet. for rev. denied 626 Fed. knowingly failed to fill them consistent
consider as ‘‘mitigating evidence’’ that Appx. 2 (Mem.) (D.C. Cir. 2015); Jayam with the prescribing physicians’
Trinity II allegedly ‘‘voluntarily ceased Krishna-Iyer, 74 FR 459, 464 (2009) instructions. Cf. Medicine Shoppe-
dispensing schedule II controlled (‘‘Because of the grave and increasing
Jonesborough, 300 Fed. Appx. 409, 411–
substances by March 1, 2014.’’ Id. at 4– harm to public health and safety caused
412 (6th Cir. 2008) (rejecting ‘‘ ‘human
5. by the diversion of prescription
I agree with the CALJ that Trinity II controlled substances, even where the error’ defense’’ to dispensing ‘‘the same
has not accepted responsibility for its Agency’s proof establishes that a drug in different concentrations’’
misconduct nor presented sufficient practitioner has committed only a few because ‘‘dispensing the right drug in
mitigating evidence to assure me that acts of diversion, this Agency will not the wrong strength ‘can have serious
Trinity II can be entrusted with the grant or continue the practitioner’s consequences for the health of
responsibility carried by a DEA registration unless he accepts patients’ ’’) (internal citations omitted).
registration. The CALJ observed: responsibility for his misconduct.’’). As I further find that the Agency’s
There was no aspect of the evidentiary the Tenth Circuit has recognized in the interest in deterring future misconduct
rulings issued during the prehearing context of physician practitioners: both on the part of Trinity II as well as
proceedings in this case that would have The DEA may properly consider whether a the community of pharmacy registrants
limited [Trinity II’s] ability to do so in any physician admits fault in determining if the supports revocation. As for the issue of
way. . . . the Respondent elected to proceed physician’s registration should be revoked.
on a peculiar course where it presented no specific deterrence, the revocation of
When faced with evidence that a doctor has Trinity II’s registration is not a
defense to these allegations, accepted no a history of distributing controlled
responsibility for them, and never indicated substances unlawfully, it is reasonable for the permanent bar. And regarding general
that it would act differently in the future. The [DEA] to consider whether that doctor will deterrence, those members of the
registrant is essentially saying, it did it, it change his or her behavior in the future. And regulated community who contemplate
liked it, and it will continue to do it. . . . that consideration is vital to whether using their registrations to divert
it has left the Agency little choice but to continued registration is in the public
revoke its registration to ensure the safety of controlled substances need to know that
interest. there will be serious consequences if
the public.
MacKay v. DEA, 664 F.3d 808, 820 (10th they choose to do so. This interest
R.D. at 54 n.124. Indeed, even in its Cir. 2011) (citing Hoxie v. DEA, 419 would be compelling even if it was not
Exceptions, Trinity II identifies no F.3d at 483 (6th Cir. 2005)). See also
evidence of acceptance of responsibility, the case that the nation faces an
Hoxie, 419 F.3d at 483 (‘‘The DEA epidemic of opioid abuse.
much less remorse, for its misconduct in properly considers the candor of the
this case. It did not even try to provide I therefore conclude that the
physician . . . and admitting fault [to
such evidence at the hearing. And it is be] important factors in determining revocation of Trinity II’s registration is
difficult to overstate the significance of whether the physician’s registration necessary to protect the public interest.
the misconduct that Trinity II has failed should be revoked.’’). And I will further order that any
to accept. Trinity II’s willingness to I further find that the misconduct application of Trinity II to renew or
knowingly fill seemingly any proven on this record is egregious and modify its registration, or for any other
prescription and any combination of supports the revocation of Respondent’s registration, be denied.
prescriptions that its customers registration. More specifically, my
presented—no matter how obvious it Order
finding that Trinity II’s pharmacists
was that the prescription lacked a dispensed multiple prescriptions in Pursuant to the authority vested in me
legitimate purpose—is alarming. Trinity violation of their corresponding
II was apparently equally ready to by 21 U.S.C. 823(f) and 824(a), as well
responsibility and thereby knowingly as 28 CFR 0.100(b), I order that DEA
provide controlled substances to an
unscrupulous customer earlier, or at Certificate of Registration FT0531586
86 Furthermore, the CALJ did not deny Trinity II,
dramatically greater dosages, than the as it claims in its Exceptions, the opportunity to
issued to Trinity Pharmacy II, Inc., be,
prescribing physician had instructed on establish that it ceased dispensing schedule II and it hereby is, revoked. I further order
the face of the prescriptions. controlled substances. Resp. Except. at 4–5. During that any application of Trinity
the hearing, one of the DIs testified to his awareness
I thus find that Trinity II has not that Trinity II stopped distributing schedule II
Pharmacy II, Inc. to renew or modify its
adequately accepted responsibility for controlled substances as of March 1, 2014. Tr. 527. registration, or for any other registration,
its misconduct. This finding provides However, Trinity II provided no evidence that this be, and it hereby is, denied. This order
reason alone to conclude that decision was intended to be remedial. More is effective immediately.
importantly, I have found that Trinity II’s violation
Respondent has not rebutted the of its corresponding responsibility extended to Dated: February 6, 2018.
Government’s prima facie showing that other controlled substances, such as alprazolam, not
regulated under schedule II. Thus, even if Trinity Robert W. Patterson,
it has committed acts which render its
II had ceased distributing schedule II controlled Acting Administrator.
continued registration ‘‘inconsistent
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substances as a remedial measure, it falls far short
with the public interest.’’ 21 U.S.C. [FR Doc. 2018–03294 Filed 2–16–18; 8:45 am]
of what would have been necessary to mitigate
824(a)(4). And having found that Trinity Trinity II’s misconduct. BILLING CODE 4410–09–P
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Document Created: 2018-02-17 02:29:18
Document Modified: 2018-02-17 02:29:18
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | (1) Oxycodone, (2) carisoprodol, and (3) alprazolam. GX 73, at 1, 2, 4-21; GX 74, 1, 2, 4-21. The same evidence also shows that J.Ha. and R.Ha. | |
| FR Citation | 83 FR 7304 |
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