81 FR 31309 - Superior Pharmacy I and Superior Pharmacy II Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 96 (May 18, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 96 (May 18, 2016)
| Page Range | 31309-31341 | |
| FR Document | 2016-11550 |
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)] [Notices] [Pages 31309-31341] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11550] [[Page 31309]] Vol. 81 Wednesday, No. 96 May 18, 2016 Part II Department of Justice ----------------------------------------------------------------------- Drug Enforcement Administration ----------------------------------------------------------------------- Superior Pharmacy I and Superior Pharmacy II; Decision and Order; Notice Federal Register / Vol. 81 , No. 96 / Wednesday, May 18, 2016 / Notices [[Page 31310]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket Nos. 15-6 and 15-7] Superior Pharmacy I and Superior Pharmacy II Decision and Order This is a consolidated proceeding involving two pharmacies located in Tampa, Florida with common ownership. On October 8, 2014, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration issued an Order to Show Cause to Superior Pharmacy, L.L.C. (hereinafter, Superior II), which proposed the revocation of its DEA Certificate of Registration BS9699731, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 5416 Town `N' Country Blvd. ALJ Ex. 1, at 1 (No. 15-7). The next day, the Deputy Assistant Administrator issued an Order to Show Cause to Superior Pharmacy, L.L.C. (hereinafter, Superior I), which proposed the revocation of its DEA Certificate of Registration BS9255274, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered location of 3007 W. Cypress Street, Suite 1. ALJ Ex. 1, at 1 (No. 15-6). As grounds for the proposed actions (which also included the denial of any pending applications), the Show Cause Orders alleged that each pharmacy's ``continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id.; see also ALJ Ex. 1, at 1 (No. 15-7); 21 U.S.C. 824(a)(4). Specifically, with respect to each pharmacy, the Orders alleged that their ``pharmacists repeatedly failed to exercise their corresponding responsibility to ensure that controlled substances they dispensed were dispensed pursuant to prescriptions issued for legitimate medical purposes by practitioners acting within the usual course of their professional practice'' and that their ``pharmacists ignored readily identifiable red flags that [the] controlled substances prescribed were being diverted and dispensed despite unresolved red flags.'' ALJ Ex. 1, at 1 (No. 15-6); ALJ Ex. 1, at 1 (No. 15-7) (both citing 21 CFR 1306.04(a); Holiday CVS. L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 FR 62315, 62319 (2012)). The Show Cause Orders further alleged that each pharmacy's ``pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose, including circumstances where the pharmacist knew or should have known that the controlled substances were abused and/or diverted by the customer.'' ALJ Ex. 1, at 2 (No. 15-6); ALJ Ex. 1, at 2 (No. 15-7). Each Show Cause Order then listed various red flags which each Respondent's pharmacists allegedly failed to resolve before dispensing prescriptions, including: (1) ``Multiple individuals presenting prescriptions for the same drugs in the same quantities from the same doctor''; (2) ``individuals presenting prescriptions for controlled substances known to be highly abused, such as oxycodone and hydromorphone''; (3) ``individuals paying . . . for controlled substances with cash''; \1\ and (4) ``individuals residing long distances from the pharmacy.'' ALJ Ex. 1, at 2 (No. 15- 6); ALJ Ex. 1, at 2 (No. 15-7). Each Show Cause Order then set forth allegations of specific instances in which Respondents' pharmacists dispensed oxycodone 30 mg or hydromorphone 8 mg without resolving various red flags presented by the patients and/or the prescriptions; the Order further alleged that several of these prescriptions were facially invalid because they lacked the patient's address. ALJ Ex 1, at 2 (No. 15-6); ALJ Ex. 1, at 2 (No. 15-7). --------------------------------------------------------------------------- \1\ With respect to Superior I, the Show Cause Order stated the red flag as ``individuals paying high prices for prescriptions for controlled substances with cash.'' ALJ 1, at 2 (No. 15-6). --------------------------------------------------------------------------- Each Show Cause Order further alleged that Respondents' pharmacists dispensed hydromorphone, notwithstanding that the ``dosage amounts . . . if taken as directed, far exceeded the recommended dosages of hydromorphone that should be taken on a daily basis.'' ALJ Ex. 1, at 2 (No. 15-6); ALJ Ex. 1, at 3 (No. 15-7). The Superior I Order also alleged that its pharmacists dispensed prescriptions, which were written by the same doctor on the same day, for ``large and substantially similar quantities of'' oxycodone 30 mg, ``to two customers . . . both of whom resided at the same address,'' in a town ``located approximately [449 miles] from'' the pharmacy. ALJ Ex. 1, at 2 (No. 15-6). Likewise, the Superior II order alleged that its ``pharmacists dispensed large and substantially similar quantities of hydromorphone and oxycodone to two individuals with the same last name who received their prescriptions on the same day from doctors at the same clinic.'' ALJ Ex. 1, at 3 (No. 15-7). In addition, the Superior I Order alleged that the pharmacy ``failed to create and maintain accurate [schedule II order forms] in violation of 21 U.S.C. 842(a)(5),'' and that ``[a]t least two [of its] pharmacists . . . shared a private key (password) for digitally signing'' controlled substances orders, ``in violation of 21 CFR 1311.30(a), (c), and (e).'' ALJ Ex. 1, at 3-4 (No. 15-6). Finally, the Superior I Order alleged that a DEA audit for the period of May 2, 2011 through February 4, 2013 found, inter alia, that the pharmacy was short 15,560 dosage units (du) of oxycodone 30 mg; 11,951 du of hydromorphone 8 mg; 946 du of hydromorphone 4 mg; and 864 du of methadone 10 mg. Id. at 4. The Superior II Order alleged that it had also failed to maintain accurate schedule II order forms and had failed to retain copy three of these forms as required by DEA regulations. ALJ Ex. 1, at 3 (No. 15-7) (citing 21 CFR 1305.13(a) & (e); id. Sec. 1305.17(a); 21 U.S.C. 827(b)). The Order further alleged that the pharmacy failed to create records of the quantity and date received for orders it placed using the Controlled Substances Ordering System (CSOS) and that it ``also failed to electronically archive and link these records to the original order.'' Id. at 4. Finally, the Superior II Order alleged that a DEA audit for the period of July 31, 2012 through February 4, 2013 found, inter alia, that the pharmacy had overages of 2,576 du of hydromorphone 8 mg; 1,189 du of oxycodone 30; and 896 du of methadone 10 mg. The Show Cause Order issued to Superior I was served on October 17, 2014, and the Show Cause Order issued to Superior II was served on October 16, 2014. See ALJ Ex. 3 (No. 15-6); ALJ Ex. 4 (No. 15-7). On November 14, 2014, each pharmacy, through its counsel, requested a hearing on the allegations. See ALJ Ex. 2 (No. 15-6); ALJ Ex. 3 (No. 15-7). Each matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge (ALJ) Christopher B. McNeil. The Prehearing Motions and Rulings On December 3, 2014, the ALJ issued an Order for Prehearing Statements and Setting the Matter for Hearing (hereinafter, Prehearing Order) in each case. See ALJ Ex. 5 (No. 15-6); ALJ Ex. 6 (No. 15-7). In each Prehearing Order, the ALJ directed the Government to file its Pre- hearing Statement no later than 2 p.m. on December 22, 2014, and each Respondent to file its Prehearing Statement no later than 2 p.m. on January 5, 2015. ALJ Ex. 5, at 1 (No. 15- [[Page 31311]] 6); ALJ Ex. 6, at 1 (No. 15-7). The Orders also directed the parties to ``[p]rovide the names and current addresses of all witnesses whose testimony is to be presented,'' and that ``[i]f the Respondent's corporate representative intends to testify, the representative must be listed, and a summary of anticipated testimony as described below must be provided.'' ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). The ALJ's Orders provided the following instruction regarding the summaries of testimony: Provide a brief summary of the testimony of each witness, with 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, and 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. ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). The ALJ's Orders also provided that ``[a]ny requests for subpoena[s] are to be filed by 2:00 p.m. E.S.T. on January 12, 2015,'' and that ``[s]ubpoena requests that do not comply with these instructions will be returned to the requestor without further action.'' \2\ ALJ Ex. 5, at 4 (No. 15-6); ALJ Ex. 6, at 4 (No. 15-7). The ALJ's Orders further provided that ``[w]henever a party seeks to file any document, motion, exhibit or otherwise communicate in writing with the Administrative Law Judge, the party must provide a true copy of the same to the opposing party, using the contact information shown in the Certificate of Service below . . . [and] [t]he party making such a filing shall include a `Certificate of Service' stating that a true copy of the submission has been provided to the opposing party, and shall specify the means by which'' this was accomplished. ALJ Ex. 5, at 5-6 (No. 15-6); ALJ Ex. 6, at 5-6 (No. 15-7). --------------------------------------------------------------------------- \2\ The Order further required that ``[a]ny motion to quash a subpoena must be filed within three working days of receipt of the subpoena request and must be served on the opposing party.'' ALJ Ex. 5, at 4-5 (No. 15-6); ALJ Ex. 6, at 4-5 (No. 15-7). --------------------------------------------------------------------------- Finally, the ALJ's Orders directed the parties to file their proposed exhibits with his Office no later than 2:00 p.m. on January 12, 2015; it also directed that a copy of the exhibits be served on the opposing party. ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). The ALJ's Orders further directed that ``[w]hen any party seeks to . . . present proposed exhibits,'' the party must ``timely provid[e] the OALJ with a facsimile copy'' and ``must mail hard copy filings sufficiently in advance of the due date to assure timely receipt by the hearing clerk'' as well as ``that documents are to be filed in triplicate.'' ALJ Ex. 5, at 5-6 (No. 15-6); ALJ Ex. 6, at 5-6 (No. 15- 7). In his Orders, the ALJ also noted that the cases appeared to ``involve common questions of law or fact'' and thus directed the parties to address whether they should be consolidated. ALJ Ex. 5, at 3 (No. 15-6); ALJ Ex. 6, at 3 (No. 15-7). Thereafter, the Government moved to consolidate the cases (as well as two other cases). Respondent opposed the Government's motion. On December 22, 2014, the Government filed its Prehearing Statements with respect to each pharmacy. In each of these, the Government disclosed that it intended to elicit testimony from an expert regarding his review of ``numerous controlled substance prescriptions filled by Respondent that contained one or more red flags for diversion which Respondent never resolved.'' ALJ Ex. 6, at 3 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). The Government then identified the same set of seven red flags. ALJ Ex. 6, at 3 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). With respect to both pharmacies, the Government then set forth the expert's proposed testimony regarding various oxycodone 30 mg prescriptions and the red flags they presented, as well as his proposed testimony regarding the pharmacy's dispensing of large quantities of hydromorphone and the red flags they presented. ALJ Ex. 6, at 4 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). And with respect to Superior I, the Government also disclosed that the expert ``will also testify about a customer who willingly purchased a prescription for oxycodone . . . that costs 37% more than the same prescription four months earlier,'' and ``that this fact, combined with the fact that the prescription was facially invalid [as it contained] no patient address constituted a red flag for diversion.'' ALJ Ex. 6, at 5 (No. 15-6). The Government then noticed both Respondents that its expert ``will testify that the facts surrounding the prescriptions listed above constituted red flags for diversion and that there is no evidence that any of the red flags were resolved prior to distributing the controlled substances to the customers.'' Id. at 3 (No. 15-6). Finally, it noticed Respondents that its expert ``will testify that . . . Respondent[s'] pharmacists failed to exercise their corresponding responsibility to ensure that prescriptions for controlled substances were issued for a legitimate medical purpose in the usual course of professional practice.'' ALJ Ex. 6, at 3 (No. 15-6); ALJ Ex. 8, at 3-4 (No. 15-7). On January 5, 2015, each Respondent filed a ``Motion to Compel'' and a ``Motion for Enlargement of Time to File . . . Pre-hearing Statement,'' as well as a Prehearing Statement. ALJ Exs. 9, 10, 11 (No. 15-6); ALJ Exs. 9, 10, 12 (No. 15-7). In their Motions to Compel, each Respondent noted that on February 4, 2013, DEA had executed an Administrative Inspection Warrant at it and sought an Order from the ALJ requiring the Government to disclose the documents and testimony submitted by DEA Investigators to the Federal Magistrate Judge in obtaining the Warrants. ALJ Ex. 10, at 2 (No.15-6); ALJ Ex 10, at 2 (No. 15-7). Each Respondent's Motion to Compel also sought to require the Government to: (1) Provide ``full and complete copies of all computer data seized . . . during the execution of the'' warrant; (2) identify ``all DEA personnel involved in the preparation and execution of the [warrant] and the subsequent review and analysis of the information, records, and data seized''; and (3) provide ``reports of, and the substance of, any statements made to DEA investigators by [Respondent's] staff.'' ALJ Ex. 10, at 5 (No.15-6); ALJ Ex 10, at 5 (No. 15-7). Each Respondent also sought an extension of the time to file its Prehearing Statement to the end of March 2015 and sought to reschedule the hearing ``to no sooner than June 2015.'' ALJ Ex. 11, at 3 (No. 15- 6); ALJ Ex. 9 (No. 15-7). As support for the motions, Respondents argued that since the execution of the warrants, the Government had 20 months to review the records, and that ``[d]uring this time, the information was not available to Respondent.'' ALJ Ex. 11, at 3 (No. 15-6); ALJ Ex. 9, at 3 (No. 15-7). Respondents further argued ``[w]hile a portion of the seized information, most notably the prescriptions, was provided to Respondent[s] in electronic format, the sheer volume of information coupled with the unreasonably short deadlines surrounding the holiday season make analysis of the information by [it] impossible.'' ALJ Ex. 11, at 3 (No. 15-6); ALJ Ex. 9, at 3 (No. 15-7). Respondents further argued that ``due process requires, and good cause exists, for a significant'' extension of the time to file the Prehearing Statements and ``to prepare for a lengthy hearing in'' these [[Page 31312]] matters. ALJ Ex. 11, at 3 (No. 15-6); ALJ Ex. 9, at 3 (No. 15-7). The Government opposed these motions. With respect to the Motions to Compel, the Government argued that in its Prehearing Statements, it had provided a summary of the testimony it intended to elicit as well as a list of the exhibits it intended to offer; the Government also noted that several weeks earlier, it had met with one of Respondents' counsels and that at no time then or since its motion, had Respondents' counsel ``communicate[d] a need for, or request[ed] any'' of the information it sought through the motions. ALJ Ex. 16, at 3 (No. 15-7). The Government further argued that it had fully complied with its disclosure obligations, and that to the extent Respondents were seeking discovery, `` `[t]here is . . . no general right to discovery under either the APA or DEA regulations, but rather only a limited right to receive in advance of the hearing the documentary evidence and summaries of the testimony which the Government intends to rely upon.' '' ALJ Ex. 16, at 4 (No. 15-7) (quoting Roy E. Berkowitz, 74 FR 36758, 36760 (2009)). Finally, the Government argued that to the extent Respondents were asserting that they had a right to receive these materials as a matter of due process, ``Respondent[s] ha[d] not even articulated how the requested materials might be relevant to this proceeding.'' ALJ Ex. 16, at 5 (No. 15-7). Each Respondent filed a Reply to [the] Government's Response to Motion to Compel. ALJ Ex. 27 (No. 15-6); ALJ Ex.18 (No. 15-7). Therein, Respondents contended that they were entitled to the documents as a matter of due process because the Government had represented that one of its proposed witnesses (a Diversion Investigator) would testify regarding his/her interviews with Respondents' staff and that they would be prejudiced if the Government did not provide the ``same.'' ALJ Ex. 27, at 2 (No. 15-6); ALJ Ex. 18, at 2 (No. 15-7). Respondents further asserted that the ``information is essential,'' because the Government intended to put on evidence that the prescriptions raised red flags and that ``Respondent[s] fail[ed] to exercise [their] corresponding responsibility to resolve the `red flag[s],' '' and the Government ``has not identified one patient or doctor related to the prescriptions allegedly containing unresolved red flags.'' ALJ Ex. 27, at 2 (No. 15-6); ALJ Ex. 18, at 2 (No. 15-7). The Government also opposed Respondents' Motions for Enlargement of Time. ALJ Ex. 16, at 6 (No. 15-7). The Government argued that the Show Cause Orders and Prehearing Statements had ``specifically outlined'' the allegations, ``as well as the approximate number of documents it intend[ed] to introduce into evidence.'' Id. The Government further argued that it was ``patently specious'' for Respondents ``[t]o characterize this matter as something much more voluminous and complicated than what it is and, as a result, argue that further delay is necessary.'' Id. The Government also contended that to the extent Respondents were seeking an extension to review records and prescriptions beyond those referenced in the Show Cause Orders and its Prehearing Statements, those documents were not ``material to the allegation that he [sic] unlawfully dispensed to customers identified in the OTSC and Government's Prehearing Statement.'' Id. at 6-7. On January 5, 2015, the ALJ denied Respondents' Motions for Enlargement. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 4 (No. 15-6). The ALJ specifically noted ``that since at least October 16, 2014, Respondent[s] ha[ve] been informed of the nature of the charges presented in the Order to Show Cause,'' and that in their motions, Respondents had acknowledged that the Government had provided them with the prescriptions. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The ALJ explained that neither Respondent had ``established that it has been prevented from evaluating those prescriptions identified in the Order to Show Cause [or] that it has been prevented from preparing its prehearing statement.'' ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The ALJ also explained that Respondents had known since the issuance of his Prehearing Orders that they were required ``to object to any term of that Order by not later than December 10, 2014,'' and that they failed to object to the orders until the day their Prehearing Statements were due. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The ALJ thus concluded that: I am compelled to consider the nature of the allegations, which if proved suggest Respondent[s'] ability to fill controlled substance prescriptions would be inconsistent with the public interest. I am further compelled to consider Respondent[s'] own role in attempting to delay th[ese] proceeding[s], given that [they] failed to timely object to the deadlines set forth in the Order[s]. I am further compelled to consider fairness to all parties, and the convenience of witnesses now identified by the Government in its timely prehearing statement[s]. I am further compelled to consider the need for orderly and prompt administration of justice. All of these considerations compel my finding that good cause has not been shown for either enlarging the time for Respondent[s] to file [their] prehearing statement[s], or for continuing the hearing now set to being on January 27, 2015. ALJ Ex. 11, at 3 (No. 15-7); ALJ Ex. 12, at 3 (No. 15-6). The same day (according to OALJ date stamps), each Respondent filed its Prehearing Statement. ALJ Ex. 9 (No. 15-6); ALJ Ex. 12 (No. 15-7). Each Respondent proposed as witnesses ``[a]ny and all patients whose prescriptions were seized . . . pursuant to the Administrative Inspection Warrant executed [on] February 4, 2013 or whose prescriptions for controlled substances were dispensed between January 1, 2011 and February 4, 2013.'' ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). Respondent Superior I further attached a list of 2,355 purported patients, ALJ Ex. 9, at Attachment A (No. 15-6); and Respondent Superior II attached a list of 2,253 purported patients. ALJ Ex. 12, at Attachment A (No. 15-7). As for the required summary of anticipated testimony, each Respondent proposed that: These patients will each be asked to provide testimony regarding their medical history, injuries and related pathology, interactions with treating physicians and dispensing pharmacists, effectiveness of the prescribed controlled substances, continuity of treatment, their reasons for patronage of Superior Pharmacy, LLC . . . such other testimony relevant to the Government's allegation that any of these prescriptions raised `red flags' which should have caused pharmacists to refuse to dispense the prescribed controlled substances. ALJ Ex. 9, at 4 (No. 15-6); ALJ Ex. 12, at 4 (No. 15-7). Respondents further proposed as witnesses ``[a]ny and all physicians who issued the prescriptions seized . . . pursuant to the Administrative Inspection Warrant[s] . . . or whose prescriptions for controlled substances were dispensed at [them] between January 1, 2011 and February 4, 2013,'' as well as ``[a]ny and all physicians who issued prescriptions for controlled substances to the patients identified . . . above after February 4, 2013.'' ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). Each Respondent attached a list of several hundred physicians who had purportedly issued the controlled substance prescriptions dispensed by them. ALJ Ex. 9, at Attachment B (No. 15-6); ALJ Ex. 12, at Attachment B (No. 15-7). As for the anticipated testimony of the physicians, Respondents represented that: These physicians will confirm they performed adequate and appropriate physical examinations of the patients to whom they [[Page 31313]] issued prescriptions for controlled substances, communication with the dispensing pharmacies regarding such prescriptions, the reasonableness and necessity of the prescriptions to control the pain or other complaints of their patients as required by the standard of care and Florida statutes. ALJ Ex. 9, at 4 (No. 15-6); ALJ Ex. 12, at 4 (No. 15-7). Next, Respondents proposed as witnesses ``[a]ny and all pharmacists who dispensed prescriptions for controlled substances to the patients identified . . . above after February 4, 2013.'' ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7) (emphasis added). As for their anticipated testimony, Respondents represented that ``[t]hese pharmacists will describe the information they obtained from the patients, physicians and other sources in order to resolve `red flags,' if any, raised by the described prescriptions for controlled substances.'' ALJ Ex. 9, at 5 (No. 15-6); ALJ Ex. 12, at 5 (No. 15-7). Respondent did not, however, provide the names of any of the pharmacists. ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). Respondents also proposed as a witness Mr. Sam Badawi, a pharmacist and attorney. ALJ Ex. 9, at 3 (No. 15-6); ALJ Ex. 12, at 3 (No. 15-7). As for Mr. Badawi's anticipated testimony, Respondents represented that he: will testify regarding his qualifications as an expert in the field of pharmacy and the legal and ethical responsibilities of the pharmacists dispensing prescriptions at [each Respondent], the procedures used at [each Respondent] to consider and resolve `red flags,' inventory, ordering and CSOS compliance issues. Mr. Badawi will further testify that he had reviewed the prescriptions at issue, the relevant inventory and ordering records and prepared summaries of the prescription dispensing activity at [each pharmacy] during 2011 and 2012, and identified significant errors in the inventory performed by the DEA. ALJ Ex. 9, at 6 (No. 15-6); ALJ Ex. 12, at 6 (No. 15-7). Respondents further proposed as a witness Mr. Jack Crowley of Gates Healthcare Associates. Respondents represented that Mr. Crowley: will testify regarding his knowledge and experience in the investigation, preparation and execution of Administrative Inspection Warrants and the subsequent investigation required. [He] will testify regarding errors in the audits performed by the agents/ investigators involved in the investigation of [Respondents]. [He] reviewed the prescriptions, inventory and CSOS records of [Respondents]. [He] will further testify regarding [Respondents'] procedure[s] for resolving potential `red flag' issues and compliance with recordkeeping requirements related to inventory records, DEA-222 order forms and CSOS issues. ALJ Ex. 9, at 5 (No. 15-6); ALJ Ex. 12, at 5 (No. 15-7).\3\ --------------------------------------------------------------------------- \3\ Respondents also proposed as witnesses each person ``who participated in the preparation of the application for the Administrative Inspection Warrant[s],'' as well as each person ``who participated in the execution of the Administrative Inspection Warrant[s].'' ALJ Ex. 9, at 3-4 (No. 15-6); ALJ Ex. 12, at 3-4 (No. 15-7). On January 9, 2012, each Respondent filed a motion to enlarge the time for filing its proposed exhibits or to alternatively provide its proposed exhibits electronically, as well as a motion to enlarge the time to file its requests for subpoenas. ALJ Ex. 22 (No. 15-6); ALJ Ex. 23 (No. 15-7). In its motion, Superior I explained that its ``Prehearing Statement identifies four categories of proposed exhibits which consist of 23,032 documents,'' of which ``20,925 pages represent the documents seized, and provided to Respondent electronically, by the DEA.'' ALJ Ex. 22, at 2 (No. 15-6). Superior I explained that to comply with the ALJ's Pre-hearing Order, which required that three copies of each exhibit be filed with the OALJ and one copy be filed with opposing counsel, this would require more than 92,000 pages and ``approximately nineteen standard boxes of paper, which is approximately 950 pounds.'' Id. Superior I further explained that because of the volume of copying needed to comply with the Pre-hearing Order, the documents would have to be sent ``to a third party for reproduction'' and ``the reproduction cannot be completed in the allotted time.'' Id. at 3. As for its subpoena requests, Superior I contended that the ALJ's Prehearing Order was ambiguous ``as to whether the requests and completed subpoenas are to be filed in triplicate with the Hearing Clerk,'' and because it was seeking to subpoena 2,861 witnesses, it ``cannot complete the . . . requests . . . with the completed subpoenas using the required template in the allotted time.'' Id. Superior II made similar assertions to Superior I, noting that its proposed exhibits ``consist of 32,123 documents,'' of which ``30,441 pages represent the documents seized, and provided to [it] electronically, by the DEA,'' and that to comply with the ALJ's Prehearing Order, it would have to provide more than 128,000 pages of documents, and require ``approximately 1,300 pounds'' of paper. ALJ Ex. 23, at 2 (No. 15-7). As did Superior I, Superior II asserted that it would have to use a third-party to perform the necessary copying, which could not ``be completed in the allotted time.'' Id. at 3. Superior II also asserted that it could not complete the 2,549 subpoena requests for its proposed witnesses on time. Id. On January 12, 2015, each Respondent submitted a letter (dated Jan. 9) to the Hearing Clerk along with thumb drives which contained ``the images of each of the exhibits in [its] Prehearing Statement.'' ALJ Ex. 24 (No. 15-6); ALJ Ex. 24 (No. 15-7). Each Respondent's letter also advised that the paper copies of the subpoena requests would be hand delivered on Monday, January 12, 2015, and on that date, the ALJ ``received more than 3,000 written requests for the issuance of subpoenas in the[] two cases.'' Tr. 18; see also ALJ Ex. 24 (No. 15-6); ALJ Ex. 24 (No. 15-7). According to the ALJ, neither Respondent provided ``a certificate of service establishing that [they] ha[d] provided the Government with a true copy of these requests.'' Tr. 18. The same day, the ALJ's Law Clerk sent a letter under his own signature to each Respondent's Counsel noting that the OALJ had received the thumb drives. ALJ Ex. 28 (No. 15-6); ALJ Ex. 28 (No. 15- 7). The Law Clerk then explained that he was returning the thumb drives to each Respondent's counsel because ``[t]he submission of the thumb drive does not adhere to the'' ALJ's Prehearing Order of December 3, 2014. ALJ Ex. 28 (No. 15-6); ALJ Ex. 28 (No. 15-7). On January 12, the ALJ denied each Respondent's Motion to Compel. The ALJ noted that in the case of Edge Pharmacy (Docket No. 15-3), the respondent had sought to compel the disclosure of much of the same material as sought by Superiors I and II. ALJ Ex. 29, at 4 (No. 15-6); ALJ Ex. 29, at 4 (No. 15-7). The ALJ further noted that in Edge, the Chief Administrative Law Judge (CALJ) had denied the motion of the respondent on the ground that it did ``not comport with the narrowly- focused grant of authority in 21 CFR 1316.52(d),'' and that the respondent did ``not seek to compel . . . the class of documents discoverable under the [Administrative Procedure Act] or subject to inspection under DEA regulations.'' ALJ Ex. 29, at 4 (No. 15-6); ALJ Ex. 29, at 4 (No. 15-7). As for the reports and the substance of any statements made by Respondents' staff to the Agency's Investigators, the ALJ also found that the CALJ's reasoning applied to these materials. ALJ Ex. 29, at 4 (No. 15-6); ALJ Ex. 29, at 4 (No. 15-7). The ALJ thus concluded that each Respondent had failed to establish its entitlement to the documents. ALJ Ex. 29, at 4 (No. 15-6); ALJ Ex. 29, at 4 (No. 15-7). [[Page 31314]] The same day, in the Superior I matter, the Government submitted its request for the issuance of subpoenas for four witnesses, and in the Superior II matter, the Government submitted its request for the issuance of subpoenas for five witnesses, all of whom had been previously identified in the respective Prehearing Statement.\4\ ALJ Ex. 25, at 1-2 (No. 15-6); ALJ Ex. 25, at 1-2 (No. 15-7). The Government also submitted its proposed exhibits in each matter. Docket Sheet, at 2 (No. 15-6); Docket Sheet, at 2 (No. 15-7). --------------------------------------------------------------------------- \4\ The Government also served a copy of both subpoena requests on each Respondent. ALJ Ex. 25, at 2 (No. 15-6); ALJ Ex. 25, at 2 (No. 15-7). --------------------------------------------------------------------------- The Government's Motions To Consolidate On January 13, 2015, the Government moved to consolidate the cases, along with a third matter (Jet Pharmacy). ALJ Ex. 31 (No. 15-6); ALJ Ex. 31 (No. 15-7). In its motions, the Government argued that there were common issues of law and fact with respect to the pharmacies, noting that it intended to call the same expert in each of the cases and each Respondent had stated that it intended to call the same two experts. ALJ Ex. 31, at 2-3 (No. 15-6); ALJ Ex. 31, at 2-3 (No. 15-7). The Government further argued that the expert's testimony would ``account for the bulk of the Government's and likely the Respondents' cases in terms of length of testimony,'' and that consolidation would ``result in a tremendous conservation of time and resources by allowing the Government to present its expert's testimony in one proceeding rather than in three separate proceedings.'' ALJ Ex. 31, at 5 (No. 15- 6); ALJ Ex. 31, at 5 (No. 15-7). The Government also argued that, although ``each of the Respondent pharmacies is a separate business entity, there are also strong indications of common ownership, management, and/or control between the Respondents,'' and that Superior I and II ``are both owned and operated by Victor Obi-Anadiume.'' \5\ ALJ Ex. 31, at 3 (No. 15-6); ALJ Ex. 31, at 3 (No. 15-7). As support for this assertion, the Government attached to its motions various documents it obtained from the Florida Department of Heath showing that Victor Obi owned both Superior I and II. The Government thus maintained that consolidation was warranted ``because the conduct of one Respondent may be imputed to other Respondents if it can be shown that the same individuals responsible for misconduct at one pharmacy also managed and/or controlled other pharmacies.'' ALJ Ex. 31, at 5 (No. 15-6); ALJ Ex. 31, at 5 (No. 15-7). --------------------------------------------------------------------------- \5\ Mr. Obi-Anadiume is also referred to as Mr. Obi throughout this decision. --------------------------------------------------------------------------- Each Respondent filed identical oppositions to the Government's motions. See ALJ Ex. 30 (No. 15-6); ALJ Ex. 32 (No. 15-7). Therein, Respondents argued that ``it is not . . . sufficient for two (2) actions to have a common defendant or one common issue of law'' and that ``other considerations are necessary such as whether maintaining separate actions would lead to inconsistent rulings on similar issues of fact and law and to ensure that the same standard is applied to the determination of such issues as they arise in each case.'' ALJ Ex. 30, at 3-4 (No. 15-6); ALJ Ex. 32, at 3-4 (No. 15-7) (citation omitted). Respondents also argued that consolidation of the cases ``may cause unnecessary confusion for the fact finder and prejudice to the parties.'' ALJ Ex. 30, at 4 (No. 15-6); ALJ Ex. 32, at 4 (No. 15-7) (citation omitted). Respondents then maintained that ``because each prescription represents a different pattern of facts, it appears there is no overlapping factual issue between the two matters,'' and ``[a]s such, there is no risk of inconsistent results'' which would support consolidation. ALJ Ex. 30, at 5 (No. 15-6); ALJ Ex. 32, at 5 (No. 15- 7). Respondents further maintained that ``there is a high risk that one defendant could be prejudiced by evidence relating to another defendant.'' ALJ Ex. 30, at 5 (No. 15-6); ALJ Ex. 32, at 5 (No. 15-7). Respondents also asserted that consolidation would not promote judicial economy ``[b]ecause of the large number . . . and limited overlap of'' the witnesses and because ``the time necessary to complete the hearing as to both parties could exceed ninety (90) days.'' ALJ Ex. 30, at 6 (No. 15-6); ALJ Ex. 32, at 6 (No. 15-7). On January 15, 2015, each Respondent filed a further pleading, which appear to be identical, on the issue of consolidation. ALJ Ex. 40 (No. 15-6); ALJ Ex. 40 (No. 15-7). In addition to the arguments they previously raised, Respondents contended that ``[t]o the extent the government seeks to rely on a single expert to prove its case in all three matters, it heightens the risk of confusion or attempts to conflate issues between three distinct defendants.'' ALJ Ex. 40, at 6 (No. 15-6); ALJ Ex. 40, at 6 (No. 15-7). They also argued that ``although Respondent[s] share Mr. Obi as a common owner, [he] is not responsible for the day-to-day operations or the implementation of policies and procedures at these separate businesses'' as each pharmacy had a ``different pharmacy manager[ ].'' ALJ Ex. 40, at 7 (No. 15-6); ALJ Ex. 40, at 7 (No. 15-7). Respondents further contended that ``Mr. Obi did not dispense medication or otherwise process prescriptions at these pharmacies during all relevant time periods described in the Orders to Show Cause.'' ALJ Ex. 40, at 7 (No. 15-6); ALJ Ex. 40, at 7 (No. 15-7). On January 21, 2015, the ALJ granted the Government's motions with respect to Superior I and Superior II. ALJ Ex. 1 (No. 15-6 & 15-7). The ALJ specifically found that ``the Government ha[d] demonstrated the presence of common questions of law and fact with respect to Superior I and Superior II, and ha[d] shown the need to take steps to avoid unnecessary cost or delay.'' Id. at 7. More specifically, the ALJ found that the Show Cause Orders ``set forth substantially similar factual claims'' in that ``pharmacists at both pharmacies dispensed controlled substances under conditions where the pharmacists knew or should have known that the controlled substances were being either diverted or abused by those who received the substances.'' Id. The ALJ further found that ``[i]n both cases, the [Government] alleged the pharmacists filled prescriptions notwithstanding red flags relating to the unusual distance the patients traveled to have their prescriptions filled, and notwithstanding red flags relating to evidence that the patients were filling multiple prescriptions which bore no address for the patients.'' Id. The ALJ also rejected Respondents' contention that there was ``a substantial risk of prejudice to Respondents in either case.'' Id. at 8. The ALJ specifically found that ``the prospect of hearing from the fact and expert witnesses in both cases will reduce the risk of inconsistencies like those that could arise through separate hearings.'' Id. The ALJ also ``expressly rejected'' Respondent's contention that there was a heightened ``risk of confusion'' because the Government intended to use the same expert to prove its case, explaining that ``[o]ne expert can easily address the conduct attributed to pharmacists working at these two pharmacies.'' Id. Finally, the ALJ reasoned that ``[g]iven there is at least some showing of common ownership, the Government should be, and will be, permitted to advance its theory that `the conduct of one Respondent may be imputed to [the] other Respondent[ ] if it can be shown that the same individuals responsible for misconduct at one pharmacy also managed and/or controlled other pharmacies.''' Id. (citation omitted). The ALJ thus ordered that the cases against Superior I and [[Page 31315]] Superior II be consolidated under Docket No. 15-6. Id. The Government's Motions in Limine On January 15, 2015, the Government also filed a Motion in Limine in each matter. Therein, the Government argued that Respondents had failed to comply with the ALJ's Pre-hearing Orders in that they failed to provide adequate summaries of the testimony of their proposed witnesses. With respect to Mr. Badawi, Respondents' proposed expert in pharmacy practice, the Government argued that Respondents' Prehearing Statements ``state[d] no facts or conclusions which, if proven, would rebut any allegations that the Government has made in its OTSC[s] or Prehearing statement[s].'' ALJ Ex. 36, at 4 (No. 15-6); ALJ Ex. 36, at 4-5 (No. 15-7). The Government specifically argued that while ``Respondent[s] state[d] that Mr. Badawi ha[d] `prepared summaries' of prescription activity and identified `errors' in DEA inventory[,] [they] fail[ ] to disclose what those summaries entail or what errors have been discovered.'' ALJ Ex. 36, at 4-5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). The Government further argued that Respondents had ``also failed to identify a single `procedure used at [the pharmacies] to consider and resolve alleged `red flags,' inventory, ordering and CSO[S] compliance issues.'' ALJ Ex. 36, at 5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). The Government also argued that ``notably absent from [the] Prehearing Statement[s] is any notice that Mr. Badawi will opine that any of the prescriptions identified in the [Show Cause Orders] and the Government's Prehearing Statement[s] were issued in compliance with federal or state law.'' ALJ Ex. 36, at 5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). As for Respondents' disclosures pertaining to the testimony of Mr. Crowley, the Government argued that ``no facts [were] proffered to give [it] any notice regarding [his] conclusions regarding audit errors, or the basis for those conclusions, should they exist.'' ALJ Ex. 36, at 5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). The Government also argued that while Respondents proposed that this witness would testify regarding their procedures for resolving red flags and complying with other requirements, Respondent had not ``offer[ed] a single fact or detail to describe, identify, or explain that procedure.'' ALJ Ex. 36, at 5 (No. 15-6); ALJ Ex. 36, at 5 (No. 15-7). The Government further contended that it is unclear whether this witness's proposed testimony would discuss the procedures in place during the period of the alleged misconduct or as to procedures subsequently instituted. ALJ Ex. 36, at 6 (No. 15-6); ALJ Ex. 36, at 6 (No. 15-7). Finally, the Government argued that Respondents' disclosure was ``void of any detail about the information [this witness] reviewed to form his opinions about the DEA audits or the procedures Respondents employed at their pharmacy.'' ALJ Ex. 36, at 6 (No. 15-6); ALJ Ex. 36, at 6 (No. 15-7). Addressing Respondents' proposed taking of the testimony of the numerous patients who filled controlled substance prescriptions at Respondents, the Government maintained that Respondents' disclosure ``constitute[d] a wholesale failure to describe `each and every matter as to which [they] intend[ed] to introduce evidence in opposition,' '' as required by the ALJ's Pre-hearing Order. ALJ Ex. 36, at 6 (No. 15- 6); ALJ Ex. 36, at 6 (No. 15-7). As for the physicians who wrote the prescriptions, the Government argued that the disclosures were inadequate because ``Respondent[s] merely indicate[ ] that these unknown individuals will testify regarding `communication[s] with the dispensing pharmacists regarding such prescriptions,'' and ``no facts about any such communications are revealed.'' \6\ ALJ Ex. 36, at 6 (No. 15-6); ALJ Ex. 36, at 6 (No. 15-7). --------------------------------------------------------------------------- \6\ Respondents did, however, disclose the names of the physicians as part of their Prehearing Statements. Respondents also stated that they intended to elicit testimony from the physicians ``confirm[ing] [that] they performed adequate and appropriate physical examinations of the patients,'' as well as testimony as to ``the reasonableness and necessity of the prescriptions to control the pain or other complaints of their patients as required by the standard of care and Florida statutes.'' ALJ Ex. 9, at 4 (No. 15-6); ALJ Ex. 12, at 4 (No. 15-7). --------------------------------------------------------------------------- The Government also contended that testimony and documentation regarding prescriptions which it did not intend to offer into evidence was irrelevant. ALJ Ex. 36, at 8 (No. 15-6) ALJ Ex. 36, at 8 (No. 15- 7). Finally, with respect to the physicians who issued prescriptions filled by Respondents after February 4, 2013 and the pharmacists who filled the prescriptions, the Government argued that Respondent had not even identified these persons and that their proposed testimony was ``stated only in general terms [and] lack[ed] conclusions.'' ALJ Ex. 36, at 7 (No. 15-6); ALJ Ex. 36, at 7 (No. 15-7). In its motion, the Government also addressed Respondents' use of a thumb drive to provide its exhibits. ALJ Ex. 36, at 3 (No. 15-6); ALJ Ex. 39, at 3 (No. 15-7). According to the Government, the thumb drive contained ``hundreds of different files, which contain, collectively, thousands of pages of documents,'' of which only one file, which ``consist[ed] of 1490 pages,'' ``appeared to be marked for identification.'' ALJ Ex. 36, at 3-4 (No. 15-6); ALJ Ex. ALJ Ex. 36, at 3-4 (No. 15-7). The Government further stated that the other files were ``neither marked for identification nor paginated.'' ALJ Ex. 36, at 4 (No. 15-6); ALJ Ex. 36, at 4 (No. 15-7). The Government argued that Respondents' submission of their proposed documentary evidence did not ``comply with the ALJ's order in terms of labeling and form.'' ALJ Ex. 36, at 8 (No. 15-6); ALJ Ex. 36, at 8 (No. 15-7). The Government also argued that because ``none of [Respondents'] summarized testimony reference[d] any particular documents or page, [it was] unable to ascertain whether any of the documents . . . would be relevant to [the] proceeding.'' ALJ Ex. 36, at 9 (No. 15-6); ALJ Ex. 36, at 9 (No. 15-7). On January 21, 2015, each Respondent filed a Response to the Government's Motion; as with Respondents' other filings, the Responses appear to be identical. Compare ALJ Ex. 53 (No. 15-6) with Response to Government's Motion In Limine (No. 15-7) (hereinafter, Superior II Response to Motion in Limine).\7\ Therein, Respondents argued that the Government's Motions were ``completely devoid of intellectual integrity'' because the Government's Prehearing Statement ``fail[ed] to specifically identify a single prescription or patient and only generally refers to areas of discussion of its witnesses,'' including the proposed testimony of its expert witness. ALJ Ex. 53, at 2 (No. 15- 6); Superior II Response to Motion in Limine, at 2. Respondents also argued that ``[t]he Government's Prehearing Statement only identifies two patients by their initials and only one by the alleged city of residence.'' ALJ Ex. 53, at 3 (No. 15-6); Superior II Response to Motion in Limine, at 3.\8\ Respondents thus contended that the Government provided an ``inadequate description of the testimony concerning specific patients and prescriptions,'' and that they were ``placed under extreme prejudice in [their] preparation for this expedited hearing.'' ALJ Ex. 53, at 3 (No. [[Page 31316]] 15-6); Superior II Response to Motion in Limine, at 3. Respondents also disputed the Government's contention that their argument should be rejected because during a December meeting with Government Counsel, they did not ask for additional information regarding the patients' names. ALJ Ex. 53, at 3 (No. 15-6); Superior II Response to Motion in Limine, at 3. --------------------------------------------------------------------------- \7\ While this filing is part of the record, it was not assigned an ALJ Exhibit Number and is not included on the list of ALJ Exhibits in the Superior II matter. \8\ While this was true with respect to Superior I, the Government's Prehearing Statement in Superior II identified each of the patients whose prescriptions were at issue by their initials, and with respect to 13 of the patients, either the Prehearing Statement or the Show Cause Order identified the patient's city of residence. ALJ Ex. 1, at 2-3 (No. 15-7); ALJ Ex. 6, at 4-6 (No. 15- 7). --------------------------------------------------------------------------- Respondents further took issue with the Government's contention (with respect to both pharmacies) that only a small number of the thousands of persons listed in their Prehearing Statements were actually identified as patients. ALJ Ex. 53, at 2 (No. 15-6); Superior II Response to Motion in Limine, at 2. According to each Respondent, it listed all of the ``patients whose prescriptions were dispensed and doctors who generated the prescriptions [that were] filled at the pharmacy during the relevant time period,'' because at the time it filed its Prehearing Statement, the Government was ``the only party . . . to know which patients, doctors, and pharmacists are material and relevant to the allegations they chose to include in the'' Show Cause Order. ALJ Ex. 53, at 3 (No. 15-6); Superior II Response to Motion in Limine, at 3. Respondents thus contend that ``the potential exclusion of material and relevant witnesses as requested by the Government . . . would be arbitrary, capricious, and an abuse of discretion.'' ALJ Ex. 53, at 3-4 (No. 15-6); Superior II Response to Motion in Limine, at 3- 4. As for the Government's contention that Respondents had failed to disclose the proposed testimony of the patients, doctors and pharmacists with adequate specificity, Respondents argued that ``without the identification of the prescriptions and/or patients at issue (as defined by the OSC), a specific summary of each and every potentially relevant witness is impossible within the timeframe provided.'' ALJ Ex. 53, at 6 (No. 15-6); Superior II Response to Motion in Limine, at 6. Continuing, Respondents argued that ``[t]he witnesses will confirm their interaction with the pharmacists in resolving `red flags' and verify the prescriptions were issued for a legitimate medical purpose in the usual course of professional practice.'' ALJ Ex. 53, at 6 (No. 15-6); Superior II Response to Motion in Limine, at 6. Notably, Respondents did not maintain that the pharmacists would testify that they resolved red flags. As for the Government's attempt to bar the testimony of Mssrs. Badawi and Crowley, Respondents argued that they ``ha[d] summarized [their] testimony to the same extent that the Government summarized its proposed testimony.'' ALJ Ex. 53, at 5 (No. 15-6); Superior II Response to Motion in Limine, at 5. Respondents appeared to argue that they could not offer more detail as to the testimony of these witnesses because they were ``without notice of what specific facts and opinions [would] be offered in the Government's prima facie case as the Government chose to not disclose specifics.'' ALJ Ex. 53, at 6 (No. 15- 6); Superior II Response to Motion in Limine, at 6. As for the Government's attempt to bar their proposed documentary evidence, Respondents argued that they were ``prejudiced by the Government's inadequate Prehearing Statement which forced Respondent[s] to incorporate and include all potential documents and witnesses from the relevant time period.'' ALJ Ex. 53, at 4 (No. 15-6); Superior II Response to Motion in Limine, at 4. Respondents further maintained that ``[t]his prejudice would have only been exasperated [sic] by the costs associated with production of multiple sets of paper copies of the voluminous records.'' ALJ Ex. 53, at 4 (No. 15-6); Superior II Response to Motion in Limine, at 4. Respondents asserted that the electronic files were organized in four separate folders, and the folder which included the documents seized pursuant to the Administrative Inspection Warrant, was simply ``a mirror copy, in the exact form, of the digital files dumped on Respondent by the DEA at the time of service of the Order to Show Cause.'' ALJ Ex. 53, at 4 (No. 15-6); Superior II Response to Motion in Limine, at 4. Respondents stated that they had no way of knowing whether folder three ``represent[ed] all documents seized and/or reviewed by the Government''; they further argued that ``the Government made no attempt to label and/or organize the material provided.'' ALJ Ex. 53, at 4 (No. 15-6); Superior II Response to Motion in Limine, at 4. Concluding, Respondents argued that the Government had nearly two years to review the documents and that between February 4, 2013 (the date the AIWs were served) and the dates of service of the Show Cause Orders), ``Respondent[s] had no access to these records.'' ALJ Ex. 53, at 5 (No. 15-6); Superior II Response to Motion in Limine, at 5. Respondents thus argued that to exclude their ``proposed testimony and exhibits, based exclusively on circumstances created by the Government, would be an extreme abuse of discretion.'' ALJ Ex. 53, at 6 (No. 15-6); Superior II Response to Motion in Limine, at 6. On January 27, 2015, the ALJ conducted the initial day of the hearing during which he addressed the Government's Motions in Limine.\9\ With respect to the proposed testimony of the more than 5,000 patients who filled their prescriptions at Respondents, the ALJ granted the Government's Motions for two reasons. First, he found that Respondents had failed to comply with his Prehearing Order because they had ``not described with sufficient detail the testimony of the proposed witnesses.'' ALJ Ex. 7, at 3 (No. 15-6/15-7) (Journal Entry and Order From Initial Day of Hearing). Second, he found that the proposed testimony of the patients ``would not constitute relevant evidence, given the nature of the charges appearing in the Orders to Show Cause, as elaborated upon by the Government's Prehearing Statements. Id. --------------------------------------------------------------------------- \9\ While the ALJ termed this day as the initial day of the hearing, he did not take any evidence. Tr. 1-36. --------------------------------------------------------------------------- As for the proposed testimony of the physicians, the ALJ found that Respondents' Pre-hearing Statement did ``not sufficiently identify the anticipated testimony of the witnesses, nor . . . make a sufficient showing that their testimony would constitute relevant evidence.'' Id. The ALJ further held that this ruling applied to both those physicians who filled the prescriptions before February 4, 2013, as well as after that date. Id. at 3-4. As to the latter category of physicians, the ALJ barred their testimony based on the additional reason that Respondents had not ``timely identif[ied] by name the proposed witnesses,'' as again required by his Prehearing Order. Id. at 4. And the ALJ further barred Respondents from offering the testimony of ``any pharmacists referred to but not identified in [their] prehearing statements.'' Id. The ALJ also granted the Government's motion to exclude the testimony of Mssrs. Badawi and Crowley. As for Mr. Badawi, the ALJ found that Respondent had not complied with his Prehearing Order because ``[u]nlike the articulation of specific red flags provided by the Government in its description of testimony for its expert, the Respondents' Prehearing Statements do not reveal the substance of this testimony, but instead presented only a list of areas to be discussed.'' Id. at 5. As for Respondents' representation that Mr. Badawi would also testify about errors he identified ``in the inventory performed by the DEA,'' the ALJ found that Respondents failed to ``articulat[e] [[Page 31317]] the nature of these errors'' and there was ``[in]sufficient information regarding the timeframe used by Mr. Badawi to permit a determination that the testimony would be relevant.'' Id. As for Mr. Crowley's proposed testimony regarding errors in the DEA audit, the ALJ found that Respondents ``fail[ed] to articulate what those errors were.'' Id. And as for his proposed testimony ``regarding procedures used by the pharmacies for resolving red flags and for complying with DEA recordkeeping requirements,'' the ALJ explained that he could not ``discern from the summary of [his] testimony whether [it] concerns the practices of the pharmacies at the time of the execution of the administrative warrants, at times before then, or at the present time.'' Id. at 5-6. Finding that Respondents had ``failed to comply with the prehearing order[s]'' and had also ``failed to establish that [his] proposed testimony would be relevant,'' the ALJ barred Mr. Crowley's testimony. Id. at 6. The ALJ also addressed the Government's contention that Respondents' documentary evidence should be excluded. In his Order, the ALJ explained that in his Prehearing Orders he had directed the parties to exchange their exhibits on or before January 12, 2015, and that the ``failure to timely do so would result in the exclusion of the documents.'' Id. at 4. According to the ALJ, ``[o]n both January 9 and . . . 12, a representative of Mr. Sisco's office contacted a member of my staff, inquiring whether Respondents [could] submit documents by using electronic files; . . . on both occasions my staff member advised that only hard copies and facsimiles would be accepted.'' Id. The ALJ explained that on January 12, he directed his staff to return the flash drives which Respondents' counsel had sent to his office, and that as of the date of the hearing, Respondents still had not filed their proposed exhibits with his office. Id. at 4-5. The ALJ then explained that he had ``considered the Government's report of the contents of what presumably was on'' the flash drives, as well as Respondents' explanation as set forth in their Responses to the Government's Motions, and found that good cause existed to grant the motions and bar Respondents from introducing their proposed exhibits. Id. at 5. The ALJ, however, provided Respondents' counsel with the opportunity to submit its proposed exhibits as a proffer, provided it did so no later than February 10, 2015, and provided his Office with an original and two copies, as well as a copy to the Government. Id. Subsequently, on February 3, 2015, the Government filed a ``Notice of Objections to Respondent's Exhibits.'' ALJ Ex. 15 (Nos. 15-6 and 15- 17). Therein, the Government noted that it had received eight binders of evidence totaling nearly 4,300 pages, of which five binders appeared to be related to Superior I and three binders Superior II. Id. at 2. While the Government contended that it was unclear whether the Respondents were offering the exhibits as a proffer or as evidence to be admitted in the proceeding, it then explained that even if the exhibits were offered as a proffer, they should not be included in the record because Respondent had not made an offer of proof as required by 21 CFR 1316.60. Id. The Government further noted that none of the documents were ``self-authenticating'' and many of them, which included patient medical records, ``appear to come from sources other than the Respondents.'' Id. at 3. At the first day of the evidentiary phase of the hearing, the ALJ addressed the Government's objection. Tr. 54. After re-affirming his earlier ruling which barred Respondents from introducing any documentary evidence, the ALJ then turned to the Government's contention that Respondents had not complied with 21 CFR 1316.60. On the issue of whether Respondents had made an adequate offer of proof, the ALJ asked one of Respondents' counsel if he was ``correct in understanding that the Respondent[s'] Pre-hearing Statements and the premises that [he] articulated during the initial day of hearing in support of receiving these exhibits should, taken together, be regarded as containing the statement of the substance of the evidence which you would have accompany the excluded documents?'' Tr. 58. Respondents' counsel answered ``[y]es.'' Id. While the ALJ had also noted that ``an offer of proof shall be part of the record only if a proper foundation has been laid for its admission,'' id. at 57, the ALJ did not ask Respondents' counsel to lay a foundation for any of the exhibits. Id. at 57-69. After noting that he received only a single copy of the proffered exhibits (vice the three copies required by his Prehearing Order), the ALJ ordered Respondents to provide two additional copies of the proffered exhibits prior to 5 p.m. that day; he further advised that if the copies were not filed, he would return the proffered exhibits to Respondents. Id. at 69. Subsequently, Respondents filed the additional copies of the exhibits, and the exhibits were forwarded as a proffer. The ALJ's Ruling on Respondents' Subpoena Requests During the January 27 hearing, the ALJ also addressed each Respondent's request for subpoenas. Tr. 17-23. As explained above, each Respondent submitted requests for an extensive number of subpoenas but failed to include with its requests a certificate of service establishing that they had provided copies to the Government. Asked by the ALJ to address its requests, Respondents' counsel asserted that ``the request for subpoenas was copied to [Government counsel] timely as to each of the subpoenas.'' Id. at 18. However, when asked by the ALJ if it was correct that he did not include a certificate of service, Respondents' counsel answered: ``If the Court says that that wasn't included then I'll accept that. However, I will represent that everything that I provided to the Court has been provided to'' Government counsel. Id. at 20. The ALJ then asked the Government's counsel if he had been provided with copies of the subpoena requests. Id. at 21. Government counsel answered that he had received a thumb drive which ``contains so many thousands of pages of documents'' that he ``did not look for specific subpoenas.'' Id. Subsequently, Respondents' counsel confirmed that he had sent the subpoena requests to the Government electronically. Id. at 22. The ALJ then explained that in his Prehearing Orders, he had advised the parties that subpoena requests that did not comply with his instructions would be returned without further action; he also explained that Respondents had neither objected to nor sought clarification of the Prehearing Orders. Id. at 23. Finding that Respondents had not complied with his Prehearing Orders, the ALJ announced that he would be returning Respondents' subpoena requests without further action. Id. The ALJ did not address whether Respondents had made an adequate showing as to relevancy with respect to either the patients or the physicians. Id. at 17-23. Respondents' Motions for a Daubert Hearing and To Exclude the Testimony of the Government's Expert On January 15, 2015, Respondents also filed motions to exclude the testimony of the Government's pharmacy expert Robert Parrado. ALJ Ex. 41 (No. 15-6); ALJ Ex. 41 (No. 15-7). The basis of Respondents' motions was that ``Mr. Parrado's proposed opinions are based on nothing more than a cursory review of the written prescriptions to the exclusion of all [[Page 31318]] other information,'' and that he ``did not apply any reliable methodology as mandated'' by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its progeny. ALJ Ex. 41, at 2 (No. 15- 6); ALJ Ex. 41, at 2 (No. 15-7). Respondents also argued that Mr. Parrado was ``not qualified to render any opinions regarding whether the physician issuing the prescriptions did so for a legitimate medical purpose in the usual course of professional practice.'' ALJ Ex. 41, at 2 (No. 15-6); ALJ Ex. 41, at 2 (No. 15-7) (both citing Fla. Stat. 766.102(5) (``person may not give expert testimony concerning the prevailing professional standard of care unless the person is a health care provider who holds an active and valid license and conducts a complete review of the pertinent medical records''). Respondents argued that the ALJ was required to perform a ``gatekeeping'' function in determining whether Mr. Parrado's testimony was admissible. ALJ Ex. 41, at 2 (No. 15-6); ALJ Ex. 41, at 2 (No. 15- 7). They further argued that under Daubert, the Government was required to show that: (1) Mr. Parrado was qualified to testify as an expert; (2) that he used a sufficiently reliable methodology in reaching his conclusions; and (3) that his testimony would assist the trier of fact. ALJ Ex. 41, at 2 (No. 15-6); ALJ Ex. 41, at 2 (No. 15-7). Respondents then suggested that under Daubert, the ALJ was required to consider ``whether the theory or technique'' used by Mr. Parrado ``has been subject to peer review and publication.'' ALJ Ex. 41, at 4 (No. 15-6); ALJ Ex. 41, at 4 (No. 15-7). According to Respondents, Mr. Parrado's testimony should be excluded as unreliable because ``he failed to conduct a thorough investigation and failed to base his proposed opinion on any reliable methodology.'' ALJ Ex. 41, at 5(No. 15-6); ALJ Ex. 41, at 5 (No. 15-7). The Government opposed the motions. Quoting agency precedent, the Government argued that where, as here, non-scientific expert testimony is at issue, the expert's `` `knowledge and experience' '' may provide a sufficient foundation for concluding that his testimony is reliable. ALJ Ex. 50, at 3 (quoting Holiday CVS, L.L.C., d/b/a CVS Pharmacy No. 219 and 5195, 77 FR 63316, 62334 (2012) (quoting Surles ex rel. Johnson v. Greyhound Lines, Inc., 474 F.3d 288, 295 (6th Cir. 2007))). The Government noted that Mr. Parrado has been a licensed pharmacist for more than 40 years and had been ``the recipient of numerous professional appointments.'' Id. The Government further argued that at the hearing, Respondents would ``have ample opportunity to question [him] regarding his knowledge and experience, but . . . to exclude him on that basis, prior to trial, is both misguided and premature.'' ALJ Ex. 50, at 4. The Government also argued that Respondents provided no support for their contention that Mr. Parrado's testimony should be excluded because ``he did not interview [the] patients or other persons.'' ALJ Ex. 50, at 4. The ALJ denied Respondents' motions. The ALJ reasoned that in each Show Cause Order and its Prehearing Statements, ``the Government identifie[d] red flags or other conditions which, according to the Government, triggered a corresponding obligation on the part of pharmacies who were presented with a number of prescriptions. The thrust of this evidence is [not] dependent upon scientific or technical analysis, but upon documentary or testimonial evidence establishing or rebutting the claimed corresponding obligation.'' ALJ Ex. 7, at 7 (Nos. 15-6 and 15-7). The ALJ then held that ``[t]he Government ha[d] made a sufficient showing to permit Mr. Parrado to appear and give testimony.'' Id. Continuing, the ALJ explained that at the hearing, he would allow Respondents to question Mr. Parrado as to his qualifications and the methodology he used, but that he was not making a ``preclusive ruling prior to the time [he] testified.'' Id. The ALJ thus denied Respondents' motions to either conduct a separate hearing on the admissibility of Mr. Parrado's testimony or to exclude his testimony prior to the hearing. Id. Respondents' Motions for a Continuance On January 15, 2015, each Respondent also moved for a continuance. ALJ Ex. 42 (No. 15-6); ALJ Ex. 42 (No. 15-7). Respondents sought a continuance of the proceeding ``to commence no sooner than June 2015.'' See, e.g., ALJ Ex. 42, at 5 (No. 15-6). Respondents asserted that they needed the continuance ``to interview and subpoena witnesses,'' and that they ``ha[d] timely requested the issuance of numerous subpoenas and . . . ha[d] exercised due diligence in this regard.'' Id. at 3. Respondents further asserted that ``[d]ue to the short time period between the issuance of the order[s] to show cause and the commencement of the hearing, and the numerous potential witnesses, [they] will undoubtedly be prejudiced by a [sic] the lack of time to adequately interview and obtain service on the necessary witnesses.'' Id. Respondents argued that ``the Government has had years to prepare its case whereas [they have] only been afforded a few months.'' Id. at 4. Continuing, Respondents contended that the Government ``has had more than 20 months to process and analyze the seized information,'' and that ``[d]uring this time, the information was not available to Respondent.'' Id. at 5. While Respondents then acknowledged that ``a portion of the seized information, most notably the prescriptions, was provided to [them] in electronic format,'' they then contended that ``the sheer volume of information coupled with the unreasonably short deadlines surrounding the holiday season makes analysis of the information . . . impossible.'' Id. On January 27, 2015 (during the initial day of the hearing), the ALJ denied Respondents' motions.\10\ In so ruling, the ALJ relied on his previous ruling that Respondents had ``failed to timely submit their request for subpoenas.'' Tr. 30. The ALJ then explained that he could not ``reconcile'' Respondents' assertion that they needed more time to prepare with the representations made in each of their Prehearing Statements that their two proposed experts had ``reviewed the prescriptions at issue, the relevant inventory and ordering history and prepared summaries of the pharmacies' dispensing activities during 2011 and 2012.'' Tr. 31; see also ALJ Ex. 9, at 5-6 (No. 15-6); ALJ Ex. 12, at 5-6 (No. 15-7).\11\ Finally, the ALJ explained that he had: --------------------------------------------------------------------------- \10\ The Government did not file a response to this motion. \11\ As found above, in their Prehearing Statements, Respondents represented that Mr. Badawi would testify about ``the procedures used at Superior Pharmacy [I and II] to consider and resolve alleged `red flags,' inventory, ordering and CSOS compliance issues. Mr. Badawi will further testify that he has reviewed the prescriptions at issue, the relevant inventory and ordering records and prepared summaries of the prescription dispensing activity at Superior Pharmacy [I and II] during 2011 and 2012, and identified significant errors in the inventory performed by the DEA.'' ALJ Ex. 9, at 6 (No. 15-6); ALJ Ex. 12, at 6 (No. 15-7). Likewise, Respondents represented that ``Mr. Crowley will testify regarding errors in the audits performed by the agent/ investigators of Superior Pharmacy [I and II]. Mr. Crowley reviewed the prescriptions, inventory and CSOS records of Superior Pharmacy [I and II]. Mr. Crowley will further testify regarding Superior Pharmacy[I and II]'s procedure for resolving potential `red flag' issues and compliance with recordkeeping requirements related to inventory records, DEA-222 order forms and CSOS issues.'' ALJ Ex. 9, at 5 (No. 15-6); ALJ Ex. 12, at 5 (No. 15-7). consider[ed] a variety of factors, including the diligence and good faith of the parties seeking the continuance; the grounds for the delay; fairness to both parties; the need for orderly administration of justice; the length [[Page 31319]] of the delay requested; whether other continuances have been requested and received; the inconvenience to litigants, witnesses, opposing counsel and the Court; and whether the requesting party contributed to the circumstances which give rise to the request for a continuance and any other relevant factors depending on the facts --------------------------------------------------------------------------- of the case. Tr. 31. The ALJ then found that ``cause has not been shown to delay this hearing'' and denied the Respondents' motions. Id. With the evidentiary phase of the hearing set to begin on February 10, 2015, on February 6, 2015, Respondents filed a second Motion for Continuance. ALJ Ex. 12, at 1 (No. 15-6/15-7). The basis for the motion was that on January 28, 2015, they had retained a third counsel, who previously been involved in resolving a matter involving another of Mr. Obi's pharmacies. Id. at 2. Citing ``the complexity of the issues in these matters,'' Respondents sought a continuance of three weeks to allow its additional counsel to prepare for the hearing. Id. The same day, the Government objected. ALJ Ex. 19 (Nos. 15-6/15-7). It argued that Respondents had been aware of the allegations since October 16 and 17, 2014, and that ``neither Respondent has been without counsel since'' they were served with the Show Cause Orders, and that Superior I had previously retained an additional counsel. Id. at 3. The Government further asserted that it was ``both disingenuous and . . . legal gamesmanship to suggest that the eleventh hour appearance of a co-counsel for Superior II and a second co-counsel for Superior I constitute grounds for disrupting a proceeding that'' in its view had commenced on January 27, 2015. Id. It then argued that Respondents had not demonstrated any hardship that justified a continuance and they ``ha[d] never timely objected to any'' of the dates set by the ALJ, ``including the date and location of the hearing which'' had been set ``more than two months'' earlier. Id. at 4. Finally, the Government stated that it was prepared to put on its case and that ``all of [its] witnesses are travelling to Arlington, Virginia, and have set aside time to participate in this matter.'' Id. The Government thus argued that ``any further delay'' would cause it prejudice. Id. The ALJ denied Respondents' motion. ALJ Ex. 24, at 2 (Nos. 15-6/15- 7). As with Respondents' previous motions for a continuance, the ALJ explained that he had considered various factors and found that ``cause has not been shown to delay the hearing.'' Id. The Evidentiary Hearing and ALJ Decision On February 10 and 11, the ALJ conducted the evidentiary phase of the hearing at the DEA Hearing Facility in Arlington, Virginia. At the hearing, the Government elicited the testimony of four witnesses, including its expert witness, Mr. Robert Parrado; the Government also introduced various documents into evidence. Consistent with the ALJ's order granting the Government's Motions in Limine, Respondents were precluded from calling any witnesses and introducing any documentary evidence. The ALJ did, however, allow Respondent to submit ten binders of documents (totaling nearly 4,300 pages) as a proffer. Following the hearing, both parties submitted briefs containing proposed findings of fact and conclusions of law (hereinafter, referred to as Post-Hearing Brief). On April 9, 2015, the ALJ issued his Recommended Decision (hereinafter, cited as R.D.); according to the Certificate of Service, on April 10, the ALJ's law clerk sent a copy of the Decision to all three of Respondents' counsels by Federal Express. In the Recommended Decision, the ALJ relied on the Government's evidence with respect to factors two and four to conclude that ``the Government has established its prima facie case by at least a preponderance of the evidence that Respondents' continued . . . registrations would be inconsistent with the public interest.'' R.D. 87. Further finding that ``Respondents have failed to rebut that case through a demonstration of sufficient remediation,'' the ALJ recommended that I revoke each Respondent's registration and deny any pending applications to renew or modify its registration. Id. On May 4, 2015, the ALJ transmitted the record to my Office. On May 6, 2015, Respondents filed a brief captioned as: Exceptions to the Recommended Decision and Request for Removal of the ALJ (hereinafter, cited as Resp.' Exceptions). Respondents, however, offered no showing of good cause to excuse the untimely filing of their brief. See generally id. In response, on May 7, 2015, the Government filed with my Office a motion to strike Respondents' Exceptions as untimely or, in the alternative, to respond to their Exceptions. See Gov. Motion to Supplement the Record, Strike Respondent[s'] Untimely Filed Exceptions to the Recommended Decision of the Administrative Law Judge Or, In the Alternative, Respond to Exceptions. Because Respondents have not demonstrated good cause to excuse the untimely filing of their Exceptions, I consider the claims raised therein only if they were previously raised in their Post-Hearing Brief. Having carefully considered the entire record in this matter and, in particular, the claims of error raised by Respondents in their Post- hearing Brief, I do not adopt the ALJ's findings of fact and conclusions of law with respect to the allegations that each Respondent's pharmacists violated 21 CFR 1306.04(a) and 1306.05(a). I do, however, adopt the ALJ's findings of fact and legal conclusions with respect to: (1) The allegations pertaining to the audits conducted of each pharmacy, (2) the allegations that Respondents were not properly maintaining required records including their schedule II order forms, and (3) that for purchases made using the electronic Controlled Substance Order System, Superior II was not electronically linking its receipt records to its purchase records. I further find that Respondent Superior II violated DEA regulations by allowing a non-authorized person to place electronic orders using the key assigned to an authorized person. I therefore conclude that the Government has made out a prima facie case to support revocation of Respondents' registrations. And because Respondents have produced no evidence of any corrective measures they have undertaken, I will order that their registrations be revoked and that any pending applications be denied. As ultimate fact finder, I make the following. Findings of Fact The parties stipulated that Respondent Superior I holds DEA Certificate of Registration BS9255274, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered address of 3007 W. Cypress St., Suite 1, Tampa, Florida. ALJ Ex. 7, at 2 (Nos. 15-6/15-7). The parties stipulated that Respondent Superior II holds DEA Certificate of Registration BS9699731, pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy, at the registered address of 5416 Town `N' Country Blvd., Tampa, Florida. Id. The DEA Investigation On February 4, 2013, DEA Investigators executed Administrative Inspection Warrants at Respondents Superior I and Superior II. Tr. 370- 71; 471. With respect to Superior I, the Investigators seized the original [[Page 31320]] prescriptions for its schedule II and III dispensings, as well as its schedule II order forms (DEA-Form 222), invoices, and inventory records. Id. at 372. At Superior I, a DEA Investigator (who assisted the lead Investigator) also conducted an inventory of the controlled substances then on hand with the assistance of the pharmacist on duty, who verified the count; the Investigator also obtained a copy of an inventory taken by Superior I which was dated May 2, 2011. Id. at 373- 78. According to a DI, because the May 2, 2011 inventory ``did not include all the drugs that were a part of the audit,'' he asked the lead Investigator to contact the pharmacy for additional inventory records, and on February 11, 2013, Superior I provided additional records which included a ``bi-annual inventory'' and an ``in-house inventory.'' Id. at 378-79. Likewise, with respect to Superior II, the lead Investigator on the warrant testified that she seized the original schedule II prescriptions and the pharmacy's purchasing records for the drugs that were subject of the audit; the DI also testified she obtained the pharmacy's schedule II order forms as well as a perpetual inventory maintained by the pharmacy which was dated July 31, 2012. Id. at 472, 474, 477. The DI also took an inventory of the controlled substances then on hand, with the DI witnessing Superior II's pharmacist counting of the pills. Id. at 477. As part of the investigations, the Government provided various schedule II prescriptions which were dispensed by each pharmacy to its expert Mr. Robert Parrado, who reviewed them to determine if they were dispensed in compliance with the Controlled Substances Act. Mr. Parrado testified that he obtained his B.S. in Pharmacy in 1970 from the University of Florida College of Pharmacy and that he has held a Florida pharmacist's license since 1971. Tr. 122; GX 2, at 1 (No. 15-6/ 15-7). Mr. Parrado testified that he has practiced as a pharmacist at both community pharmacies as well as hospital pharmacies; he also testified that he had been the Pharmacy Department Manager at multiple pharmacies, including two pharmacies that he owned for approximately 19 years. Tr. 124-26; GX 2, at 1-2. Mr. Parrado was a member of the Florida Board of Pharmacy from January 2001 through February 2009, and had served as both Vice Chairman and Chairman of the Board. Tr. 128-29; GX 2, at 3. He is a member of the Florida Pharmacy Association, having served as both its President and then Chairman of the Board. GX 2, at 3. He is also a member of the Hillsborough County Alcohol & Drug Abuse Task Force, the National Community Pharmacists Association, and the American Society for Pharmacy Law. Id. Finally, he has made numerous presentations on the dispensing of controlled substances by pharmacists, id. at 3-7, and has testified as an expert witness for both the prosecution and defense in criminal and administrative matters. Tr. 133; see also id. at 152 (answering ``no'' when asked on voir dire if, in criminal matters, he has always testified for the Government). Asked to explain what the standard of care (in Florida) requires of a pharmacist who is presented with a prescription for a controlled substance, Mr. Parrado testified: You have to ensure that the prescription is appropriate and that it's valid. And in doing that he has to look at the prescription. He has to understand the nature of the drug, the nature of the disease state that they're treating, the appropriateness of the therapy and the dosing. And then make sure that the prescription was issued under . . . the valid circumstances of a physician . . . having written the prescription in the course of his practice and that the prescription is . . . for [a] legitimate medical purpose. Id. at 137. Asked to explain what a ``red flag'' is as it relates to the dispensing of controlled substances, Mr. Parrado then testified that: [a] red flag is anything that will cause the pharmacist concern as to the validity of that prescription. It could be numerous things. And a lot of times it's just dependent on the patient presenting the prescriptions or the circumstances. Or just looking at the prescription itself might raise a red flag . . . and cause you concern. Id. at 138. Mr. Parrado then proceeded to identify various red flags, including if the prescription was for ``a known drug of abuse'' and if the dosing is ``appropriate.'' \12\ Id. Continuing, Mr. Parrado explained that after ``mak[ing] sure the dosing is appropriate . . . you look at the quantity of tablets'' and ask if it is ``an appropriate therapy for the condition . . . [t]hat the physician is treating.'' Id. at 139. Mr. Parrado then testified that he looks at what he termed the ``triangle''--the locations of ``the patient['s] home, the physician's office and the pharmacy'' and that ``whenever one of those legs seems to get a little bit long I seem to get a little concerned,'' thus leading him to ``want to verify why a person would drive a long way to [go] to a particular clinic'' and why the person would ``drive a long way from that clinic to a pharmacy.'' Id. at 140. --------------------------------------------------------------------------- \12\ At this point, Respondents' counsel objected on the ground that the testimony was ``outside the scope of the'' Government's Prehearing Statements. Tr. 138. However, in its Prehearing Statements, the Government notified Respondents that Mr. Parrado would identify and discuss ``prescriptions for controlled substances which are known to be highly abused'' and ``prescriptions for quantities of narcotics that exceeded the recommended daily dosages.'' ALJ Ex. 6, at 3 (No. 15-6); ALJ Ex. 7, at 3 (No. 15-7). I thus find that the ALJ properly overruled the objection. --------------------------------------------------------------------------- Mr. Parrado also identified other red flags to include ``[m]ultiple people presenting with identical or very similar prescriptions from the same clinic,'' as well as where a person presents prescriptions for ``cocktails that are known to be abused on the street.'' Id. Mr. Parrado then explained that a cocktail ``is a combination of drugs,'' which usually includes an ``opioid such as oxycodone or hydromorphone,'' ``a benzodiazepine such as Xanax or Valium,'' and ``a muscle relaxant such as Soma.'' Id. at 140-41. Mr. Parrado further identified as a red flag the circumstance where multiple persons present the ``same prescriptions'' from either ``the same practitioner'' or ``clinic.'' Id. at 141. Mr. Parrado then explained that multiple persons getting the same prescriptions ``from the same clinic'' would be a red flag because ``there's supposed to be an individualization of therapy whenever a physician is ordering a pain medication.'' \13\ Id. Of similar import, Mr. Parrado testified that he was familiar with the term ``pattern prescribing,'' which he explained was when ``prescriptions com[e] from the same clinic in . . . the same drug,'' with the same or ``very similar'' dosing and quantities. Id. at 142. Reaffirming his earlier testimony, Mr. Parrado explained while ``there could be a small difference'' in the quantity (i.e., 168 vs. 180 pills) prescribed, ``[t]hat doesn't [[Page 31321]] show me that there's any attempt at individualization of therapy.'' Id. --------------------------------------------------------------------------- \13\ Here again, Respondents objected to the testimony, asserting that it was ``outside the scope of [Mr. Parrado's] testimony'' and that Mr. Parrado was not ``qualified to testify about what the standard of care is for . . . a healthcare practitioner'' under Florida Statute Sec. 766.102. Tr. 141-42. Of note, in its Prehearing Statements, the Government disclosed to Respondents that Mr. Parrado would discuss ``prescriptions issued to multiple individuals presenting prescriptions for the same drugs in the same quantities from the same doctor.'' ALJ Ex. 6, at 3 (No. 15- 6); ALJ Ex. 7, at 3 (No. 15-7). The ALJ overruled the objection. Tr. 142. Respondent did not, however, explain how it was prejudiced because the Government then asked whether a red flag was also presented because the prescriptions came from the same clinic. As for Respondent's contention that Mr. Parrado was not qualified under the Florida Statute to render an opinion on the issue, Florida law does not control the scope of permissible testimony in this proceeding. --------------------------------------------------------------------------- Mr. Parrado then identified two more red flags. The first of these is when ``two people in the same household or [with the] same address were needing the exact same drugs.'' Id. at 143. While Mr. Parrado explained that this could possibly be legitimate, the ``onus of verifying that prescription has been seriously moved up a notch.'' Id. Mr. Parrado then testified that a red flag is also raised when prescriptions are issued to multiple persons with the same last name. Id. Asked by the Government what steps a pharmacist should take upon being presented with a prescription that raises a red flag, Mr. Parrado explained: At that point the pharmacist--first thing he has to do, he has to verify that prescription with the prescriber. Florida law says you check with the prescriber. Not the prescriber's office, with the prescriber. And then you speak with the prescriber and get his opinion. You ask him the questions that you feel, you know, address your concerns. And then at that point I have to . . . use my professional judgment. Did I believe him or not. Because a physician who had written a script is always going to say, yes they wrote it. But I'm trying to determine if it was written for a legitimate medical purpose. So that's why I'm asking the questions I'm asking. Id. at 144. Continuing, the Government asked Mr. Parrado if some red flags are unresolvable, prompting objections by each Respondent that this testimony was beyond the scope of the summary of the testimony disclosed by the Government in its Prehearing Statements. Id. at 144- 45. The ALJ overruled the objections \14\ and Mr. Parrado testified: --------------------------------------------------------------------------- \14\ This was the first of several objections to the Government's elicitation of testimony from its Expert as to whether some of prescriptions presented red flags that could not be resolved. As Respondents argued, the Government Pre-hearing Statements ``do [ ] not anywhere discuss irresolvable red flags. And this is a last minute attempt to prejudice the ability of the Respondent[s] to put on a case here.'' Tr. 144. One of the fundamental tenets of Due Process is that the Agency must provide a respondent with notice of those acts which the Agency intends to rely on in seeking the revocation of its registration so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agency's action. See NLRB v. I.W.G., Inc., 144 F.3d 685, 688-89 (10th Cir. 1998); Pergament United Sales, Inc., v. NLRB, 920 F.2d 130, 134 (2d Cir. 1990). See also 5 U.S.C. 554(b) (``Persons entitled to notice of an agency hearing shall be timely informed of . . . the matters of fact and law asserted.''). However, `` `[p]leadings in administrative proceedings are not judged by the standards applied to an indictment at common law.' '' Citizens State Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th Cir. 1984) (quoting Aloha Airlines v. Civil Aeronautics Bd., 598 F.2d 250, 262 (D.C. Cir. 1979)). See also Boston Carrier, Inc. v. ICC, 746 F.2d 1555, 1560 (D.C. Cir. 1984) (quoted in Edmund Chein, 72 FR 6580, 6592 n.21 (2007) (``an agency is not required `to give every [Respondent] a complete bill of particulars as to every allegation that [he] will confront''). Thus, the failure of the Government to disclose an allegation in the Order to Show Cause is not dispositive, and an issue can be litigated if the Government otherwise timely notifies a respondent of its intent to litigate the issue. The Agency has thus recognized that ``the parameters of the hearing are determined by the prehearing statements.'' Darrell Risner, D.M.D., 61 FR 728, 730 (1996). Accordingly, in Risner, the Agency held that where the Government has failed to disclose ``in its prehearing statements or indicate at any time prior to the hearing'' that an issue will be litigated, the issue cannot be the basis for a sanction. 61 FR at 730. See also Nicholas A. Sychak, d/ b/a Medicap Pharmacy, 65 FR 75959, 75961 (2000) (noting that the function of prehearing statements is to provide Due Process through ``adequate . . . disclosure of the issues and evidence to be submitted in . . . proceedings''); cf. John Stafford Noell, 59 FR 47359, 47361 (1994) (holding that notice was adequate where allegations were not included in the Order to Show Cause but ``were set forth in the Government's Prehearing Statement''). However, consistent with numerous court decisions, the Agency has also held that even where an allegation was not raised in either the show cause order or the prehearing statements, the parties may nonetheless litigate an issue by consent. Pergament United Sales, 920 F.2d at 135-37; see also Duane v. Department of Defense, 275 F.3d 988, 995 (10th Cir. 2002) (discussing Facet Enterprises, Inc., v. NLRB, 907 F.2d 963, 974 (10th Cir. 1990); ``we held that defendant had constructive notice of an alternate theory of liability not described in the formal charge when the agency detailed that theory during its opening argument and at other points during the hearing and when the defendant's conduct revealed that it understood and attempted to defend against that theory''). See also Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44077 n.23 (2012) (holding that while the Government did not provide adequate notice of its intent to litigate an allegation in either the show cause order or its prehearing statements, where respondents ``did not object that the allegation was beyond the scope of the proceeding and that they were denied adequate notice of it'' and ``fully litigated the issue,'' the allegation was litigated by consent) (citing Citizens State Bank, 751 F.2d at 213; Kuhn v. Civil Aeronautics Bd., 183 F.2d 839, 841-42 (D.C. Cir. 1950); and Yellow Freight System, Inc., v. Martin, 954 F.2d 353, 358 (6th Cir. 1992)). Here, I conclude that the ALJ erred when he overruled Respondents' objections to the testimony, as neither the Show Cause Orders, nor the Government's Prehearing Statements ever identified any prescription as presenting red flags that could not be resolved. As the Second Circuit has explained, ``[t]he primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.'' Pergament United Sales, 920 F.2d at 135 (citation omitted). The defense of the allegation that a prescription presented red flags that could not be resolved requires entirely different proof, i.e., testimony as to why a prescription did not lack a legitimate medical purpose, than the defense of the allegation that a pharmacist failed to resolve red flags, and Respondents' multiple objections make clear that they did not consent to the litigation of the issue. Accordingly, the Expert's testimony to this effect cannot be considered in determining whether Respondents' pharmacists violated their corresponding responsibility under 21 CFR 1306.4(a). Well anytime that there is a red flag my job is to resolve that red flag. And at that point I'm having to use my professional judgment when I'm weighing all the different factors that are causing me concern. If I cannot resolve all these things that are bothering me, at that point that becomes unresolvable and I cannot fill that prescription. Id. at 145-46. See also id. at 361 (agreeing that a pharmacist's education, experience and training inform his/her professional judgment). The Government then asked Mr. Parrado if a retail pharmacist would document his/her resolution of a red flag ``somewhere?'' Id. at 146. Mr. Parrado answered: ``Absolutely. Anytime you have a concern with appropriateness of therapy, you always do what you have to do to resolve it and then you document it on the prescription.'' Id. Asked by the Government if the resolution of a red flag ``would be documented on the prescription itself,'' Mr. Parrado answered: ``Yes. Unless you have another form of doing that I don't know about, but the standard of practice has always been you document it on the prescription.'' Id. On Respondent's voir dire, Mr. Parrado was asked whether ``the manner in which a pharmacist documents their [sic] efforts to resolve red flags is not mandated by any statute, regulations or guidance document?'' Id. at 154. Mr. Parrado answered: ``The pharmacist has a duty to verify that's done. And when he's done that he needs to document it. Because if you haven't documented it you haven't done it.'' Id. Upon further questioning by Respondents, Mr. Parrado acknowledged that neither the Florida Statutes nor the Florida Administrative Code state where the pharmacist has to document his/her resolution of a red flag. Id. at 156. On further voir dire by Respondents, Mr. Parrado testified that his opinions were not based on conversations he had with the pharmacists at Respondents, or any statements of the pharmacists provided to him by DEA. Id. at 158. He also testified that his opinions were not based on any statements made by the patients, or the prescribers. Id. at 158- [[Page 31322]] 59.\15\ Over Respondents' objections,\16\ Mr. Parrado was accepted as an expert. Id. at 165. --------------------------------------------------------------------------- \15\ Regarding whether his opinions were based on the presentations on red flags made by the former head of the Agency's Office of Diversion Control, Mr. Parrado acknowledged that he has seen these presentations on two occasions. Tr. 159. However, Mr. Parrado stated that the presentations ``reinforced'' his existing opinions on red flags. Id. at 160. As for the presentations he had previously given, Mr. Parrado acknowledged that he no longer considers a patient's asking for a drug by brand name to be a red flag. Id. at 161-62. When asked whether his opinions were based on information in the DEA Pharmacist's Manual, Mr. Parrado answered ``yes'', and when asked if he disagreed with anything in the Manual as it relates to red flags and their resolution, answered ``no.'' Id. at 163. \16\ The basis of Respondents' objection to Mr. Parrado being accepted as an expert was that he ``is a practicing pharmacist. He's experienced in retail pharmacy but qualification as an expert, there's no need.'' Tr. 165. Given Mr. Parrado's extensive years of practice as a retail pharmacist; his years as a member of the Florida Board of Pharmacy, which includes service as both Vice Chairman and Chairman; his involvement in the Florida Pharmacy Association which includes his service in leadership positions; his membership in other professional associations; and his numerous presentations; the ALJ properly overruled Respondents' objection. --------------------------------------------------------------------------- Mr. Parrado then testified that he was retained to ``review the prescriptions.'' Id. at 166. He also acknowledged having ``reviewed some patient records'' and ``a patient profile,'' before clarifying that ``the main thing [he] relied on was the prescriptions and those partial patient records.'' \17\ Id. --------------------------------------------------------------------------- \17\ On cross-examination, Mr. Parrado testified that he had review only one patient profile ``a couple of weeks'' before the hearing. Tr. 232. --------------------------------------------------------------------------- The Superior I Prescriptions The Government then proceeded to question Mr. Parrado regarding the 25 prescriptions contained in Government Exhibit 3 (No. 15-6). Id. at 167. Each of the prescriptions was issued by a physician at the 24th Century Medical Center, which, according to the prescriptions, was located at 7747 W. Hillsborough Avenue in Tampa. GX 3. Sixteen of the prescriptions were issued on August 5, 2011 for oxycodone 30 and were filled by Superior I on the same day. See id. at 1-16; Tr. 169. Moreover, 13 of these 16 prescriptions were written by the same physician (Dr. C.), with the remaining three written by another physician (Dr. R.). GX 3, at 1-16. Each page of this exhibit contains two images; one showing the front of the prescriptions; the other showing the back. See generally GX 3. With respect to the first page of the exhibit, Mr. Parrado testified that the bottom image was the back of the prescription. Tr. 169. He explained that when a pharmacy fills a prescription, its computer generates labels, one of which goes on the prescription bottle and the other goes on the prescription. Id. Mr. Parrado then explained that the number following the letters ``RX'' on the label was the prescription number and that the number is generated sequentially by the pharmacy's ``computer as prescriptions are being filled.'' Id. at 170-71. However, Mr. Parrado subsequently testified that ``[d]epending on the computer format they have, some will generate a number with the first number being different . . . depending on the schedule of the drug.'' Id. at 174. The Government then asked Mr. Parrado whether there were ``any red flags associated with'' the 16 prescriptions, which were filled on August 5, 2011. Id. at 178. Mr. Parrado testified that the prescriptions presented multiple red flags: Well first thing I would see was the drug, [o]xycodone, 30 milligrams. Then I would see that they're all coming from the same clinic. They're all for the same strength written by the same physician on the same day. So there's multiple patients coming from the same clinic. Which was one of my concerns earlier. Multiple people presenting from the same clinic with a like or similar prescription. These are definitely alike in similar prescriptions. So that would be my first red flag. Then the next red flag I would have looked at was the dosing. The appropriateness of therapy. A red flag I would have to resolve at this point was knowing that 80 milligrams a day of [o]xycodone is a lethal dose to an opioid na[iuml]ve patient. These are much higher than 80 milligrams a day dosing. I would have to verify--I'd have to feel good about the fact that the patient had been on this drug therapy and established to this dose. Would have been the first thing. Then the next thing I would have looked at would have been the patient[']s address. How far he drove to get there. Then another thing I would have looked at was what . . . did he pay for it with cash. And how much did he pay. How much is he willing to pay for.\18\ --------------------------------------------------------------------------- \18\ At this point, Mr. Parrado testified that ``in that time period,'' oxycodone cost from $.33 to $1.00 per tablet, at which point Respondents' counsel objected to the testimony, asserting that it was outside the scope of the Government's Prehearing Statements and that there was no foundation for Mr. Parrado's testimony. Tr. 179. While the Government's Prehearing Statement did not disclose the precise prices he testified to, the Government did disclose that Mr. Parrado would ``identify and discuss . . . prescriptions for individuals playing [sic] high prices . . . for controlled substances with cash.'' ALJ Ex. 6, at 3 (No. 15-6). Moreover, the label attached to the back of each of the prescriptions contains data as to both the price to the patient and the cost of the prescription and the prescriptions were provided to Respondents prior to the hearing. The labels suggest that Mr. Parrado's testimony as to the cost per tablet was accurate. See, e.g., generally GX 3 (No. 15-6). As to the issue of foundation, Mr. Parrado testified that ``I know the pharmacy I was working in at that time [was] paying about $.33 a pill for [o]xycodone.'' Tr. 182. He then added that the average price charged to a patient ``may have gotten to a $1.00.'' Id. On cross-examination, Mr. Parrado further testified that his knowledge of pricing was not based on his having called individual pharmacies, but rather his ``general knowledge of what the market place was.'' Tr. 242. --------------------------------------------------------------------------- Id. at 178-79. Mr. Parrado further testified that each of the 16 prescriptions was paid for in cash. Id. at 181. Asked whether based on his experience and knowledge of retail pharmacy practice, the prices being charged by Respondent for these prescriptions ``were considered high prices for oxycodone,'' Mr. Parrado answered ``[v]ery.'' Id. at 182. Mr. Parrado subsequently explained that ``these prices are very, very high'' and that this would be an additional red flag. Id.at 183. As the evidence shows, 13 of the patients paid $784 or more for their prescriptions, and five of the patients paid $952 or more. GX 3, at 1-16. The Government then questioned Mr. Parrado regarding the red flags presented by the relative location of the patients to the prescriber and Superior I. With respect to the prescriptions reproduced at pages one (112 oxycodone 30 to M.L.) and nine (224 oxycodone 30 to V.P.), both patients' addresses were listed as being in Spring Hill, Florida.\19\ See id. at 1, 9. According to Mr. Parrado, Spring Hill is located 45 to 50 miles from Superior I.\20\ Tr. 185. Mr. Parrado then explained that ``[t]here [[Page 31323]] are many pharmacies between Spring Hill and Tampa.'' Id. --------------------------------------------------------------------------- \19\ See also GX 3, at 2 (Rx for 160 oxycodone 30 to J.R.). \20\ Here again, Respondents objected to Mr. Parrado's testimony, arguing that the Government's Prehearing Statement did not disclose that he was ``going to be offering testimony with regard to the distances between locations or the relative locations of these patients and the pharmacy.'' Tr. 184. Respondents further argued that they had ``prepared to cross examine the person who [the Government] said would testify to that. It was the intelligence analyst. It is not Mr. Parrado.'' Id. It is correct that the Government did not disclose in its Prehearing Statement for Superior I that Mr. Parrado would specifically testify about the distances between Superior I and the towns of Spring Hill (as well as New Port Richey and others). It also true that in its Prehearing Statement, the Government indicated that it intended to call a different witness (an intelligence analyst) to testify about a chart she created showing the large number of Superior I's patients who lived long distances from the pharmacy. However, the Government also disclosed that it intended to ask the ALJ to take official notice of the approximate mileage between Superior I and the various municipalities where the patients lived. Moreover, the distances between Superior I and the towns of Spring Hill and New Port Richey are disputable only to the extent one argues over the precise addresses used to ascertain that distance or the route taken. I thus conclude that Respondent cannot show how it was prejudiced by the ALJ's overruling of its objection. --------------------------------------------------------------------------- Regarding the prescriptions reproduced at page four (168 oxycodone 30 S.M.) and 16 (224 oxycodone 30 for S.A.), Mr. Parrado testified that both patients gave addresses in New Port Richey. Id. He then testified that New Port Richey is ``[a]bout 40 miles north of Tampa.'' Id. Mr. Parrado then noted that patient addresses for other prescriptions included Bradenton (40-45 miles south and west of Tampa), id. at 186; Port Richey (which is next to New Port Richey), id. at 187; Ocala (90- 100 miles north of Tampa), id. at 188; Gainesville (130 miles north of Tampa), id.; High Springs (``probably a 150 miles'' from Tampa), id. at 188-89; Jacksonville (200 miles north and east of Tampa), id. at 189- 90; Alachua (140-150 miles from Tampa); id. at 190; Middleburg (``[c]lose to Jacksonville'' and ``about 200 miles'' from Tampa); id. at 191; and Uvalda, Georgia (``probably . . . close to 300 miles'' from Tampa). Id. at 192. Next, the Mr. Parrado testified that each of the 16 prescriptions was ``facially invalid'' because the prescribing physician did not include the patient's address. Id. Mr. Parrado explained that under Florida law ``at the time \21\ . . . the patient name and address had to be on the front of the prescription.'' Id. While Mr. Parrado testified that a missing address is a red flag, he acknowledged that the pharmacist could resolve it by adding in the patient's address. Id. Asked by the Government whether it appeared that Superior I's pharmacists had resolved this red flag with respect to the prescriptions reproduced at pages one and four of GX 3, Mr. Parrado acknowledged that it appeared that they had done so as evidenced by the ``computer generated sticker[s] that the pharmacist[s] put'' on the prescriptions. Id. at 193. However, Mr. Parrado then explained that it ``would have been [the pharmacist's] duty'' to verify that the address on the sticker ``was accurate.'' Id. --------------------------------------------------------------------------- \21\ While Mr. Parrado referred to Florida law ``at the time,'' Florida law still requires that the face of a controlled substance prescription contain ``[t]he full name and address of the person for whom . . . the controlled substance is dispensed.'' Fla. Sta. Sec. 893.04(c)(1)(2015). --------------------------------------------------------------------------- The Government then asked Mr. Parrado about the prescriptions found at pages 11 (RX#452161), 12 (RX#452160), 14 (RX#452156), 15 (RX#452155), and 16 (RX#452159). Tr. 194-95. Of note, these prescriptions were issued to patients who reported their addresses respectively as being in High Springs, Alachua, Middleburg, Florida; Uvalda, Georgia; and New Port Richey, Florida. See GX 3, at 11-12, 14- 16. Specifically, the Government asked whether ``the fact that these numbers are so close together, looking at these prescriptions collectively, does that raise any additional red flags for you?'' Tr. 195. After the ALJ overruled Respondent's objection that the testimony was outside the scope of the Prehearing Statement, Mr. Parrado answered: Yes. Yes, it would have caught my attention that we had people coming from long distances and places that were close together, coming to get these prescriptions. What I don't see on there is, you know, it looks like the [patient address] sticker was put on the front to resolve the red flag. It doesn't tell me how they resolved the red flag. Id. The Government then asked Mr. Parrado about the prescriptions reproduced at pages 13 (RX#452157) and 14 (RX#452156); these prescriptions listed the patient's addresses as being in Jacksonville (J.M.) and Middleburg, Florida (B.M.). Id. at 196; GX 3, at 13-14. According to Mr. Parrado, these ``two prescriptions were filled sequentially for people from Middleburg and Jacksonville, which are both very close to each other.'' Tr. 196. Continuing, Mr. Parrado opined: ``So they could have travelled together to come there.'' \22\ Id. Mr. Parrado further observed that these patients had the same last name. Id. at 197. --------------------------------------------------------------------------- \22\ Here again, Respondent objected to the testimony as ``rank speculation'' for which there was ``no foundation.'' Tr. 196. He also argued that it was beyond scope of the Government's Prehearing Statement. Id. The ALJ overruled the objection. As for Respondent's objection on the ground that the testimony was ``rank speculation,'' given that Mr. Parrado testified and the prescriptions show that: (1) These two patients had the same last name, (2) provided addresses which suggested that they lived near each other, and (3) their prescriptions bore sequential prescription numbers, Mr. Parrado's testimony was a permissible inference. In any event, even if the patients did not travel together, each of these prescriptions presented red flags. Moreover, even acknowledging that the Government did not disclose that Mr. Parrado would testify that these two persons could have travelled to Superior together, the Government nonetheless disclosed that it intended to elicit testimony regarding Respondent's filling of multiple prescriptions for patients who travelled long distances to obtain their prescriptions. ALJ Ex. 1, at 2-3 (No. 15-6); ALJ Ex 7, at 3-5 (No. 15-6). See also supra note 12 (collecting cases). --------------------------------------------------------------------------- Next, the Government asked Mr. Parrado about the prescriptions reproduced at pages 14 and 15. Of note, the latter prescription was issued to a patient (C.M.), who provided an address in Uvalda, Georgia and who has the same last name as that of the patients discussed in the preceding paragraph. See GX 3, at 15. Mr. Parrado again opined that he believed these persons travelled together to obtain the prescriptions. Tr. 198. Asked by the Government--over the overruled objection of Respondent--whether the red flags presented by these were resolvable, Mr. Parrado explained: These are the kinds of prescriptions that would cause me not to be able to resolve that--this many red flags together. The long distance, the same name, the like, similar drugs, thousands of dollars involved here, in cash, would cause me . . . concern. It's not, in my practice, it's not been--the average customer doesn't come into the pharmacy with $1,000 in their pocket. You know, it's average you tell the person they have a $20 copay they get upset. For these process [sic] to be charged, you know, it's just-- that's a red flag that I would have a hard time resolving.\23\ --------------------------------------------------------------------------- \23\ Here too, Respondent objected that Mr. Parrado ``ha[d] no idea what people who come into a pharmacy have in their pocket or they don't.'' Tr. 199-200. Respondent thus contended that Mr. Parrado's testimony was speculation and was outside the scope of the Prehearing Statement. Id. at 200. The ALJ stated that he noted the objection and that he did not need Respondent to tell him ``what should be or should not be allowed in this hearing.'' Id. The ALJ then explained that he had made his ruling and instructed the Government to ask its next question. Id. I agree with Respondent that this testimony was speculative because the patients could well have paid for their prescriptions with credit cards. However, the prescriptions list their respective prices as $833 (RX 452157), $952 (RX452156), and $833 (RX452155). GX3, at 13-15. Regardless of the method of payment used to purchase them, Mr. Parrado testified that the cost of the prescriptions was also a red flag. Id. at 199. Asked the same question with respect to the prescriptions reproduced at pages 13 and 14, Mr. Parrado testified: ``It would be the same answer. It's the same situation.'' \24\ Id. at 200. --------------------------------------------------------------------------- \24\ This prompted the same objection by Respondent and the same ruling. Tr. 200. The Government then asked Mr. Parrado whether, with respect to the 16 oxycodone 30 prescriptions (GX 3, at 1-16), which were issued and filled on August 5, 2011, there was any evidence, other than the placement of the address stickers, that the red flags they presented ``were resolved?'' Tr. 200. Mr. Parrado testified: ``[t]here is no documentation to that effect on any of these prescriptions.'' Id. Following up, the Government asked Mr. Parrado if he had seen any evidence ``that any of the red flags [other than the missing addresses] --------------------------------------------------------------------------- were even investigated?'' Id. at 201. Mr. Parrado replied: In some of the partial medical records I looked at, there wasn't any evidence of any conversations between the clinics and the [[Page 31324]] pharmacist.\25\ Also, this is one of the things I got out of the partial medical records, that there wasn't any evidence that they had even talked with the pharmacy. And there was nothing here being documented either. --------------------------------------------------------------------------- \25\ On cross-examination, Mr. Parrado testified that he had been given the partial medical records after the New Year's holiday. Tr. 357-58. --------------------------------------------------------------------------- Id. Mr. Parrado then opined that it ``would be outside the standard of care for a pharmacist to fill these without having resolved the red flags before dispensing.'' Id. Asked to opine on whether, based on the prescriptions and records he reviewed, the pharmacists ``exercise[d] their corresponding responsibility to ensure that a prescription for a controlled substance was issued for [a] legitimate medical purpose,'' Mr. Parrado answered: ``[n]ot that I can tell from the records shown to me.'' Id. at 201-02. The Government then questioned Mr. Parrado about the remaining prescriptions in its Exhibit 3. These included a prescription for 240 oxycodone 30 issued on December 10, 2011 to J.M.; as with the other prescriptions, the prescriber had not written the patient's address on the prescription but the prescription contained a small sticker listing J.M.'s address as Lenoir, Tennessee. GX 3, at 22 (No. 15-6). Asked if the prescription raised any red flags, Mr. Parrado noted J.M.'s address and explained that his ``first concern'' was the ``person coming from Tennessee.'' Tr. 202. Mr. Parrado identified additional red flags presented by the prescriptions, including the physician's failure to include the patient address on the prescription, that the quantity of 240 pills was a ``very high dose'' for oxycodone 30, that the prescription came ``from the same clinic,'' and that it cost $1,155. Id. Mr. Parrado then explained that ``[t]hose are all red flags that I could not have resolved.'' Id. However, when asked by the Government if he could tell who filled the prescription, Mr. Parrado testified that the prescription bore the initials ``CD,'' thus indicating ``the pharmacist responsible'' for the script; he then added that ``there's a scribble on the front from somebody that canceled the prescription.'' Id. at 203. Moreover, the prescription has two diagonal lines drawn through it, along with a circle with the letter ``C'' in bold, and while there is a copy of the dispensing label attached to the back, see GX 3, at 22, the Government offered no further evidence to clarify whether the prescription was actually dispensed. Next, the Government asked Mr. Parrado whether the prescriptions (reproduced at GX 3, at 17-18), which are dated August 6, 2011 and bear sequential prescription numbers presented any red flags. Both of these prescriptions were issued by Dr. S.A.H., a physician at the same 24th Century Medical Center in Tampa, to two persons (E.P. and R.B.) for 150 and 140 tablets respectively of oxycodone 30. GX 3, at 17-18. Here too, the front of each prescription lacked the patient's address. See id. However, each prescription bore a sticker listing the patient's address, and the stickers indicated that E.P. and R.B. lived at the same street address in Milton, Florida. See id. Asked by the Government whether the prescriptions presented any red flags, Mr. Parrado identified the patients' addresses and added that ``Milton, Florida is way in the [w]estern panhandle of Florida. It's well over 400 miles'' to the pharmacy. Tr. 204.\26\ Mr. Parrado noted that ``both of them seem to have the same address.'' Id. However, he then testified that the driver's license that was in R.B.'s ``partial medical records'' listed his address as being in a different city (Pace, Florida) than Milton. Id. at 205. Mr. Parrado explained that the disparity between the address on the prescription and the address on the driver's license ``caused me concern that they weren't looking very closely.'' Id. at 205-06. --------------------------------------------------------------------------- \26\ Respondent's counsel objected that the testimony was outside the scope of the Government's Prehearing Statement and was rank speculation. Tr. 204-5. The ALJ overruled the objection. Id. at 205. Here again, the Show Cause Order specifically alleged that ``[o]n August 6, 2011, one or more Superior I pharmacists dispensed large and substantially similar quantities of thirty milligram tablets of oxycodone to two customers, E.P. and R.B., both of whom resided at the same address in Milton, Florida, which is located approximately four hundred and forty nine miles (449) from Superior I's location.'' ALJ Ex. 1, at 2 (No. 15-6). While this alone provided adequate notice, the Government's Prehearing Statement further advised that ``Mr. Parrado will further testify that, on August 6, 2011, Respondent dispensed large quantities of thirty milligram oxycodone to two individuals, E.P. and R.B., who resided at the same address in a city located more than 440 miles . . . from Respondent's pharmacy.'' ALJ EX. 7, at 4 (No. 15-6). The ALJ thus properly overruled the objection. --------------------------------------------------------------------------- After noting that E.P.'s prescription cost $562 and R.B.'s prescription cost $525, Mr. Parrado testified that ``two people from one address paying over $1,000 would be a red flag from somebody coming . . . from 400 miles away.'' Id. at 206. He further noted that both prescriptions were written by the same physician and were for the same drug and in essentially the same quantities. Id. Mr. Parrado then testified that he had seen ``no documentation anywhere'' that Superior I's pharmacist resolved the red flags, including in the ``partial medical records,'' which contained ``no evidence that there was any conversation between the pharmacy and the physician['s] office.'' Id. at 206-07. Next, the Government asked Mr. Parrado about a prescription issued by Dr. V.S. (also of the 24th Century Medical Center) and dispensed on December 2, 2011 to B.W., for 200 tablets of Dilaudid (hydromorphone) 8 mg. See GX 3, at 21; Tr. 207. Here again, the prescription lacked the handwritten patient's address but contained a sticker which listed B.W.'s address as being in Fort Ogden, Florida. GX 3, at 21. Asked if the prescription presented any red flags, Mr. Parrado testified that there were multiple red flags, including that ``it's a very, very potent drug'' and that the quantity was for 200 pills. Tr. 208. Continuing, Mr. Parrado testified that: I have never seen a prescription in my 41 years as a pharmacist for a quantity like that of . . . Dilaudid 8 milligrams as being dosed at every . . . three to four hours. Which would be six to eight times a day. So 48 to 72 milligrams . . . would be the daily dose for a drug that the recommended upper dose be probably 24 milligrams. So it's a much higher dose then [sic] what I have ever seen as a pharmacist. And that would have caused me serious concern that I had to resolve before I could do anything, period. The fact that they came a long way, again, from Fort Ogden, from that same clinic that I'm seeing all these prescriptions from, would cause me not to be able to resolve that red flag. Id. at 208-09. Mr. Parrado was then asked whether a prescription (GX 3, at 19) for 196 Dilaudid 8 mg issued by Dr. P.C. and dispensed on December 1, 2011 to R.L. (Largo, Fl.) also presented red flags. Tr. 209. Mr. Parrado testified that the quantity and dosing raised the ``exact same concern'' as the dosing was ``well outside the recommended upper dosage of that drug.'' Id. Continuing, he explained: ``And I don't see anything where that was resolved to establish that the patient had developed a tolerance to that drug to avoid the respiratory depression that would have been inherent at that dose.'' Id. Asked whether R.L.'s address in Largo was also a red flag (here too, the patient's address had not been written on the prescription but had been added by a sticker), Mr. Parrado testified that the distance was 20 to 25 miles. Id. at 209-10. While he acknowledged that this was not ``a very long distance,'' he [[Page 31325]] explained that ``the fact that there's so many coming from outside the area just starts compounding the fact that this is almost . . . like a destination clinic or destination pharmacy where people know to go there.'' Id. at 210. Mr. Parrado then testified that he found no evidence that Superior I's pharmacist attempted to resolve the red flags. As for the prescription (GX 3, at 20), which was issued by Dr. R. (also of 24th Century) to C.L. for 224 Dilaudid 8 mg on December 1, 2011 and filled the same day, Mr. Parrado again found the quantity to be a red flag, testifying that this would be ``a lethal dose to an opioid na[iuml]ve patient.'' Tr. 211. He then explained that ``there's nothing here to show that the patient has developed a tolerance to this drug.'' Id.\27\ As for the prescription (GX 3, at 23), which was issued by Dr. V.S. (of the same clinic) to M.A. for 224 Dilaudid 8 mg on December 2, 2011 and filled the same day, Mr. Parrado testified that the ``very high dose'' was a red flag and that there was no evidence that the patient had developed tolerance to the drug. Tr. 212. --------------------------------------------------------------------------- \27\ In response to the Government's question whether the fact that these two prescriptions were presented the same day raised ``[a]ny additional red flags,'' Mr. Parrado testified that ``[t]hat's another pattern prescribing red flag. To me.'' Tr. 211- 12. I conclude, however, that two prescriptions do not establish pattern prescribing. --------------------------------------------------------------------------- Concluding its direct examination of Mr. Parrado regarding the Superior I prescriptions, the Government asked if he had an opinion as to whether the pharmacists who dispensed the prescriptions knew or had reason to know that they were issued without a valid doctor-patient relationship. Tr. 220-21. After the ALJ overruled Respondent's objection,\28\ Mr. Parrado explained: --------------------------------------------------------------------------- \28\ Respondent objected on the ground that ``[t]here's no opinion summarized anywhere in the Government's [P]re-hearing [S]tatement . . . that relates to whether or not . . . the pharmacist knew or should have known that those prescriptions were issued. And it's outside his area of expertise. It's nothing but rank speculation.'' Tr. 221. Even assuming that the first ground for objection was that the Government did not provide notice that it intended to ask whether the pharmacists knew or should have known that the prescriptions were issued without a valid doctor-patient relationship, in its Prehearing Statement, the Government advised that Mr. Parrado ``will testify that, based on his expertise, training, and experience, and based on his review of the evidence summarized above, Respondent's pharmacists failed to exercise their corresponding responsibility to ensure that prescriptions for controlled substances were issued for a legitimate medical purpose in the usual course of professional practice.'' ALJ Ex. 7, at 5. Asking whether the prescriptions ``were issued without a valid-doctor patient relationship'' is just another way of asking whether the prescriptions ``were issued for a legitimate medical purpose in the usual course of professional practice,'' as a physician must establish and maintain a valid doctor-patient relationship to act in the usual course of practice and to issue a prescription for a legitimate medical purpose. Nor was it beyond Mr. Parrado's expertise to opine on whether the prescriptions were issued outside of a valid doctor-patient relationship. See United States v. Hayes, 595 F.2d 258, 261 & n.6 (5th Cir. 1979) (``[A] pharmacist can know that prescriptions are issued for no legitimate medical purpose without his needing to know anything about medical science.''). Indeed, pharmacists are expected to review the patient record and each prescription for therapeutic appropriateness and identify, inter alia, over-utilization, incorrect drug dosage, and clinical abuse/misuse. Fla. Admin Code r.64B16-27.810(1). A pharmacist is obviously required to be able to determine when a prescription calls for the dispensing of such potent narcotics as oxycodone or Dilaudid in quantities that far exceed recommended upper dosages and would be lethal in an opioid na[iuml]ve patient, let alone when a patient presents such other red flags of abuse or diversion, such as travelling long distances to obtain narcotics. There's no documentation that I saw that there was any conversation with a physician determining that. Because at these doses there would had to have been conversation determining tolerance. There would have been conversation determining medical need at this dosing. So at that point I would have had a question in my mind, as a pharmacist filling or being presented with this prescription, that there may have been . . . not a very good valid patient-doctor relationship going on at that point in time. Id. at 221-22. On cross-examination, Mr. Parrado acknowledged that he could not offer an opinion as to whether any of the patients, whose prescriptions were provided in GX 3, were opioid na[iuml]ve. Tr. 235-36. Asked whether it was true that he had no knowledge as to the procedures used at Superior I to revolve red flags, Mr. Parrado answered that ``[n]othing that was documented on the prescriptions showed that anything had been done.'' Id. at 237. After acknowledging that ``there's nothing that mandates where [documentation] has to be,'' he also acknowledged that if the resolution of the red flags was documented someplace other than on the prescription itself, the documentation wasn't provided to him, and thus he does not know whether it exists or not. Id. at 237-38. While Mr. Parrado testified that he knew one of the pharmacists who worked at Superior I, he stated that he had not spoken with her about any of the prescriptions. Id. at 246. Nor has he discussed with any of Superior I's pharmacists the policies or procedures the pharmacy had in place from January 1, 2011 through February 4, 2013, or currently has in place, for identifying diversion and for documenting the resolution of red flags. Id. at 246-47. Mr. Parrado further testified that he asked DEA ``for complete profiles on all these patients'' but was told to look at only the prescriptions. Id. at 247. He then testified that he believed the Agency had the profiles because he had seen some of them in the DEA's office. Id. Mr. Parrado testified that he had not consulted with any other pharmacists in forming his opinions. Id. at 248. He also testified that he did not speak with any of the prescribers of the 25 prescriptions or with the patients who received them. Id. at 249. He then testified that he did not know what training or experience the prescribers had. Id. at 250. Asked by Respondent whether, based on the materials provided to him by DEA, he knew if Superior I's pharmacists had called the prescribers ``to discuss any issues related to the patients or the prescriptions,'' Mr. Parrado answered that ``did not see anything to that effect.'' Id. at 251. He then testified that if ``[i]t wasn't documented[,] [i]n my mind, they didn't do it.'' Id. However, Mr. Parrado acknowledged that he did not know if this was documented other than on the prescriptions. Id. at 252. Mr. Parrado did not know whether Superior I kept a paper file which included medical records on their patients. Id. at 254. He also did not know if Superior I's pharmacists obtained copies of MRIs, X-Rays and CT scans. Id. He then testified that: In the partial patient records that I did receive, there was evidence of some MRIs. What struck me was that these MRIs were old and not ordered by the physician who was writing these prescriptions, which would have been a red flag to me. Some of these MRIs were two/three years old. They were ordered by someone else. There were some . . . MRIs, reports didn't even have a referring prescription on it. That would have concerned me as a pharmacist filling that prescription. Id. at 254-55. Respondent then asked Mr. Parrado if, based on the information provided to him, he was ``aware that the pharmacists were obtaining copies of radiographic studies [and] reports of radiographic studies?'' Id. at 255. Mr. Parrado answered: No, I didn't say I saw it in the pharmacy records. I saw it in the medical records. If the pharmacist would have had access to that, that would have presented another red flag in the fact that that was an old record ordered by someone else. That would have raised the bar there if you will. Id. Mr. Parrado then explained that he did not know the source of the medical records.\29\ Id. --------------------------------------------------------------------------- \29\ Subsequently, the lead Investigator testified that the medical records had been obtained pursuant to a subpoena issue to the 24th Century Clinic and had been provided to Mr. Parrado by Government Counsel. Tr. 578, 589-90. [[Page 31326]] --------------------------------------------------------------------------- Mr. Parrado acknowledged patients become dependent and develop tolerance to opioid analgesics and that there is no upper limit as to the quantity or dose that can be prescribed. Id. at 260. He also acknowledged that he did not know if any of the patients who received the prescriptions in GX 3 worked in Tampa. Id. He also conceded that the patients ``were seeing the physicians regularly over a good period of time.'' Id. Continuing, Mr. Parrado acknowledged that there is an expressway which runs from Spring Hill to Tampa, and that people may commute from the former to the latter for work. Id. at 261. Mr. Parrado testified that this red flag would have been resolvable if the question had been asked and answered. Id. at 262. Next, Mr. Parrado testified that a pharmacist can add an address to a prescription if ``you've checked with the physician and gotten the correct thing and that matches what the patient is telling you.'' Id. at 263. He then acknowledged that he did not attempt to determine if any of the prescriptions in GX 3 were necessary for the treatment of chronic or recurring disease. Id. at 264. On re-direct, Mr. Parrado was asked whether the one patient profile he was provided with was for P.D. (GX 3, at 24) and whether the profile showed that there was a gap in care. Tr. 268. Asked to describe what was on the document, Mr. Parrado testified that: [t]there was a list of dates for Mr. P.D. that showed the dates he had prescriptions filled for this drug and there was a gap of two months in there which, as a pharmacist, anybody that stops taking opioids or if I don't know he's continued taking opioids, at that point I can't fill a further prescription till I've established that. He could have been in jail. He could have been in a rehab unit. It is well-documented that patients that have gone into these things, gone back in the community and accessed a prescription at the old dosage they were on would kill them and it has killed them. Id. at 269-70.\30\ Asked by the Government whether when he reviewed this document, he saw any indication that red flags had been resolved or explained, Mr. Parrado answered ``no.'' Id. at 271. --------------------------------------------------------------------------- \30\ At this point, Respondent objected, arguing that if Mr. Parrado was going to talk about this document, the Government should be required to ``produce the document so that we can see what it is that he's talking about. You know, he's talking about some amorphous document.'' Tr. 270. He also argued that the testimony was outside the scope of either cross examination or the Prehearing statement. Id. While the ALJ disagreed that it was outside the scope, he explained that because there was ``no document in front of him'' and he was ``relying on the frailties of human memory,'' he was not going to give this testimony ``a whole lot of weight.'' Id. at 271. Questioned by the ALJ as to where he would document the red flags presented by a prescription, Mr. Parrado testified that: ``I would have identified the red flags that concerned me when the prescription was presented. I would have noted that on the back and I would have noted what I did to resolve each one of those if there was more than one.'' Id. at 273. Mr. Parrado added that ``you scribble on the back and/or you write on a piece of paper and staple it to that prescription.'' Id. The ALJ then asked Mr. Parrado if, in his ``experience working with other pharmacists, . . . they have other ways of making records . . . to keep track of the red flags and how they've been resolved?'' Id. at 274. Mr. Parrado answered: ``[n]ot in the 43 years I've been a pharmacist.'' Id. On further re-cross, Respondent asked Mr. Parrado: ``Not all pharmacists document in the same way that you do, do they?'' Id. Mr. Parrado answered: ``[a]s a Board of Pharmacy member, I would have expected them when they came before the Board to show me that documentation. It was always on the prescription. It's always on that prescription record somehow.'' Id. Noting that Mr. Parrado had not been on the Board of Pharmacy for some time, Respondent then asked if he had ``ever seen in your 43 years[,] pharmacists document the same information in different ways?'' Id. at 275. Mr. Parrado answered: ``I've seen them document in different ways but always on the prescription.'' Id. The Superior II Prescriptions With respect to the Superior II prescriptions, Mr. Parrado testified that he reviewed them in the same manner as he did the Superior I prescriptions. Id. at 277. He then proceeded to identify various red flags presented by the prescriptions. The first of these was a prescription issued by Dr. H.V.D. (also of the 24th Century Medical Center) to J.T. of Fort Meyers, Florida, for 280 oxycodone 30. GX 3, at 1-2 (No. 15-7). Here again, the patient's address was left blank and the address was provided by a sticker, which was affixed to the front of the prescription. Id. at 1. Mr. Parrado testified that prescription presented the following red flags: The drug having ``a high potential for abuse''; the ``very large quantity'' and ``the dosing at a very high rate, well above . . . 80 milligrams a day''; the ``patient travelling from Fort Meyers, which is . . . 150 miles or so from Tampa''; and the patient paying $1,260 cash for the drugs. Tr. 277-78.\31\ Mr. Parrado then testified ``there was nothing on the prescription to show me that these things had been discussed.'' Id. at 279. --------------------------------------------------------------------------- \31\ Respondent objected to Mr. Parrado's testimony as to the price, asserting it was beyond the scope of the Pre-hearing Statement because it did not specifically identify ``the pricing issue'' as being one of the red flags associated with the prescription. Tr. 278. The Government did, however, identify that it intended to elicit testimony on the issue of ``individuals playing [sic] high prices for prescriptions . . . with cash.'' ALJ Ex. 7, at 3 (No. 15-7). --------------------------------------------------------------------------- The second prescription was issued on December 2, 2011 by Dr. R. (the same Dr. R. of 24th Century), to R.B. of Milton, Florida (the same R.B. discussed in the Superior I findings) for 168 oxycodone 30. GX 3, at 3-4 (No. 15-7). Here again, the patient's address was left blank and the address was provided by a sticker, which was affixed to the front of the prescription. Id. at 3. After Mr. Parrado identified R.B. as being one the persons who filled a prescription at Superior I which presented red flags, the Government asked him to also look at the prescriptions reproduced at pages 5-6 of the exhibit. The latter prescription was also issued on December 2, 2011 by Dr. V.S. (also of 24th Century) to E.P., who again used R.B.'s address as her address; the prescription was also for 168 oxycodone 30. Id. at 5-6. Of further note, R.B.'s and E.P.'s prescriptions had sequential RX numbers. Id. Asked if these prescriptions presented any red flags, Mr. Parrado testified that ``[t]hese were the same two patients that had gotten prescriptions filled at the other pharmacy, both with the same Milton, Florida address, both paying $924 in cash, travelling a long way, very high dosing, all the same concerns I had with the previous prescriptions.'' Tr. 280-81. He also observed that the prescriptions ``were filled consecutively'' and that the dispensing labels show that the same pharmacist (M.F.) filled the prescriptions, and that these circumstances would have caused him concern. Id. at 282-83. And Mr. Parrado further testified that he saw no evidence that the pharmacist attempted to resolve the red flags. Id. at 283. The next prescription was issued on September 18, 2012 by Dr. V.S. (the same Dr. V.S. who had worked at 24th Century) to L.P. of Jacksonville, for 168 oxycodone 30. GX 3, at 7-8. Mr. Parrado testified that the prescription presented multiple red flags including ``the drug,'' the ``very high quantity,'' that the patient was ``coming from Jacksonville . . . over 200 miles'' from Tampa, and that the patient was ``paying $1,344 in [[Page 31327]] cash.'' Tr. 284. Mr. Parrado then testified that there was ``nothing documented'' regarding the pharmacist's attempt to resolve the red flags. Id. After Respondent ``object[ed] to the repetitive nature of this,'' the ALJ asked Mr. Parrado if he had found ``the same kinds of red flags'' throughout the Exhibit. Id. at 285. Mr. Parrado answered ``[y]es.'' Id. The ALJ then asked Mr. Parrado if he had also found that ``the failure to resolve the red flags is documented on the documents there?'' Id. Mr. Parrado answered ``[y]es.'' However, after the ALJ asserted that ``[t]hat seems to address all of Exhibit 3,'' the Government advised the ALJ that there were ``some differences.'' Id. The Government then questioned Mr. Parrado about two prescriptions which were issued on May 22, 2102 by Dr. C. (also of 24th Century) to L.B. of Dover, Florida, which the latter filled the same day. GX 3, at 11-14. The prescriptions were for 168 oxycodone 30 and 84 Dilaudid 8 mg. See id. Asked by the Government whether the combination of these two drugs raised a red flag, Mr. Parrado testified that ``that's a major red flag in that you have two immediate use opioids being dispensed at the same time. The practice is never to dispense two immediate use opioids at once, at the same time for the same patient.'' Id. at 286. Mr. Parrado then testified that both of the drugs were immediate release, and upon being asked if there was a way to resolve this red flag, Respondent objected to the testimony, arguing that it was beyond the scope of the Government's Prehearing Statement. Id. at 287. The ALJ overruled the objection, explaining that ``I'd like to know.'' \32\ Id. Mr. Parrado then testified that he could not resolve the red flag, and that while it was proper therapy to prescribe a ``long-acting opioid, like OxyContin'' and an immediate release drug ``such as hydromorphone for breakthrough,'' using ``two immediate use opioids[,] [y]ou just don't do that.'' Id. Here again, Respondent objected on the ground that the opinion was beyond the scope of Mr. Parrado's expertise because he is not a physician. Id. at 287-88. The ALJ overruled the objection. Id. at 288. --------------------------------------------------------------------------- \32\ As discussed above, the Government failed to provide Respondent with constitutionally adequate notice on this issue. See, e.g., Pergament United Sales, 920 F.2d at 135 (``The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.''). --------------------------------------------------------------------------- On May 22, 2012, Respondent filled prescriptions for 168 oxycodone 30 and 56 Dilaudid 8 issued by Dr. S.A.H. (of 24th Century) to V.B., who has the same last name and lived in the same town as L.B.\33\ GX 3, at 15-18. Asked whether ``seeing these prescriptions together,'' there were ``additional red flags,'' Mr. Parrado testified that ``the fact that two people from essentially the same address were coming together with the same last name for the same drugs which were two immediate use opioids from the same clinic . . . I would have found that unresolvable.'' Tr. 289-90. Mr. Parrado then testified that he found no evidence that the red flags were resolved. Id. at 290. --------------------------------------------------------------------------- \33\ Mr. Parrado noted that while the prescriptions for L.B. and V.B. indicated that they lived on different streets, they had the same house number. Tr. 288. While Mr. Parrado then suggested that ``may have been just a typo,'' id., the Government offered no further evidence to corroborate this testimony. --------------------------------------------------------------------------- On October 22, 2012, Dr. V.S. (who, according to the prescription was then working at the MD Plus Clinic in Lakeland), issued a prescription for 168 oxycodone 30 to J.P., whose address (which again was not written on the prescription) was in Ft. Walton Beach, Florida; Respondent filled the prescription the same day. GX 3, at 19-20. Upon being asked ``what kind of route J.P. [would have] follow[ed] if he came from home, went to the doctor's office in Lakeland and then went to Tampa'' to fill the prescription, Respondent objected on the ground that the testimony would be speculative because Dr. V.S. could legally prescribe at any place in the State. Tr. 293-94. After the ALJ overruled the objection, Mr. Parrado testified that while he did not ``know the exact route [J.P.] took . . . the triangle between . . . the three places is very large [and] would have to be resolved.'' Id. On October 23, 2012, Dr. V.S. (of the MD Plus Clinic) issued a prescription to K.B. of Jacksonville, for 168 oxycodone 30; Respondent filled the prescription on November 7, 2012. GX 3, at 21-22. On October 22, 2012, Dr. R.R. (of the 24th Century Medical Center) issued a prescription to R.B. of Milton for 168 oxycodone 30; Respondent filled the prescription on November 1, 2012. Id. at 23-24. Mr. Parrado testified that both prescriptions presented the same red flags that he had previously discussed. Tr. 295-96. On November 5, 2012, Dr. H.D. (of the 24th Century Medical Center) issued a prescription to J.S. of Panama City Beach, for 180 oxycodone 30; Respondent filled 120 tablets of the prescription the same day. GX 3, at 25-26. Asked where Panama City Beach is in relation to Tampa, Mr. Parrado testified that it is located in the ``extreme western part of the Florida panhandle'' and 450 miles from Tampa. Tr. 297. Notably, the prescription contains a handwritten notation: ``120 per pat'' with the rest of the word obscured by the address sticker, below which is the date and time. GX 3, at 25. According to Mr. Parrado, ``this was the only form of any kind of notation or documentation I saw on any of the records showing that they did document at one point and the only thing they documented was that they shorted the person pills.'' \34\ Tr. 298. Mr. Parrado further noted while the address on prescription listed Panama City Beach as J.S.'s town of residence, the sticker attached to the prescription, as well as the dispensing label, listed her town of residence as Port Charlotte, which is in the ``opposite direction'' from Tampa. Id. --------------------------------------------------------------------------- \34\ Mr. Parrado further testified that it is common practice to make a note on the prescription when pharmacist does not provide a patient with the entire quantity of the prescription. Id. at 299. --------------------------------------------------------------------------- On November 5, 2012, Dr. R.R. (24th Century) issued a prescription to A.R. for 180 oxycodone 30; Respondent filled the prescription the same day. GX 3, at 27-28. While the prescription lists the patient's address as Lawtey, Florida, both the address sticker attached to the prescription and the dispensing label list A.R.'s address as in Gainesville, Florida. Id. Over Respondent's objection (on grounds of no notice), Mr. Parrado testified that this was an additional red flag and the ``difference . . . should have been documented.'' Tr. 300-01. On April 23, 2012, Dr. S.A.H. (24th Century) issued a prescription to T.P. of St. Augustine, Florida for 180 oxycodone 30; Respondent filled the prescription the same day. GX 3, at 29-30. Noting that Saint Augustine is located ``just below Jacksonville'' in ``the upper northeast corner of Florida,'' Mr. Parrado testified that ``the distance'' between T.P.'s residence and Respondent was a red flag. Tr. 301-02. Also on April 23, 2012, Dr. P.C. (24th Century) issued a prescription to A.W. of Mayo, Florida, for 200 oxycodone 30; Respondent filled the prescription the same day. GX 3, at 31-32. Mr. Parrado testified that Mayo is located 150 to 200 miles from Tampa and that this was a red flag ``along with all the other things,'' including ``the drug and the price paid,'' which was $1,400. Tr. 302-03; GX 3, at 32. On April 23, 2012, Dr. P.C. issued a prescription to D.T. of Gainesville for 190 oxycodone 30; Respondent filled the prescription the same day. GX 3, at [[Page 31328]] 33-34. Also on April 23, Dr. S.A.H. issued a prescription to J.S. of Tallahassee for 168 oxycodone 30; Respondent filled the prescription the same day. Id. at 35-36. Mr. Parrado testified that neither prescription raised ``any additional red flags'' beyond those he had previously discussed. Tr. 303. However, on further questioning, he testified that Tallahassee is 250 to 260 miles from Tampa.\35\ Id. at 303-04. --------------------------------------------------------------------------- \35\ Respondent objected to Mr. Parrado's testimony regarding the distances from Mayo to Tampa and Tallahassee to Tampa on the ground that this testimony was not disclosed in advance of the hearing. Tr. 302-03. In its Pre-Hearing Statement, the Government did disclose that Mr. Parrado ``will . . . testify regarding large quantities of oxycodone distributed by Respondent on April 23, 2012, to at least twelve persons . . . and four of them (T.P., A.W., D.T., and J.S.) resided more 100 miles from Respondent's pharmacy.'' ALJ Ex. 7, at 5 (No. 15-7). Respondent thus had notice that the distance between it and the residences of the patients would be at issue even if the Government did not disclose that Mr. Parrado would testify as to the precise distances. --------------------------------------------------------------------------- On November 2, 2012, Dr. R.R. issued a prescription for 112 Dilaudid 8 mg to T.N., which Respondent filled the same day. GX 3, at 37-38. Of note, while the prescription as prepared by Dr. R.R. listed T.N.'s address as being in Port Salerno, Florida, both the address sticker placed on the front of the prescription and the dispensing label listed an address in Gainesville. See id. Mr. Parrado testified that this was a red flag, as was the high dose of the prescription (32 mg per day), which was ``above the 24 milligram upper dose recommendation.'' Tr. 304. The final prescription in the exhibit was issued on November 5, 2012 by Dr. H.D. to K.P. of Spring Hill for 140 Dilaudid 8 mg. GX 3, at 39-40. Asked the same question as with previous prescription (``How about the drug and the amount?''), Mr. Parrado testified: ``[t]he answer will be the same.'' Tr. 304. Thereafter, the Government moved Exhibit 3 into evidence in the Superior II matter, and the ALJ admitted the exhibit. Id. at 305. The Government then moved to admit into evidence its Exhibits 4 and 14. Id. The former is a compilation of 25 additional prescriptions for oxycodone 30 and Dilaudid 8 mg, which was offered to show additional instances in which patients presented the ``red flag of long distance'' between their residence, the prescriber, and Superior II. Id.; see also GX 4 (No. 15-7). The latter is a collection of MapQuest maps and printouts showing the distances between the patient's residence, the prescriber, and Superior II. Id.; see also GX 14 (No. 15-7). Both exhibits were admitted over Respondent's objection.\36\ Tr. 305-06. --------------------------------------------------------------------------- \36\ With respect to the MapQuest printouts, Respondent did not object based on authenticity, but rather on lack of foundation, arguing that ``there are ways to set parameters to avoid highways, to take the shortest route, to take the fastest route.'' Tr. 307. The objection is not without some merit. However, given the distances of the patients from the prescribers and Superior, any differences in mileage or driving time which would be caused by choosing between these two parameters is not significant enough to be material. --------------------------------------------------------------------------- As for the prescriptions in GX 4, Mr. Parrado testified that they all presented the red flag of the patients travelling long distances. Tr. 308. He further testified that he used Google to ``get an approximation of the mileage'' for those cities for which he did not know the exact mileage. Id. at 310. Asked by the Government whether he had seen any evidence that Superior II's pharmacists attempted to resolve the red flags presented by the prescriptions in both its Exhibits 3 and 4, Mr. Parrado testified that ``[t]he only documentation I saw was that shortage of tablets. That's the only thing I saw documented anywhere.'' Tr. 312. With respect to these prescriptions, Mr. Parrado then testified that he did not ``see any evidence'' that the dispensing pharmacist had complied with his/her corresponding responsibility to ensure that prescriptions were issued for a legitimate medical purpose. Id. The Government concluded its direct examination of Mr. Parrado, asking him--over Respondent's objection--whether the pharmacists, who filled the prescriptions in GXs 3 and 4, ``knew or had reason to know that the prescriptions were being issued without a valid doctor/patient relationship?'' Id. at 313-14. Mr. Parrado answered: All these red flags would have caused me concern to where I had to call that physician to verify all these things. And at that point I would have to use my professional judgment and whether or not even though possibly faced with what could ostensibly be a valid prescription I should know or either knew or should have known that these were being used . . . for not a legitimate medical purpose, just based on all the red flags that are present. So even if the doctor had told me, yes, he did fill it, I would still, I still would not have filled them. Id. at 314-15. On cross-examination, Mr. Parrado adhered to his earlier testimony that if the resolution of a red flag was not documented on the prescription, ``it wasn't done.'' Id. at 316. While Parrado acknowledged that he did not know whether Florida law requires that this be documented on the prescription, he testified that ``[i]t's been standard practice since I've been practicing for 43 years.'' Id. He further acknowledged that DEA does not require that the resolution of a red flag be documented on the face of the prescription. Id. at 318. And he also acknowledged that in rendering an opinion as to whether another pharmacist had properly exercised his professional judgment in deciding to dispense a controlled substance, it is important to understand the circumstances, including whether the pharmacist has a history with the prescriber of the prescription. Id. at 321. Asked by Respondent whether he ``wouldn't think twice about'' a prescription he received from a reputable prescriber which was missing the patient's address, Mr. Parrado testified that ``I would do something to address that and fix it.'' Id. Asked if he would then go into his pharmacy software and use the information to put an address label on the prescription and that this would not cause him ``to be concerned about diversion,'' Mr. Parrado answered: ``Not if I knew the patient. And there's always a circumstance where it [the prescription] could be good.'' Id. at 321-22. When then asked whether ``one of those circumstances would be if you knew the prescribing practitioner and . . . . [his] practice[] and . . . protocols and . . . knew that when you called them [he] answered your questions about the diagnoses and the reasons for things,'' the ALJ, without any objection by the Government, stated that he would not allow Mr. Parrado to answer the question because there was ``no evidence that the Respondent, through any of its pharmacists, did that.'' Id. at 322. Even after Respondent argued that it was a hypothetical question and that Mr. Parrado ``was proffered as an expert'' and had testified that he had asked for additional information from DEA and been denied it, the ALJ adhered to his ruling. Id. at 322- 23. However, Mr. Parrado subsequently agreed with Respondent that in trying to determine whether a red flag had been resolved, it is ``important to know what the pharmacist knew about'' the patient. Id. at 324. Mr. Parrado testified that he had asked for the patient profiles for the Superior II patients and that the Government told him not to look at those. Id. at 324-25. Mr. Parrado then acknowledged that a patient profile would show the complete history of prescriptions filled by the pharmacy in the period for which it was run and would show whether the patient was also receiving non-controlled drugs. Id. 325. He also acknowledged that the patient profile would be important in [[Page 31329]] determining whether the patient was opioid na[iuml]ve or tolerant. Id. Mr. Parrado then testified that he was given some ``partial medical records,'' and that these showed that ``these people were on multiple controlled substances [and] not just the prescriptions that were given to me.'' Id. He then added that there were ``multiple people from the same address getting the exact same cocktails of these drugs.'' \37\ Id. at 325-26. --------------------------------------------------------------------------- \37\ No evidence established what the cocktails were, let alone the strength and dosing of the drugs. --------------------------------------------------------------------------- Asked if his opinions were based on these medical records, Mr. Parrado testified that the medical records did not form his opinions but ``just reinforced'' them, because he did not ``see any documentation of conversations between the pharmacy and the clinic'' and the records ``showed on a lot of these patients the cocktails.'' Id. at 326. After Mr. Parrado testified that the medical records were those ``of the prescribing physician,'' Respondent attempted to ask if he knew whether a physician is supposed to note a conversation with the pharmacist in the chart. Id. The ALJ barred the question, even in the absence of an objection of the Government, reasoning that there was no evidence that any of Superior II's pharmacists had called the prescriber. Id. at 327. Mr. Parrado then acknowledged that there is ``no upper limit on the amount of an opioid that a patient can develop a tolerance to'' and that there is no federal limit on the quantity of a drug that can be prescribed. Id. He further testified that whether a prescription is medically necessary is patient specific and depends on such factors as tolerance, the condition causing the pain, and the duration, intensity and frequency of the pain. Id. at 330. Asked whether it was per se unlawful to fill an oxycodone 30 prescription, Mr. Parrado testified that ``I would have to evaluate each prescription individually and know that . . . that patient had developed that tolerance . . . before I fill it.'' Id. at 331. Then asked whether ``[o]xycodone 30 standing alone is not an indicator that a prescription'' lacks a legitimate medical purpose, Mr. Parrado answered: ``Well, it's the leading drug of abuse on the street. So that is the first potential for a red flag.'' Id. Mr. Parrado acknowledged that patients have the right to pay for their prescriptions in cash and that in some States, the law requires a pharmacy to allow a patient to pay in cash. Id. at 332. Mr. Parrado then testified that it is ``not so much the paying cash, it's the quantity of cash that raised the red flag to me.'' Id. While Mr. Parrado agreed that physicians may use a particular drug as their default option in treating a patient such as in prescribing a cholesterol-lowering medication, he disagreed that this practice also applies to pain management. Id. at 333. As he explained: ``how you treat diabetes, blood pressure, . . . cholesterol therapy, those are relatively standard therapies. But not in pain, pain has to be individualized, starting low and going slow as you reach the proper limit'' of dosing. Id. Respondent then asked if the fact that a prescriber tends to prescribe one drug over another for pain patients ``is not necessarily indicative of diversion, is it?'' Id. at 334. Mr. Parrado answered: ``It becomes a cause for concern when it's always the number one known drug of abuse on the streets. That's where it becomes a concern. And in oxycodone and Percocet, there's a very low dose, it's only five milligrams, whereas . . . oxycodone 30 presents a different issue.'' Id. Asked if when he verified the identity of a person filling a prescription, he would place a photocopy of the patient's identification on the prescription, Mr. Parrado acknowledged that ``[a] lot of times we did,'' or we had ``another page with it,'' or we ``scanned it into our computer where it showed up as part of that patient's profile.'' Id. at 336. When, however, Respondent asked Mr. Parrado if ``it would be appropriate for certain types of verifications and resolving of red flags to keep, say for example, a photo ID in an electronic file of a pharmacy, particularly in the age of computers,'' the ALJ intervened--again, in absence of an objection by the Government--and disallowed the question, explaining that ``whether it's appropriate or not, there is nothing before me that suggests that that was kept.'' Id. at 337. Mr. Parrado subsequently agreed with Respondent that ``not every failure to catch a red flag is intentional'' and that pharmacists can make mistakes. Id. at 337-38. While he agreed that a pharmacist may make mistakes in dispensing drugs, he then explained: The question is that it doesn't happen over and over and over and over, which was my concern in this case and the records I was looking at. Could a person come from a long distance once? Sure. Does it happen every day from a long distance multiple times? No. Id. at 338. Turning more specifically to the prescriptions filled by Superior II, Mr. Parrado reiterated that he did not interview any of the patients or prescribers, as well as that DEA did not provide him with any statements made by the patients or information about the patients' conditions. Id. at 339. Asked whether it would be appropriate for a pharmacist, who knew the address placed on the prescription by the prescriber was incorrect, to verify the patient's address and place a sticker on the prescription with the correct address, Mr. Parrado answered: ``I would want to document that I had . . . addressed that question . . . and then put [the sticker] on there.'' Id. at 341. He then maintained that while the stickers were placed on the prescriptions, he did not know that the pharmacists had verified the patients' addresses. Id. Asked whether it is appropriate for a pharmacist to add the address to the prescription when the physician did not include it, Mr. Parrado testified: ``[a]fter consultation with the physician.'' Id. at 342. When then asked if a DEA letter addressing the prescribing of schedule II drugs ``says that,'' Mr. Parrado testified that Florida law (Chapter 893) ``says that you verify with the prescriber,'' before acknowledging that a DEA letter ``does not say that.'' Id. Mr. Parrado agreed with Respondent that it would be permissible for a physician to prescribe pain medicine to ``two people who share a residence'' and who ``have chronic pain due to a car accident.'' Id. at 343-44. Asked whether ``if the prescriptions were legitimate, it would be permissible for a pharmacy to fill'' them, Mr. Parrado answered that it would be as long as the pharmacist had resolved the red flag and documented it. Id. at 344. As for the ``partial medical files'' he reviewed, Mr. Parrado could not answer as to how many of them were for Superior II's patients. Id. at 344. As for why he was provided with partial and not the full files, Mr. Parrado explained that it was his understanding that the files ``came from the Respondent to DEA who sent them to me.'' Id. at 345. Mr. Parrado acknowledged that as long as a prescriber is registered within a State, he can prescribe from anywhere in the State. Id. at 346. He then acknowledged that he had not looked into whether any of the prescribers had issued the prescriptions from locations other than where they were registered. Id. at 347. Regarding the prescription issued to J.S. for 180 oxycodone 30 but which was only filled for 120 tablets, see GX 3, at 25, Mr. Parrado acknowledged that a pharmacist can change the quantity in consultation with the prescriber. Tr. 347. As for the prescription issued to T.N. for Dilaudid which listed her address as Port Salerno but the address [[Page 31330]] and dispensing labels listed her address as Gainesville, GX 3, at 37- 38; Mr. Parrado agreed that the prescription did not present the red flag of a different address when it was presented to the pharmacy and that the sole red flag was the distance.\38\ Tr. 352. He then agreed that ``it is not a red flag for a pharmacist to affix the correct address to a prescription that contains an incorrect address,'' before adding that he ``would have documented'' his reason for ``changing the address.'' Id. at 353. However, on re-direct regarding the same exhibit, Mr. Parrado testified that if a patient presents a prescription which lists a different address for the patient from that in the pharmacy's records, this needs to be investigated and there was no evidence that the disparity was investigated. Id. at 362. --------------------------------------------------------------------------- \38\ Contrary to the question, Mr. Parrado had earlier identified the dosage as a red flag. Tr. 304. --------------------------------------------------------------------------- After Mr. Parrado noted that some of the partial medical records contained an opioid contract that required the patient to fill the prescriptions at one pharmacy, that being Respondent, he then acknowledged ``that there are a number of experts who believe that the one doctor, one pharmacy, one patient is the best way to prevent diversion when it comes to pain management.'' Id. at 355. And he agreed that ``[a]s long as everybody's doing their obligations,'' this approach is in ``the best interests of the patient.'' Id. He also acknowledged that Florida law requires the use of a pain management contract, and that the contract is supposed to identify where the prescriptions will be filled. Id. at 356. Evidence Regarding the Audits and Recordkeeping Allegations Next to testify for the Government was a Diversion Investigator (DI) who participated in the execution of the Administrative Inspection Warrant at Superior I. Id. at 370-71. The DI testified that at the time of the hearing, he had been a Diversion Investigator for more than five years and that he had conducted approximately 130 pharmacy inspections. Id. at 368-69. He also testified that he had received training in how to conduct controlled substance audits as part of his training to become a DI. Id. at 390. According to the DI, ``we collected original prescriptions,'' as well as DEA 222s (schedule II order forms), invoices and inventory records. Id. at 372. He also ``conducted the closing inventory'' and ``helped package the documents and all controlled substance related records.'' \39\ Id. The DI testified that he conducted an audit of Superior I's handling of controlled substances and prepared a computation chart. Tr. 373; see also GX 4 (No. 15-6). --------------------------------------------------------------------------- \39\ Asked whether he had any knowledge as to whether Superior I's computer records were electronically copied, the DI testified that while he did not handle that, he believed that digital evidence was collected. Tr. 372. --------------------------------------------------------------------------- With respect to the closing inventory, the DI testified that this involved a count of the drugs the pharmacy had on hand at the time of the inspection and that he was assisted by the pharmacist in performing the closing inventory. Id. at 373-74. He also testified that he used the pharmacy's ``bi-annual [sic] inventory'' which was dated May 2, 2011 (beginning of business),\40\ and used this as the beginning date of the audit. Id. at 374-75. As for the closing inventory, the DI testified that he counted the drugs on hand ``with the pharmacist,'' and that the pharmacist attested to the accuracy of the inventory. Id. at 376. The DI further testified that after the warrant was executed, he requested additional records through the lead Investigator because ``the bi-annual [sic] inventory'' which was provided by Superior I when the warrant was executed ``did not include all the drugs that were a part of the audit.'' Id. at 378. On February 11, 2013, the DI received additional inventories which included ``the bi-annual [sic] inventory and . . . an in-house inventory conducted by the'' pharmacy. Id. at 379. --------------------------------------------------------------------------- \40\ The DI subsequently explained he used the inventory which must be taken every two years (i.e., the biennial), ``which is required . . . per regulation 1304.11.'' Tr. 374. --------------------------------------------------------------------------- The DI then explained that in conducting the audit he reviewed the purchase records, ``the distribution transfers,'' ``any returns,'' and ``any disposition records'' which included the actual prescriptions.'' Id. at 378, 410. Subsequently, with respect to the prescriptions, he supervised a team which computed the dispensings, which were counted on a monthly basis. Id. at 412-13. The DI also explained that each of the team members was a DI, and as such, had been trained in how to conduct an audit. Id. at 414. According to the DI, ``we use whatever we have as well . . . to make cross checks and to verify that there are no inconsistencies.'' Id. at 378. Still later, the DI explained that he personally cross- checked some of the monthly dispensing totals. Id. at 412. The DI testified that his audit found that Superior I had shortages of multiple drugs. Id. at 380-382. The most significant of these were the shortages of 15,560 dosage units (du) of oxycodone 30 mg and 11,951 du of hydromorphone 8 mg. GX 4 (No. 15-6). In addition, the audit found that Superior had shortages of 946 du of hydromorphone 4 mg, 864 du of methadone 10 mg, 474 dosage units of morphine sulfate 100 mg ER, and 447 du of morphine sulfate 30 mg ER.\41\ Id. --------------------------------------------------------------------------- \41\ The audit also found an overage of 159 du of morphine sulfate 60 mg ER. GX 4 (No. 15-6). --------------------------------------------------------------------------- The DI also testified regarding the manner in which Superior I kept its Schedule II order forms (DEA 222). According to the DI, one of the order forms (GX 5, at 2) should not have been used because the pharmacist had lined out the National Drug Code (NDC) number for the drug being ordered and added a new NDC number. Tr. 383-84; see also id. at 386. The DI testified that according to 21 CFR 1305.15(a)(2), ``any alteration or any erasure or change of description should be a cause for a DEA 222 form not to be used.'' Id. at 383. The Government then asked the DI whether a second order form (GX5, at 3) was filled out properly. Id. at 384. The DI answered ``[n]o,'' and explained that ``the information in regard to the number of package[s] receive [sic] . . . was omitted.'' Id. On cross-examination regarding the altered order form (GX 5, at 2), the DI conceded that according to the regulation, the manufacturer should not have filled the order. Tr. 387. Then asked whether there was ``any problem with the pharmacy having corrected the Form 222, or is the problem that the manufacturer filled the order,'' the DI explained that ``the regulation says any alteration, any erasure, and that should not be used.'' Id. at 387-88. When then asked if it is unlawful to make a mistake on the form, the DI testified ``[t]he regulation is clear on how to use DEA 222 forms. And [the] DEA 222 form[] states that it should not be filled.'' Id. at 388. On cross-examination regarding the audit, Respondent's counsel asked the DI if there were any spreadsheets that showed how the DEA 222s were counted and how the dispensings were counted. Tr. 393. The DI answered: ``No, I don't have that at this time, sir.'' Id. Then asked whether he had ever had such documents ``at any time,'' the DI answered: ``I do not recall at this time if I have this or not.'' Id. Respondent's counsel then represented that when DEA provided Respondent with the CDs (which contained the records obtained from them) after the Order to Show Cause was served, the CDs included ``some scratch papers.'' Tr. 393. Counsel then [[Page 31331]] asked the DI if he ``recall[ed] working out some scratch papers where you may have done the math?'' Id. at 393-94. Counsel also advised the ALJ that he had copies if it would refresh the DI's recollection. Id. at 394. After the DI answered that he did ``not recall this,'' Respondent's counsel asked the DI if it would ``refresh [his] recollection if [he] looked at the notes?'' Id. The ALJ then intervened, stating: ``Documentation, even if it does, this documentation is not going to be allowed.'' Id. When Respondent's Counsel then argued that ``it's just for impeachment,'' the ALJ explained that while Respondent's Counsel could impeach the witness, he could not use documents which he did not provide ``ahead of time'' and that he had ``an obligation to provide [the documents] as part of the response to the Pre-hearing Statement.'' Id. at 394-95. Respondent's counsel then asserted that the documents were ``not intended to be used as an exhibit'' but ``merely to check the math.'' Id. at 395. He further asserted that when he went ``through the DEA 222s on the [m]orphine [s]ulphate tabs and add them up, all the ones that were were returned . . . by the Government, I get to a number of 7,200. And what I'm trying to figure out is whether or not there are any supporting documents where we can see your math to see if you got it correct.'' Id. After the Government objected that Respondent's counsel was testifying and the ALJ expressed his agreement with the Government, Respondents' counsel stated that he wanted to present the 222s to the DI and ``walk through the math together and see if Your Honor comes to the same number that they [sic] do.'' Id. at 396. The ALJ ruled that because Respondent's counsel ``didn't [timely] present the 222s as evidence,'' he would not allow the question. Id. Then asked whether he did his calculations ``by hand'' or by creating a spreadsheet, the DI testified that he could not recall what procedure he used because he did the audit two years earlier. Id. at 396-97. Asked if he used only the hard copy 222s or also used the electronic order records, the DI testified that he ``used all the DEA 222s that were there[] and there were some CSOS'' (electronic orders) as well. Id. at 397. The DI subsequently explained that the electronic orders were printed out and that he used the paper copy of these. Id. at 401. Then asked whether he did anything to control for math errors, the DI testified that he ``reviewed [his] counts on many occasions'' and ``did some cross checks'' with ``other documents provided by the pharmacy.'' Id. at 402. The DI also testified that he cross-checked Respondent's purchases by using ARCOS data,\42\ but because some distributors report only every quarter, he could only check approximately 95 percent of the purchase data. Id. at 402-04. --------------------------------------------------------------------------- \42\ See 21 CFR 1304.33 (setting forth ARCOS reporting obligations imposed on manufacturers and distributors). --------------------------------------------------------------------------- The Government called another DI, who testified regarding the execution of the AIW at Superior II and the subsequent audit of its handling of controlled substances. Id. at 469, 471. The DI testified that she delivered the warrant to the pharmacy manager and did a closing inventory. Id. at 471. She then asked for the purchasing records and the hard copy controlled substance prescriptions. Id. at 472. The DI testified that she was familiar with patient profiles and that no patient profiles were obtained during the execution of the warrant. Id. at 473. The Government then asked the DI about a number of Superior II's schedule II order forms. Id. at 473-74. Regarding the orders forms in GX 6 (No. 15-07), the DI testified that the forms were not filled out properly, as ``[t]hey are missing the number of packages received and date received on some of the lines on each form.'' Id. at 474. With respect to the first form in the exhibit, which had two line entries, each for 12 packages of 100 count of oxycodone 30, she identified line two as not being properly completed, apparently because it did not list the number of packages received and the date received. Id. Turning to the second form, she also identified the second line of the form as not being properly completed, apparently because it did not list the number of packages received and the date received. Id. However, the first two forms have the same serial number, thus establishing that one of them is a duplicate. Compare GX 6, at 1, with id. at 2. As for the next four forms, the DI testified that each was a copy and not the original and was thus a violation. Tr. 474-75; see also id. at 521. With respect to several of the remaining forms in the exhibit, she identified that for several of the line items there was no notation that ``no packages [were] received or date received.'' Id. at 475; see also id. at 476. However, on cross-examination, the DI testified that she relied on the entries on the forms maintained by Respondent and did not verify whether every line on the 222s had been actually shipped by the distributors. Id. at 518. While the DI acknowledged that sometimes distributors don't ship an entire order at once, she then testified that ``after 60 days, the 222 is invalid'' and the purchaser ``should go back and put a zero and the date they put the zero'' on the form. Id. at 520. However, when asked where, in the Pharmacist's Manual, it instructs registrants to do this, the DI answered: ``I couldn't tell you which page. But it does say they have to complete the 222 forms.'' Id. When then asked where in the regulation it says that, the DI stated that she did not ``know the specific quotation.'' Id. Moving back to the audit, the DI testified that ``we asked for purchasing records \43\ and dispensing records, and that the hardcopy original prescriptions \44\ were used as the dispensing record.'' Id. at 477. As the starting point of the audit, the DI testified that she ``asked when their last physical count was. And we used the July 31st, 2012. And the pharmacist got the numbers from their perpetual inventory.'' Id. On cross-examination, the DI reiterated her earlier testimony that she ``did not ask for perpetual inventory numbers. I asked for an actual physical count of those seven drugs.'' Id. at 491. She then explained that Superior II's employees ``told me that they take physical counts very frequently'' and that she ``asked them when their most recent one was that was at least six months'' old, ``[a]nd these were the numbers I was given.'' Id. at 491-92. As for the closing inventory, the DI testified that the pharmacist ``counted the pills, and I witnessed.'' Id. at 477. --------------------------------------------------------------------------- \43\ On cross-examination, the DI testified that she used both the paper and electronic 222 forms in doing the audit. Tr. 504. She also testified that ``[w]e always ask if there's been any theft or loss, returns, or if they have any outdated drugs.'' Id. She then testified that she specifically recalled asking a pharmacist for these records. Id. at 505. \44\ The DI testified that she asked for the hard copy Schedule II prescriptions for the period of January 1, 2011 through October 31, 2011, and from December 1, 2012 to the date of the warrant, February 4, 2013. Tr. 515. She also testified that ``I asked for specific date ranges, because there had been a notice of inspection prior to the admin. inspection warrant. So I asked for different date ranges.'' Id. at 514. The DI then explained that she did not participate in the prior inspection. Id. --------------------------------------------------------------------------- According to the DI, the audit found that Superior II was short 40 du of hydromorphone 4 mg and had an overage of 2,576 du of hydromorphone 8 mg. Id. at 479. As for the other drugs, the audit found overages of 1,189 du of oxycodone 30 mg, 896 du of methadone 10 mg, 674 du of morphine sulfate 30 mg, 563 du of morphine sulfate 60 mg, and 426 du of morphine sulfate 100 mg. GX 12. According to the DI, ``[a]n overage indicates that all records either [[Page 31332]] were not maintained or not provided.'' Tr. 480.\45\ --------------------------------------------------------------------------- \45\ Respondent objected to the admission of the computation chart, arguing that the opening inventory was based on Superior II's perpetual inventory, which it is not lawfully required to maintain. Tr. 483. The ALJ overruled the objection. Id. While there is no requirement to maintain a perpetual inventory, there is no requirement that the Government use only an actual hand counted inventory in establishing the quantities on hand on the beginning date of the audit period. Indeed, at times, a pharmacy is entirely missing the required inventory and the DIs use zero as the opening inventory. Most significantly, Respondent ignores that the DI testified multiple times that she asked for an actual physical count which was at least six months old and used what Superior II gave her. --------------------------------------------------------------------------- On cross-examination, the DI testified that she did not do any interviews and was not present during any interviews. Id. at 485. She further testified that she did not notify Superior II of the audit results and did not know whether another DI had done so. Id. at 486. She also testified that she did not do any further investigation into Superior II other than to review the records that were obtained and to complete the audit. Id. at 487. On further cross, the DI testified that in performing the audit, she did not compare the 222 forms she obtained from Superior II with those its suppliers provided to the Agency.\46\ Id. at 501. She also testified that she could not recall if she obtained ARCOS data to verify whether the documents obtained pursuant to the warrant contained ``accurate information,'' explaining that ``[w]hen we conduct [an] audit, it is the registrant's responsibility to provide all documents.'' Id. at 502. Subsequently, the lead investigator on the matter testified that she did not instruct anyone working on the investigation to ``consult ARCOS'' or to look at either the paper or electronic 222 forms that had been sent to the Agency.\47\ Id. at 583. --------------------------------------------------------------------------- \46\ Pursuant to 21 CFR 1305.13(d), ``[t]he supplier must retain Copy 1 of the DEA Form 222 for [its] files and forward Copy 2 to the Special Agent in Charge . . . in the area in which the supplier is located.'' \47\ The evidence also showed that only the DI and the lead DI ``handled the prescription records and the 222s.'' Id. at 584. --------------------------------------------------------------------------- The DI further testified that she kept track of the serial numbers on the 222s by spreading them out on a desk but did not ``make a document.'' Id. at 505. Respondent's counsel then asked her if she had considered several orders which he identified by drug, quantity, date, and the order form number. Id. The DI responded to these questions stating that if the record was provided, it was considered. Id. at 505- 08. Subsequently, the DI acknowledged that pharmacy personnel filling a prescription could make an error when counting the pills. Id. at 512. She then identified another DI who was involved in calculating the dispensing totals for the audit, as well as the pharmacy's receipts. Id. at 513. The Government's final witness was a DI from the Tampa office with 19 years of experience as such, who was the lead investigator in the Superior II matter. Id. at 539-40; 558. She testified that on November 30, 2012, she participated in a Notice of Inspection at Superior II, which she explained involved ``go[ing] on-site and advis[ing] the registrant that we're going to be doing an audit of their controlled substance records.'' Id. at 541. She further testified that during the Notice of Inspection issued to Superior II, ``[w]e obtained records, purchase records, and dispensing records which consisted of the prescriptions.'' Id. The DI testified that she was not present at Superior II when the AIW was executed. Id. at 542. However, she did review the records seized from Superior II to include its purchases and dispensing records. Id. at 543. She also testified that no patient profiles were taken during the November 30 inspection and that when she reviewed the records obtained from Superior II pursuant to the AIW, she did not see any patient profiles. Id. at 544. Subsequently, she testified that the records she told Mr. Parrado that he could not review were the records she obtained from the State's Prescription Drug Monitoring Program. Id. at 546-48. And later, on cross-examination, she clarified that Mr. Parrado did not get the PDMP records. Id. at 559. She also testified that she did not provide the ``partial medical records'' to Mr. Parrado, id. at 577, and that the records were provided by Government Counsel.\48\ Id. at 578. --------------------------------------------------------------------------- \48\ Later, on re-direct, the Government asked the DI if she had ``ever subpoenaed any medical records from any clinics owned by Mr. Obi-Anaduime?'' Tr. 589-90. The DI testified that ``[o]n the same day of the administrative inspection warrant, we issued subpoenas for the clinic, 21st [sic] Century.'' Id. --------------------------------------------------------------------------- Thereafter, the DI acknowledged that various notations made on the Superior II order forms were her initials and that she did not keep a clean copy of the documents. Id. at 549. According to the DI, when she reviews records, she ``will usually initial it in some way or the other just to let me know that I did review that record.'' Id. She testified that the 222s that were returned to Respondent had her initials on them. Id. at 550. Turning to Superior's II ordering of controlled substances using the Controlled Substances Order System (CSOS), the DI testified that during the November 30, 2012 inspection, she met with a pharmacist (Mr. Majed) and asked to see its primary records for the receipt of controlled substances. Id. at 551. According to the DI, Mr. Majed stated ``that once he gets the orders he inputs it into the system[,] . . . places the order[,] . . . then . . . prints out'' the form, and upon receipt of ``the product, he jots it down where it says packages shipped and packages and dates shipped. So I said this is your receipt. After you receive them manually,'' at which point Respondent objected.\49\ Id. at 551-52. After the ALJ overruled the objection, the DI testified that when she asked Mr. Majed what he did once he received product, Mr. Majed said that ``he notates [the receipt of product] on this paper form'' and that he did not go back into the CSOS and enter the receipt because ``he wasn't aware that he had to do that.'' Id. at 554. She then asked Mr. Majed if the paper records were the ``primary records'' and was told ``yes.'' The DI then testified that these were the records she used for the audit. Id. --------------------------------------------------------------------------- \49\ Respondent objected on the grounds of hearsay and the lack of notice. As for the latter objection, this was based on the Government having been ``aware of [Mr. Majed's] participation in this and [it] gave us no notice in [its] pre-hearing statement that [it] intended to have this witness testify about things that he said.'' Tr. 552. Respondent did, however, have notice of the issue through the Government's disclosure of the DI's testimony. ALJ Ex. 6, at 6-7 (No. 15-7) (``She will testify that Respondent, as a purchaser of controlled substances via [the CSOS], failed to create an accurate record of the quantity of controlled substances received and the date received. She will testify that Respondent failed to electronically archive and link these records to the original order, as required by the . . . [r]egulations.''). As for Respondent's objection that the testimony was hearsay, hearsay is admissible in these proceedings and Respondent made no argument as to why the testimony was unreliable. --------------------------------------------------------------------------- Continuing, the Government asked the DI whether a printout of an electronic 222 form complied with DEA regulations. Id. at 555. According to the DI, the document ``should have been linked'' and was the ``supplier's copy'' and not the ``purchaser's copy.'' Id. at 556. The DI further explained that ``[y]ou see where it says packages shipped? He's not the supplier. He's the purchaser. So that should be packages received and date received. What he's showing me here is the supplier's copy.'' Id. Moreover, to the DI's knowledge, this record was not included in any database. Id. The DI further explained that in order for a person to use the CSOS, the person has to have a pass key. Id. at 556-57. However, while Mr. Majed represented that he had a key, the DI subsequently determined that he did not, and that only Mr. Obi (the owner) and another [[Page 31333]] pharmacist (Ms. Minozzi) had pass keys. Id. at 557-58. On cross-examination, the DI acknowledged that because she had the PDMP records she could determine whether the patients were opioid tolerant or opioid na[iuml]ve. Id. at 559-60. The DI did not, however, use that information. Id. at 560. The DI further testified that electronic 222 forms found in Government Exhibit 7 were obtained during the AIW, when she was not present. Id. at 563. When then asked whether her testimony regarding the statements made by Mr. Majed were based on her personal knowledge, the DI testified that they were made during the notice of inspection. Id. The DI also testified that Mr. Majed told her that the handwritten notations on printouts of the electronic 222 forms were of the packages that the pharmacy had actually received and the date received. Id. at 567. The DI testified that if Superior II pharmacists had correctly documented their receipts of drugs, ``they would have printed out the receipt and the receipt date'' on a different form and not used the supplier's copy. Id. The DI then testified that the receipt record must be electronically linked to the same record that the pharmacy used to place the order. Id. at 569. Respondent's counsel further attempted to ask the DI if she had investigated if Superior II had stopped ordering oxycodone after the AIW. Id. at 574. While the Government objected that the question was outside the scope, the ALJ initially overruled the objection. Id. However, after Respondent re-asked the question with only an immaterial change in wording, the ALJ barred the question, on the ground that Respondent had not acknowledged any misconduct in its Pre-hearing Statement. Id. at 575-77. Before the Government rested, it requested a ruling from the ALJ clarifying whether Respondents would be allowed to call any witnesses. Id. at 594. After the ALJ stated that he agreed with the Government's understanding that Respondents would not be allowed to call any witnesses, Superior II's counsel stated that he intended to call a witness. Id. Asked by the ALJ to provide ``the legal basis for . . . Superior II to produce any witnesses, given [his] prior orders,'' Superior II's counsel stated that ``we have noticed witnesses in the Pre-hearing Statement,'' including Mr. Obi-Anadiume. Id. at 595. Again asked to explain the legal basis for calling any witnesses, Superior II's counsel argued that in its Prehearing Statement, it notified the Government that it intended to call ``any and all witnesses identified in the Government's Pre-hearing Statement.'' Id. at 597. As to the issues that Mr. Obi would testify to, Superior II's counsel argued that ``the summary of [his] testimony'' was ``covered sufficiently'' by the Government in its Prehearing Statement and that ``the Government has no prejudice with respect to this.'' Id. at 597-98. Superior II's counsel then asserted that because Government counsel had represented in its Prehearing Statement that it intended to call Mr. Obi and had subpoenaed him, he should be allowed to testify. Id. Superior II's counsel further argued that under section 555 of the Administrative Procedure Act, Mr. Obi was an interested person who had the right to participate in the proceeding, and that ``fundamental fairness'' required that he be allowed to testify. Id. at 598-602. After Superior II's counsel represented that he was making the same motion with respect to Superior I, the ALJ asked if he was relying on the Government's Prehearing Statements as his proffer. Id. at 604. Superior II's counsel advised that there was one additional matter that went beyond the scope of the proposed testimony--``the acceptance of responsibility and corrective action.'' Id. at 604. Superior II's counsel further represented that he had ``submitted written information to [Government Counsel] with language of proposed acceptance of responsibility and with specific corrective actions that have already been taken, and those that are being taken and those that will be taken in the future.'' Id. at 605. The ALJ denied the motion, noting that the proffer ``clearly . . . exceed[ed] what the Government presented in its Pre-hearing Statement.'' Id. at 606. Continuing, the ALJ stated: With all due respect to your colleagues, I think these were well informed lawyers making strategic decisions to keep as little information in the Pre-hearing Statements as possible. And I think it ill-served the course of justice and makes this proceeding a much more difficult process merely because of a strategic decision to keep me in the dark. I'm not attributing that to you at all. And I don't expect a response, nor will I care to hear a response with respect to that. I've already given Mr. Sisco the opportunity to explain why the record is as it is in documents that I've received from Respondents. And that record will stand, I will address that at another time in another forum. But from what you've told me, I don't see a legal justification for allowing the Respondent to, in either case . . . present testimony. Id.\50\ The ALJ thus denied Respondents' motion. Id. at 606-07. \50\ While the ALJ then offered the Government the opportunity to respond to the motion, the Government chose not to. Tr. 607. --------------------------------------------------------------------------- Superior II's counsel then sought to allow Mr. Obi to testify by asking and ``answering the questions [himself] that are posed in the Government's Pre-hearing Statement.'' Id. at 608. The ALJ denied the request. Id. Superior II's counsel then sought to take an interlocutory appeal of the ALJ's ruling. Id. The ALJ denied the motion. Id. Explaining that he wanted to understand how the proffer would be done, Superior II's counsel then asked the ALJ if he wished for him ``to proffer what would be said'' by Mr. Obi. Id. at 609. The ALJ responded ``no,'' and explained that Superior II's counsel had given him the ``substance of what that information would be.'' Id. Superior II's counsel then argued that he should be allowed ``to put the full proffer . . . on the record.'' Id. In response, the ALJ stated that Superior II's counsel had made ``a sufficient proffer,'' noting that he had sought to go ``beyond the scope of what the Government covered and enter[] into the area of acknowledgment and remediation [which] would not be permitted[,] [b]ecause you did not disclose it in advance.'' Id. at 610. The ALJ then stated that this told him ``the broad parameters'' and that was all he needed ``to preserve your client's right.'' Id. Superior II's counsel then explained that his ``statements about the Government's Pre-hearing statement and the broader subject matters [was] not the proffer [and] that the proffer is substantially broader [as] it addresses individual patients, because the Government's Pre- hearing Statement called for those things.'' Id. at 610-11. Superior II's counsel then explained that he understood ``that this may be a bifurcated issue where there's a notice issue on acceptance of responsibility [and] corrective action,'' but ``no notice issue on what's in the Government's Pre-hearing statement but [was] still being excluded from the record.'' Id. at 611. Superior II's counsel then represented that with respect to ``the matter of what is in the Government's Pre-hearing Statement . . . Respondent has an extensive proffer about that for the record which would address a wide variety of things.'' Id. Continuing, Superior II's counsel explained that his previous statements were his ``legal argument rather than the factual proffer'' and then asked that he ``be [[Page 31334]] permitted to actually make the detailed proffer.'' Id. at 611-12. The ALJ rejected the request, explaining that ``[y]ou were permitted to do so. That's what the Pre-hearing Statement was for.'' Id. at 612. Continuing, the ALJ explained that the record now reflected Respondent's proffer and ``that the detailed proffer that you're describing was appropriate and was not provided to me in a timely fashion. And I believe that was a strategic decision of prior counsel.'' Id. The Government then rested. Id. at 612-13. Thereafter, Superior II's counsel sought to call Mr. Obi. Id. at 614. The ALJ denied the request for the reasons he had previously explained. Discussion Under the 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. ``[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.\51\ --------------------------------------------------------------------------- \51\ 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, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821. Likewise, findings under a single factor can support the denial of an application. --------------------------------------------------------------------------- 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. 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.\52\ For reasons explained below, I find the Government's evidence insufficient to establish that Respondents' pharmacists violated their corresponding responsibility when they dispensed the prescriptions at issue. However, I find that the Government has established by substantial evidence that Respondents have failed to maintain accurate records, as well as other violations, and that it has thus established that Respondents have committed acts which render their registrations ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). Because I further find that Respondents did not properly disclose in advance of the proceeding their proposed evidence as to any remedial measures, I conclude that Respondents have not rebutted the Government's prima facie showing. I will therefore order that each Respondent's registration be revoked and that any pending application be denied. --------------------------------------------------------------------------- \52\ 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 either Respondent, or taken any disciplinary action against either Respondent. See 21 U.S.C. 823(f)(1). However, even assuming that each Respondent currently possesses authority to dispense controlled substances under Florida law and thus meets a prerequisite for maintaining its registration, 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 each Respondent'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 (D.C. Cir. 2008)). As to factor three, I acknowledge that there is no evidence that either of the Respondents, or Mr. Obi-Anadiume, or any of the Respondents' 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, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). The Agency has therefore held that ``the absence of such a conviction is of considerably less consequence in the public interest inquiry'' and is therefore not dispositive. Id. As to factor five, no evidence was offered with respect to it. --------------------------------------------------------------------------- Factors Two and Four--The Respondent's Experience in Dispensing Controlled Substances and Compliance with Applicable Laws Related to Controlled Substances The Dispensing Allegations ``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.'' Id. Sec. 802(10). 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. 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.\53\ --------------------------------------------------------------------------- \53\ 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)). [[Page 31335]] --------------------------------------------------------------------------- Id. (emphasis added). As the Agency has made clear, to prove a violation of the corresponding responsibility, the Government must show that the pharmacist acted with the requisite degree of scienter. 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: (1) That pharmacist filled a prescription notwithstanding his/ her actual knowledge that the prescription lacked a legitimate medical purpose; or (2) that the pharmacist was willfully blind (or deliberately ignorant) to 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)). Here, the Government makes no claim that any of Respondents' 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 dispenses a controlled substance prescription ``in the face of a red flag (i.e.[,] a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he . . . takes steps to resolve the red flag and ensure that the prescription is valid.'' Gov. Post- Hrng. Br. 16. The Government argues that each Respondent's pharmacists violated this regulation by filling oxycodone prescriptions which presented various ``red flags'' which were never resolved. Gov. Post- Hrng. Br. 15-18. Noting that its pharmacy expert gave ``unrefuted testimony,'' the Government argues that ``[a]ll of the prescriptions discussed by [its Expert] we[re] for highly abused drugs such as oxycodone and hydromorphone'' and ``contained one or more of'' some six ``red flags.'' Id. at 17. It further argues that the Expert ``testified that no evidence could be found to show the red flags had been resolved prior to dispensing.'' Id. As proof for its assertion that the red flags were not resolved, the Government points to its Expert's testimony ``that, in the practice of pharmacy, a red flag which is resolved must be documented and that the documentation should be placed on the prescription itself.'' Id. It further notes that the prescriptions contained no notations showing that the pharmacists resolved the red flags (with the exception of the address stickers that were placed on the prescriptions). It further contends that ``[t]o the extent the Respondents may argue that [their] practice was to place such documentation elsewhere, that argument flies in the face of evidence showing that [the pharmacies] habitually corrected `mistakes' related to prescriptions on the prescriptions themselves,'' such as the missing patient addresses and the instance in which a pharmacist marked on the prescription that it had only been partially filled. Id.at 17-18. Here, I assume that the red flags with respect to each prescription or the convergence of red flags--as there were typically multiple red flags associated with each prescription--establishes that the pharmacists ``subjectively believed that there was a high probability'' that the various prescriptions lacked a legitimate medical purpose.\54\ I nonetheless conclude that the Government has failed to put forward sufficient evidence to establish that the pharmacists failed to resolve the various red flags (i.e., that they deliberately failed to avoid learning of the fact that the prescriptions lacked a legitimate medical purpose). --------------------------------------------------------------------------- \54\ All red flags do not have the same hue, and as the Supreme Court's decision in Global-Tech makes plain, proof that a pharmacist dispensed a controlled substance prescription without resolving a red flag which only created a ``reasonable suspicion'' that the prescription lacked a legitimate medical purpose, is not enough to establish that a pharmacist acted with the requisite scienter. However, where there are multiple red flags, none of which alone would establish the requisite scienter, the combination of red flags may well create a subjective belief that there is a high probability that a prescription lacks a legitimate medical purpose. --------------------------------------------------------------------------- As noted above, as proof that the pharmacists failed to resolve the red flags, the Government relies solely on the absence of such documentation on the prescriptions themselves and the Expert's testimony that it is the custom in pharmacy practice to document the resolution of a red flag on the prescription. Yet as the Expert conceded, no provision of the Controlled Substances Act, DEA regulations, Florida law, or the Florida Board of Pharmacy's regulations requires that a pharmacist document the resolution of red flags on the prescription itself.\55\ While it would be reasonable to draw an adverse inference that a pharmacist failed to resolve a red flag (or flags) from the failure to document the resolution in any manner, the Government offered no evidence that the DIs even asked the pharmacists at either Respondent if they documented their resolution of red flags, and if so, where they did so. --------------------------------------------------------------------------- \55\ While it may be customary in the profession to document the resolution of a red flag on the prescription itself, that does not make it improper to document the resolution someplace else. Moreover, while evidence of a custom certainly has probative value, it is not conclusive proof. See Sorrels v. NCL (Bahamas) Ltd., 796 F.3d 1275, 1282 (11th Cir. 2015) (`` `[E]vidence of custom within a particular industry, group, or organization is admissible as bearing on the standard of care in determining negligence. Compliance or noncompliance with such custom, though not conclusive on the issue of negligence, is one of the factors the trier of fact may consider in applying the standard of care.' '') (emphasis added) (quoting Muncie Aviation Corp. v. Party Doll Fleet, Inc., 519 F.2d 1178, 1180-81 (5th Cir. 1975)); II Wigmore, Evidence, Sec. 379, at 403 (Tillers rev. ed. 1983) (explaining that with respect to evidence of custom or usage of trade, ``the question is not whether the offered instances fully prove the custom alleged, but merely whether they are receivable as having probative value''). --------------------------------------------------------------------------- Here, a regulation of the Florida Board of Pharmacy (then in effect) specifically 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 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. The rule further required that the record include the ``[p]harmacist['s] comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.'' Id. 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. Finally, the rule required that ``[t]he pharmacist . . . record any related information indicated by a licensed health care practitioner.'' Id.\56\ --------------------------------------------------------------------------- \56\ This rule remains in effect today; however, the rule now requires that the information be maintained for a period of four years preceding the most recent entry. --------------------------------------------------------------------------- [[Page 31336]] Of further note, the Board of Pharmacy's rules require that a pharmacist ``review the patient record and each new and refill prescription presented for dispensing in order to promote therapeutic appropriateness.'' Fla Admin Code r. 64B16-27.810. This rule specifically requires that a pharmacist identify such issues as: ``[o]ver-utilization,'' ``[t]herapeutic duplication,'' ``[d]rug-drug interactions,'' ``[i]ncorrect drug dosage,'' and ``[c]linical abuse/ misuse.'' Id. On cross-examination, the Expert testified that he asked DEA ``for complete profiles on all these patients'' but was told to look at only the prescriptions. Tr. 247; see also id. at 324-25 (testimony of Expert that he had asked for patient profiles for the Superior II patients and was told not look at them, although it was unclear whether he actually received them). He further acknowledged that a patient profile would show a patient's complete history of the prescriptions filled at the pharmacy during the period for which it was run, as well as whether the patient was opioid na[iuml]ve or tolerant. Id. at 325. While subsequent testimony suggests that the Agency's Investigators did not obtain the patient profiles (at least with respect to Superior II) \57\ but only state PMP reports, both the Board's regulation and the Expert's testimony establish that the patient profiles were relevant evidence in assessing whether Respondents' pharmacists had resolved the red flags, whether they contained such proof or not. --------------------------------------------------------------------------- \57\ With respect to Superior I, a DI testified that he believed that digital evidence was collected. Tr. 372. --------------------------------------------------------------------------- The Government nonetheless argues that it had no obligation to produce the patient profiles and that the Respondents' position would force the Government to ``search the entire universe for exculpatory evidence.'' Gov. Mot. to Supplement the Record, Strike Respondent's Untimely Exceptions, . . . Or, In the Alternative, Respond to Exceptions, at 15. It further argues that it is entitled to an adverse inference that Respondents' pharmacists did not resolve the various red flags because such evidence, if it does exist, is ``under the complete control of the Respondent'' and ``not DEA'' and Respondent ``fail[ed] to produce'' it. Id. (citing Int'l Union, UAW v. NLRB, 459 F.2d 1329, 1336 (D.C. Cir. 1972)). As for the contention that Respondents' position would force the Government to ``search the entire universe for exculpatory evidence,'' it does no such thing. Indeed, the Government ignores that its own Expert sought to review the patient profiles and that the Board of Pharmacy's rules mandate that a pharmacist review the patient's profile as part of the prospective drug use review which is required before filling a prescription. Unexplained by the Government is why it would be improper for pharmacists to document their resolution of a red flag in the patient profile given that the Board's rules required (and still require) that a pharmacist document his/her ``comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug,'' as well as ``any related information indicated by a licensed health care practitioner'' in that record. Of further consequence, the Government produced no evidence establishing when the various patients first filled prescriptions at Respondents for the drugs in the prescriptions at issue here. Unexplained by the Government is why, if the red flags associated with a specific patient and prescription had been previously resolved and this was documented in the patient profile, the pharmacists were nonetheless required to document this on subsequent prescriptions. I also reject the Government's contention that it is entitled to an adverse inference based on the failure of Respondents to produce any evidence showing that they resolved the red flags. Under the adverse inference rule, if a party has evidence within its control that ``would in fact strengthen [its] case, [it] can be expected to introduce it even if it is not subpoenaed.'' Int'l Union, 459 F.2d at 1338. Be that as it may, while the patient profiles remained within Respondents' control, International Union itself recognizes that ``if a party has good reason to believe his opponent has failed to meet [its] burden of proof, [it] may find no need to introduce his strong evidence.'' Id. Here, the Government has the burden of proof. See 21 CFR 1301.44(d) & (e). While it may be that there is nothing in the patient profiles which would have been favorable to Respondents, given that the Government's Expert acknowledged the relevance of these records and the scope of the information required by the Board's rule to be maintained in them, requiring the Government to put forward evidence as to whether the patient profiles show that the various red flags were not resolved, is not fairly described as requiring it ``to search the entire universe for exculpatory evidence.'' To the contrary, obtaining and reviewing patient profiles would seem to be fundamental to conducting an adequate investigation of the dispensing allegations. As further support for its contention that the absence of documentation on the prescriptions is proof that the red flags were not resolved, the Government points to the evidence showing that where the physicians failed to include the patients' address, the pharmacists placed address stickers on the prescriptions. It also points to a single prescription, which was partially filled, and that the pharmacist documented this on the face of the prescription. Yet Florida law expressly required (and still requires) that a patient's address ``appear on the face of the prescription.'' Fla. Sta. Ann. Sec. 893.04(c); see also 21 CFR 1306.05(a) (``All prescriptions for controlled substances . . . shall bear the full name and address of the patient[.]'').\58\ As for the partially filled prescription, a DEA regulation requires that the pharmacist ``make a notation of the quantity supplied on the face of the written prescription . . . or in the electronic prescription record.'' 21 CFR 1306.13(a). By contrast, no law or rule requires the documentation of the resolution of a red flag to be placed on the prescription itself. Finally, it bears repeating that there is no evidence in the record that the Investigators even asked Respondents' pharmacists, as a general matter, if they resolved red flags presented by controlled substance [[Page 31337]] prescriptions, and if so, how they documented having done so.\59\ --------------------------------------------------------------------------- \58\ Quoting 21 CFR 1306.05(a), the Government suggests that prescriptions were ``[d]ispensed in an [i]mproper manner.'' Gov. Post-Hrng. Br. 18. The Government then states: ``[a]s evidenced [b]y many of the prescriptions themselves for both Superior I and II, prescriptions were repeatedly issued absent a patient address.'' Id. The Government, however, offers no further explanation as to why Respondents violated federal law by filling the prescriptions given that they contain address stickers for the patients. Of note, the DEA Office of Diversion Control maintains a Web page of ``Questions & Answers'' pertaining to prescriptions. See http://www.deadiversion.usdoj.gov/faq/prescriptions.htm. One of the questions is: ``What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?'' Id. at 2. In its answer, the Office of Diversion Control noted a conflict between its previous policy and a statement made in a 2007 rulemaking entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances; the answer further explained that the Agency ``plans to resolve this matter through a future rulemaking.'' Id. The Answer then advised that ``[u]ntil that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.'' Id. Because the Government has produced no evidence that Florida law, the Board of Pharmacy's regulations, or the Board's policy prohibited the pharmacists from adding the patient's address to the prescriptions, I reject the Government's suggestion. \59\ The Government also alludes to testimony by its Expert to the effect that he was shown partial medical records for the patients and that he found no evidence in these records ``that any conversation had taken place between the prescriber and the Respondents' pharmacist.'' Gov. Post-Hrng. Br. 17 n.10. None of these records are in evidence, and thus, there is no evidence establishing when the patients first saw the physicians and whether there was any communication between the pharmacists and prescribers at that time. In any event, there is no evidence in the record establishing that a physician has an obligation under the standard of care to document phone calls from a pharmacist questioning his prescription. Accordingly, I place no weight on this testimony. --------------------------------------------------------------------------- Accordingly, I find that the Government's allegations that Respondents' pharmacists violated 21 CFR 1306.04(a) and Fla. Stat. Ann. Sec. 465.016(1)(s)) when they dispensed controlled substance prescriptions without resolving the red flags presented by the prescriptions are not supported by substantial evidence.\60\ --------------------------------------------------------------------------- \60\ As found above, on various occasions, the Government elicited testimony from its Expert, over Respondents' objections, to the effect that some of the prescriptions presented red flags that could not be resolved. While the Government made no argument based on this testimony in its Post-hearing Brief, the ALJ made multiple findings that several of the prescriptions presented red flags that could not be resolved. See R.D. 80-81 (FoF#s 9, 10). Moreover, in its Response to Respondent's Exceptions, the Government invokes this evidence. See Gov. Response to Resp.'s Exceptions, at 14 (``Notwithstanding the fact that Mr. Parrado credibly testified that he discovered red flags which, in his opinion, were unresolvable . . . Respondents are now arguing for a new rule that requires the Government to prove a negative.'') (citing Tr. 145-46, 289-90). While in the Show Cause Orders, the Government made conclusory allegations to the effect that the Respondents' ``pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose,'' ALJ Ex. 1, at 2 (No. 15-6), which implies that the red flags could not be resolved, the Government never identified a specific prescription in either Show Cause Order or any of its Prehearing Statements that could not be resolved. As explained previously, while the ALJ overruled Respondents' objections, the correct standard is not whether the ALJ wanted to know the answer to the Government's question, Tr. 287, but whether Respondents knew ``what conduct was being alleged and ha[d] a fair opportunity to present [their] defense.'' Duane v. DOD, 275 F.3d 988, 995 (10th Cir. 2002) (quoting Facet Enters., Inc., v. NLRB, 907 F.2d 963, 972 (10th Cir. 1990). See also Pergament United Sales, 920 F.2d at 135 (``Notice does not mean a complaint necessarily must state the legal theory upon which the General Counsel intends to proceed. Instead notice must inform the respondent of the acts forming the basis of the complaint.''); see also id. (``The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.''). Because the Government never alleged that any of the prescriptions could not be resolved, and Respondents objected to this line of inquiry, there is no basis for a finding of litigation by consent. Accordingly, I do not consider the testimony that the some of the prescriptions presented unresolvable red flags. --------------------------------------------------------------------------- The Audits and Recordkeeping Allegations The evidence nonetheless shows that both Respondents violated the CSA by failing to maintain and/or properly maintain required records. With respect to Superior I, the evidence is particularly egregious, as an audit conducted by Agency Investigators found that the pharmacy had shortages of 15,560 du of oxycodone 30 mg and 11,951 du of hydromorphone 8 mg. In addition, Superior I was short 946 du of hydromorphone 4 mg, 864 du of methadone 10 mg, 474 du of morphine sulfate 100 mg ER, and 447 du of morphine sulfate 30 mg ER. Thus, Superior I was short more than 30,000 du of highly abused controlled substances. And while Superior II had only a small shortage of a single drug, it had substantial overages in several drugs, including 2,576 du of hydromorphone 8 mg and 1,189 du of oxycodone 30 mg. ``Recordkeeping is one of the CSA's central features; a registrant's accurate and diligent adherence to this obligation is absolutely essential to protect against the diversion of controlled substances.'' Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Fred Samimi, 79 FR 18698, 18712 (2014) (finding where physician ``had shortages totaling more than 40,000 dosage units'' of various drugs that his ``inability to account for this significant number of dosage units creates a grave risk of diversion,'' and that ``even were there no other proven violations, the audit results alone are sufficient to . . . establish[] that [physician's] registration[] `would be inconsistent with the public interest''') (citations omitted). During the hearing, Respondents raised various challenges to the validity of the audits. With respect to the Superior I audit, Respondent's counsel attempted to impeach the DI's result by using a document he described as ``scratch paper'' which, according to his representation, had been included among the documents returned to Respondents on the CD and which listed the DEA 222 forms for Superior I's morphine sulfate orders; Respondent's counsel further represented that when he added up the orders, he got a number of 7,200 du. Tr. 395. I need not decide whether the ALJ erred when he barred Superior I's counsel from using this document to impeach the DI, Tr. 394-95, because Respondent did not properly preserve the claim of error. Notably, Respondent's counsel did not seek to submit the document even as a rejected impeachment exhibit, and in its Post-hearing Brief, Respondent did not specifically identify this ruling as being in error. Indeed, while in its Post-hearing Brief, Superior I proposes as a factual finding that it ``proffered Exhibits 3 through 9 including invoices and other records that demonstrate errors in the DEA audit which resolve the alleged inventory overages,'' Resp. Post-Hrng. Br. 9 (emphasis added), with respect to Superior I, the gravamen of the Government's audit allegation was that it had shortages of multiple drugs.\61\ Moreover, Exhibits 3 through 9, which comprise nearly 1500 pages of assorted documents, and which purportedly include relevant records for each of the audited drugs, are just that--raw documents, with no accompanying explanation or calculations showing why the Government's audit results are in error.\62\ --------------------------------------------------------------------------- \61\ Likewise, even assuming the correctness of Superior I's counsel's representation that when he added up the morphine sulfate orders, he got ``a number of 7,200,'' Tr. 395, he made no proffer as to errors with respect to the audit results for oxycodone 30 mg and hydromorphone 8 mg, which found massive shortages. \62\ It is noted that Respondents attached, as supplements to their untimely filed Exceptions, charts which purport to show audit results for both pharmacies which are dramatically different from those found by the Government. See Resp. Exceptions, at Appendices A & B. Respondents offered no foundation for consideration of the charts, and in any event, the charts are not properly considered as newly discovered evidence. Furthermore, while throughout the proceeding, Respondents have argued that their due process rights have been violated because the Agency's Lead Investigator ``unlawfully retained'' records seized pursuant to the Administrative Inspection Warrants for some 611 days, Resp. Post-Hrng. Br. 18, Respondents were provided with the records on or about the same day they were served with the Show Cause Orders, which made specific allegations as to the audits. Thus, Respondents had approximately 80 days from the date they were informed of the allegations to the date on which they were required to file their Prehearing Statements to investigate the allegations pertaining to the audits and prepare a defense. While Respondents argue that ``[t]he first access [they] had to what may or may not be all of the evidence was on the day that DEA served its Order to Show Cause,'' Resp. Post-Hrng. Br. 19, they did not identify any records that were necessary to complete their audits which were not provided to them when their records were returned. --------------------------------------------------------------------------- Respondent also questioned the validity of the audits on the ground that while the DIs could have verified their calculations as to the level of Respondents' purchases of the drugs by obtaining data from the Agency's ARCOS database, they ``willfully chose to ignore that evidence which would have demonstrated the accuracy of the pharmacies' records with respect to [their] purchases.'' Id. at 20. Contrary to Respondent's understanding, one of the purposes of an audit is to determine whether the audited party is maintaining ``a complete and accurate [[Page 31338]] record of each [controlled] substance . . . received, sold, delivered, or otherwise disposed of by him.'' See 21 U.S.C. 827(a)(3); see also id. at Sec. 827(a)(1) (requiring registrants to ``make a complete and accurate record of all stocks . . . on hand'' when ``first engag[ing] in the . . . dispensing of controlled substances, and every second year thereafter''). Putting aside that Respondents produced no evidence showing discrepancies between the DIs' calculations as to the quantities of the drugs received by them and the distributions as reported by their suppliers to the ARCOS system, the DIs were entitled to rely on the records provided by Respondent in response to the warrant. Given that ARCOS data is compiled from distribution reports submitted by manufacturers and distributors, and Respondents were not required to file reports to ARCOS, see 21 CFR 1304.33(c), the DIs had no obligation to cross-check their calculations with ARCOS data. Respondent Superior II questioned the validity of the audit pertaining to it, on the ground that the DI based her initial inventory figures on a perpetual inventory which Respondent is not lawfully required to maintain. However, the DI testified multiple times that she asked for an actual physical count which was at least six months old and used what Superior II gave her. Tr. 491-92. I thus reject Respondent's challenge to the findings of the audit of Superior II, which establishes that it had overages in several drugs.\63\ --------------------------------------------------------------------------- \63\ While Superior II also argues that DEA failed to consider ARCOS data in auditing it, I reject the argument for the same reasons that I rejected the argument with respect to Superior I's. --------------------------------------------------------------------------- I thus find that both pharmacies failed to maintain complete and accurate records as required by 21 U.S.C. 827(a)(1) & (3). While this finding alone supports the conclusion that each pharmacy has committed such acts as to render its continued registration ``inconsistent with the public interest,'' see 21 U.S.C. 824(a)(4), the scope of the shortages of oxycodone 30 mg and hydromorphone 8 mg found during the audit of Superior I supports a sanction of revocation. See Samimi, 79 FR at 18712. The Government further alleges that Respondents failed to properly complete various schedule II order forms. More specifically, with respect to Superior I, the Government's evidence included an Order Form for oxycodone 30 on which the National Drug Code was changed. GX 5, at 1 (No. 15-6). However, while the DI testified that ``any alteration or any erasure or change of description'' should result in the form not being used,'' the applicable regulation actually states that the order ``must not be filled if . . . [t]he order shows any alteration, erasure, or change of any description.'' 21 CFR 1305.15(a) (emphasis added). Thus, the regulation is not fairly read as imposing liability on Superior I for changing the National Drug Code. The DI also testified that a second order form was not filled out properly, because ``information in regard to the number of package[s] receive [sic] . . . was omitted.'' Tr. 384. However, the Government offered no evidence that any portion of the two orders listed on the form were filled. While DEA's regulation states that ``[t]he purchaser must record on Copy 3 of the . . . 222 the number of commercial or bulk containers on each item and the dates on which the containers are received by the purchaser,'' 21 CFR 1305.13(e), the Government points to no provision which requires, where no portion of a line entry has been filled by the expiration of the 60-day period in which the Order Form is valid, id. Sec. 1305.13(b), the purchaser to notate on the form that no portion of that entry was received.\64\ --------------------------------------------------------------------------- \64\ While the purchaser's copy 3 of the form includes columns ``To Be Filled In By Purchaser'' in which the purchaser lists the ``No. of Packages Received'' and the ``Date Received'' for each line item, see GX 5 (No. 15-6), if no packages of that item have been received, then there is no date on which they were received. --------------------------------------------------------------------------- The Government made similar claims with respect to Superior II. For example, it identified the first two pages of GX 6 (No. 15-7) as examples of Order Forms that were not properly completed because the second entry on each form did not list the number of packages received and the date received. Putting aside that these two documents bear the exact same serial number, here again, the Government put forward no evidence that any portion of the order listed in the second line item was filled. While here too, this DI insisted that ``after 60 days, the 222 is invalid'' and that Respondent ``should go back and put a zero and the date they put the zeros'' on the form, as explained above, the regulations do not so require. And while the DI also asserted that the Pharmacist's Manual--which does not have the force and effect of law anyway--instructs pharmacists to do this, the Manual actually states that ``[w]hen the items are received, the pharmacist must document on the purchaser's copy (copy three) the actual number of packages received and the date received'' and nothing more. DEA, Pharmacist's Manual--An Informational Outline of the Controlled Substances Act 23 (Rev. ed. 2010). While the DI further identified other Order Forms in this Exhibit which she alleged were not properly completed, she did not identify a single instance in which a line item had actually been shipped to Respondent and the entry had not been made. Indeed, with respect to the Exhibit, the only violations the DI identified were that the forms were copies and not the original. Tr. 474-75, 521. Under a DEA regulation, ``[t]he purchaser must retain Copy 3 of each executed DEA Form 222.'' 21 CFR 1305.13(a). Standing alone these violations would be of minimal consequence. The evidence further showed that while Superior II used the electronic Controlled Substances Ordering System to purchase controlled substances, it did not comply with 21 CFR 1305.22(g). Under this provision, ``[w]hen a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record must be electronically linked to the original order and archived.'' 21 CFR 1305.22(g). The evidence shows that Respondent's pharmacists would print out a copy of the electronic order form and by hand, notate in the boxes in which the Supplier is to list the ``Packages Shipped'' and the ``Date Shipped,'' the number of packages received and the date received. See generally GXs 7 & 10; Tr. 551. According to the DI, when she asked Mr. Majed (one of Superior II pharmacists), how he documented the pharmacy's receipt of the drugs, the pharmacist explained that he did not go back into the CSOS because ``he wasn't aware that he had to do that.'' Tr. 554. The record thus supports the conclusion that Superior II's receipts were not documented electronically and were not linked to the original order. Thus, I conclude Superior II violated 21 CFR 1305.22(g) with respect to the numerous electronic orders it placed. The DI also testified that Mr. Majed represented that he had a key which is required under the Agency's regulations for placing electronic orders through the CSOS. Tr. 557-58. Under DEA's regulation, a person must ``obtain a CSOS digital certificate from the DEA Certification Authority to sign electronic orders for controlled substances.'' 21 CFR 1311.10. However, a person is eligible to obtain a CSOS digital certificate only if he/she: (1) is the person who ``signed the most recent registration application or renewal application,'' (2) is ``a person authorized to sign a registration application,'' or (3) has been ``granted power of attorney by [the] registrant to sign orders for one or more schedules of controlled [[Page 31339]] substances.'' Id. DEA's regulations further provide that ``[o]nly the certificate holder may access or use his or her digital certificate and private key,'' and ``[a] certificate holder must ensure that no one else use the private key'' and ``prevent unauthorized use of that private key.'' Id. Sec. 1311.30. According to the DI, after her conversation with Mr. Majed, she determined that only Mr. Obi, Respondent's owner, and Ms. Minozzi, another pharmacist, had been issued CSOS keys. Accordingly, I conclude that Respondent violated 21 CFR 1311.30(a) and (c). Accordingly, I conclude that the evidence with respect to factor four--Respondents' compliance with applicable laws related to controlled substances--establishes that each Respondent ``has committed such acts as would render [its] registration . . . inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). Sanction Under Agency precedent, 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). While a registrant must accept responsibility and demonstrate that it will not engage in future misconduct in order to establish that its continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can ``argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ``manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant''); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). 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); Michael S. Moore, 76 FR 45867, 45868 (2011). 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 record contains no evidence that the principals of either Respondent acknowledge its misconduct. So too, the record contains no evidence that either Respondent has undertaken any remedial measures. Respondents attribute this to the ALJ's ruling barring Mr. Obi (Respondents' owner) from testifying. They argue that the ALJ's ruling denied them their right to due process and a fair hearing under the Administrative Procedure Act. See Resp. Post-Hrng. Br. 23 (citing, inter alia, Oshodi v. Holder, 729 F.3d 883, 889 (9th Cir. 2013) (en banc); Block v. SEC, 50 F.3d 1078, 1085 (D.C. Cir. 1995); 21 [sic] U.S.C. 556). Tallying up the number of each party's objections which the ALJ overruled versus those he sustained, as well as the number of times the ALJ, sua sponte, instructed a witness not to answer a question, they assert that ``[t]his unmistakable pattern reflects the [ALJ's] clear bias against Respondents.'' Id. at 27. As additional grounds for their contention that the ALJ was biased, they assert that he ``refused to require the DEA to obey the order of the Federal Magistrate Judge.'' Id. at 34. As for their claim of bias, none of their assertions establish bias. As found above, while several of the ALJ's rulings on objections were erroneous, many of them were not, and some of Respondents' objections were clearly lacking in merit. In any event, ``judicial rulings alone almost never constitute a valid basis for a bias or partiality motion.'' Liteky v. United States, 510 U.S. 540, 555-56 (1994) (citing United States v. Grinnell Corp., 384 U.S. 563, 583 (1966)). As for the contention that bias is established by the ALJ's refusal to require the DI to obey the Federal Magistrate Judge's order, Respondents point to no provision of law which grants an Administrative Law Judge authority to order the Government to comply with an order of a Federal Magistrate Judge.\65\ A Magistrate Judge has authority to ensure compliance with his orders, including the power to hold a disobeying party in contempt. See 28 U.S.C. 636. Respondents offer no explanation for why they did not seek an order compelling the return of the documents from the Magistrate Judge who approved the warrant. I thus reject Respondents' claim that the ALJ's ruling on Mr. Obi's testimony should be rejected on the ground of bias.\66\ Indeed, Respondents self-refute their claim of bias when they argue that ``[t]he real reason that the ALJ refused to let Mr. Obi testify was because he felt like Respondents' counsel had not adequately complied with the [[Page 31340]] disclosure requirements of the ALJ's prehearing order.'' Resp. Exceptions, at 24 (emphasis added). --------------------------------------------------------------------------- \65\ Respondents do not identify what orders the DI violated. If Respondents mean the administrative inspection warrants, the language of the warrants only provided for a return of the warrant to the court and an accounting of the property seized. Resp.'s Post- Hrng. Br., at Attachments 1 and 2. The warrants contained no provision requiring the return of the seized property, and Respondents point to no further orders by the court to return the records. \66\ Respondents further assert that the ALJ's ``general bias . . . finds its roots in'' what they characterize as ``the Administrator's public scolding of the ALJ in Clair L. Pettinger, M.D., 78 [FR] 61591 (2013), for requiring the DEA to follow the procedural rules of the Agency and for his interpretation of the law.'' Id. at 35. Not only is Respondents' explanation of Pettinger counterfactual (both the pleading burden imposed by the ALJ and his interpretation of factor two were inconsistent with agency precedent), they cite no authority for their theory. Beyond that, Respondents ignore the extensive protections provided to ALJs under federal law to ensure decisional independence, including that they are not subject to performance appraisals, 5 U.S.C. 4301(2)(D), their pay is set by OPM independent of any evaluation by the Agency, id. Sec. 5372, and they are subject to discipline only upon a showing of good cause by the MSPB. Id. Sec. 3105. --------------------------------------------------------------------------- Respondents thus assert that the ALJ erred in barring Mr. Obi from testifying because he was an interested person within the meaning of the APA. That Mr. Obi is an interested person is hardly disputable. However, while an interested person has a right to participate in a proceeding, that right is subject to the reasonable procedural rules of the Agency and rulings of the ALJ. See, e.g., 5 U.S.C. 556(c) (``Subject to published rules of the agency and within its powers, employees presiding at hearings may . . . regulate the course of the hearing.''); 21 CFR 1316.58(a) (``The presiding officer may direct that summaries of the direct testimony of witnesses be prepared in writing and served on all parties in advance of the hearing.''). Here, in his Orders for Prehearing Statements, which were issued more than one month before Respondents' Prehearing Statements were due, the ALJ specifically warned Respondents that if their ``corporate representative intends to testify, the representative must be listed as a witness, and a summary of anticipated testimony as described below must be provided.'' ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). The Orders for Prehearing Statements also cautioned Respondents that their summaries of testimony must ``indicate clearly each and every matter as to which Respondent[s] intend[ ] to introduce evidence in opposition'' and that ``[t]he summaries are to state what the testimony will be rather than merely listing the areas to be covered.'' ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). And finally, the Orders for Prehearing Statements further warned ``that testimony not disclosed in the prehearing statements or pursuant to subsequent rulings is likely to be excluded at the hearing.'' ALJ Ex. 5, at 2 (No. 15-6); ALJ Ex. 6, at 2 (No. 15-7). Respondents thus had fair notice of the steps they were obligated to take to present Mr. Obi's testimony. While Respondents represented in their Prehearing Statements that they intended to call ``[a]ny and all witnesses identified in the Government's Prehearing Statement[s] in th[ese] matter[s],'' and the Government identified Mr. Obi as a potential witness therein, Respondents entirely failed to provide a summary of the testimony they intended to elicit from him. ALJ Ex. 9, at 4 (No. 15-6); ALJ Ex. 12, at 4 (No. 15-7). While at the hearing Respondents asserted that there would be no prejudice to the Government because ``the summary of Mr. Obi's testimony'' was ``covered sufficiently'' by the Government in its Prehearing Statements, the Government's summary of Mr. Obi's anticipated testimony was confined to questioning him about past acts. Tr. 597-98; see also ALJ Ex. 7, at 6-7 (No. 15-6); ALJ Ex. 7, at 8-9 (No. 15-7). Indeed, Respondents' Counsel conceded that he intended to elicit testimony from Mr. Obi as to the corrective actions Respondents had undertaken and that this raised a notice issue. Id. at 611. Moreover, at no point prior to the hearing did Respondents provide notice to the Government that any of their proposed witnesses would testify regarding any corrective actions undertaken by the pharmacies.\67\ See ALJ Ex. 9, at 4-6 (No. 15-6); ALJ Ex. 12, at 4-6 (No. 15-7). Thus, the ALJ did not abuse his discretion when he barred Mr. Obi from testifying.\68\ See Gunderson v. Department of Labor, 601 F.3d 1013, 1021 (10th Cir. 2010). --------------------------------------------------------------------------- \67\ Respondents' reliance on Oshodi is not persuasive. Therein, the Ninth Circuit overturned a decision of the Board of Immigration Appeals (BIA), which affirmed a decision of an Immigration Judge that Oshodi, who was an applicant for asylum, was not credible. 729 F.3d at 885. Specifically, the court held that the Immigration Judge violated the applicant's right to due process ``by cutting off his testimony on the event of his alleged past persecution . . . that [were] the foundation of his'' claims, and denied his claims ``solely on the basis of [an] adverse credibility finding.'' Id. Respondents also cite to Kerciku v. INS, 314 F.3d 913 (7th Cir. 2003), asserting that the ALJ violated their rights to due process by precluding them from putting on any case. Resp. Post-Hrng. Br. 2. In Kericku, the Seventh Circuit vacated a BIA decision which upheld an IJ's denial of applications for asylum, faulting the IJ for not allowing the applicants ``to make any presentation.'' 314 F.3d at 918. Neither case, however, raised the issue of whether a party could be barred from putting on testimony when the party entirely failed to comply with an agency rule which requires disclosure of the substance of that testimony in advance of the proceeding to prevent prejudice. While Respondents also argue that the ALJ did not neutrally apply this rule, I have carefully reviewed the parties' respective Prehearing Statements, and conclude otherwise. \68\ In Hatem M. Ataya, M.D., 81 FR 8221, 8243 (2016), I held that while the Agency's case law requires a respondent to acknowledge its misconduct and put on evidence of its remedial measures to rebut the Government's prima facie case, the Agency's cases do not require a respondent ``to admit to the allegations even before [it] even has the opportunity to challenge the Government's evidence.'' Thus, in Attaya, I held that a respondent's failure to acknowledge his misconduct in his prehearing statement could not bar him from introducing evidence of his remedial measures. Id. at 8242. However, in Attaya, I also held that because the respondent had not adequately disclosed ``with sufficient particularity'' his evidence of remedial measures, the testimony could nonetheless be barred. Here, while Respondents failed to set forth any proposed testimony by Mr. Obi on the issue of acceptance of responsibility in advance of the hearing, this would not have been a bar to Mr. Obi's testimony as to Respondents' corrective measures, had such proposed testimony on the latter issue been disclosed in advance of the hearing. Just as in federal court, evidence that a respondent had undertaken remedial measures is not proof that it has engaged in culpable conduct. Cf. Fed. R. Evid. R.407. While a respondent retains the right to challenge the allegations at the proceeding, when the Government serves a party with a show cause order, a respondent should assume that the Government has probable cause to support the allegations and a good faith basis for seeking the action (revocation or suspension) it proposes. A wise respondent conducts its own investigation to determine whether the allegations are true, and if they are, to then determine what measures are needed to correct the violations or offending practices. Thus, while a respondent retains the right to challenge the Government's evidence at the hearing, it is still properly charged with the obligation to disclose the remedial measures it has undertaken as a condition of being able to present such evidence at the hearing. Of course, where the Government fails to prove an allegation at the hearing, a respondent need not put on evidence of any corrective measures relevant to that allegation. --------------------------------------------------------------------------- Indeed, in their Post-Hearing Brief, Respondents argue that ``Mr. Obi's testimony could have been restricted to the issues discussed in the DEA's prehearing statement.'' Resp. Post-Hrng. Br. 24. However, as explained above, to rebut the Government's prima facie case, Respondents bore the burden of producing evidence as to their remedial measures. Thus, even if Mr. Obi had testified to those issues identified in the Government's Prehearing Statements and acknowledged Respondents' misconduct (as to those violations proven on the record), Respondents still would have failed to rebut the Government's prima facie case. Accordingly, even if it was error to bar Mr. Obi's testimony as to the issues discussed in the Government's Prehearing Statements, Respondents have not shown prejudice. See Gunderson, 601 F.3d at 1021 (An ALJ's error in excluding evidence must `` `prejudicially affect a substantial right of a party' ''; ``[a]n error is prejudicial only `if it can be reasonably concluded that with . . . such evidence, there would have been a contrary result.''') (quoting Sanjuan v. IBP, Inc., 160 F.3d 1291, 1296 (10th Cir. 1998)); see also Air Canada v. Department of Trans., 148 F.3d 1142, 1156 (D.C. Cir. 1998) (``As incorporated into the APA, the harmless error rule requires the party asserting error to demonstrate prejudice from the error.'') (citing 5 U.S.C. 706). I thus reject Respondents' contentions with respect to the ALJ's ruling which barred Mr. Obi's testimony.\69\ --------------------------------------------------------------------------- \69\ As for Respondents' arguments with respect to the ALJ's ruling which precluded them from submitting their documentary evidence, see Resps.' Post-Hrng. Br. at 30-32, the ALJ's Prehearing Orders were clear enough that the documents had to be submitted in hard copy. Moreover, my holding that the Government has failed to prove any of the dispensing violations renders moot their contentions with respect to those exhibits that were relevant to those allegations. As for the thousands of pages of exhibits that include records of Respondents' purchases and dispensings of the controlled substances audited by the Government, because Respondents failed to make an adequate proffer as to their audit results prior to the hearing, the ALJ did not abuse his discretion in declining to admit this evidence. --------------------------------------------------------------------------- [[Page 31341]] Because Respondents failed to produce any evidence of remedial measures undertaken to address the numerous recordkeeping issues that I find proven on the record, I conclude that Respondents have not rebutted the Government's prima facie showing they have ``committed such acts as [to] render [their] registration[s] inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). And based on the substantial shortages found at Superior I, which supports the conclusion that it has major recordkeeping issues and/or has engaged in diversion, I conclude that revocation of its registration is warranted to protect the public interest.\70\ --------------------------------------------------------------------------- \70\ Given the size of the shortages, the Agency's deterrence interests also support revocation. --------------------------------------------------------------------------- I acknowledge that Superior II's recordkeeping violations did not involve large shortages but rather overages. However, the pharmacy nonetheless failed to maintain complete and accurate records as required by the CSA, did not properly document its receipts on electronic order forms, and allowed an unauthorized person to access the electronic ordering system. In addition, the pharmacies have common ownership in that they are both owned by Mr. Obi. Thus, while the conduct proven with respect to Superior I is more egregious than that proved with respect to Superior II, given that Mr. Obi owns and controls each pharmacy, I conclude that revocation is warranted with respect to Superior II as well.\71\ --------------------------------------------------------------------------- \71\ In numerous cases, DEA has held that where misconduct has previously been proved with respect to the owners, officers, or key employees of a pharmacy, the Agency can deny an application or revoke a registration of a second or subsequent pharmacy where the Government shows that such individuals have influence over the management or control of the second pharmacy. See, e.g., Lawsons & Sons Pharmacy and Fenwick Pharmacy, 48 FR 16140, 16141 (1983); Orlando Wholesale, L.L.C., 71 FR 71555, 71557 (2006) (denying application noting evidence that ``one of Respondent's managing members had previously operated a business which distributed List I chemicals without a valid registration''); Cf. 4 OTC, Inc., 77 FR 35031, 35035 (2012) (denying application for registration as List I chemical distributor where evidence showed that a person holding a 10 percent interest in applicant had been found by Canadian regulatory agency to have violated its List I regulations). --------------------------------------------------------------------------- Order Pursuant to the authority vested in me by 21 U.S.C. 824(a)(4) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration BS9255274 and BS9699731 issued to Superior Pharmacy, L.L.C., be, and they hereby are, revoked. I further order that any application of Superior Pharmacy, L.L.C., to renew or modify either registration, be, and it hereby is, denied. This Order is effective June 17, 2016. Dated: May 7, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-11550 Filed 5-17-16; 8:45 am] BILLING CODE 4410-09-P
![31310 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
DEPARTMENT OF JUSTICE not issued in the usual course of In addition, the Superior I Order
professional practice or for a legitimate alleged that the pharmacy ‘‘failed to
Drug Enforcement Administration medical purpose, including create and maintain accurate [schedule
[Docket Nos. 15–6 and 15–7] circumstances where the pharmacist II order forms] in violation of 21 U.S.C.
knew or should have known that the 842(a)(5),’’ and that ‘‘[a]t least two [of
Superior Pharmacy I and Superior controlled substances were abused and/ its] pharmacists . . . shared a private
Pharmacy II Decision and Order or diverted by the customer.’’ ALJ Ex. 1, key (password) for digitally signing’’
at 2 (No. 15–6); ALJ Ex. 1, at 2 (No. 15– controlled substances orders, ‘‘in
This is a consolidated proceeding violation of 21 CFR 1311.30(a), (c), and
7). Each Show Cause Order then listed
involving two pharmacies located in (e).’’ ALJ Ex. 1, at 3–4 (No. 15–6).
various red flags which each
Tampa, Florida with common Finally, the Superior I Order alleged
Respondent’s pharmacists allegedly
ownership. On October 8, 2014, the that a DEA audit for the period of May
failed to resolve before dispensing
Deputy Assistant Administrator, Office 2, 2011 through February 4, 2013 found,
of Diversion Control, Drug Enforcement prescriptions, including: (1) ‘‘Multiple inter alia, that the pharmacy was short
Administration issued an Order to Show individuals presenting prescriptions for 15,560 dosage units (du) of oxycodone
Cause to Superior Pharmacy, L.L.C. the same drugs in the same quantities
from the same doctor’’; (2) ‘‘individuals 30 mg; 11,951 du of hydromorphone 8
(hereinafter, Superior II), which mg; 946 du of hydromorphone 4 mg;
proposed the revocation of its DEA presenting prescriptions for controlled
substances known to be highly abused, and 864 du of methadone 10 mg. Id. at
Certificate of Registration BS9699731, 4.
pursuant to which it is authorized to such as oxycodone and
hydromorphone’’; (3) ‘‘individuals The Superior II Order alleged that it
dispense controlled substances in had also failed to maintain accurate
schedules II through V as a retail paying . . . for controlled substances
schedule II order forms and had failed
pharmacy, at the registered location of with cash’’; 1 and (4) ‘‘individuals
to retain copy three of these forms as
5416 Town ‘N’ Country Blvd. ALJ Ex. 1, residing long distances from the required by DEA regulations. ALJ Ex. 1,
at 1 (No. 15–7). The next day, the pharmacy.’’ ALJ Ex. 1, at 2 (No. 15–6);
at 3 (No. 15–7) (citing 21 CFR 1305.13(a)
Deputy Assistant Administrator issued ALJ Ex. 1, at 2 (No. 15–7). Each Show & (e); id. § 1305.17(a); 21 U.S.C. 827(b)).
an Order to Show Cause to Superior Cause Order then set forth allegations of The Order further alleged that the
Pharmacy, L.L.C. (hereinafter, Superior specific instances in which pharmacy failed to create records of the
I), which proposed the revocation of its Respondents’ pharmacists dispensed quantity and date received for orders it
DEA Certificate of Registration oxycodone 30 mg or hydromorphone 8 placed using the Controlled Substances
BS9255274, pursuant to which it is mg without resolving various red flags Ordering System (CSOS) and that it
authorized to dispense controlled presented by the patients and/or the ‘‘also failed to electronically archive and
substances in schedules II through V as prescriptions; the Order further alleged link these records to the original order.’’
a retail pharmacy, at the registered that several of these prescriptions were Id. at 4. Finally, the Superior II Order
location of 3007 W. Cypress Street, facially invalid because they lacked the alleged that a DEA audit for the period
Suite 1. ALJ Ex. 1, at 1 (No. 15–6). patient’s address. ALJ Ex 1, at 2 (No. 15– of July 31, 2012 through February 4,
As grounds for the proposed actions 6); ALJ Ex. 1, at 2 (No. 15–7). 2013 found, inter alia, that the
(which also included the denial of any Each Show Cause Order further pharmacy had overages of 2,576 du of
pending applications), the Show Cause alleged that Respondents’ pharmacists hydromorphone 8 mg; 1,189 du of
Orders alleged that each pharmacy’s dispensed hydromorphone, oxycodone 30; and 896 du of methadone
‘‘continued registration is inconsistent notwithstanding that the ‘‘dosage 10 mg.
with the public interest, as that term is amounts . . . if taken as directed, far The Show Cause Order issued to
defined in 21 U.S.C. 823(f).’’ Id.; see also exceeded the recommended dosages of Superior I was served on October 17,
ALJ Ex. 1, at 1 (No. 15–7); 21 U.S.C. hydromorphone that should be taken on 2014, and the Show Cause Order issued
824(a)(4). Specifically, with respect to a daily basis.’’ ALJ Ex. 1, at 2 (No. 15– to Superior II was served on October 16,
each pharmacy, the Orders alleged that 6); ALJ Ex. 1, at 3 (No. 15–7). The 2014. See ALJ Ex. 3 (No. 15–6); ALJ Ex.
their ‘‘pharmacists repeatedly failed to Superior I Order also alleged that its 4 (No. 15–7). On November 14, 2014,
exercise their corresponding pharmacists dispensed prescriptions, each pharmacy, through its counsel,
responsibility to ensure that controlled which were written by the same doctor requested a hearing on the allegations.
substances they dispensed were on the same day, for ‘‘large and See ALJ Ex. 2 (No. 15–6); ALJ Ex. 3 (No.
dispensed pursuant to prescriptions substantially similar quantities of’’ 15–7). Each matter was placed on the
issued for legitimate medical purposes oxycodone 30 mg, ‘‘to two customers docket of the Office of Administrative
by practitioners acting within the usual . . . both of whom resided at the same Law Judges and assigned to
course of their professional practice’’ address,’’ in a town ‘‘located Administrative Law Judge (ALJ)
and that their ‘‘pharmacists ignored approximately [449 miles] from’’ the Christopher B. McNeil.
readily identifiable red flags that [the] pharmacy. ALJ Ex. 1, at 2 (No. 15–6).
controlled substances prescribed were The Prehearing Motions and Rulings
Likewise, the Superior II order alleged
being diverted and dispensed despite On December 3, 2014, the ALJ issued
that its ‘‘pharmacists dispensed large
unresolved red flags.’’ ALJ Ex. 1, at 1 an Order for Prehearing Statements and
and substantially similar quantities of
(No. 15–6); ALJ Ex. 1, at 1 (No. 15–7) Setting the Matter for Hearing
hydromorphone and oxycodone to two
(both citing 21 CFR 1306.04(a); Holiday (hereinafter, Prehearing Order) in each
individuals with the same last name
sradovich on DSK3TPTVN1PROD with NOTICES2
CVS. L.L.C., d/b/a CVS Pharmacy Nos. case. See ALJ Ex. 5 (No. 15–6); ALJ Ex.
who received their prescriptions on the
219 and 5195, 77 FR 62315, 62319 6 (No. 15–7). In each Prehearing Order,
same day from doctors at the same
(2012)). the ALJ directed the Government to file
clinic.’’ ALJ Ex. 1, at 3 (No. 15–7).
The Show Cause Orders further its Pre-hearing Statement no later than
alleged that each pharmacy’s 1 With respect to Superior I, the Show Cause
2 p.m. on December 22, 2014, and each
‘‘pharmacists dispensed controlled Order stated the red flag as ‘‘individuals paying
Respondent to file its Prehearing
substances when they knew or should high prices for prescriptions for controlled Statement no later than 2 p.m. on
have known that the prescriptions were substances with cash.’’ ALJ 1, at 2 (No. 15–6). January 5, 2015. ALJ Ex. 5, at 1 (No. 15–
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/2.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31311
6); ALJ Ex. 6, at 1 (No. 15–7). The Orders further directed that ‘‘[w]hen any failed to exercise their corresponding
Orders also directed the parties to party seeks to . . . present proposed responsibility to ensure that
‘‘[p]rovide the names and current exhibits,’’ the party must ‘‘timely prescriptions for controlled substances
addresses of all witnesses whose provid[e] the OALJ with a facsimile were issued for a legitimate medical
testimony is to be presented,’’ and that copy’’ and ‘‘must mail hard copy filings purpose in the usual course of
‘‘[i]f the Respondent’s corporate sufficiently in advance of the due date professional practice.’’ ALJ Ex. 6, at 3
representative intends to testify, the to assure timely receipt by the hearing (No. 15–6); ALJ Ex. 8, at 3–4 (No. 15–
representative must be listed, and a clerk’’ as well as ‘‘that documents are to 7).
summary of anticipated testimony as be filed in triplicate.’’ ALJ Ex. 5, at 5– On January 5, 2015, each Respondent
described below must be provided.’’ ALJ 6 (No. 15–6); ALJ Ex. 6, at 5–6 (No. 15– filed a ‘‘Motion to Compel’’ and a
Ex. 5, at 2 (No. 15–6); ALJ Ex. 6, at 2 7). ‘‘Motion for Enlargement of Time to File
(No. 15–7). The ALJ’s Orders provided In his Orders, the ALJ also noted that . . . Pre-hearing Statement,’’ as well as
the following instruction regarding the the cases appeared to ‘‘involve common a Prehearing Statement. ALJ Exs. 9, 10,
summaries of testimony: questions of law or fact’’ and thus 11 (No. 15–6); ALJ Exs. 9, 10, 12 (No.
directed the parties to address whether 15–7). In their Motions to Compel, each
Provide a brief summary of the testimony
of each witness, with counsel for the
they should be consolidated. ALJ Ex. 5, Respondent noted that on February 4,
Government to indicate clearly each and at 3 (No. 15–6); ALJ Ex. 6, at 3 (No. 15– 2013, DEA had executed an
every act, omission or occurrence upon 7). Thereafter, the Government moved to Administrative Inspection Warrant at it
which it relies in seeking to revoke the consolidate the cases (as well as two and sought an Order from the ALJ
Respondent’s Certificate of Registration, and other cases). Respondent opposed the requiring the Government to disclose
counsel for Respondent to indicate clearly Government’s motion.
each and every matter as to which
the documents and testimony submitted
On December 22, 2014, the by DEA Investigators to the Federal
Respondent intends to introduce evidence in Government filed its Prehearing
opposition. The summaries are to state what Magistrate Judge in obtaining the
Statements with respect to each
the testimony will be, rather than merely Warrants. ALJ Ex. 10, at 2 (No.15–6);
pharmacy. In each of these, the
listing the areas to be covered. The parties are ALJ Ex 10, at 2 (No. 15–7). Each
reminded that testimony not disclosed in the Government disclosed that it intended
Respondent’s Motion to Compel also
prehearing statements or pursuant to to elicit testimony from an expert
sought to require the Government to: (1)
subsequent rulings is likely to be excluded at regarding his review of ‘‘numerous
Provide ‘‘full and complete copies of all
the hearing. controlled substance prescriptions filled
computer data seized . . . during the
ALJ Ex. 5, at 2 (No. 15–6); ALJ Ex. 6, at by Respondent that contained one or
execution of the’’ warrant; (2) identify
more red flags for diversion which
2 (No. 15–7). ‘‘all DEA personnel involved in the
Respondent never resolved.’’ ALJ Ex. 6,
The ALJ’s Orders also provided that at 3 (No. 15–6); ALJ Ex. 8, at 3–4 (No. preparation and execution of the
‘‘[a]ny requests for subpoena[s] are to be 15–7). The Government then identified [warrant] and the subsequent review
filed by 2:00 p.m. E.S.T. on January 12, the same set of seven red flags. ALJ Ex. and analysis of the information, records,
2015,’’ and that ‘‘[s]ubpoena requests 6, at 3 (No. 15–6); ALJ Ex. 8, at 3–4 (No. and data seized’’; and (3) provide
that do not comply with these 15–7). With respect to both pharmacies, ‘‘reports of, and the substance of, any
instructions will be returned to the the Government then set forth the statements made to DEA investigators
requestor without further action.’’ 2 ALJ expert’s proposed testimony regarding by [Respondent’s] staff.’’ ALJ Ex. 10, at
Ex. 5, at 4 (No. 15–6); ALJ Ex. 6, at 4 various oxycodone 30 mg prescriptions 5 (No.15–6); ALJ Ex 10, at 5 (No. 15–7).
(No. 15–7). The ALJ’s Orders further and the red flags they presented, as well Each Respondent also sought an
provided that ‘‘[w]henever a party seeks as his proposed testimony regarding the extension of the time to file its
to file any document, motion, exhibit or pharmacy’s dispensing of large Prehearing Statement to the end of
otherwise communicate in writing with quantities of hydromorphone and the March 2015 and sought to reschedule
the Administrative Law Judge, the party red flags they presented. ALJ Ex. 6, at the hearing ‘‘to no sooner than June
must provide a true copy of the same to 4 (No. 15–6); ALJ Ex. 8, at 3–4 (No. 15– 2015.’’ ALJ Ex. 11, at 3 (No. 15–6); ALJ
the opposing party, using the contact 7). And with respect to Superior I, the Ex. 9 (No. 15–7). As support for the
information shown in the Certificate of Government also disclosed that the motions, Respondents argued that since
Service below . . . [and] [t]he party expert ‘‘will also testify about a the execution of the warrants, the
making such a filing shall include a customer who willingly purchased a Government had 20 months to review
‘Certificate of Service’ stating that a true prescription for oxycodone . . . that the records, and that ‘‘[d]uring this time,
copy of the submission has been costs 37% more than the same the information was not available to
provided to the opposing party, and prescription four months earlier,’’ and Respondent.’’ ALJ Ex. 11, at 3 (No. 15–
shall specify the means by which’’ this ‘‘that this fact, combined with the fact 6); ALJ Ex. 9, at 3 (No. 15–7).
was accomplished. ALJ Ex. 5, at 5–6 that the prescription was facially invalid Respondents further argued ‘‘[w]hile a
(No. 15–6); ALJ Ex. 6, at 5–6 (No. 15– [as it contained] no patient address portion of the seized information, most
7). constituted a red flag for diversion.’’ ALJ notably the prescriptions, was provided
Finally, the ALJ’s Orders directed the Ex. 6, at 5 (No. 15–6). to Respondent[s] in electronic format,
parties to file their proposed exhibits The Government then noticed both the sheer volume of information
with his Office no later than 2:00 p.m. Respondents that its expert ‘‘will testify coupled with the unreasonably short
on January 12, 2015; it also directed that that the facts surrounding the deadlines surrounding the holiday
a copy of the exhibits be served on the
sradovich on DSK3TPTVN1PROD with NOTICES2
prescriptions listed above constituted season make analysis of the information
opposing party. ALJ Ex. 5, at 2 (No. 15– red flags for diversion and that there is by [it] impossible.’’ ALJ Ex. 11, at 3 (No.
6); ALJ Ex. 6, at 2 (No. 15–7). The ALJ’s no evidence that any of the red flags 15–6); ALJ Ex. 9, at 3 (No. 15–7).
were resolved prior to distributing the Respondents further argued that ‘‘due
2 The Order further required that ‘‘[a]ny motion
controlled substances to the customers.’’ process requires, and good cause exists,
to quash a subpoena must be filed within three
working days of receipt of the subpoena request and
Id. at 3 (No. 15–6). Finally, it noticed for a significant’’ extension of the time
must be served on the opposing party.’’ ALJ Ex. 5, Respondents that its expert ‘‘will testify to file the Prehearing Statements and ‘‘to
at 4–5 (No. 15–6); ALJ Ex. 6, at 4–5 (No. 15–7). that . . . Respondent[s’] pharmacists prepare for a lengthy hearing in’’ these
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/3.svg)
![31312 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
matters. ALJ Ex. 11, at 3 (No. 15–6); ALJ Cause Orders and Prehearing Statements finding that good cause has not been shown
Ex. 9, at 3 (No. 15–7). had ‘‘specifically outlined’’ the for either enlarging the time for
The Government opposed these allegations, ‘‘as well as the approximate Respondent[s] to file [their] prehearing
motions. With respect to the Motions to statement[s], or for continuing the hearing
number of documents it intend[ed] to
now set to being on January 27, 2015.
Compel, the Government argued that in introduce into evidence.’’ Id. The
its Prehearing Statements, it had Government further argued that it was ALJ Ex. 11, at 3 (No. 15–7); ALJ Ex. 12,
provided a summary of the testimony it ‘‘patently specious’’ for Respondents at 3 (No. 15–6).
intended to elicit as well as a list of the ‘‘[t]o characterize this matter as The same day (according to OALJ date
exhibits it intended to offer; the something much more voluminous and stamps), each Respondent filed its
Government also noted that several complicated than what it is and, as a Prehearing Statement. ALJ Ex. 9 (No.
weeks earlier, it had met with one of result, argue that further delay is 15–6); ALJ Ex. 12 (No. 15–7). Each
Respondents’ counsels and that at no necessary.’’ Id. The Government also Respondent proposed as witnesses
time then or since its motion, had contended that to the extent ‘‘[a]ny and all patients whose
Respondents’ counsel ‘‘communicate[d] Respondents were seeking an extension prescriptions were seized . . . pursuant
a need for, or request[ed] any’’ of the to review records and prescriptions to the Administrative Inspection
information it sought through the beyond those referenced in the Show Warrant executed [on] February 4, 2013
motions. ALJ Ex. 16, at 3 (No. 15–7). Cause Orders and its Prehearing or whose prescriptions for controlled
The Government further argued that it Statements, those documents were not substances were dispensed between
had fully complied with its disclosure ‘‘material to the allegation that he [sic] January 1, 2011 and February 4, 2013.’’
obligations, and that to the extent unlawfully dispensed to customers ALJ Ex. 9, at 3 (No. 15–6); ALJ Ex. 12,
Respondents were seeking discovery, identified in the OTSC and at 3 (No. 15–7). Respondent Superior I
‘‘ ‘[t]here is . . . no general right to Government’s Prehearing Statement.’’ further attached a list of 2,355 purported
discovery under either the APA or DEA Id. at 6–7. patients, ALJ Ex. 9, at Attachment A
regulations, but rather only a limited On January 5, 2015, the ALJ denied (No. 15–6); and Respondent Superior II
right to receive in advance of the Respondents’ Motions for Enlargement. attached a list of 2,253 purported
hearing the documentary evidence and ALJ Ex. 11, at 3 (No. 15–7); ALJ Ex. 12, patients. ALJ Ex. 12, at Attachment A
summaries of the testimony which the at 4 (No. 15–6). The ALJ specifically (No. 15–7). As for the required summary
Government intends to rely upon.’ ’’ ALJ noted ‘‘that since at least October 16, of anticipated testimony, each
Ex. 16, at 4 (No. 15–7) (quoting Roy E. 2014, Respondent[s] ha[ve] been Respondent proposed that:
Berkowitz, 74 FR 36758, 36760 (2009)). informed of the nature of the charges These patients will each be asked to
Finally, the Government argued that to presented in the Order to Show Cause,’’ provide testimony regarding their medical
the extent Respondents were asserting and that in their motions, Respondents history, injuries and related pathology,
that they had a right to receive these had acknowledged that the Government interactions with treating physicians and
materials as a matter of due process, had provided them with the dispensing pharmacists, effectiveness of the
‘‘Respondent[s] ha[d] not even prescriptions. ALJ Ex. 11, at 3 (No. 15– prescribed controlled substances, continuity
articulated how the requested materials 7); ALJ Ex. 12, at 3 (No. 15–6). The ALJ of treatment, their reasons for patronage of
might be relevant to this proceeding.’’ Superior Pharmacy, LLC . . . such other
explained that neither Respondent had
ALJ Ex. 16, at 5 (No. 15–7). testimony relevant to the Government’s
‘‘established that it has been prevented allegation that any of these prescriptions
Each Respondent filed a Reply to [the] from evaluating those prescriptions raised ‘red flags’ which should have caused
Government’s Response to Motion to identified in the Order to Show Cause pharmacists to refuse to dispense the
Compel. ALJ Ex. 27 (No. 15–6); ALJ [or] that it has been prevented from prescribed controlled substances.
Ex.18 (No. 15–7). Therein, Respondents preparing its prehearing statement.’’ ALJ
contended that they were entitled to the ALJ Ex. 9, at 4 (No. 15–6); ALJ Ex. 12,
Ex. 11, at 3 (No. 15–7); ALJ Ex. 12, at at 4 (No. 15–7).
documents as a matter of due process 3 (No. 15–6). The ALJ also explained
because the Government had Respondents further proposed as
that Respondents had known since the witnesses ‘‘[a]ny and all physicians who
represented that one of its proposed issuance of his Prehearing Orders that
witnesses (a Diversion Investigator) issued the prescriptions seized . . .
they were required ‘‘to object to any pursuant to the Administrative
would testify regarding his/her term of that Order by not later than
interviews with Respondents’ staff and Inspection Warrant[s] . . . or whose
December 10, 2014,’’ and that they prescriptions for controlled substances
that they would be prejudiced if the failed to object to the orders until the
Government did not provide the were dispensed at [them] between
day their Prehearing Statements were January 1, 2011 and February 4, 2013,’’
‘‘same.’’ ALJ Ex. 27, at 2 (No. 15–6); ALJ due. ALJ Ex. 11, at 3 (No. 15–7); ALJ Ex.
Ex. 18, at 2 (No. 15–7). Respondents as well as ‘‘[a]ny and all physicians who
12, at 3 (No. 15–6). The ALJ thus issued prescriptions for controlled
further asserted that the ‘‘information is concluded that:
essential,’’ because the Government substances to the patients identified
intended to put on evidence that the I am compelled to consider the nature of . . . above after February 4, 2013.’’ ALJ
the allegations, which if proved suggest Ex. 9, at 3 (No. 15–6); ALJ Ex. 12, at 3
prescriptions raised red flags and that
Respondent[s’] ability to fill controlled (No. 15–7). Each Respondent attached a
‘‘Respondent[s] fail[ed] to exercise substance prescriptions would be
[their] corresponding responsibility to inconsistent with the public interest. I am list of several hundred physicians who
resolve the ‘red flag[s],’ ’’ and the further compelled to consider Respondent[s’] had purportedly issued the controlled
Government ‘‘has not identified one own role in attempting to delay th[ese] substance prescriptions dispensed by
sradovich on DSK3TPTVN1PROD with NOTICES2
patient or doctor related to the proceeding[s], given that [they] failed to them. ALJ Ex. 9, at Attachment B (No.
prescriptions allegedly containing timely object to the deadlines set forth in the 15–6); ALJ Ex. 12, at Attachment B (No.
unresolved red flags.’’ ALJ Ex. 27, at 2 Order[s]. I am further compelled to consider 15–7). As for the anticipated testimony
fairness to all parties, and the convenience of of the physicians, Respondents
(No. 15–6); ALJ Ex. 18, at 2 (No. 15–7). witnesses now identified by the Government
The Government also opposed in its timely prehearing statement[s]. I am
represented that:
Respondents’ Motions for Enlargement further compelled to consider the need for These physicians will confirm they
of Time. ALJ Ex. 16, at 6 (No. 15–7). The orderly and prompt administration of justice. performed adequate and appropriate physical
Government argued that the Show All of these considerations compel my examinations of the patients to whom they
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/4.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31313
issued prescriptions for controlled related to inventory records, DEA–222 order that it could not complete the 2,549
substances, communication with the forms and CSOS issues. subpoena requests for its proposed
dispensing pharmacies regarding such witnesses on time. Id.
ALJ Ex. 9, at 5 (No. 15–6); ALJ Ex. 12,
prescriptions, the reasonableness and
necessity of the prescriptions to control the
at 5 (No. 15–7).3 On January 12, 2015, each
pain or other complaints of their patients as On January 9, 2012, each Respondent Respondent submitted a letter (dated
required by the standard of care and Florida filed a motion to enlarge the time for Jan. 9) to the Hearing Clerk along with
statutes. filing its proposed exhibits or to thumb drives which contained ‘‘the
alternatively provide its proposed images of each of the exhibits in [its]
ALJ Ex. 9, at 4 (No. 15–6); ALJ Ex. 12,
exhibits electronically, as well as a Prehearing Statement.’’ ALJ Ex. 24 (No.
at 4 (No. 15–7).
motion to enlarge the time to file its 15–6); ALJ Ex. 24 (No. 15–7). Each
Next, Respondents proposed as requests for subpoenas. ALJ Ex. 22 (No. Respondent’s letter also advised that the
witnesses ‘‘[a]ny and all pharmacists 15–6); ALJ Ex. 23 (No. 15–7). In its paper copies of the subpoena requests
who dispensed prescriptions for motion, Superior I explained that its would be hand delivered on Monday,
controlled substances to the patients ‘‘Prehearing Statement identifies four January 12, 2015, and on that date, the
identified . . . above after February 4, categories of proposed exhibits which ALJ ‘‘received more than 3,000 written
2013.’’ ALJ Ex. 9, at 3 (No. 15–6); ALJ consist of 23,032 documents,’’ of which requests for the issuance of subpoenas
Ex. 12, at 3 (No. 15–7) (emphasis ‘‘20,925 pages represent the documents in the[] two cases.’’ Tr. 18; see also ALJ
added). As for their anticipated seized, and provided to Respondent Ex. 24 (No. 15–6); ALJ Ex. 24 (No. 15–
testimony, Respondents represented electronically, by the DEA.’’ ALJ Ex. 22, 7). According to the ALJ, neither
that ‘‘[t]hese pharmacists will describe at 2 (No. 15–6). Superior I explained Respondent provided ‘‘a certificate of
the information they obtained from the that to comply with the ALJ’s Pre- service establishing that [they] ha[d]
patients, physicians and other sources hearing Order, which required that three provided the Government with a true
in order to resolve ‘red flags,’ if any, copies of each exhibit be filed with the copy of these requests.’’ Tr. 18.
raised by the described prescriptions for OALJ and one copy be filed with The same day, the ALJ’s Law Clerk
controlled substances.’’ ALJ Ex. 9, at 5 opposing counsel, this would require sent a letter under his own signature to
(No. 15–6); ALJ Ex. 12, at 5 (No. 15–7). more than 92,000 pages and each Respondent’s Counsel noting that
Respondent did not, however, provide ‘‘approximately nineteen standard boxes the OALJ had received the thumb
the names of any of the pharmacists. of paper, which is approximately 950 drives. ALJ Ex. 28 (No. 15–6); ALJ Ex.
ALJ Ex. 9, at 3 (No. 15–6); ALJ Ex. 12, pounds.’’ Id. Superior I further 28 (No. 15–7). The Law Clerk then
at 3 (No. 15–7). explained that because of the volume of explained that he was returning the
Respondents also proposed as a copying needed to comply with the Pre- thumb drives to each Respondent’s
witness Mr. Sam Badawi, a pharmacist hearing Order, the documents would counsel because ‘‘[t]he submission of
and attorney. ALJ Ex. 9, at 3 (No. 15– have to be sent ‘‘to a third party for the thumb drive does not adhere to the’’
6); ALJ Ex. 12, at 3 (No. 15–7). As for reproduction’’ and ‘‘the reproduction ALJ’s Prehearing Order of December 3,
Mr. Badawi’s anticipated testimony, cannot be completed in the allotted 2014. ALJ Ex. 28 (No. 15–6); ALJ Ex. 28
Respondents represented that he: time.’’ Id. at 3. As for its subpoena (No. 15–7).
will testify regarding his qualifications as an requests, Superior I contended that the On January 12, the ALJ denied each
expert in the field of pharmacy and the legal ALJ’s Prehearing Order was ambiguous Respondent’s Motion to Compel. The
and ethical responsibilities of the ‘‘as to whether the requests and ALJ noted that in the case of Edge
pharmacists dispensing prescriptions at [each completed subpoenas are to be filed in
Respondent], the procedures used at [each Pharmacy (Docket No. 15–3), the
triplicate with the Hearing Clerk,’’ and respondent had sought to compel the
Respondent] to consider and resolve ‘red because it was seeking to subpoena
flags,’ inventory, ordering and CSOS disclosure of much of the same material
2,861 witnesses, it ‘‘cannot complete the as sought by Superiors I and II. ALJ Ex.
compliance issues. Mr. Badawi will further
testify that he had reviewed the prescriptions . . . requests . . . with the completed 29, at 4 (No. 15–6); ALJ Ex. 29, at 4 (No.
at issue, the relevant inventory and ordering subpoenas using the required template 15–7). The ALJ further noted that in
records and prepared summaries of the in the allotted time.’’ Id. Edge, the Chief Administrative Law
prescription dispensing activity at [each Superior II made similar assertions to
Judge (CALJ) had denied the motion of
pharmacy] during 2011 and 2012, and Superior I, noting that its proposed
the respondent on the ground that it did
identified significant errors in the inventory exhibits ‘‘consist of 32,123 documents,’’
performed by the DEA. ‘‘not comport with the narrowly-focused
of which ‘‘30,441 pages represent the
grant of authority in 21 CFR
ALJ Ex. 9, at 6 (No. 15–6); ALJ Ex. 12, documents seized, and provided to [it]
1316.52(d),’’ and that the respondent
at 6 (No. 15–7). electronically, by the DEA,’’ and that to
did ‘‘not seek to compel . . . the class
Respondents further proposed as a comply with the ALJ’s Prehearing
of documents discoverable under the
Order, it would have to provide more
witness Mr. Jack Crowley of Gates [Administrative Procedure Act] or
than 128,000 pages of documents, and
Healthcare Associates. Respondents subject to inspection under DEA
require ‘‘approximately 1,300 pounds’’
represented that Mr. Crowley: regulations.’’ ALJ Ex. 29, at 4 (No. 15–
of paper. ALJ Ex. 23, at 2 (No. 15–7). As
will testify regarding his knowledge and did Superior I, Superior II asserted that 6); ALJ Ex. 29, at 4 (No. 15–7). As for
experience in the investigation, preparation it would have to use a third-party to the reports and the substance of any
and execution of Administrative Inspection perform the necessary copying, which statements made by Respondents’ staff
Warrants and the subsequent investigation to the Agency’s Investigators, the ALJ
could not ‘‘be completed in the allotted
sradovich on DSK3TPTVN1PROD with NOTICES2
required. [He] will testify regarding errors in also found that the CALJ’s reasoning
the audits performed by the agents/ time.’’ Id. at 3. Superior II also asserted
applied to these materials. ALJ Ex. 29,
investigators involved in the investigation of at 4 (No. 15–6); ALJ Ex. 29, at 4 (No. 15–
3 Respondents also proposed as witnesses each
[Respondents]. [He] reviewed the
prescriptions, inventory and CSOS records of person ‘‘who participated in the preparation of the 7). The ALJ thus concluded that each
[Respondents]. [He] will further testify
application for the Administrative Inspection Respondent had failed to establish its
Warrant[s],’’ as well as each person ‘‘who entitlement to the documents. ALJ Ex.
regarding [Respondents’] procedure[s] for participated in the execution of the Administrative
resolving potential ‘red flag’ issues and Inspection Warrant[s].’’ ALJ Ex. 9, at 3–4 (No. 15– 29, at 4 (No. 15–6); ALJ Ex. 29, at 4 (No.
compliance with recordkeeping requirements 6); ALJ Ex. 12, at 3–4 (No. 15–7). 15–7).
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/5.svg)
![31314 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
The same day, in the Superior I managed and/or controlled other ALJ Ex. 40, at 7 (No. 15–6); ALJ Ex. 40,
matter, the Government submitted its pharmacies.’’ ALJ Ex. 31, at 5 (No. 15– at 7 (No. 15–7). Respondents further
request for the issuance of subpoenas for 6); ALJ Ex. 31, at 5 (No. 15–7). contended that ‘‘Mr. Obi did not
four witnesses, and in the Superior II Each Respondent filed identical dispense medication or otherwise
matter, the Government submitted its oppositions to the Government’s process prescriptions at these
request for the issuance of subpoenas for motions. See ALJ Ex. 30 (No. 15–6); ALJ pharmacies during all relevant time
five witnesses, all of whom had been Ex. 32 (No. 15–7). Therein, Respondents periods described in the Orders to Show
previously identified in the respective argued that ‘‘it is not . . . sufficient for Cause.’’ ALJ Ex. 40, at 7 (No. 15–6); ALJ
Prehearing Statement.4 ALJ Ex. 25, at 1– two (2) actions to have a common Ex. 40, at 7 (No. 15–7).
2 (No. 15–6); ALJ Ex. 25, at 1–2 (No. 15– defendant or one common issue of law’’ On January 21, 2015, the ALJ granted
7). The Government also submitted its and that ‘‘other considerations are the Government’s motions with respect
proposed exhibits in each matter. necessary such as whether maintaining to Superior I and Superior II. ALJ Ex. 1
Docket Sheet, at 2 (No. 15–6); Docket separate actions would lead to (No. 15–6 & 15–7). The ALJ specifically
Sheet, at 2 (No. 15–7). inconsistent rulings on similar issues of found that ‘‘the Government ha[d]
fact and law and to ensure that the same demonstrated the presence of common
The Government’s Motions To standard is applied to the determination questions of law and fact with respect
Consolidate of such issues as they arise in each to Superior I and Superior II, and ha[d]
On January 13, 2015, the Government case.’’ ALJ Ex. 30, at 3–4 (No. 15–6); ALJ shown the need to take steps to avoid
moved to consolidate the cases, along Ex. 32, at 3–4 (No. 15–7) (citation unnecessary cost or delay.’’ Id. at 7.
with a third matter (Jet Pharmacy). ALJ omitted). Respondents also argued that More specifically, the ALJ found that
Ex. 31 (No. 15–6); ALJ Ex. 31 (No. 15– consolidation of the cases ‘‘may cause the Show Cause Orders ‘‘set forth
7). In its motions, the Government unnecessary confusion for the fact substantially similar factual claims’’ in
argued that there were common issues finder and prejudice to the parties.’’ ALJ that ‘‘pharmacists at both pharmacies
of law and fact with respect to the Ex. 30, at 4 (No. 15–6); ALJ Ex. 32, at dispensed controlled substances under
pharmacies, noting that it intended to 4 (No. 15–7) (citation omitted). conditions where the pharmacists knew
call the same expert in each of the cases Respondents then maintained that or should have known that the
and each Respondent had stated that it ‘‘because each prescription represents a controlled substances were being either
intended to call the same two experts. different pattern of facts, it appears diverted or abused by those who
ALJ Ex. 31, at 2–3 (No. 15–6); ALJ Ex. there is no overlapping factual issue received the substances.’’ Id. The ALJ
31, at 2–3 (No. 15–7). The Government between the two matters,’’ and ‘‘[a]s further found that ‘‘[i]n both cases, the
further argued that the expert’s such, there is no risk of inconsistent [Government] alleged the pharmacists
testimony would ‘‘account for the bulk results’’ which would support filled prescriptions notwithstanding red
of the Government’s and likely the consolidation. ALJ Ex. 30, at 5 (No. 15– flags relating to the unusual distance the
Respondents’ cases in terms of length of 6); ALJ Ex. 32, at 5 (No. 15–7). patients traveled to have their
testimony,’’ and that consolidation Respondents further maintained that prescriptions filled, and
would ‘‘result in a tremendous ‘‘there is a high risk that one defendant notwithstanding red flags relating to
conservation of time and resources by could be prejudiced by evidence evidence that the patients were filling
allowing the Government to present its relating to another defendant.’’ ALJ Ex. multiple prescriptions which bore no
expert’s testimony in one proceeding 30, at 5 (No. 15–6); ALJ Ex. 32, at 5 (No. address for the patients.’’ Id.
rather than in three separate 15–7). Respondents also asserted that The ALJ also rejected Respondents’
proceedings.’’ ALJ Ex. 31, at 5 (No. 15– consolidation would not promote contention that there was ‘‘a substantial
6); ALJ Ex. 31, at 5 (No. 15–7). judicial economy ‘‘[b]ecause of the large risk of prejudice to Respondents in
The Government also argued that, number . . . and limited overlap of’’ the either case.’’ Id. at 8. The ALJ
although ‘‘each of the Respondent witnesses and because ‘‘the time specifically found that ‘‘the prospect of
pharmacies is a separate business entity, necessary to complete the hearing as to hearing from the fact and expert
there are also strong indications of both parties could exceed ninety (90) witnesses in both cases will reduce the
common ownership, management, and/ days.’’ ALJ Ex. 30, at 6 (No. 15–6); ALJ risk of inconsistencies like those that
or control between the Respondents,’’ Ex. 32, at 6 (No. 15–7). could arise through separate hearings.’’
and that Superior I and II ‘‘are both On January 15, 2015, each Id. The ALJ also ‘‘expressly rejected’’
owned and operated by Victor Obi- Respondent filed a further pleading, Respondent’s contention that there was
Anadiume.’’ 5 ALJ Ex. 31, at 3 (No. 15– which appear to be identical, on the a heightened ‘‘risk of confusion’’
6); ALJ Ex. 31, at 3 (No. 15–7). As issue of consolidation. ALJ Ex. 40 (No. because the Government intended to use
support for this assertion, the 15–6); ALJ Ex. 40 (No. 15–7). In addition the same expert to prove its case,
Government attached to its motions to the arguments they previously raised, explaining that ‘‘[o]ne expert can easily
various documents it obtained from the Respondents contended that ‘‘[t]o the address the conduct attributed to
Florida Department of Heath showing extent the government seeks to rely on pharmacists working at these two
that Victor Obi owned both Superior I a single expert to prove its case in all pharmacies.’’ Id. Finally, the ALJ
and II. The Government thus three matters, it heightens the risk of reasoned that ‘‘[g]iven there is at least
maintained that consolidation was confusion or attempts to conflate issues some showing of common ownership,
warranted ‘‘because the conduct of one between three distinct defendants.’’ ALJ the Government should be, and will be,
Respondent may be imputed to other Ex. 40, at 6 (No. 15–6); ALJ Ex. 40, at permitted to advance its theory that ‘the
sradovich on DSK3TPTVN1PROD with NOTICES2
Respondents if it can be shown that the 6 (No. 15–7). They also argued that conduct of one Respondent may be
same individuals responsible for ‘‘although Respondent[s] share Mr. Obi imputed to [the] other Respondent[ ] if
misconduct at one pharmacy also as a common owner, [he] is not it can be shown that the same
responsible for the day-to-day individuals responsible for misconduct
4 The Government also served a copy of both
operations or the implementation of at one pharmacy also managed and/or
subpoena requests on each Respondent. ALJ Ex. 25,
at 2 (No. 15–6); ALJ Ex. 25, at 2 (No. 15–7). policies and procedures at these controlled other pharmacies.’’’ Id.
5 Mr. Obi-Anadiume is also referred to as Mr. Obi separate businesses’’ as each pharmacy (citation omitted). The ALJ thus ordered
throughout this decision. had a ‘‘different pharmacy manager[ ].’’ that the cases against Superior I and
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/6.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31315
Superior II be consolidated under misconduct or as to procedures documents,’’ of which only one file,
Docket No. 15–6. Id. subsequently instituted. ALJ Ex. 36, at 6 which ‘‘consist[ed] of 1490 pages,’’
(No. 15–6); ALJ Ex. 36, at 6 (No. 15–7). ‘‘appeared to be marked for
The Government’s Motions in Limine
Finally, the Government argued that identification.’’ ALJ Ex. 36, at 3–4 (No.
On January 15, 2015, the Government Respondents’ disclosure was ‘‘void of 15–6); ALJ Ex. ALJ Ex. 36, at 3–4 (No.
also filed a Motion in Limine in each any detail about the information [this 15–7). The Government further stated
matter. Therein, the Government argued witness] reviewed to form his opinions that the other files were ‘‘neither
that Respondents had failed to comply about the DEA audits or the procedures marked for identification nor
with the ALJ’s Pre-hearing Orders in Respondents employed at their paginated.’’ ALJ Ex. 36, at 4 (No. 15–6);
that they failed to provide adequate pharmacy.’’ ALJ Ex. 36, at 6 (No. 15–6); ALJ Ex. 36, at 4 (No. 15–7). The
summaries of the testimony of their ALJ Ex. 36, at 6 (No. 15–7). Government argued that Respondents’
proposed witnesses. With respect to Mr. Addressing Respondents’ proposed submission of their proposed
Badawi, Respondents’ proposed expert taking of the testimony of the numerous documentary evidence did not ‘‘comply
in pharmacy practice, the Government patients who filled controlled substance with the ALJ’s order in terms of labeling
argued that Respondents’ Prehearing prescriptions at Respondents, the and form.’’ ALJ Ex. 36, at 8 (No. 15–6);
Statements ‘‘state[d] no facts or Government maintained that ALJ Ex. 36, at 8 (No. 15–7). The
conclusions which, if proven, would Respondents’ disclosure ‘‘constitute[d] a Government also argued that because
rebut any allegations that the wholesale failure to describe ‘each and ‘‘none of [Respondents’] summarized
Government has made in its OTSC[s] or every matter as to which [they] testimony reference[d] any particular
Prehearing statement[s].’’ ALJ Ex. 36, at intend[ed] to introduce evidence in documents or page, [it was] unable to
4 (No. 15–6); ALJ Ex. 36, at 4–5 (No. 15– opposition,’ ’’ as required by the ALJ’s ascertain whether any of the documents
7). The Government specifically argued Pre-hearing Order. ALJ Ex. 36, at 6 (No. . . . would be relevant to [the]
that while ‘‘Respondent[s] state[d] that 15–6); ALJ Ex. 36, at 6 (No. 15–7). As proceeding.’’ ALJ Ex. 36, at 9 (No. 15–
Mr. Badawi ha[d] ‘prepared summaries’ for the physicians who wrote the 6); ALJ Ex. 36, at 9 (No. 15–7).
of prescription activity and identified prescriptions, the Government argued On January 21, 2015, each
‘errors’ in DEA inventory[,] [they] fail[ ] that the disclosures were inadequate Respondent filed a Response to the
to disclose what those summaries entail because ‘‘Respondent[s] merely Government’s Motion; as with
or what errors have been discovered.’’ indicate[ ] that these unknown Respondents’ other filings, the
ALJ Ex. 36, at 4–5 (No. 15–6); ALJ Ex. individuals will testify regarding Responses appear to be identical.
36, at 5 (No. 15–7). The Government ‘communication[s] with the dispensing Compare ALJ Ex. 53 (No. 15–6) with
further argued that Respondents had pharmacists regarding such Response to Government’s Motion In
‘‘also failed to identify a single prescriptions,’’ and ‘‘no facts about any Limine (No. 15–7) (hereinafter, Superior
‘procedure used at [the pharmacies] to such communications are revealed.’’ 6 II Response to Motion in Limine).7
consider and resolve alleged ‘red flags,’ ALJ Ex. 36, at 6 (No. 15–6); ALJ Ex. 36, Therein, Respondents argued that the
inventory, ordering and CSO[S] at 6 (No. 15–7). Government’s Motions were
compliance issues.’’ ALJ Ex. 36, at 5 The Government also contended that ‘‘completely devoid of intellectual
(No. 15–6); ALJ Ex. 36, at 5 (No. 15–7). testimony and documentation regarding integrity’’ because the Government’s
The Government also argued that prescriptions which it did not intend to Prehearing Statement ‘‘fail[ed] to
‘‘notably absent from [the] Prehearing offer into evidence was irrelevant. ALJ specifically identify a single
Statement[s] is any notice that Mr. Ex. 36, at 8 (No. 15–6) ALJ Ex. 36, at 8 prescription or patient and only
Badawi will opine that any of the (No. 15–7). Finally, with respect to the generally refers to areas of discussion of
prescriptions identified in the [Show physicians who issued prescriptions its witnesses,’’ including the proposed
Cause Orders] and the Government’s filled by Respondents after February 4, testimony of its expert witness. ALJ Ex.
Prehearing Statement[s] were issued in 2013 and the pharmacists who filled the 53, at 2 (No. 15–6); Superior II Response
compliance with federal or state law.’’ prescriptions, the Government argued to Motion in Limine, at 2. Respondents
ALJ Ex. 36, at 5 (No. 15–6); ALJ Ex. 36, that Respondent had not even identified also argued that ‘‘[t]he Government’s
at 5 (No. 15–7). these persons and that their proposed Prehearing Statement only identifies
As for Respondents’ disclosures testimony was ‘‘stated only in general two patients by their initials and only
pertaining to the testimony of Mr. terms [and] lack[ed] conclusions.’’ ALJ one by the alleged city of residence.’’
Crowley, the Government argued that Ex. 36, at 7 (No. 15–6); ALJ Ex. 36, at ALJ Ex. 53, at 3 (No. 15–6); Superior II
‘‘no facts [were] proffered to give [it] any 7 (No. 15–7). Response to Motion in Limine, at 3.8
notice regarding [his] conclusions In its motion, the Government also Respondents thus contended that the
regarding audit errors, or the basis for addressed Respondents’ use of a thumb Government provided an ‘‘inadequate
those conclusions, should they exist.’’ drive to provide its exhibits. ALJ Ex. 36, description of the testimony concerning
ALJ Ex. 36, at 5 (No. 15–6); ALJ Ex. 36, at 3 (No. 15–6); ALJ Ex. 39, at 3 (No. 15– specific patients and prescriptions,’’ and
at 5 (No. 15–7). The Government also 7). According to the Government, the that they were ‘‘placed under extreme
argued that while Respondents thumb drive contained ‘‘hundreds of prejudice in [their] preparation for this
proposed that this witness would testify different files, which contain, expedited hearing.’’ ALJ Ex. 53, at 3 (No.
regarding their procedures for resolving collectively, thousands of pages of
red flags and complying with other 7 While this filing is part of the record, it was not
requirements, Respondent had not 6 Respondents did, however, disclose the names assigned an ALJ Exhibit Number and is not
included on the list of ALJ Exhibits in the Superior
sradovich on DSK3TPTVN1PROD with NOTICES2
‘‘offer[ed] a single fact or detail to of the physicians as part of their Prehearing
Statements. Respondents also stated that they II matter.
describe, identify, or explain that intended to elicit testimony from the physicians 8 While this was true with respect to Superior I,
procedure.’’ ALJ Ex. 36, at 5 (No. 15–6); ‘‘confirm[ing] [that] they performed adequate and the Government’s Prehearing Statement in Superior
ALJ Ex. 36, at 5 (No. 15–7). The appropriate physical examinations of the patients,’’ II identified each of the patients whose
Government further contended that it is as well as testimony as to ‘‘the reasonableness and prescriptions were at issue by their initials, and
necessity of the prescriptions to control the pain or with respect to 13 of the patients, either the
unclear whether this witness’s proposed other complaints of their patients as required by the Prehearing Statement or the Show Cause Order
testimony would discuss the procedures standard of care and Florida statutes.’’ ALJ Ex. 9, identified the patient’s city of residence. ALJ Ex. 1,
in place during the period of the alleged at 4 (No. 15–6); ALJ Ex. 12, at 4 (No. 15–7). at 2–3 (No. 15–7); ALJ Ex. 6, at 4–6 (No. 15–7).
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/7.svg)
![31316 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
15–6); Superior II Response to Motion in the same extent that the Government On January 27, 2015, the ALJ
Limine, at 3. Respondents also disputed summarized its proposed testimony.’’ conducted the initial day of the hearing
the Government’s contention that their ALJ Ex. 53, at 5 (No. 15–6); Superior II during which he addressed the
argument should be rejected because Response to Motion in Limine, at 5. Government’s Motions in Limine.9 With
during a December meeting with Respondents appeared to argue that they respect to the proposed testimony of the
Government Counsel, they did not ask could not offer more detail as to the more than 5,000 patients who filled
for additional information regarding the testimony of these witnesses because their prescriptions at Respondents, the
patients’ names. ALJ Ex. 53, at 3 (No. they were ‘‘without notice of what ALJ granted the Government’s Motions
15–6); Superior II Response to Motion in specific facts and opinions [would] be for two reasons. First, he found that
Limine, at 3. offered in the Government’s prima facie Respondents had failed to comply with
Respondents further took issue with case as the Government chose to not his Prehearing Order because they had
the Government’s contention (with disclose specifics.’’ ALJ Ex. 53, at 6 (No. ‘‘not described with sufficient detail the
respect to both pharmacies) that only a 15–6); Superior II Response to Motion in testimony of the proposed witnesses.’’
small number of the thousands of Limine, at 6. ALJ Ex. 7, at 3 (No. 15–6/15–7) (Journal
persons listed in their Prehearing As for the Government’s attempt to Entry and Order From Initial Day of
Statements were actually identified as bar their proposed documentary Hearing). Second, he found that the
patients. ALJ Ex. 53, at 2 (No. 15–6); evidence, Respondents argued that they proposed testimony of the patients
Superior II Response to Motion in were ‘‘prejudiced by the Government’s ‘‘would not constitute relevant
Limine, at 2. According to each inadequate Prehearing Statement which evidence, given the nature of the
Respondent, it listed all of the ‘‘patients forced Respondent[s] to incorporate and charges appearing in the Orders to Show
whose prescriptions were dispensed include all potential documents and Cause, as elaborated upon by the
and doctors who generated the witnesses from the relevant time Government’s Prehearing Statements.
prescriptions [that were] filled at the period.’’ ALJ Ex. 53, at 4 (No. 15–6); Id.
pharmacy during the relevant time Superior II Response to Motion in As for the proposed testimony of the
period,’’ because at the time it filed its Limine, at 4. Respondents further physicians, the ALJ found that
Prehearing Statement, the Government maintained that ‘‘[t]his prejudice would Respondents’ Pre-hearing Statement did
was ‘‘the only party . . . to know which have only been exasperated [sic] by the ‘‘not sufficiently identify the anticipated
patients, doctors, and pharmacists are costs associated with production of testimony of the witnesses, nor . . .
material and relevant to the allegations multiple sets of paper copies of the make a sufficient showing that their
they chose to include in the’’ Show voluminous records.’’ ALJ Ex. 53, at 4 testimony would constitute relevant
Cause Order. ALJ Ex. 53, at 3 (No. 15– (No. 15–6); Superior II Response to evidence.’’ Id. The ALJ further held that
6); Superior II Response to Motion in Motion in Limine, at 4. Respondents this ruling applied to both those
Limine, at 3. Respondents thus contend asserted that the electronic files were physicians who filled the prescriptions
that ‘‘the potential exclusion of material organized in four separate folders, and before February 4, 2013, as well as after
and relevant witnesses as requested by the folder which included the that date. Id. at 3–4. As to the latter
the Government . . . would be arbitrary, documents seized pursuant to the category of physicians, the ALJ barred
capricious, and an abuse of discretion.’’ Administrative Inspection Warrant, was their testimony based on the additional
ALJ Ex. 53, at 3–4 (No. 15–6); Superior simply ‘‘a mirror copy, in the exact reason that Respondents had not
II Response to Motion in Limine, at 3– form, of the digital files dumped on ‘‘timely identif[ied] by name the
4. Respondent by the DEA at the time of proposed witnesses,’’ as again required
As for the Government’s contention service of the Order to Show Cause.’’ by his Prehearing Order. Id. at 4. And
that Respondents had failed to disclose ALJ Ex. 53, at 4 (No. 15–6); Superior II the ALJ further barred Respondents
the proposed testimony of the patients, Response to Motion in Limine, at 4. from offering the testimony of ‘‘any
doctors and pharmacists with adequate Respondents stated that they had no pharmacists referred to but not
specificity, Respondents argued that way of knowing whether folder three identified in [their] prehearing
‘‘without the identification of the ‘‘represent[ed] all documents seized statements.’’ Id.
prescriptions and/or patients at issue (as and/or reviewed by the Government’’; The ALJ also granted the
defined by the OSC), a specific they further argued that ‘‘the Government’s motion to exclude the
summary of each and every potentially Government made no attempt to label testimony of Mssrs. Badawi and
relevant witness is impossible within and/or organize the material provided.’’ Crowley. As for Mr. Badawi, the ALJ
the timeframe provided.’’ ALJ Ex. 53, at ALJ Ex. 53, at 4 (No. 15–6); Superior II found that Respondent had not
6 (No. 15–6); Superior II Response to Response to Motion in Limine, at 4. complied with his Prehearing Order
Motion in Limine, at 6. Continuing, Concluding, Respondents argued that because ‘‘[u]nlike the articulation of
Respondents argued that ‘‘[t]he the Government had nearly two years to specific red flags provided by the
witnesses will confirm their interaction review the documents and that between Government in its description of
with the pharmacists in resolving ‘red February 4, 2013 (the date the AIWs testimony for its expert, the
flags’ and verify the prescriptions were were served) and the dates of service of Respondents’ Prehearing Statements do
issued for a legitimate medical purpose the Show Cause Orders), not reveal the substance of this
in the usual course of professional ‘‘Respondent[s] had no access to these testimony, but instead presented only a
practice.’’ ALJ Ex. 53, at 6 (No. 15–6); records.’’ ALJ Ex. 53, at 5 (No. 15–6); list of areas to be discussed.’’ Id. at 5.
Superior II Response to Motion in Superior II Response to Motion in As for Respondents’ representation that
sradovich on DSK3TPTVN1PROD with NOTICES2
Limine, at 6. Notably, Respondents did Limine, at 5. Respondents thus argued Mr. Badawi would also testify about
not maintain that the pharmacists that to exclude their ‘‘proposed errors he identified ‘‘in the inventory
would testify that they resolved red testimony and exhibits, based performed by the DEA,’’ the ALJ found
flags. exclusively on circumstances created by that Respondents failed to ‘‘articulat[e]
As for the Government’s attempt to the Government, would be an extreme
bar the testimony of Mssrs. Badawi and abuse of discretion.’’ ALJ Ex. 53, at 6 9 While the ALJ termed this day as the initial day
Crowley, Respondents argued that they (No. 15–6); Superior II Response to of the hearing, he did not take any evidence. Tr. 1–
‘‘ha[d] summarized [their] testimony to Motion in Limine, at 6. 36.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/8.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31317
the nature of these errors’’ and there was Subsequently, on February 3, 2015, The ALJ’s Ruling on Respondents’
‘‘[in]sufficient information regarding the the Government filed a ‘‘Notice of Subpoena Requests
timeframe used by Mr. Badawi to permit Objections to Respondent’s Exhibits.’’ During the January 27 hearing, the
a determination that the testimony ALJ Ex. 15 (Nos. 15–6 and 15–17). ALJ also addressed each Respondent’s
would be relevant.’’ Id. Therein, the Government noted that it request for subpoenas. Tr. 17–23. As
As for Mr. Crowley’s proposed had received eight binders of evidence explained above, each Respondent
testimony regarding errors in the DEA totaling nearly 4,300 pages, of which submitted requests for an extensive
audit, the ALJ found that Respondents five binders appeared to be related to number of subpoenas but failed to
‘‘fail[ed] to articulate what those errors Superior I and three binders Superior II. include with its requests a certificate of
were.’’ Id. And as for his proposed Id. at 2. While the Government service establishing that they had
testimony ‘‘regarding procedures used contended that it was unclear whether provided copies to the Government.
by the pharmacies for resolving red flags the Respondents were offering the Asked by the ALJ to address its
and for complying with DEA exhibits as a proffer or as evidence to be requests, Respondents’ counsel asserted
recordkeeping requirements,’’ the ALJ admitted in the proceeding, it then that ‘‘the request for subpoenas was
explained that he could not ‘‘discern explained that even if the exhibits were copied to [Government counsel] timely
from the summary of [his] testimony offered as a proffer, they should not be as to each of the subpoenas.’’ Id. at 18.
whether [it] concerns the practices of included in the record because However, when asked by the ALJ if it
the pharmacies at the time of the Respondent had not made an offer of was correct that he did not include a
execution of the administrative proof as required by 21 CFR 1316.60. Id. certificate of service, Respondents’
warrants, at times before then, or at the The Government further noted that none counsel answered: ‘‘If the Court says
present time.’’ Id. at 5–6. Finding that of the documents were ‘‘self- that that wasn’t included then I’ll accept
Respondents had ‘‘failed to comply with authenticating’’ and many of them, that. However, I will represent that
the prehearing order[s]’’ and had also which included patient medical records, everything that I provided to the Court
‘‘failed to establish that [his] proposed ‘‘appear to come from sources other has been provided to’’ Government
testimony would be relevant,’’ the ALJ than the Respondents.’’ Id. at 3. counsel. Id. at 20. The ALJ then asked
barred Mr. Crowley’s testimony. Id. at 6. the Government’s counsel if he had
The ALJ also addressed the At the first day of the evidentiary
been provided with copies of the
Government’s contention that phase of the hearing, the ALJ addressed
subpoena requests. Id. at 21.
Respondents’ documentary evidence the Government’s objection. Tr. 54.
Government counsel answered that he
should be excluded. In his Order, the After re-affirming his earlier ruling
had received a thumb drive which
ALJ explained that in his Prehearing which barred Respondents from
‘‘contains so many thousands of pages
Orders he had directed the parties to introducing any documentary evidence,
of documents’’ that he ‘‘did not look for
exchange their exhibits on or before the ALJ then turned to the Government’s
specific subpoenas.’’ Id. Subsequently,
January 12, 2015, and that the ‘‘failure contention that Respondents had not
Respondents’ counsel confirmed that he
to timely do so would result in the complied with 21 CFR 1316.60. On the
had sent the subpoena requests to the
exclusion of the documents.’’ Id. at 4. issue of whether Respondents had made Government electronically. Id. at 22.
According to the ALJ, ‘‘[o]n both an adequate offer of proof, the ALJ asked The ALJ then explained that in his
January 9 and . . . 12, a representative one of Respondents’ counsel if he was Prehearing Orders, he had advised the
of Mr. Sisco’s office contacted a member ‘‘correct in understanding that the parties that subpoena requests that did
of my staff, inquiring whether Respondent[s’] Pre-hearing Statements not comply with his instructions would
Respondents [could] submit documents and the premises that [he] articulated be returned without further action; he
by using electronic files; . . . on both during the initial day of hearing in also explained that Respondents had
occasions my staff member advised that support of receiving these exhibits neither objected to nor sought
only hard copies and facsimiles would should, taken together, be regarded as clarification of the Prehearing Orders.
be accepted.’’ Id. The ALJ explained that containing the statement of the Id. at 23. Finding that Respondents had
on January 12, he directed his staff to substance of the evidence which you not complied with his Prehearing
return the flash drives which would have accompany the excluded Orders, the ALJ announced that he
Respondents’ counsel had sent to his documents?’’ Tr. 58. Respondents’ would be returning Respondents’
office, and that as of the date of the counsel answered ‘‘[y]es.’’ Id. While the subpoena requests without further
hearing, Respondents still had not filed ALJ had also noted that ‘‘an offer of action. Id. The ALJ did not address
their proposed exhibits with his office. proof shall be part of the record only if whether Respondents had made an
Id. at 4–5. The ALJ then explained that a proper foundation has been laid for its adequate showing as to relevancy with
he had ‘‘considered the Government’s admission,’’ id. at 57, the ALJ did not respect to either the patients or the
report of the contents of what ask Respondents’ counsel to lay a physicians. Id. at 17–23.
presumably was on’’ the flash drives, as foundation for any of the exhibits. Id. at
well as Respondents’ explanation as set 57–69. After noting that he received Respondents’ Motions for a Daubert
forth in their Responses to the only a single copy of the proffered Hearing and To Exclude the Testimony
Government’s Motions, and found that exhibits (vice the three copies required of the Government’s Expert
good cause existed to grant the motions by his Prehearing Order), the ALJ On January 15, 2015, Respondents
and bar Respondents from introducing ordered Respondents to provide two also filed motions to exclude the
sradovich on DSK3TPTVN1PROD with NOTICES2
their proposed exhibits. Id. at 5. The additional copies of the proffered testimony of the Government’s
ALJ, however, provided Respondents’ exhibits prior to 5 p.m. that day; he pharmacy expert Robert Parrado. ALJ
counsel with the opportunity to submit further advised that if the copies were Ex. 41 (No. 15–6); ALJ Ex. 41 (No. 15–
its proposed exhibits as a proffer, not filed, he would return the proffered 7). The basis of Respondents’ motions
provided it did so no later than exhibits to Respondents. Id. at 69. was that ‘‘Mr. Parrado’s proposed
February 10, 2015, and provided his Subsequently, Respondents filed the opinions are based on nothing more
Office with an original and two copies, additional copies of the exhibits, and than a cursory review of the written
as well as a copy to the Government. Id. the exhibits were forwarded as a proffer. prescriptions to the exclusion of all
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/9.svg)
![31318 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
other information,’’ and that he ‘‘did not Respondents would ‘‘have ample Respondents argued that ‘‘the
apply any reliable methodology as opportunity to question [him] regarding Government has had years to prepare its
mandated’’ by Daubert v. Merrell Dow his knowledge and experience, but . . . case whereas [they have] only been
Pharmaceuticals, Inc., 509 U.S. 579 to exclude him on that basis, prior to afforded a few months.’’ Id. at 4.
(1993), and its progeny. ALJ Ex. 41, at trial, is both misguided and premature.’’ Continuing, Respondents contended
2 (No. 15–6); ALJ Ex. 41, at 2 (No. 15– ALJ Ex. 50, at 4. The Government also that the Government ‘‘has had more
7). Respondents also argued that Mr. argued that Respondents provided no than 20 months to process and analyze
Parrado was ‘‘not qualified to render support for their contention that Mr. the seized information,’’ and that
any opinions regarding whether the Parrado’s testimony should be excluded ‘‘[d]uring this time, the information was
physician issuing the prescriptions did because ‘‘he did not interview [the] not available to Respondent.’’ Id. at 5.
so for a legitimate medical purpose in patients or other persons.’’ ALJ Ex. 50, While Respondents then acknowledged
the usual course of professional at 4. that ‘‘a portion of the seized
practice.’’ ALJ Ex. 41, at 2 (No. 15–6); The ALJ denied Respondents’ information, most notably the
ALJ Ex. 41, at 2 (No. 15–7) (both citing motions. The ALJ reasoned that in each prescriptions, was provided to [them] in
Fla. Stat. 766.102(5) (‘‘person may not Show Cause Order and its Prehearing electronic format,’’ they then contended
give expert testimony concerning the Statements, ‘‘the Government that ‘‘the sheer volume of information
prevailing professional standard of care identifie[d] red flags or other conditions coupled with the unreasonably short
unless the person is a health care which, according to the Government, deadlines surrounding the holiday
provider who holds an active and valid triggered a corresponding obligation on season makes analysis of the
license and conducts a complete review the part of pharmacies who were information . . . impossible.’’ Id.
of the pertinent medical records’’). presented with a number of On January 27, 2015 (during the
Respondents argued that the ALJ was prescriptions. The thrust of this initial day of the hearing), the ALJ
required to perform a ‘‘gatekeeping’’ evidence is [not] dependent upon denied Respondents’ motions.10 In so
function in determining whether Mr. scientific or technical analysis, but upon ruling, the ALJ relied on his previous
Parrado’s testimony was admissible. ALJ documentary or testimonial evidence ruling that Respondents had ‘‘failed to
Ex. 41, at 2 (No. 15–6); ALJ Ex. 41, at establishing or rebutting the claimed timely submit their request for
2 (No. 15–7). They further argued that corresponding obligation.’’ ALJ Ex. 7, at subpoenas.’’ Tr. 30. The ALJ then
under Daubert, the Government was 7 (Nos. 15–6 and 15–7). explained that he could not ‘‘reconcile’’
required to show that: (1) Mr. Parrado Respondents’ assertion that they needed
was qualified to testify as an expert; (2) The ALJ then held that ‘‘[t]he more time to prepare with the
that he used a sufficiently reliable Government ha[d] made a sufficient representations made in each of their
methodology in reaching his showing to permit Mr. Parrado to appear Prehearing Statements that their two
conclusions; and (3) that his testimony and give testimony.’’ Id. Continuing, the proposed experts had ‘‘reviewed the
would assist the trier of fact. ALJ Ex. 41, ALJ explained that at the hearing, he prescriptions at issue, the relevant
at 2 (No. 15–6); ALJ Ex. 41, at 2 (No. 15– would allow Respondents to question inventory and ordering history and
7). Respondents then suggested that Mr. Parrado as to his qualifications and prepared summaries of the pharmacies’
under Daubert, the ALJ was required to the methodology he used, but that he dispensing activities during 2011 and
consider ‘‘whether the theory or was not making a ‘‘preclusive ruling 2012.’’ Tr. 31; see also ALJ Ex. 9, at 5–
technique’’ used by Mr. Parrado ‘‘has prior to the time [he] testified.’’ Id. The 6 (No. 15–6); ALJ Ex. 12, at 5–6 (No. 15–
been subject to peer review and ALJ thus denied Respondents’ motions 7).11 Finally, the ALJ explained that he
publication.’’ ALJ Ex. 41, at 4 (No. 15– to either conduct a separate hearing on had:
6); ALJ Ex. 41, at 4 (No. 15–7). the admissibility of Mr. Parrado’s
testimony or to exclude his testimony consider[ed] a variety of factors, including
According to Respondents, Mr. the diligence and good faith of the parties
Parrado’s testimony should be excluded prior to the hearing. Id. seeking the continuance; the grounds for the
as unreliable because ‘‘he failed to Respondents’ Motions for a delay; fairness to both parties; the need for
conduct a thorough investigation and Continuance orderly administration of justice; the length
failed to base his proposed opinion on
any reliable methodology.’’ ALJ Ex. 41, On January 15, 2015, each 10 The Government did not file a response to this
at 5(No. 15–6); ALJ Ex. 41, at 5 (No. 15– Respondent also moved for a motion.
11 As found above, in their Prehearing Statements,
7). continuance. ALJ Ex. 42 (No. 15–6); ALJ
Respondents represented that Mr. Badawi would
The Government opposed the Ex. 42 (No. 15–7). Respondents sought testify about ‘‘the procedures used at Superior
motions. Quoting agency precedent, the a continuance of the proceeding ‘‘to Pharmacy [I and II] to consider and resolve alleged
Government argued that where, as here, commence no sooner than June 2015.’’ ‘red flags,’ inventory, ordering and CSOS
See, e.g., ALJ Ex. 42, at 5 (No. 15–6). compliance issues. Mr. Badawi will further testify
non-scientific expert testimony is at that he has reviewed the prescriptions at issue, the
issue, the expert’s ‘‘ ‘knowledge and Respondents asserted that they needed relevant inventory and ordering records and
experience’ ’’ may provide a sufficient the continuance ‘‘to interview and prepared summaries of the prescription dispensing
foundation for concluding that his subpoena witnesses,’’ and that they activity at Superior Pharmacy [I and II] during 2011
‘‘ha[d] timely requested the issuance of and 2012, and identified significant errors in the
testimony is reliable. ALJ Ex. 50, at 3 inventory performed by the DEA.’’ ALJ Ex. 9, at 6
(quoting Holiday CVS, L.L.C., d/b/a CVS numerous subpoenas and . . . ha[d] (No. 15–6); ALJ Ex. 12, at 6 (No. 15–7).
Pharmacy No. 219 and 5195, 77 FR exercised due diligence in this regard.’’ Likewise, Respondents represented that ‘‘Mr.
63316, 62334 (2012) (quoting Surles ex Id. at 3. Respondents further asserted Crowley will testify regarding errors in the audits
sradovich on DSK3TPTVN1PROD with NOTICES2
rel. Johnson v. Greyhound Lines, Inc., that ‘‘[d]ue to the short time period performed by the agent/investigators of Superior
Pharmacy [I and II]. Mr. Crowley reviewed the
474 F.3d 288, 295 (6th Cir. 2007))). The between the issuance of the order[s] to prescriptions, inventory and CSOS records of
Government noted that Mr. Parrado has show cause and the commencement of Superior Pharmacy [I and II]. Mr. Crowley will
been a licensed pharmacist for more the hearing, and the numerous potential further testify regarding Superior Pharmacy[I and
than 40 years and had been ‘‘the witnesses, [they] will undoubtedly be II]’s procedure for resolving potential ‘red flag’
issues and compliance with recordkeeping
recipient of numerous professional prejudiced by a [sic] the lack of time to requirements related to inventory records, DEA–222
appointments.’’ Id. The Government adequately interview and obtain service order forms and CSOS issues.’’ ALJ Ex. 9, at 5 (No.
further argued that at the hearing, on the necessary witnesses.’’ Id. 15–6); ALJ Ex. 12, at 5 (No. 15–7).
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/10.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31319
of the delay requested; whether other The Evidentiary Hearing and ALJ the untimely filing of their Exceptions,
continuances have been requested and Decision I consider the claims raised therein only
received; the inconvenience to litigants, if they were previously raised in their
witnesses, opposing counsel and the Court; On February 10 and 11, the ALJ
conducted the evidentiary phase of the Post-Hearing Brief.
and whether the requesting party contributed Having carefully considered the entire
to the circumstances which give rise to the hearing at the DEA Hearing Facility in
record in this matter and, in particular,
request for a continuance and any other Arlington, Virginia. At the hearing, the
relevant factors depending on the facts of the the claims of error raised by
Government elicited the testimony of
case. Respondents in their Post-hearing Brief,
four witnesses, including its expert
I do not adopt the ALJ’s findings of fact
Tr. 31. The ALJ then found that ‘‘cause witness, Mr. Robert Parrado; the
and conclusions of law with respect to
has not been shown to delay this Government also introduced various
the allegations that each Respondent’s
hearing’’ and denied the Respondents’ documents into evidence. Consistent
pharmacists violated 21 CFR 1306.04(a)
motions. Id. with the ALJ’s order granting the
and 1306.05(a). I do, however, adopt the
With the evidentiary phase of the Government’s Motions in Limine, ALJ’s findings of fact and legal
hearing set to begin on February 10, Respondents were precluded from conclusions with respect to: (1) The
2015, on February 6, 2015, Respondents calling any witnesses and introducing allegations pertaining to the audits
filed a second Motion for Continuance. any documentary evidence. The ALJ conducted of each pharmacy, (2) the
ALJ Ex. 12, at 1 (No. 15–6/15–7). The did, however, allow Respondent to allegations that Respondents were not
basis for the motion was that on January submit ten binders of documents properly maintaining required records
28, 2015, they had retained a third (totaling nearly 4,300 pages) as a proffer. including their schedule II order forms,
counsel, who previously been involved Following the hearing, both parties and (3) that for purchases made using
in resolving a matter involving another submitted briefs containing proposed the electronic Controlled Substance
of Mr. Obi’s pharmacies. Id. at 2. Citing findings of fact and conclusions of law Order System, Superior II was not
‘‘the complexity of the issues in these (hereinafter, referred to as Post-Hearing electronically linking its receipt records
matters,’’ Respondents sought a Brief). On April 9, 2015, the ALJ issued to its purchase records. I further find
continuance of three weeks to allow its his Recommended Decision (hereinafter, that Respondent Superior II violated
additional counsel to prepare for the cited as R.D.); according to the DEA regulations by allowing a non-
hearing. Id. Certificate of Service, on April 10, the authorized person to place electronic
The same day, the Government ALJ’s law clerk sent a copy of the orders using the key assigned to an
objected. ALJ Ex. 19 (Nos. 15–6/15–7). Decision to all three of Respondents’ authorized person. I therefore conclude
It argued that Respondents had been counsels by Federal Express. that the Government has made out a
aware of the allegations since October In the Recommended Decision, the prima facie case to support revocation
16 and 17, 2014, and that ‘‘neither ALJ relied on the Government’s of Respondents’ registrations. And
Respondent has been without counsel evidence with respect to factors two and because Respondents have produced no
since’’ they were served with the Show four to conclude that ‘‘the Government evidence of any corrective measures
Cause Orders, and that Superior I had has established its prima facie case by they have undertaken, I will order that
previously retained an additional at least a preponderance of the evidence their registrations be revoked and that
counsel. Id. at 3. The Government that Respondents’ continued . . . any pending applications be denied. As
further asserted that it was ‘‘both registrations would be inconsistent with ultimate fact finder, I make the
disingenuous and . . . legal the public interest.’’ R.D. 87. Further following.
gamesmanship to suggest that the finding that ‘‘Respondents have failed to
eleventh hour appearance of a co- rebut that case through a demonstration Findings of Fact
counsel for Superior II and a second co- of sufficient remediation,’’ the ALJ The parties stipulated that
counsel for Superior I constitute recommended that I revoke each Respondent Superior I holds DEA
grounds for disrupting a proceeding Respondent’s registration and deny any Certificate of Registration BS9255274,
that’’ in its view had commenced on pending applications to renew or pursuant to which it is authorized to
January 27, 2015. Id. It then argued that modify its registration. Id. dispense controlled substances in
Respondents had not demonstrated any On May 4, 2015, the ALJ transmitted schedules II through V as a retail
hardship that justified a continuance the record to my Office. On May 6, pharmacy, at the registered address of
and they ‘‘ha[d] never timely objected to 2015, Respondents filed a brief 3007 W. Cypress St., Suite 1, Tampa,
any’’ of the dates set by the ALJ, captioned as: Exceptions to the Florida. ALJ Ex. 7, at 2 (Nos. 15–6/15–
‘‘including the date and location of the Recommended Decision and Request for 7).
hearing which’’ had been set ‘‘more than Removal of the ALJ (hereinafter, cited as The parties stipulated that
two months’’ earlier. Id. at 4. Finally, Resp.’ Exceptions). Respondents, Respondent Superior II holds DEA
the Government stated that it was however, offered no showing of good Certificate of Registration BS9699731,
prepared to put on its case and that ‘‘all cause to excuse the untimely filing of pursuant to which it is authorized to
of [its] witnesses are travelling to their brief. See generally id. In response, dispense controlled substances in
Arlington, Virginia, and have set aside on May 7, 2015, the Government filed schedules II through V as a retail
time to participate in this matter.’’ Id. with my Office a motion to strike pharmacy, at the registered address of
The Government thus argued that ‘‘any Respondents’ Exceptions as untimely or, 5416 Town ‘N’ Country Blvd., Tampa,
further delay’’ would cause it prejudice. in the alternative, to respond to their Florida. Id.
sradovich on DSK3TPTVN1PROD with NOTICES2
Id. Exceptions. See Gov. Motion to
The ALJ denied Respondents’ motion. Supplement the Record, Strike The DEA Investigation
ALJ Ex. 24, at 2 (Nos. 15–6/15–7). As Respondent[s’] Untimely Filed On February 4, 2013, DEA
with Respondents’ previous motions for Exceptions to the Recommended Investigators executed Administrative
a continuance, the ALJ explained that Decision of the Administrative Law Inspection Warrants at Respondents
he had considered various factors and Judge Or, In the Alternative, Respond to Superior I and Superior II. Tr. 370–71;
found that ‘‘cause has not been shown Exceptions. Because Respondents have 471. With respect to Superior I, the
to delay the hearing.’’ Id. not demonstrated good cause to excuse Investigators seized the original
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/11.svg)
![31320 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
prescriptions for its schedule II and III the Board. GX 2, at 3. He is also a treating.’’ Id. at 139. Mr. Parrado then
dispensings, as well as its schedule II member of the Hillsborough County testified that he looks at what he termed
order forms (DEA-Form 222), invoices, Alcohol & Drug Abuse Task Force, the the ‘‘triangle’’—the locations of ‘‘the
and inventory records. Id. at 372. At National Community Pharmacists patient[’s] home, the physician’s office
Superior I, a DEA Investigator (who Association, and the American Society and the pharmacy’’ and that ‘‘whenever
assisted the lead Investigator) also for Pharmacy Law. Id. Finally, he has one of those legs seems to get a little bit
conducted an inventory of the made numerous presentations on the long I seem to get a little concerned,’’
controlled substances then on hand dispensing of controlled substances by thus leading him to ‘‘want to verify why
with the assistance of the pharmacist on pharmacists, id. at 3–7, and has testified a person would drive a long way to [go]
duty, who verified the count; the as an expert witness for both the to a particular clinic’’ and why the
Investigator also obtained a copy of an prosecution and defense in criminal and person would ‘‘drive a long way from
inventory taken by Superior I which administrative matters. Tr. 133; see also that clinic to a pharmacy.’’ Id. at 140.
was dated May 2, 2011. Id. at 373–78. id. at 152 (answering ‘‘no’’ when asked Mr. Parrado also identified other red
According to a DI, because the May 2, on voir dire if, in criminal matters, he flags to include ‘‘[m]ultiple people
2011 inventory ‘‘did not include all the has always testified for the presenting with identical or very similar
drugs that were a part of the audit,’’ he Government). prescriptions from the same clinic,’’ as
asked the lead Investigator to contact Asked to explain what the standard of well as where a person presents
the pharmacy for additional inventory care (in Florida) requires of a prescriptions for ‘‘cocktails that are
records, and on February 11, 2013, pharmacist who is presented with a known to be abused on the street.’’ Id.
Superior I provided additional records prescription for a controlled substance, Mr. Parrado then explained that a
which included a ‘‘bi-annual inventory’’ Mr. Parrado testified: cocktail ‘‘is a combination of drugs,’’
and an ‘‘in-house inventory.’’ Id. at 378– You have to ensure that the prescription is which usually includes an ‘‘opioid such
79. appropriate and that it’s valid. And in doing as oxycodone or hydromorphone,’’ ‘‘a
Likewise, with respect to Superior II, that he has to look at the prescription. He has benzodiazepine such as Xanax or
the lead Investigator on the warrant to understand the nature of the drug, the Valium,’’ and ‘‘a muscle relaxant such
testified that she seized the original nature of the disease state that they’re as Soma.’’ Id. at 140–41.
schedule II prescriptions and the treating, the appropriateness of the therapy
pharmacy’s purchasing records for the and the dosing. Mr. Parrado further identified as a red
drugs that were subject of the audit; the And then make sure that the prescription flag the circumstance where multiple
DI also testified she obtained the was issued under . . . the valid persons present the ‘‘same
pharmacy’s schedule II order forms as circumstances of a physician . . . having prescriptions’’ from either ‘‘the same
written the prescription in the course of his practitioner’’ or ‘‘clinic.’’ Id. at 141. Mr.
well as a perpetual inventory practice and that the prescription is . . . for
maintained by the pharmacy which was Parrado then explained that multiple
[a] legitimate medical purpose. persons getting the same prescriptions
dated July 31, 2012. Id. at 472, 474, 477.
The DI also took an inventory of the Id. at 137. ‘‘from the same clinic’’ would be a red
controlled substances then on hand, Asked to explain what a ‘‘red flag’’ is flag because ‘‘there’s supposed to be an
with the DI witnessing Superior II’s as it relates to the dispensing of individualization of therapy whenever a
pharmacist counting of the pills. Id. at controlled substances, Mr. Parrado then physician is ordering a pain
477. testified that: medication.’’ 13 Id. Of similar import,
As part of the investigations, the [a] red flag is anything that will cause the
Mr. Parrado testified that he was
Government provided various schedule pharmacist concern as to the validity of that familiar with the term ‘‘pattern
II prescriptions which were dispensed prescription. It could be numerous things. prescribing,’’ which he explained was
by each pharmacy to its expert Mr. And a lot of times it’s just dependent on when ‘‘prescriptions com[e] from the
Robert Parrado, who reviewed them to the patient presenting the prescriptions or same clinic in . . . the same drug,’’ with
determine if they were dispensed in the circumstances. Or just looking at the the same or ‘‘very similar’’ dosing and
compliance with the Controlled prescription itself might raise a red flag . . . quantities. Id. at 142. Reaffirming his
Substances Act. Mr. Parrado testified and cause you concern. earlier testimony, Mr. Parrado explained
that he obtained his B.S. in Pharmacy in Id. at 138. while ‘‘there could be a small
1970 from the University of Florida Mr. Parrado then proceeded to difference’’ in the quantity (i.e., 168 vs.
College of Pharmacy and that he has identify various red flags, including if 180 pills) prescribed, ‘‘[t]hat doesn’t
held a Florida pharmacist’s license the prescription was for ‘‘a known drug
since 1971. Tr. 122; GX 2, at 1 (No. 15– of abuse’’ and if the dosing is 13 Here again, Respondents objected to the
6/15–7). Mr. Parrado testified that he ‘‘appropriate.’’ 12 Id. Continuing, Mr. testimony, asserting that it was ‘‘outside the scope
has practiced as a pharmacist at both of [Mr. Parrado’s] testimony’’ and that Mr. Parrado
Parrado explained that after ‘‘mak[ing] was not ‘‘qualified to testify about what the
community pharmacies as well as sure the dosing is appropriate . . . you standard of care is for . . . a healthcare
hospital pharmacies; he also testified look at the quantity of tablets’’ and ask practitioner’’ under Florida Statute § 766.102. Tr.
that he had been the Pharmacy if it is ‘‘an appropriate therapy for the 141–42. Of note, in its Prehearing Statements, the
Department Manager at multiple Government disclosed to Respondents that Mr.
condition . . . [t]hat the physician is Parrado would discuss ‘‘prescriptions issued to
pharmacies, including two pharmacies multiple individuals presenting prescriptions for
that he owned for approximately 19 12 At this point, Respondents’ counsel objected on the same drugs in the same quantities from the
years. Tr. 124–26; GX 2, at 1–2. the ground that the testimony was ‘‘outside the same doctor.’’ ALJ Ex. 6, at 3 (No. 15–6); ALJ Ex.
sradovich on DSK3TPTVN1PROD with NOTICES2
Mr. Parrado was a member of the scope of the’’ Government’s Prehearing Statements. 7, at 3 (No. 15–7). The ALJ overruled the objection.
Tr. 138. However, in its Prehearing Statements, the Tr. 142. Respondent did not, however, explain how
Florida Board of Pharmacy from January Government notified Respondents that Mr. Parrado it was prejudiced because the Government then
2001 through February 2009, and had would identify and discuss ‘‘prescriptions for asked whether a red flag was also presented because
served as both Vice Chairman and controlled substances which are known to be highly the prescriptions came from the same clinic. As for
Chairman of the Board. Tr. 128–29; GX abused’’ and ‘‘prescriptions for quantities of Respondent’s contention that Mr. Parrado was not
narcotics that exceeded the recommended daily qualified under the Florida Statute to render an
2, at 3. He is a member of the Florida dosages.’’ ALJ Ex. 6, at 3 (No. 15–6); ALJ Ex. 7, at opinion on the issue, Florida law does not control
Pharmacy Association, having served as 3 (No. 15–7). I thus find that the ALJ properly the scope of permissible testimony in this
both its President and then Chairman of overruled the objection. proceeding.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/12.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31321
show me that there’s any attempt at Well anytime that there is a red flag my job
Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th
individualization of therapy.’’ Id. is to resolve that red flag. And at that point
Cir. 1984) (quoting Aloha Airlines v. Civil
Mr. Parrado then identified two more Aeronautics Bd., 598 F.2d 250, 262 (D.C. Cir. I’m having to use my professional judgment
red flags. The first of these is when ‘‘two 1979)). See also Boston Carrier, Inc. v. ICC, 746 F.2d when I’m weighing all the different factors
people in the same household or [with 1555, 1560 (D.C. Cir. 1984) (quoted in Edmund that are causing me concern.
Chein, 72 FR 6580, 6592 n.21 (2007) (‘‘an agency If I cannot resolve all these things that are
the] same address were needing the is not required ‘to give every [Respondent] a
exact same drugs.’’ Id. at 143. While Mr. complete bill of particulars as to every allegation
bothering me, at that point that becomes
Parrado explained that this could that [he] will confront’’). Thus, the failure of the unresolvable and I cannot fill that
possibly be legitimate, the ‘‘onus of Government to disclose an allegation in the Order prescription.
verifying that prescription has been to Show Cause is not dispositive, and an issue can
be litigated if the Government otherwise timely Id. at 145–46. See also id. at 361
seriously moved up a notch.’’ Id. Mr. notifies a respondent of its intent to litigate the
Parrado then testified that a red flag is (agreeing that a pharmacist’s education,
issue.
also raised when prescriptions are The Agency has thus recognized that ‘‘the
experience and training inform his/her
issued to multiple persons with the parameters of the hearing are determined by the professional judgment).
prehearing statements.’’ Darrell Risner, D.M.D., 61
same last name. Id. FR 728, 730 (1996). Accordingly, in Risner, the The Government then asked Mr.
Asked by the Government what steps Agency held that where the Government has failed Parrado if a retail pharmacist would
a pharmacist should take upon being to disclose ‘‘in its prehearing statements or indicate document his/her resolution of a red
presented with a prescription that raises at any time prior to the hearing’’ that an issue will
flag ‘‘somewhere?’’ Id. at 146. Mr.
a red flag, Mr. Parrado explained: be litigated, the issue cannot be the basis for a
sanction. 61 FR at 730. See also Nicholas A. Parrado answered: ‘‘Absolutely.
At that point the pharmacist—first thing he Sychak, d/b/a Medicap Pharmacy, 65 FR 75959, Anytime you have a concern with
has to do, he has to verify that prescription 75961 (2000) (noting that the function of prehearing appropriateness of therapy, you always
with the prescriber. Florida law says you statements is to provide Due Process through
‘‘adequate . . . disclosure of the issues and do what you have to do to resolve it and
check with the prescriber.
Not the prescriber’s office, with the evidence to be submitted in . . . proceedings’’); cf. then you document it on the
John Stafford Noell, 59 FR 47359, 47361 (1994) prescription.’’ Id. Asked by the
prescriber. And then you speak with the
(holding that notice was adequate where allegations
prescriber and get his opinion. were not included in the Order to Show Cause but
Government if the resolution of a red
You ask him the questions that you feel, ‘‘were set forth in the Government’s Prehearing flag ‘‘would be documented on the
you know, address your concerns. And then Statement’’). prescription itself,’’ Mr. Parrado
at that point I have to . . . use my However, consistent with numerous court answered: ‘‘Yes. Unless you have
professional judgment. Did I believe him or decisions, the Agency has also held that even where
not. an allegation was not raised in either the show
another form of doing that I don’t know
Because a physician who had written a cause order or the prehearing statements, the parties about, but the standard of practice has
script is always going to say, yes they wrote may nonetheless litigate an issue by consent. always been you document it on the
it. But I’m trying to determine if it was Pergament United Sales, 920 F.2d at 135–37; see prescription.’’ Id.
also Duane v. Department of Defense, 275 F.3d 988,
written for a legitimate medical purpose. So
that’s why I’m asking the questions I’m
995 (10th Cir. 2002) (discussing Facet Enterprises, On Respondent’s voir dire, Mr.
Inc., v. NLRB, 907 F.2d 963, 974 (10th Cir. 1990); Parrado was asked whether ‘‘the manner
asking. ‘‘we held that defendant had constructive notice of
an alternate theory of liability not described in the in which a pharmacist documents their
Id. at 144.
formal charge when the agency detailed that theory [sic] efforts to resolve red flags is not
Continuing, the Government asked during its opening argument and at other points mandated by any statute, regulations or
Mr. Parrado if some red flags are during the hearing and when the defendant’s
guidance document?’’ Id. at 154. Mr.
unresolvable, prompting objections by conduct revealed that it understood and attempted
to defend against that theory’’). See also Grider Drug Parrado answered: ‘‘The pharmacist has
each Respondent that this testimony
#1 & Grider Drug #2, 77 FR 44070, 44077 n.23 a duty to verify that’s done. And when
was beyond the scope of the summary (2012) (holding that while the Government did not he’s done that he needs to document it.
of the testimony disclosed by the provide adequate notice of its intent to litigate an
Government in its Prehearing allegation in either the show cause order or its Because if you haven’t documented it
Statements. Id. at 144–45. The ALJ prehearing statements, where respondents ‘‘did not you haven’t done it.’’ Id. Upon further
object that the allegation was beyond the scope of questioning by Respondents, Mr.
overruled the objections 14 and Mr. the proceeding and that they were denied adequate
Parrado testified: notice of it’’ and ‘‘fully litigated the issue,’’ the
Parrado acknowledged that neither the
allegation was litigated by consent) (citing Citizens Florida Statutes nor the Florida
14 This was the first of several objections to the State Bank, 751 F.2d at 213; Kuhn v. Civil Administrative Code state where the
Government’s elicitation of testimony from its Aeronautics Bd., 183 F.2d 839, 841–42 (D.C. Cir. pharmacist has to document his/her
Expert as to whether some of prescriptions 1950); and Yellow Freight System, Inc., v. Martin,
presented red flags that could not be resolved. As 954 F.2d 353, 358 (6th Cir. 1992)). resolution of a red flag. Id. at 156.
Respondents argued, the Government Pre-hearing Here, I conclude that the ALJ erred when he On further voir dire by Respondents,
Statements ‘‘do [ ] not anywhere discuss overruled Respondents’ objections to the testimony,
as neither the Show Cause Orders, nor the
Mr. Parrado testified that his opinions
irresolvable red flags. And this is a last minute
attempt to prejudice the ability of the Respondent[s] Government’s Prehearing Statements ever identified were not based on conversations he had
to put on a case here.’’ Tr. 144. any prescription as presenting red flags that could with the pharmacists at Respondents, or
One of the fundamental tenets of Due Process is not be resolved. As the Second Circuit has any statements of the pharmacists
that the Agency must provide a respondent with explained, ‘‘[t]he primary function of notice is to
notice of those acts which the Agency intends to afford [a] respondent an opportunity to prepare a provided to him by DEA. Id. at 158. He
rely on in seeking the revocation of its registration defense by investigating the basis of the complaint also testified that his opinions were not
so as to provide a full and fair opportunity to and fashioning an explanation that refutes the based on any statements made by the
challenge the factual and legal basis for the charge of unlawful behavior.’’ Pergament United
Sales, 920 F.2d at 135 (citation omitted). The patients, or the prescribers. Id. at 158–
Agency’s action. See NLRB v. I.W.G., Inc., 144 F.3d
sradovich on DSK3TPTVN1PROD with NOTICES2
685, 688–89 (10th Cir. 1998); Pergament United defense of the allegation that a prescription
Sales, Inc., v. NLRB, 920 F.2d 130, 134 (2d Cir. presented red flags that could not be resolved
1990). See also 5 U.S.C. 554(b) (‘‘Persons entitled requires entirely different proof, i.e., testimony as
to notice of an agency hearing shall be timely to why a prescription did not lack a legitimate
informed of . . . the matters of fact and law medical purpose, than the defense of the allegation
asserted.’’). that a pharmacist failed to resolve red flags, and
However, ‘‘ ‘[p]leadings in administrative Respondents’ multiple objections make clear that Respondents’ pharmacists violated their
proceedings are not judged by the standards applied they did not consent to the litigation of the issue. corresponding responsibility under 21 CFR
to an indictment at common law.’ ’’ Citizens State Accordingly, the Expert’s testimony to this effect 1306.4(a).
cannot be considered in determining whether
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/13.svg)
![31322 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
59.15 Over Respondents’ objections,16 computer generates labels, one of which Id. at 178–79.
Mr. Parrado was accepted as an expert. goes on the prescription bottle and the
Mr. Parrado further testified that each
Id. at 165. other goes on the prescription. Id. Mr.
Mr. Parrado then testified that he was of the 16 prescriptions was paid for in
Parrado then explained that the number
retained to ‘‘review the prescriptions.’’ following the letters ‘‘RX’’ on the label cash. Id. at 181. Asked whether based
Id. at 166. He also acknowledged having was the prescription number and that on his experience and knowledge of
‘‘reviewed some patient records’’ and ‘‘a the number is generated sequentially by retail pharmacy practice, the prices
patient profile,’’ before clarifying that the pharmacy’s ‘‘computer as being charged by Respondent for these
‘‘the main thing [he] relied on was the prescriptions are being filled.’’ Id. at prescriptions ‘‘were considered high
prescriptions and those partial patient 170–71. However, Mr. Parrado prices for oxycodone,’’ Mr. Parrado
records.’’ 17 Id. subsequently testified that ‘‘[d]epending answered ‘‘[v]ery.’’ Id. at 182. Mr.
on the computer format they have, some Parrado subsequently explained that
The Superior I Prescriptions ‘‘these prices are very, very high’’ and
will generate a number with the first
The Government then proceeded to number being different . . . depending that this would be an additional red
question Mr. Parrado regarding the 25 on the schedule of the drug.’’ Id. at 174. flag. Id.at 183. As the evidence shows,
prescriptions contained in Government The Government then asked Mr. 13 of the patients paid $784 or more for
Exhibit 3 (No. 15–6). Id. at 167. Each of Parrado whether there were ‘‘any red their prescriptions, and five of the
the prescriptions was issued by a flags associated with’’ the 16 patients paid $952 or more. GX 3, at 1–
physician at the 24th Century Medical prescriptions, which were filled on 16.
Center, which, according to the August 5, 2011. Id. at 178. Mr. Parrado The Government then questioned Mr.
prescriptions, was located at 7747 W. testified that the prescriptions presented Parrado regarding the red flags
Hillsborough Avenue in Tampa. GX 3. multiple red flags: presented by the relative location of the
Sixteen of the prescriptions were issued
Well first thing I would see was the drug, patients to the prescriber and Superior
on August 5, 2011 for oxycodone 30 and
[o]xycodone, 30 milligrams. Then I would I. With respect to the prescriptions
were filled by Superior I on the same see that they’re all coming from the same reproduced at pages one (112
day. See id. at 1–16; Tr. 169. Moreover, clinic. They’re all for the same strength oxycodone 30 to M.L.) and nine (224
13 of these 16 prescriptions were written by the same physician on the same oxycodone 30 to V.P.), both patients’
written by the same physician (Dr. C.), day.
addresses were listed as being in Spring
with the remaining three written by So there’s multiple patients coming from
the same clinic. Which was one of my Hill, Florida.19 See id. at 1, 9. According
another physician (Dr. R.). GX 3, at 1–
16. concerns earlier. Multiple people presenting to Mr. Parrado, Spring Hill is located 45
Each page of this exhibit contains two from the same clinic with a like or similar to 50 miles from Superior I.20 Tr. 185.
images; one showing the front of the prescription. Mr. Parrado then explained that ‘‘[t]here
These are definitely alike in similar
prescriptions; the other showing the
prescriptions. So that would be my first red As to the issue of foundation, Mr. Parrado
back. See generally GX 3. With respect flag. testified that ‘‘I know the pharmacy I was working
to the first page of the exhibit, Mr. Then the next red flag I would have looked in at that time [was] paying about $.33 a pill for
Parrado testified that the bottom image at was the dosing. The appropriateness of [o]xycodone.’’ Tr. 182. He then added that the
was the back of the prescription. Tr. therapy. A red flag I would have to resolve average price charged to a patient ‘‘may have gotten
169. He explained that when a at this point was knowing that 80 milligrams to a $1.00.’’ Id. On cross-examination, Mr. Parrado
a day of [o]xycodone is a lethal dose to an further testified that his knowledge of pricing was
pharmacy fills a prescription, its not based on his having called individual
opioid naı̈ve patient. These are much higher pharmacies, but rather his ‘‘general knowledge of
15 Regarding whether his opinions were based on than 80 milligrams a day dosing. what the market place was.’’ Tr. 242.
the presentations on red flags made by the former I would have to verify—I’d have to feel 19 See also GX 3, at 2 (Rx for 160 oxycodone 30
head of the Agency’s Office of Diversion Control, good about the fact that the patient had been to J.R.).
Mr. Parrado acknowledged that he has seen these on this drug therapy and established to this 20 Here again, Respondents objected to Mr.
presentations on two occasions. Tr. 159. However, dose. Would have been the first thing. Parrado’s testimony, arguing that the Government’s
Mr. Parrado stated that the presentations Then the next thing I would have looked Prehearing Statement did not disclose that he was
‘‘reinforced’’ his existing opinions on red flags. Id. at would have been the patient[’]s address. ‘‘going to be offering testimony with regard to the
at 160. As for the presentations he had previously distances between locations or the relative locations
given, Mr. Parrado acknowledged that he no longer
How far he drove to get there.
Then another thing I would have looked at of these patients and the pharmacy.’’ Tr. 184.
considers a patient’s asking for a drug by brand Respondents further argued that they had ‘‘prepared
name to be a red flag. Id. at 161–62. was what . . . did he pay for it with cash. to cross examine the person who [the Government]
When asked whether his opinions were based on And how much did he pay. How much is he said would testify to that. It was the intelligence
information in the DEA Pharmacist’s Manual, Mr. willing to pay for.18 analyst. It is not Mr. Parrado.’’ Id.
Parrado answered ‘‘yes’’, and when asked if he It is correct that the Government did not disclose
disagreed with anything in the Manual as it relates 18 At this point, Mr. Parrado testified that ‘‘in that in its Prehearing Statement for Superior I that Mr.
to red flags and their resolution, answered ‘‘no.’’ Id. time period,’’ oxycodone cost from $.33 to $1.00 per Parrado would specifically testify about the
at 163. tablet, at which point Respondents’ counsel distances between Superior I and the towns of
16 The basis of Respondents’ objection to Mr.
objected to the testimony, asserting that it was Spring Hill (as well as New Port Richey and others).
Parrado being accepted as an expert was that he ‘‘is outside the scope of the Government’s Prehearing It also true that in its Prehearing Statement, the
a practicing pharmacist. He’s experienced in retail Statements and that there was no foundation for Mr. Government indicated that it intended to call a
pharmacy but qualification as an expert, there’s no Parrado’s testimony. Tr. 179. While the different witness (an intelligence analyst) to testify
need.’’ Tr. 165. Given Mr. Parrado’s extensive years Government’s Prehearing Statement did not about a chart she created showing the large number
of practice as a retail pharmacist; his years as a disclose the precise prices he testified to, the of Superior I’s patients who lived long distances
member of the Florida Board of Pharmacy, which Government did disclose that Mr. Parrado would from the pharmacy. However, the Government also
includes service as both Vice Chairman and
sradovich on DSK3TPTVN1PROD with NOTICES2
‘‘identify and discuss . . . prescriptions for disclosed that it intended to ask the ALJ to take
Chairman; his involvement in the Florida Pharmacy individuals playing [sic] high prices . . . for official notice of the approximate mileage between
Association which includes his service in controlled substances with cash.’’ ALJ Ex. 6, at 3 Superior I and the various municipalities where the
leadership positions; his membership in other (No. 15–6). Moreover, the label attached to the back patients lived. Moreover, the distances between
professional associations; and his numerous of each of the prescriptions contains data as to both Superior I and the towns of Spring Hill and New
presentations; the ALJ properly overruled the price to the patient and the cost of the Port Richey are disputable only to the extent one
Respondents’ objection. prescription and the prescriptions were provided to argues over the precise addresses used to ascertain
17 On cross-examination, Mr. Parrado testified Respondents prior to the hearing. The labels suggest that distance or the route taken. I thus conclude that
that he had review only one patient profile ‘‘a that Mr. Parrado’s testimony as to the cost per tablet Respondent cannot show how it was prejudiced by
couple of weeks’’ before the hearing. Tr. 232. was accurate. See, e.g., generally GX 3 (No. 15–6). the ALJ’s overruling of its objection.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/14.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31323
are many pharmacies between Spring Georgia; and New Port Richey, Florida. See GX 3, at 15. Mr. Parrado again
Hill and Tampa.’’ Id. See GX 3, at 11–12, 14–16. Specifically, opined that he believed these persons
Regarding the prescriptions the Government asked whether ‘‘the fact travelled together to obtain the
reproduced at page four (168 oxycodone that these numbers are so close together, prescriptions. Tr. 198. Asked by the
30 S.M.) and 16 (224 oxycodone 30 for looking at these prescriptions Government—over the overruled
S.A.), Mr. Parrado testified that both collectively, does that raise any objection of Respondent—whether the
patients gave addresses in New Port additional red flags for you?’’ Tr. 195. red flags presented by these were
Richey. Id. He then testified that New After the ALJ overruled Respondent’s resolvable, Mr. Parrado explained:
Port Richey is ‘‘[a]bout 40 miles north objection that the testimony was outside
of Tampa.’’ Id. Mr. Parrado then noted These are the kinds of prescriptions that
the scope of the Prehearing Statement,
that patient addresses for other would cause me not to be able to resolve
Mr. Parrado answered:
prescriptions included Bradenton (40– that—this many red flags together. The long
Yes. Yes, it would have caught my distance, the same name, the like, similar
45 miles south and west of Tampa), id. attention that we had people coming from
at 186; Port Richey (which is next to drugs, thousands of dollars involved here, in
long distances and places that were close cash, would cause me . . . concern.
New Port Richey), id. at 187; Ocala (90– together, coming to get these prescriptions.
100 miles north of Tampa), id. at 188; It’s not, in my practice, it’s not been—the
What I don’t see on there is, you know, it
Gainesville (130 miles north of Tampa), looks like the [patient address] sticker was average customer doesn’t come into the
id.; High Springs (‘‘probably a 150 put on the front to resolve the red flag. It pharmacy with $1,000 in their pocket. You
miles’’ from Tampa), id. at 188–89; doesn’t tell me how they resolved the red know, it’s average you tell the person they
Jacksonville (200 miles north and east of flag. have a $20 copay they get upset.
Tampa), id. at 189–90; Alachua (140– For these process [sic] to be charged, you
Id.
150 miles from Tampa); id. at 190; know, it’s just—that’s a red flag that I would
The Government then asked Mr. have a hard time resolving.23
Middleburg (‘‘[c]lose to Jacksonville’’ Parrado about the prescriptions
and ‘‘about 200 miles’’ from Tampa); id. reproduced at pages 13 (RX#452157) Id. at 199. Asked the same question with
at 191; and Uvalda, Georgia (‘‘probably and 14 (RX#452156); these prescriptions respect to the prescriptions reproduced
. . . close to 300 miles’’ from Tampa). listed the patient’s addresses as being in at pages 13 and 14, Mr. Parrado
Id. at 192. Jacksonville (J.M.) and Middleburg, testified: ‘‘It would be the same answer.
Next, the Mr. Parrado testified that
Florida (B.M.). Id. at 196; GX 3, at 13– It’s the same situation.’’ 24 Id. at 200.
each of the 16 prescriptions was
14. According to Mr. Parrado, these
‘‘facially invalid’’ because the The Government then asked Mr.
‘‘two prescriptions were filled
prescribing physician did not include Parrado whether, with respect to the 16
sequentially for people from Middleburg
the patient’s address. Id. Mr. Parrado oxycodone 30 prescriptions (GX 3, at 1–
explained that under Florida law ‘‘at the and Jacksonville, which are both very
close to each other.’’ Tr. 196. 16), which were issued and filled on
time 21 . . . the patient name and August 5, 2011, there was any evidence,
address had to be on the front of the Continuing, Mr. Parrado opined: ‘‘So
they could have travelled together to other than the placement of the address
prescription.’’ Id. While Mr. Parrado stickers, that the red flags they
testified that a missing address is a red come there.’’ 22 Id. Mr. Parrado further
observed that these patients had the presented ‘‘were resolved?’’ Tr. 200. Mr.
flag, he acknowledged that the Parrado testified: ‘‘[t]here is no
pharmacist could resolve it by adding in same last name. Id. at 197.
Next, the Government asked Mr. documentation to that effect on any of
the patient’s address. Id. Asked by the these prescriptions.’’ Id. Following up,
Government whether it appeared that Parrado about the prescriptions
reproduced at pages 14 and 15. Of note, the Government asked Mr. Parrado if he
Superior I’s pharmacists had resolved had seen any evidence ‘‘that any of the
this red flag with respect to the the latter prescription was issued to a
patient (C.M.), who provided an address red flags [other than the missing
prescriptions reproduced at pages one
in Uvalda, Georgia and who has the addresses] were even investigated?’’ Id.
and four of GX 3, Mr. Parrado
same last name as that of the patients at 201. Mr. Parrado replied:
acknowledged that it appeared that they
had done so as evidenced by the discussed in the preceding paragraph. In some of the partial medical records I
‘‘computer generated sticker[s] that the 22 Here
looked at, there wasn’t any evidence of any
again, Respondent objected to the conversations between the clinics and the
pharmacist[s] put’’ on the prescriptions. testimony as ‘‘rank speculation’’ for which there
Id. at 193. However, Mr. Parrado then was ‘‘no foundation.’’ Tr. 196. He also argued that
explained that it ‘‘would have been [the it was beyond scope of the Government’s 23 Here too, Respondent objected that Mr. Parrado
pharmacist’s] duty’’ to verify that the Prehearing Statement. Id. The ALJ overruled the ‘‘ha[d] no idea what people who come into a
address on the sticker ‘‘was accurate.’’ objection. pharmacy have in their pocket or they don’t.’’ Tr.
As for Respondent’s objection on the ground that 199–200. Respondent thus contended that Mr.
Id. the testimony was ‘‘rank speculation,’’ given that Parrado’s testimony was speculation and was
The Government then asked Mr. Mr. Parrado testified and the prescriptions show outside the scope of the Prehearing Statement. Id.
Parrado about the prescriptions found at that: (1) These two patients had the same last name, at 200. The ALJ stated that he noted the objection
pages 11 (RX#452161), 12 (RX#452160), (2) provided addresses which suggested that they and that he did not need Respondent to tell him
lived near each other, and (3) their prescriptions ‘‘what should be or should not be allowed in this
14 (RX#452156), 15 (RX#452155), and bore sequential prescription numbers, Mr. Parrado’s hearing.’’ Id. The ALJ then explained that he had
16 (RX#452159). Tr. 194–95. Of note, testimony was a permissible inference. In any made his ruling and instructed the Government to
these prescriptions were issued to event, even if the patients did not travel together, ask its next question. Id.
patients who reported their addresses each of these prescriptions presented red flags. I agree with Respondent that this testimony was
speculative because the patients could well have
sradovich on DSK3TPTVN1PROD with NOTICES2
respectively as being in High Springs, Moreover, even acknowledging that the
Government did not disclose that Mr. Parrado paid for their prescriptions with credit cards.
Alachua, Middleburg, Florida; Uvalda, would testify that these two persons could have However, the prescriptions list their respective
travelled to Superior together, the Government prices as $833 (RX 452157), $952 (RX452156), and
21 While Mr. Parrado referred to Florida law ‘‘at nonetheless disclosed that it intended to elicit $833 (RX452155). GX3, at 13–15. Regardless of the
the time,’’ Florida law still requires that the face of testimony regarding Respondent’s filling of method of payment used to purchase them, Mr.
a controlled substance prescription contain ‘‘[t]he multiple prescriptions for patients who travelled Parrado testified that the cost of the prescriptions
full name and address of the person for whom . . . long distances to obtain their prescriptions. ALJ Ex. was also a red flag.
the controlled substance is dispensed.’’ Fla. Sta. 1, at 2–3 (No. 15–6); ALJ Ex 7, at 3–5 (No. 15–6). 24 This prompted the same objection by
§ 893.04(c)(1)(2015). See also supra note 12 (collecting cases). Respondent and the same ruling. Tr. 200.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/15.svg)
![31324 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
pharmacist.25 Also, this is one of the things Next, the Government asked Mr. that he had seen ‘‘no documentation
I got out of the partial medical records, that Parrado whether the prescriptions anywhere’’ that Superior I’s pharmacist
there wasn’t any evidence that they had even (reproduced at GX 3, at 17–18), which resolved the red flags, including in the
talked with the pharmacy. And there was are dated August 6, 2011 and bear ‘‘partial medical records,’’ which
nothing here being documented either.
sequential prescription numbers contained ‘‘no evidence that there was
Id. presented any red flags. Both of these any conversation between the pharmacy
Mr. Parrado then opined that it prescriptions were issued by Dr. S.A.H., and the physician[’s] office.’’ Id. at 206–
‘‘would be outside the standard of care a physician at the same 24th Century 07.
for a pharmacist to fill these without Medical Center in Tampa, to two Next, the Government asked Mr.
having resolved the red flags before persons (E.P. and R.B.) for 150 and 140 Parrado about a prescription issued by
dispensing.’’ Id. Asked to opine on tablets respectively of oxycodone 30. GX Dr. V.S. (also of the 24th Century
whether, based on the prescriptions and 3, at 17–18. Here too, the front of each Medical Center) and dispensed on
records he reviewed, the pharmacists prescription lacked the patient’s December 2, 2011 to B.W., for 200
‘‘exercise[d] their corresponding address. See id. However, each tablets of Dilaudid (hydromorphone) 8
responsibility to ensure that a prescription bore a sticker listing the mg. See GX 3, at 21; Tr. 207. Here again,
patient’s address, and the stickers the prescription lacked the handwritten
prescription for a controlled substance
indicated that E.P. and R.B. lived at the patient’s address but contained a sticker
was issued for [a] legitimate medical
same street address in Milton, Florida. which listed B.W.’s address as being in
purpose,’’ Mr. Parrado answered: ‘‘[n]ot
See id. Fort Ogden, Florida. GX 3, at 21.
that I can tell from the records shown Asked by the Government whether
to me.’’ Id. at 201–02. Asked if the prescription presented
the prescriptions presented any red any red flags, Mr. Parrado testified that
The Government then questioned Mr. flags, Mr. Parrado identified the
Parrado about the remaining there were multiple red flags, including
patients’ addresses and added that that ‘‘it’s a very, very potent drug’’ and
prescriptions in its Exhibit 3. These ‘‘Milton, Florida is way in the [w]estern
included a prescription for 240 that the quantity was for 200 pills. Tr.
panhandle of Florida. It’s well over 400 208. Continuing, Mr. Parrado testified
oxycodone 30 issued on December 10, miles’’ to the pharmacy. Tr. 204.26 Mr.
2011 to J.M.; as with the other that:
Parrado noted that ‘‘both of them seem
prescriptions, the prescriber had not I have never seen a prescription in my 41
to have the same address.’’ Id. However,
written the patient’s address on the years as a pharmacist for a quantity like that
he then testified that the driver’s license of . . . Dilaudid 8 milligrams as being dosed
prescription but the prescription that was in R.B.’s ‘‘partial medical
contained a small sticker listing J.M.’s at every . . . three to four hours.
records’’ listed his address as being in Which would be six to eight times a day.
address as Lenoir, Tennessee. GX 3, at a different city (Pace, Florida) than So 48 to 72 milligrams . . . would be the
22 (No. 15–6). Asked if the prescription Milton. Id. at 205. Mr. Parrado daily dose for a drug that the recommended
raised any red flags, Mr. Parrado noted explained that the disparity between the upper dose be probably 24 milligrams.
J.M.’s address and explained that his address on the prescription and the So it’s a much higher dose then [sic] what
‘‘first concern’’ was the ‘‘person coming address on the driver’s license ‘‘caused I have ever seen as a pharmacist. And that
from Tennessee.’’ Tr. 202. Mr. Parrado would have caused me serious concern that
me concern that they weren’t looking
identified additional red flags presented I had to resolve before I could do anything,
very closely.’’ Id. at 205–06. period.
by the prescriptions, including the After noting that E.P.’s prescription
physician’s failure to include the patient The fact that they came a long way, again,
cost $562 and R.B.’s prescription cost from Fort Ogden, from that same clinic that
address on the prescription, that the $525, Mr. Parrado testified that ‘‘two I’m seeing all these prescriptions from,
quantity of 240 pills was a ‘‘very high people from one address paying over would cause me not to be able to resolve that
dose’’ for oxycodone 30, that the $1,000 would be a red flag from red flag.
prescription came ‘‘from the same somebody coming . . . from 400 miles
clinic,’’ and that it cost $1,155. Id. Mr. Id. at 208–09.
away.’’ Id. at 206. He further noted that
Parrado then explained that ‘‘[t]hose are both prescriptions were written by the Mr. Parrado was then asked whether
all red flags that I could not have same physician and were for the same a prescription (GX 3, at 19) for 196
resolved.’’ Id. drug and in essentially the same Dilaudid 8 mg issued by Dr. P.C. and
However, when asked by the quantities. Id. Mr. Parrado then testified dispensed on December 1, 2011 to R.L.
Government if he could tell who filled (Largo, Fl.) also presented red flags. Tr.
the prescription, Mr. Parrado testified 26 Respondent’s counsel objected that the 209. Mr. Parrado testified that the
that the prescription bore the initials testimony was outside the scope of the quantity and dosing raised the ‘‘exact
‘‘CD,’’ thus indicating ‘‘the pharmacist Government’s Prehearing Statement and was rank same concern’’ as the dosing was ‘‘well
speculation. Tr. 204–5. The ALJ overruled the outside the recommended upper dosage
responsible’’ for the script; he then objection. Id. at 205. Here again, the Show Cause
added that ‘‘there’s a scribble on the Order specifically alleged that ‘‘[o]n August 6, 2011,
of that drug.’’ Id. Continuing, he
front from somebody that canceled the one or more Superior I pharmacists dispensed large explained: ‘‘And I don’t see anything
prescription.’’ Id. at 203. Moreover, the and substantially similar quantities of thirty where that was resolved to establish that
milligram tablets of oxycodone to two customers, the patient had developed a tolerance to
prescription has two diagonal lines E.P. and R.B., both of whom resided at the same
drawn through it, along with a circle address in Milton, Florida, which is located
that drug to avoid the respiratory
with the letter ‘‘C’’ in bold, and while approximately four hundred and forty nine miles depression that would have been
there is a copy of the dispensing label (449) from Superior I’s location.’’ ALJ Ex. 1, at 2 inherent at that dose.’’ Id.
sradovich on DSK3TPTVN1PROD with NOTICES2
(No. 15–6). While this alone provided adequate Asked whether R.L.’s address in Largo
attached to the back, see GX 3, at 22, the notice, the Government’s Prehearing Statement
Government offered no further evidence further advised that ‘‘Mr. Parrado will further testify
was also a red flag (here too, the
to clarify whether the prescription was that, on August 6, 2011, Respondent dispensed patient’s address had not been written
actually dispensed. large quantities of thirty milligram oxycodone to on the prescription but had been added
two individuals, E.P. and R.B., who resided at the by a sticker), Mr. Parrado testified that
same address in a city located more than 440 miles
25 On cross-examination, Mr. Parrado testified . . . from Respondent’s pharmacy.’’ ALJ EX. 7, at
the distance was 20 to 25 miles. Id. at
that he had been given the partial medical records 4 (No. 15–6). The ALJ thus properly overruled the 209–10. While he acknowledged that
after the New Year’s holiday. Tr. 357–58. objection. this was not ‘‘a very long distance,’’ he
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/16.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31325
explained that ‘‘the fact that there’s so There’s no documentation that I saw that these patients’’ but was told to look at
many coming from outside the area just there was any conversation with a physician only the prescriptions. Id. at 247. He
starts compounding the fact that this is determining that. Because at these doses then testified that he believed the
there would had to have been conversation
almost . . . like a destination clinic or Agency had the profiles because he had
determining tolerance. There would have
destination pharmacy where people been conversation determining medical need seen some of them in the DEA’s office.
know to go there.’’ Id. at 210. Mr. at this dosing. Id.
Parrado then testified that he found no So at that point I would have had a Mr. Parrado testified that he had not
evidence that Superior I’s pharmacist question in my mind, as a pharmacist filling consulted with any other pharmacists in
attempted to resolve the red flags. or being presented with this prescription, forming his opinions. Id. at 248. He also
As for the prescription (GX 3, at 20), that there may have been . . . not a very testified that he did not speak with any
which was issued by Dr. R. (also of 24th good valid patient–doctor relationship going of the prescribers of the 25 prescriptions
on at that point in time. or with the patients who received them.
Century) to C.L. for 224 Dilaudid 8 mg
on December 1, 2011 and filled the same Id. at 221–22. Id. at 249. He then testified that he did
day, Mr. Parrado again found the On cross-examination, Mr. Parrado not know what training or experience
quantity to be a red flag, testifying that acknowledged that he could not offer an the prescribers had. Id. at 250.
this would be ‘‘a lethal dose to an opinion as to whether any of the Asked by Respondent whether, based
opioid naı̈ve patient.’’ Tr. 211. He then patients, whose prescriptions were on the materials provided to him by
explained that ‘‘there’s nothing here to provided in GX 3, were opioid naı̈ve. Tr. DEA, he knew if Superior I’s
show that the patient has developed a 235–36. Asked whether it was true that pharmacists had called the prescribers
tolerance to this drug.’’ Id.27 As for the he had no knowledge as to the ‘‘to discuss any issues related to the
prescription (GX 3, at 23), which was procedures used at Superior I to revolve patients or the prescriptions,’’ Mr.
issued by Dr. V.S. (of the same clinic) red flags, Mr. Parrado answered that Parrado answered that ‘‘did not see
to M.A. for 224 Dilaudid 8 mg on ‘‘[n]othing that was documented on the anything to that effect.’’ Id. at 251. He
December 2, 2011 and filled the same prescriptions showed that anything had then testified that if ‘‘[i]t wasn’t
day, Mr. Parrado testified that the ‘‘very been done.’’ Id. at 237. After documented[,] [i]n my mind, they didn’t
high dose’’ was a red flag and that there acknowledging that ‘‘there’s nothing do it.’’ Id. However, Mr. Parrado
was no evidence that the patient had that mandates where [documentation] acknowledged that he did not know if
developed tolerance to the drug. Tr. 212. has to be,’’ he also acknowledged that if this was documented other than on the
Concluding its direct examination of the resolution of the red flags was prescriptions. Id. at 252.
Mr. Parrado regarding the Superior I documented someplace other than on Mr. Parrado did not know whether
prescriptions, the Government asked if the prescription itself, the Superior I kept a paper file which
he had an opinion as to whether the documentation wasn’t provided to him, included medical records on their
pharmacists who dispensed the and thus he does not know whether it patients. Id. at 254. He also did not
prescriptions knew or had reason to know if Superior I’s pharmacists
exists or not. Id. at 237–38.
While Mr. Parrado testified that he obtained copies of MRIs, X-Rays and CT
know that they were issued without a
knew one of the pharmacists who scans. Id. He then testified that:
valid doctor-patient relationship. Tr.
220–21. After the ALJ overruled worked at Superior I, he stated that he In the partial patient records that I did
Respondent’s objection,28 Mr. Parrado had not spoken with her about any of receive, there was evidence of some MRIs.
the prescriptions. Id. at 246. Nor has he What struck me was that these MRIs were old
explained:
and not ordered by the physician who was
discussed with any of Superior I’s writing these prescriptions, which would
27 In response to the Government’s question pharmacists the policies or procedures have been a red flag to me. Some of these
whether the fact that these two prescriptions were the pharmacy had in place from January
presented the same day raised ‘‘[a]ny additional red
MRIs were two/three years old. They were
flags,’’ Mr. Parrado testified that ‘‘[t]hat’s another
1, 2011 through February 4, 2013, or ordered by someone else.
pattern prescribing red flag. To me.’’ Tr. 211–12. I currently has in place, for identifying There were some . . . MRIs, reports didn’t
conclude, however, that two prescriptions do not diversion and for documenting the even have a referring prescription on it. That
establish pattern prescribing. resolution of red flags. Id. at 246–47. would have concerned me as a pharmacist
28 Respondent objected on the ground that
Mr. Parrado further testified that he filling that prescription.
‘‘[t]here’s no opinion summarized anywhere in the
Government’s [P]re-hearing [S]tatement . . . that asked DEA ‘‘for complete profiles on all Id. at 254–55.
relates to whether or not . . . the pharmacist knew Respondent then asked Mr. Parrado if,
or should have known that those prescriptions were relationship to act in the usual course of practice based on the information provided to
issued. And it’s outside his area of expertise. It’s and to issue a prescription for a legitimate medical him, he was ‘‘aware that the
nothing but rank speculation.’’ Tr. 221. purpose.
Even assuming that the first ground for objection Nor was it beyond Mr. Parrado’s expertise to
pharmacists were obtaining copies of
was that the Government did not provide notice opine on whether the prescriptions were issued radiographic studies [and] reports of
that it intended to ask whether the pharmacists outside of a valid doctor-patient relationship. See radiographic studies?’’ Id. at 255. Mr.
knew or should have known that the prescriptions United States v. Hayes, 595 F.2d 258, 261 & n.6 (5th Parrado answered:
were issued without a valid doctor-patient Cir. 1979) (‘‘[A] pharmacist can know that
relationship, in its Prehearing Statement, the prescriptions are issued for no legitimate medical No, I didn’t say I saw it in the pharmacy
Government advised that Mr. Parrado ‘‘will testify purpose without his needing to know anything records. I saw it in the medical records. If the
that, based on his expertise, training, and about medical science.’’). Indeed, pharmacists are pharmacist would have had access to that,
experience, and based on his review of the evidence expected to review the patient record and each that would have presented another red flag
summarized above, Respondent’s pharmacists prescription for therapeutic appropriateness and in the fact that that was an old record ordered
failed to exercise their corresponding responsibility identify, inter alia, over-utilization, incorrect drug by someone else. That would have raised the
sradovich on DSK3TPTVN1PROD with NOTICES2
to ensure that prescriptions for controlled dosage, and clinical abuse/misuse. Fla. Admin Code
bar there if you will.
substances were issued for a legitimate medical r.64B16–27.810(1). A pharmacist is obviously
purpose in the usual course of professional required to be able to determine when a Id. Mr. Parrado then explained that he
practice.’’ ALJ Ex. 7, at 5. Asking whether the prescription calls for the dispensing of such potent did not know the source of the medical
prescriptions ‘‘were issued without a valid-doctor narcotics as oxycodone or Dilaudid in quantities
patient relationship’’ is just another way of asking that far exceed recommended upper dosages and records.29 Id.
whether the prescriptions ‘‘were issued for a would be lethal in an opioid naı̈ve patient, let alone
legitimate medical purpose in the usual course of when a patient presents such other red flags of 29 Subsequently, the lead Investigator testified
professional practice,’’ as a physician must abuse or diversion, such as travelling long distances that the medical records had been obtained
establish and maintain a valid doctor-patient to obtain narcotics. Continued
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/17.svg)
![31326 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
Mr. Parrado acknowledged patients this document, he saw any indication from Tampa’’; and the patient paying
become dependent and develop that red flags had been resolved or $1,260 cash for the drugs. Tr. 277–78.31
tolerance to opioid analgesics and that explained, Mr. Parrado answered ‘‘no.’’ Mr. Parrado then testified ‘‘there was
there is no upper limit as to the quantity Id. at 271. nothing on the prescription to show me
or dose that can be prescribed. Id. at Questioned by the ALJ as to where he that these things had been discussed.’’
260. He also acknowledged that he did would document the red flags presented Id. at 279.
not know if any of the patients who by a prescription, Mr. Parrado testified The second prescription was issued
received the prescriptions in GX 3 that: ‘‘I would have identified the red on December 2, 2011 by Dr. R. (the same
worked in Tampa. Id. He also conceded flags that concerned me when the Dr. R. of 24th Century), to R.B. of
that the patients ‘‘were seeing the prescription was presented. I would Milton, Florida (the same R.B. discussed
physicians regularly over a good period have noted that on the back and I would in the Superior I findings) for 168
of time.’’ Id. have noted what I did to resolve each oxycodone 30. GX 3, at 3–4 (No. 15–7).
Continuing, Mr. Parrado one of those if there was more than Here again, the patient’s address was
acknowledged that there is an one.’’ Id. at 273. Mr. Parrado added that left blank and the address was provided
expressway which runs from Spring Hill ‘‘you scribble on the back and/or you by a sticker, which was affixed to the
to Tampa, and that people may write on a piece of paper and staple it front of the prescription. Id. at 3. After
commute from the former to the latter to that prescription.’’ Id. Mr. Parrado identified R.B. as being one
for work. Id. at 261. Mr. Parrado The ALJ then asked Mr. Parrado if, in the persons who filled a prescription at
testified that this red flag would have his ‘‘experience working with other Superior I which presented red flags,
been resolvable if the question had been pharmacists, . . . they have other ways the Government asked him to also look
asked and answered. Id. at 262. of making records . . . to keep track of at the prescriptions reproduced at pages
Next, Mr. Parrado testified that a the red flags and how they’ve been 5–6 of the exhibit. The latter
pharmacist can add an address to a resolved?’’ Id. at 274. Mr. Parrado prescription was also issued on
prescription if ‘‘you’ve checked with the answered: ‘‘[n]ot in the 43 years I’ve December 2, 2011 by Dr. V.S. (also of
physician and gotten the correct thing been a pharmacist.’’ Id. 24th Century) to E.P., who again used
and that matches what the patient is On further re-cross, Respondent asked R.B.’s address as her address; the
telling you.’’ Id. at 263. He then Mr. Parrado: ‘‘Not all pharmacists prescription was also for 168 oxycodone
acknowledged that he did not attempt to document in the same way that you do, 30. Id. at 5–6. Of further note, R.B.’s and
determine if any of the prescriptions in do they?’’ Id. Mr. Parrado answered: E.P.’s prescriptions had sequential RX
GX 3 were necessary for the treatment ‘‘[a]s a Board of Pharmacy member, I numbers. Id.
of chronic or recurring disease. Id. at would have expected them when they Asked if these prescriptions presented
264. came before the Board to show me that any red flags, Mr. Parrado testified that
On re-direct, Mr. Parrado was asked documentation. It was always on the ‘‘[t]hese were the same two patients that
whether the one patient profile he was prescription. It’s always on that had gotten prescriptions filled at the
provided with was for P.D. (GX 3, at 24) prescription record somehow.’’ Id. other pharmacy, both with the same
and whether the profile showed that Noting that Mr. Parrado had not been on Milton, Florida address, both paying
there was a gap in care. Tr. 268. Asked the Board of Pharmacy for some time, $924 in cash, travelling a long way, very
to describe what was on the document, Respondent then asked if he had ‘‘ever high dosing, all the same concerns I had
Mr. Parrado testified that: seen in your 43 years[,] pharmacists with the previous prescriptions.’’ Tr.
[t]there was a list of dates for Mr. P.D. that document the same information in 280–81. He also observed that the
showed the dates he had prescriptions filled different ways?’’ Id. at 275. Mr. Parrado prescriptions ‘‘were filled
for this drug and there was a gap of two answered: ‘‘I’ve seen them document in consecutively’’ and that the dispensing
months in there which, as a pharmacist, different ways but always on the labels show that the same pharmacist
anybody that stops taking opioids or if I don’t prescription.’’ Id. (M.F.) filled the prescriptions, and that
know he’s continued taking opioids, at that these circumstances would have caused
point I can’t fill a further prescription till I’ve The Superior II Prescriptions him concern. Id. at 282–83. And Mr.
established that.
He could have been in jail. He could have With respect to the Superior II Parrado further testified that he saw no
been in a rehab unit. It is well-documented prescriptions, Mr. Parrado testified that evidence that the pharmacist attempted
that patients that have gone into these things, he reviewed them in the same manner to resolve the red flags. Id. at 283.
gone back in the community and accessed a as he did the Superior I prescriptions. The next prescription was issued on
prescription at the old dosage they were on Id. at 277. He then proceeded to identify September 18, 2012 by Dr. V.S. (the
would kill them and it has killed them. various red flags presented by the same Dr. V.S. who had worked at 24th
Id. at 269–70.30 Asked by the prescriptions. Century) to L.P. of Jacksonville, for 168
Government whether when he reviewed The first of these was a prescription oxycodone 30. GX 3, at 7–8. Mr. Parrado
issued by Dr. H.V.D. (also of the 24th testified that the prescription presented
pursuant to a subpoena issue to the 24th Century Century Medical Center) to J.T. of Fort multiple red flags including ‘‘the drug,’’
Clinic and had been provided to Mr. Parrado by Meyers, Florida, for 280 oxycodone 30. the ‘‘very high quantity,’’ that the
Government Counsel. Tr. 578, 589–90. GX 3, at 1–2 (No. 15–7). Here again, the patient was ‘‘coming from Jacksonville
30 At this point, Respondent objected, arguing that
if Mr. Parrado was going to talk about this
patient’s address was left blank and the . . . over 200 miles’’ from Tampa, and
document, the Government should be required to address was provided by a sticker, that the patient was ‘‘paying $1,344 in
‘‘produce the document so that we can see what it which was affixed to the front of the
sradovich on DSK3TPTVN1PROD with NOTICES2
is that he’s talking about. You know, he’s talking prescription. Id. at 1. Mr. Parrado 31 Respondent objected to Mr. Parrado’s
about some amorphous document.’’ Tr. 270. He also testimony as to the price, asserting it was beyond
argued that the testimony was outside the scope of
testified that prescription presented the
the scope of the Pre-hearing Statement because it
either cross examination or the Prehearing following red flags: The drug having ‘‘a did not specifically identify ‘‘the pricing issue’’ as
statement. Id. While the ALJ disagreed that it was high potential for abuse’’; the ‘‘very being one of the red flags associated with the
outside the scope, he explained that because there large quantity’’ and ‘‘the dosing at a very prescription. Tr. 278. The Government did,
was ‘‘no document in front of him’’ and he was however, identify that it intended to elicit
‘‘relying on the frailties of human memory,’’ he was
high rate, well above . . . 80 milligrams testimony on the issue of ‘‘individuals playing [sic]
not going to give this testimony ‘‘a whole lot of a day’’; the ‘‘patient travelling from Fort high prices for prescriptions . . . with cash.’’ ALJ
weight.’’ Id. at 271. Meyers, which is . . . 150 miles or so Ex. 7, at 3 (No. 15–7).
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/18.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31327
cash.’’ Tr. 284. Mr. Parrado then 56 Dilaudid 8 issued by Dr. S.A.H. (of testified that it is located in the
testified that there was ‘‘nothing 24th Century) to V.B., who has the same ‘‘extreme western part of the Florida
documented’’ regarding the last name and lived in the same town as panhandle’’ and 450 miles from Tampa.
pharmacist’s attempt to resolve the red L.B.33 GX 3, at 15–18. Asked whether Tr. 297.
flags. Id. ‘‘seeing these prescriptions together,’’ Notably, the prescription contains a
After Respondent ‘‘object[ed] to the there were ‘‘additional red flags,’’ Mr. handwritten notation: ‘‘120 per pat’’
repetitive nature of this,’’ the ALJ asked Parrado testified that ‘‘the fact that two with the rest of the word obscured by
Mr. Parrado if he had found ‘‘the same people from essentially the same the address sticker, below which is the
kinds of red flags’’ throughout the address were coming together with the date and time. GX 3, at 25. According
Exhibit. Id. at 285. Mr. Parrado same last name for the same drugs to Mr. Parrado, ‘‘this was the only form
answered ‘‘[y]es.’’ Id. The ALJ then which were two immediate use opioids of any kind of notation or
asked Mr. Parrado if he had also found from the same clinic . . . I would have documentation I saw on any of the
that ‘‘the failure to resolve the red flags found that unresolvable.’’ Tr. 289–90. records showing that they did document
is documented on the documents Mr. Parrado then testified that he found at one point and the only thing they
there?’’ Id. Mr. Parrado answered no evidence that the red flags were documented was that they shorted the
‘‘[y]es.’’ However, after the ALJ asserted resolved. Id. at 290. person pills.’’ 34 Tr. 298. Mr. Parrado
that ‘‘[t]hat seems to address all of On October 22, 2012, Dr. V.S. (who, further noted while the address on
Exhibit 3,’’ the Government advised the according to the prescription was then prescription listed Panama City Beach
ALJ that there were ‘‘some differences.’’ working at the MD Plus Clinic in as J.S.’s town of residence, the sticker
Id. Lakeland), issued a prescription for 168 attached to the prescription, as well as
The Government then questioned Mr. oxycodone 30 to J.P., whose address the dispensing label, listed her town of
Parrado about two prescriptions which (which again was not written on the residence as Port Charlotte, which is in
were issued on May 22, 2102 by Dr. C. prescription) was in Ft. Walton Beach, the ‘‘opposite direction’’ from Tampa.
(also of 24th Century) to L.B. of Dover, Florida; Respondent filled the Id.
Florida, which the latter filled the same prescription the same day. GX 3, at 19– On November 5, 2012, Dr. R.R. (24th
day. GX 3, at 11–14. The prescriptions 20. Upon being asked ‘‘what kind of Century) issued a prescription to A.R.
were for 168 oxycodone 30 and 84 route J.P. [would have] follow[ed] if he for 180 oxycodone 30; Respondent filled
Dilaudid 8 mg. See id. Asked by the came from home, went to the doctor’s the prescription the same day. GX 3, at
Government whether the combination of office in Lakeland and then went to 27–28. While the prescription lists the
these two drugs raised a red flag, Mr. Tampa’’ to fill the prescription, patient’s address as Lawtey, Florida,
Parrado testified that ‘‘that’s a major red Respondent objected on the ground that both the address sticker attached to the
flag in that you have two immediate use the testimony would be speculative prescription and the dispensing label
opioids being dispensed at the same because Dr. V.S. could legally prescribe list A.R.’s address as in Gainesville,
time. The practice is never to dispense at any place in the State. Tr. 293–94. Florida. Id. Over Respondent’s objection
two immediate use opioids at once, at After the ALJ overruled the objection, (on grounds of no notice), Mr. Parrado
the same time for the same patient.’’ Id. Mr. Parrado testified that while he did testified that this was an additional red
at 286. Mr. Parrado then testified that not ‘‘know the exact route [J.P.] took flag and the ‘‘difference . . . should
both of the drugs were immediate . . . the triangle between . . . the three have been documented.’’ Tr. 300–01.
release, and upon being asked if there places is very large [and] would have to On April 23, 2012, Dr. S.A.H. (24th
was a way to resolve this red flag, be resolved.’’ Id. Century) issued a prescription to T.P. of
Respondent objected to the testimony, On October 23, 2012, Dr. V.S. (of the St. Augustine, Florida for 180
arguing that it was beyond the scope of MD Plus Clinic) issued a prescription to oxycodone 30; Respondent filled the
the Government’s Prehearing Statement. K.B. of Jacksonville, for 168 oxycodone prescription the same day. GX 3, at 29–
Id. at 287. 30; Respondent filled the prescription 30. Noting that Saint Augustine is
The ALJ overruled the objection, on November 7, 2012. GX 3, at 21–22. located ‘‘just below Jacksonville’’ in
explaining that ‘‘I’d like to know.’’ 32 Id. On October 22, 2012, Dr. R.R. (of the ‘‘the upper northeast corner of Florida,’’
Mr. Parrado then testified that he could 24th Century Medical Center) issued a Mr. Parrado testified that ‘‘the distance’’
not resolve the red flag, and that while prescription to R.B. of Milton for 168 between T.P.’s residence and
it was proper therapy to prescribe a oxycodone 30; Respondent filled the Respondent was a red flag. Tr. 301–02.
‘‘long-acting opioid, like OxyContin’’ prescription on November 1, 2012. Id. at Also on April 23, 2012, Dr. P.C. (24th
and an immediate release drug ‘‘such as 23–24. Mr. Parrado testified that both Century) issued a prescription to A.W.
hydromorphone for breakthrough,’’ prescriptions presented the same red of Mayo, Florida, for 200 oxycodone 30;
using ‘‘two immediate use opioids[,] flags that he had previously discussed. Respondent filled the prescription the
[y]ou just don’t do that.’’ Id. Here again, Tr. 295–96. same day. GX 3, at 31–32. Mr. Parrado
Respondent objected on the ground that On November 5, 2012, Dr. H.D. (of the testified that Mayo is located 150 to 200
the opinion was beyond the scope of 24th Century Medical Center) issued a miles from Tampa and that this was a
Mr. Parrado’s expertise because he is prescription to J.S. of Panama City red flag ‘‘along with all the other
not a physician. Id. at 287–88. The ALJ Beach, for 180 oxycodone 30; things,’’ including ‘‘the drug and the
overruled the objection. Id. at 288. Respondent filled 120 tablets of the price paid,’’ which was $1,400. Tr. 302–
On May 22, 2012, Respondent filled prescription the same day. GX 3, at 25– 03; GX 3, at 32.
prescriptions for 168 oxycodone 30 and 26. Asked where Panama City Beach is On April 23, 2012, Dr. P.C. issued a
sradovich on DSK3TPTVN1PROD with NOTICES2
in relation to Tampa, Mr. Parrado prescription to D.T. of Gainesville for
32 As discussed above, the Government failed to
190 oxycodone 30; Respondent filled
provide Respondent with constitutionally adequate 33 Mr. Parrado noted that while the prescriptions
notice on this issue. See, e.g., Pergament United for L.B. and V.B. indicated that they lived on the prescription the same day. GX 3, at
Sales, 920 F.2d at 135 (‘‘The primary function of different streets, they had the same house number.
notice is to afford [a] respondent an opportunity to Tr. 288. While Mr. Parrado then suggested that 34 Mr. Parrado further testified that it is common
prepare a defense by investigating the basis of the ‘‘may have been just a typo,’’ id., the Government practice to make a note on the prescription when
complaint and fashioning an explanation that offered no further evidence to corroborate this pharmacist does not provide a patient with the
refutes the charge of unlawful behavior.’’). testimony. entire quantity of the prescription. Id. at 299.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/19.svg)
![31328 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
33–34. Also on April 23, Dr. S.A.H. admitted over Respondent’s objection.36 practice since I’ve been practicing for 43
issued a prescription to J.S. of Tr. 305–06. years.’’ Id. He further acknowledged that
Tallahassee for 168 oxycodone 30; As for the prescriptions in GX 4, Mr. DEA does not require that the resolution
Respondent filled the prescription the Parrado testified that they all presented of a red flag be documented on the face
same day. Id. at 35–36. Mr. Parrado the red flag of the patients travelling of the prescription. Id. at 318. And he
testified that neither prescription raised long distances. Tr. 308. He further also acknowledged that in rendering an
‘‘any additional red flags’’ beyond those testified that he used Google to ‘‘get an opinion as to whether another
he had previously discussed. Tr. 303. approximation of the mileage’’ for those pharmacist had properly exercised his
However, on further questioning, he cities for which he did not know the professional judgment in deciding to
testified that Tallahassee is 250 to 260 exact mileage. Id. at 310. dispense a controlled substance, it is
miles from Tampa.35 Id. at 303–04. Asked by the Government whether he important to understand the
had seen any evidence that Superior II’s circumstances, including whether the
On November 2, 2012, Dr. R.R. issued pharmacists attempted to resolve the red
a prescription for 112 Dilaudid 8 mg to pharmacist has a history with the
flags presented by the prescriptions in prescriber of the prescription. Id. at 321.
T.N., which Respondent filled the same both its Exhibits 3 and 4, Mr. Parrado
day. GX 3, at 37–38. Of note, while the Asked by Respondent whether he
testified that ‘‘[t]he only documentation ‘‘wouldn’t think twice about’’ a
prescription as prepared by Dr. R.R. I saw was that shortage of tablets. That’s
listed T.N.’s address as being in Port prescription he received from a
the only thing I saw documented reputable prescriber which was missing
Salerno, Florida, both the address anywhere.’’ Tr. 312. With respect to
sticker placed on the front of the the patient’s address, Mr. Parrado
these prescriptions, Mr. Parrado then testified that ‘‘I would do something to
prescription and the dispensing label testified that he did not ‘‘see any
listed an address in Gainesville. See id. address that and fix it.’’ Id. Asked if he
evidence’’ that the dispensing would then go into his pharmacy
Mr. Parrado testified that this was a red pharmacist had complied with his/her
flag, as was the high dose of the software and use the information to put
corresponding responsibility to ensure an address label on the prescription and
prescription (32 mg per day), which was that prescriptions were issued for a
‘‘above the 24 milligram upper dose that this would not cause him ‘‘to be
legitimate medical purpose. Id. concerned about diversion,’’ Mr.
recommendation.’’ Tr. 304. The Government concluded its direct Parrado answered: ‘‘Not if I knew the
The final prescription in the exhibit examination of Mr. Parrado, asking patient. And there’s always a
was issued on November 5, 2012 by Dr. him—over Respondent’s objection— circumstance where it [the prescription]
H.D. to K.P. of Spring Hill for 140 whether the pharmacists, who filled the could be good.’’ Id. at 321–22.
Dilaudid 8 mg. GX 3, at 39–40. Asked prescriptions in GXs 3 and 4, ‘‘knew or When then asked whether ‘‘one of
the same question as with previous had reason to know that the those circumstances would be if you
prescription (‘‘How about the drug and prescriptions were being issued without knew the prescribing practitioner and
the amount?’’), Mr. Parrado testified: a valid doctor/patient relationship?’’ Id. . . . . [his] practice[] and . . . protocols
‘‘[t]he answer will be the same.’’ Tr. 304. at 313–14. Mr. Parrado answered: and . . . knew that when you called
Thereafter, the Government moved All these red flags would have caused me them [he] answered your questions
Exhibit 3 into evidence in the Superior concern to where I had to call that physician about the diagnoses and the reasons for
II matter, and the ALJ admitted the to verify all these things. things,’’ the ALJ, without any objection
exhibit. Id. at 305. And at that point I would have to use my by the Government, stated that he
professional judgment and whether or not
The Government then moved to admit would not allow Mr. Parrado to answer
even though possibly faced with what could
into evidence its Exhibits 4 and 14. Id. ostensibly be a valid prescription I should the question because there was ‘‘no
The former is a compilation of 25 know or either knew or should have known evidence that the Respondent, through
additional prescriptions for oxycodone that these were being used . . . for not a any of its pharmacists, did that.’’ Id. at
30 and Dilaudid 8 mg, which was legitimate medical purpose, just based on all 322. Even after Respondent argued that
offered to show additional instances in the red flags that are present. it was a hypothetical question and that
which patients presented the ‘‘red flag So even if the doctor had told me, yes, he Mr. Parrado ‘‘was proffered as an
of long distance’’ between their did fill it, I would still, I still would not have expert’’ and had testified that he had
residence, the prescriber, and Superior filled them. asked for additional information from
II. Id.; see also GX 4 (No. 15–7). The Id. at 314–15. DEA and been denied it, the ALJ
latter is a collection of MapQuest maps On cross-examination, Mr. Parrado adhered to his ruling. Id. at 322–23.
and printouts showing the distances adhered to his earlier testimony that if However, Mr. Parrado subsequently
between the patient’s residence, the the resolution of a red flag was not agreed with Respondent that in trying to
prescriber, and Superior II. Id.; see also documented on the prescription, ‘‘it determine whether a red flag had been
GX 14 (No. 15–7). Both exhibits were wasn’t done.’’ Id. at 316. While Parrado resolved, it is ‘‘important to know what
acknowledged that he did not know the pharmacist knew about’’ the patient.
35 Respondent objected to Mr. Parrado’s
whether Florida law requires that this Id. at 324. Mr. Parrado testified that he
testimony regarding the distances from Mayo to be documented on the prescription, he had asked for the patient profiles for the
Tampa and Tallahassee to Tampa on the ground
that this testimony was not disclosed in advance of testified that ‘‘[i]t’s been standard Superior II patients and that the
the hearing. Tr. 302–03. In its Pre-Hearing Government told him not to look at
Statement, the Government did disclose that Mr. 36 With respect to the MapQuest printouts, those. Id. at 324–25. Mr. Parrado then
sradovich on DSK3TPTVN1PROD with NOTICES2
Parrado ‘‘will . . . testify regarding large quantities Respondent did not object based on authenticity, acknowledged that a patient profile
of oxycodone distributed by Respondent on April but rather on lack of foundation, arguing that ‘‘there
23, 2012, to at least twelve persons . . . and four are ways to set parameters to avoid highways, to
would show the complete history of
of them (T.P., A.W., D.T., and J.S.) resided more 100 take the shortest route, to take the fastest route.’’ Tr. prescriptions filled by the pharmacy in
miles from Respondent’s pharmacy.’’ ALJ Ex. 7, at 307. The objection is not without some merit. the period for which it was run and
5 (No. 15–7). Respondent thus had notice that the However, given the distances of the patients from would show whether the patient was
distance between it and the residences of the the prescribers and Superior, any differences in
patients would be at issue even if the Government mileage or driving time which would be caused by
also receiving non-controlled drugs. Id.
did not disclose that Mr. Parrado would testify as choosing between these two parameters is not 325. He also acknowledged that the
to the precise distances. significant enough to be material. patient profile would be important in
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/20.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31329
determining whether the patient was quantity of cash that raised the red flag prescribers, as well as that DEA did not
opioid naı̈ve or tolerant. Id. to me.’’ Id. provide him with any statements made
Mr. Parrado then testified that he was While Mr. Parrado agreed that by the patients or information about the
given some ‘‘partial medical records,’’ physicians may use a particular drug as patients’ conditions. Id. at 339. Asked
and that these showed that ‘‘these their default option in treating a patient whether it would be appropriate for a
people were on multiple controlled such as in prescribing a cholesterol- pharmacist, who knew the address
substances [and] not just the lowering medication, he disagreed that placed on the prescription by the
prescriptions that were given to me.’’ Id. this practice also applies to pain prescriber was incorrect, to verify the
He then added that there were ‘‘multiple management. Id. at 333. As he patient’s address and place a sticker on
people from the same address getting explained: ‘‘how you treat diabetes, the prescription with the correct
the exact same cocktails of these blood pressure, . . . cholesterol therapy, address, Mr. Parrado answered: ‘‘I
drugs.’’ 37 Id. at 325–26. those are relatively standard therapies. would want to document that I had . . .
Asked if his opinions were based on But not in pain, pain has to be addressed that question . . . and then
these medical records, Mr. Parrado individualized, starting low and going put [the sticker] on there.’’ Id. at 341. He
testified that the medical records did slow as you reach the proper limit’’ of then maintained that while the stickers
not form his opinions but ‘‘just dosing. Id. Respondent then asked if the were placed on the prescriptions, he did
reinforced’’ them, because he did not fact that a prescriber tends to prescribe not know that the pharmacists had
‘‘see any documentation of one drug over another for pain patients verified the patients’ addresses. Id.
conversations between the pharmacy ‘‘is not necessarily indicative of Asked whether it is appropriate for a
and the clinic’’ and the records ‘‘showed diversion, is it?’’ Id. at 334. Mr. Parrado pharmacist to add the address to the
on a lot of these patients the cocktails.’’ answered: ‘‘It becomes a cause for prescription when the physician did not
Id. at 326. After Mr. Parrado testified concern when it’s always the number include it, Mr. Parrado testified: ‘‘[a]fter
that the medical records were those ‘‘of one known drug of abuse on the streets. consultation with the physician.’’ Id. at
the prescribing physician,’’ Respondent That’s where it becomes a concern. And 342. When then asked if a DEA letter
attempted to ask if he knew whether a in oxycodone and Percocet, there’s a addressing the prescribing of schedule II
physician is supposed to note a very low dose, it’s only five milligrams, drugs ‘‘says that,’’ Mr. Parrado testified
conversation with the pharmacist in the whereas . . . oxycodone 30 presents a that Florida law (Chapter 893) ‘‘says that
chart. Id. The ALJ barred the question, different issue.’’ Id. you verify with the prescriber,’’ before
even in the absence of an objection of Asked if when he verified the identity acknowledging that a DEA letter ‘‘does
the Government, reasoning that there of a person filling a prescription, he not say that.’’ Id.
would place a photocopy of the Mr. Parrado agreed with Respondent
was no evidence that any of Superior
patient’s identification on the that it would be permissible for a
II’s pharmacists had called the
prescription, Mr. Parrado acknowledged physician to prescribe pain medicine to
prescriber. Id. at 327.
that ‘‘[a] lot of times we did,’’ or we had ‘‘two people who share a residence’’ and
Mr. Parrado then acknowledged that who ‘‘have chronic pain due to a car
there is ‘‘no upper limit on the amount ‘‘another page with it,’’ or we ‘‘scanned
it into our computer where it showed up accident.’’ Id. at 343–44. Asked whether
of an opioid that a patient can develop ‘‘if the prescriptions were legitimate, it
a tolerance to’’ and that there is no as part of that patient’s profile.’’ Id. at
336. When, however, Respondent asked would be permissible for a pharmacy to
federal limit on the quantity of a drug fill’’ them, Mr. Parrado answered that it
that can be prescribed. Id. He further Mr. Parrado if ‘‘it would be appropriate
for certain types of verifications and would be as long as the pharmacist had
testified that whether a prescription is resolved the red flag and documented it.
medically necessary is patient specific resolving of red flags to keep, say for
example, a photo ID in an electronic file Id. at 344.
and depends on such factors as As for the ‘‘partial medical files’’ he
tolerance, the condition causing the of a pharmacy, particularly in the age of
reviewed, Mr. Parrado could not answer
pain, and the duration, intensity and computers,’’ the ALJ intervened—again,
as to how many of them were for
frequency of the pain. Id. at 330. in absence of an objection by the
Superior II’s patients. Id. at 344. As for
Asked whether it was per se unlawful Government—and disallowed the
why he was provided with partial and
to fill an oxycodone 30 prescription, Mr. question, explaining that ‘‘whether it’s
not the full files, Mr. Parrado explained
Parrado testified that ‘‘I would have to appropriate or not, there is nothing
that it was his understanding that the
evaluate each prescription individually before me that suggests that that was
files ‘‘came from the Respondent to DEA
and know that . . . that patient had kept.’’ Id. at 337. who sent them to me.’’ Id. at 345.
developed that tolerance . . . before I Mr. Parrado subsequently agreed with Mr. Parrado acknowledged that as
fill it.’’ Id. at 331. Then asked whether Respondent that ‘‘not every failure to long as a prescriber is registered within
‘‘[o]xycodone 30 standing alone is not catch a red flag is intentional’’ and that a State, he can prescribe from anywhere
an indicator that a prescription’’ lacks a pharmacists can make mistakes. Id. at in the State. Id. at 346. He then
legitimate medical purpose, Mr. Parrado 337–38. While he agreed that a acknowledged that he had not looked
answered: ‘‘Well, it’s the leading drug of pharmacist may make mistakes in into whether any of the prescribers had
abuse on the street. So that is the first dispensing drugs, he then explained: issued the prescriptions from locations
potential for a red flag.’’ Id. The question is that it doesn’t happen over other than where they were registered.
Mr. Parrado acknowledged that and over and over and over, which was my Id. at 347.
patients have the right to pay for their concern in this case and the records I was Regarding the prescription issued to
looking at. Could a person come from a long
sradovich on DSK3TPTVN1PROD with NOTICES2
prescriptions in cash and that in some J.S. for 180 oxycodone 30 but which was
distance once? Sure. Does it happen every
States, the law requires a pharmacy to only filled for 120 tablets, see GX 3, at
day from a long distance multiple times? No.
allow a patient to pay in cash. Id. at 332. 25, Mr. Parrado acknowledged that a
Mr. Parrado then testified that it is ‘‘not Id. at 338. pharmacist can change the quantity in
so much the paying cash, it’s the Turning more specifically to the consultation with the prescriber. Tr.
prescriptions filled by Superior II, Mr. 347. As for the prescription issued to
37 No evidence established what the cocktails Parrado reiterated that he did not T.N. for Dilaudid which listed her
were, let alone the strength and dosing of the drugs. interview any of the patients or address as Port Salerno but the address
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/21.svg)
![31330 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
and dispensing labels listed her address records.’’ 39 Id. The DI testified that he 15,560 dosage units (du) of oxycodone
as Gainesville, GX 3, at 37–38; Mr. conducted an audit of Superior I’s 30 mg and 11,951 du of hydromorphone
Parrado agreed that the prescription did handling of controlled substances and 8 mg. GX 4 (No. 15–6). In addition, the
not present the red flag of a different prepared a computation chart. Tr. 373; audit found that Superior had shortages
address when it was presented to the see also GX 4 (No. 15–6). of 946 du of hydromorphone 4 mg, 864
pharmacy and that the sole red flag was With respect to the closing inventory, du of methadone 10 mg, 474 dosage
the distance.38 Tr. 352. He then agreed the DI testified that this involved a units of morphine sulfate 100 mg ER,
that ‘‘it is not a red flag for a pharmacist count of the drugs the pharmacy had on and 447 du of morphine sulfate 30 mg
to affix the correct address to a hand at the time of the inspection and ER.41 Id.
prescription that contains an incorrect that he was assisted by the pharmacist The DI also testified regarding the
address,’’ before adding that he ‘‘would in performing the closing inventory. Id. manner in which Superior I kept its
have documented’’ his reason for at 373–74. He also testified that he used Schedule II order forms (DEA 222).
‘‘changing the address.’’ Id. at 353. the pharmacy’s ‘‘bi-annual [sic] According to the DI, one of the order
However, on re-direct regarding the inventory’’ which was dated May 2, forms (GX 5, at 2) should not have been
same exhibit, Mr. Parrado testified that 2011 (beginning of business),40 and used used because the pharmacist had lined
if a patient presents a prescription this as the beginning date of the audit. out the National Drug Code (NDC)
which lists a different address for the Id. at 374–75. As for the closing number for the drug being ordered and
patient from that in the pharmacy’s inventory, the DI testified that he added a new NDC number. Tr. 383–84;
records, this needs to be investigated counted the drugs on hand ‘‘with the see also id. at 386. The DI testified that
and there was no evidence that the pharmacist,’’ and that the pharmacist according to 21 CFR 1305.15(a)(2), ‘‘any
attested to the accuracy of the inventory. alteration or any erasure or change of
disparity was investigated. Id. at 362.
Id. at 376. The DI further testified that description should be a cause for a DEA
After Mr. Parrado noted that some of after the warrant was executed, he 222 form not to be used.’’ Id. at 383. The
the partial medical records contained an requested additional records through Government then asked the DI whether
opioid contract that required the patient the lead Investigator because ‘‘the bi- a second order form (GX5, at 3) was
to fill the prescriptions at one annual [sic] inventory’’ which was filled out properly. Id. at 384. The DI
pharmacy, that being Respondent, he provided by Superior I when the answered ‘‘[n]o,’’ and explained that
then acknowledged ‘‘that there are a warrant was executed ‘‘did not include ‘‘the information in regard to the
number of experts who believe that the all the drugs that were a part of the number of package[s] receive [sic] . . .
one doctor, one pharmacy, one patient audit.’’ Id. at 378. On February 11, 2013, was omitted.’’ Id.
is the best way to prevent diversion the DI received additional inventories On cross-examination regarding the
when it comes to pain management.’’ Id. which included ‘‘the bi-annual [sic] altered order form (GX 5, at 2), the DI
at 355. And he agreed that ‘‘[a]s long as inventory and . . . an in-house conceded that according to the
everybody’s doing their obligations,’’ inventory conducted by the’’ pharmacy. regulation, the manufacturer should not
this approach is in ‘‘the best interests of Id. at 379. have filled the order. Tr. 387. Then
the patient.’’ Id. He also acknowledged The DI then explained that in asked whether there was ‘‘any problem
that Florida law requires the use of a conducting the audit he reviewed the with the pharmacy having corrected the
pain management contract, and that the purchase records, ‘‘the distribution Form 222, or is the problem that the
contract is supposed to identify where transfers,’’ ‘‘any returns,’’ and ‘‘any manufacturer filled the order,’’ the DI
the prescriptions will be filled. Id. at disposition records’’ which included the explained that ‘‘the regulation says any
356. actual prescriptions.’’ Id. at 378, 410. alteration, any erasure, and that should
Subsequently, with respect to the not be used.’’ Id. at 387–88. When then
Evidence Regarding the Audits and asked if it is unlawful to make a mistake
Recordkeeping Allegations prescriptions, he supervised a team
which computed the dispensings, which on the form, the DI testified ‘‘[t]he
Next to testify for the Government were counted on a monthly basis. Id. at regulation is clear on how to use DEA
was a Diversion Investigator (DI) who 412–13. The DI also explained that each 222 forms. And [the] DEA 222 form[]
participated in the execution of the of the team members was a DI, and as states that it should not be filled.’’ Id. at
Administrative Inspection Warrant at such, had been trained in how to 388.
Superior I. Id. at 370–71. The DI conduct an audit. Id. at 414. On cross-examination regarding the
testified that at the time of the hearing, According to the DI, ‘‘we use audit, Respondent’s counsel asked the
he had been a Diversion Investigator for whatever we have as well . . . to make DI if there were any spreadsheets that
more than five years and that he had cross checks and to verify that there are showed how the DEA 222s were
conducted approximately 130 pharmacy no inconsistencies.’’ Id. at 378. Still counted and how the dispensings were
inspections. Id. at 368–69. He also later, the DI explained that he counted. Tr. 393. The DI answered: ‘‘No,
testified that he had received training in personally cross-checked some of the I don’t have that at this time, sir.’’ Id.
how to conduct controlled substance monthly dispensing totals. Id. at 412. Then asked whether he had ever had
audits as part of his training to become The DI testified that his audit found such documents ‘‘at any time,’’ the DI
a DI. Id. at 390. that Superior I had shortages of multiple answered: ‘‘I do not recall at this time
drugs. Id. at 380–382. The most if I have this or not.’’ Id.
According to the DI, ‘‘we collected Respondent’s counsel then
significant of these were the shortages of
original prescriptions,’’ as well as DEA represented that when DEA provided
sradovich on DSK3TPTVN1PROD with NOTICES2
222s (schedule II order forms), invoices 39 Asked whether he had any knowledge as to Respondent with the CDs (which
and inventory records. Id. at 372. He whether Superior I’s computer records were contained the records obtained from
also ‘‘conducted the closing inventory’’ electronically copied, the DI testified that while he them) after the Order to Show Cause
and ‘‘helped package the documents did not handle that, he believed that digital
evidence was collected. Tr. 372.
was served, the CDs included ‘‘some
and all controlled substance related 40 The DI subsequently explained he used the scratch papers.’’ Tr. 393. Counsel then
inventory which must be taken every two years (i.e.,
38 Contrary to the question, Mr. Parrado had the biennial), ‘‘which is required . . . per regulation 41 The audit also found an overage of 159 du of
earlier identified the dosage as a red flag. Tr. 304. 1304.11.’’ Tr. 374. morphine sulfate 60 mg ER. GX 4 (No. 15–6).
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/22.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31331
asked the DI if he ‘‘recall[ed] working cross-checked Respondent’s purchases days, the 222 is invalid’’ and the
out some scratch papers where you may by using ARCOS data,42 but because purchaser ‘‘should go back and put a
have done the math?’’ Id. at 393–94. some distributors report only every zero and the date they put the zero’’ on
Counsel also advised the ALJ that he quarter, he could only check the form. Id. at 520. However, when
had copies if it would refresh the DI’s approximately 95 percent of the asked where, in the Pharmacist’s
recollection. Id. at 394. After the DI purchase data. Id. at 402–04. Manual, it instructs registrants to do
answered that he did ‘‘not recall this,’’ The Government called another DI, this, the DI answered: ‘‘I couldn’t tell
Respondent’s counsel asked the DI if it who testified regarding the execution of you which page. But it does say they
would ‘‘refresh [his] recollection if [he] the AIW at Superior II and the have to complete the 222 forms.’’ Id.
looked at the notes?’’ Id. The ALJ then subsequent audit of its handling of When then asked where in the
intervened, stating: ‘‘Documentation, controlled substances. Id. at 469, 471. regulation it says that, the DI stated that
even if it does, this documentation is The DI testified that she delivered the she did not ‘‘know the specific
not going to be allowed.’’ Id. When warrant to the pharmacy manager and quotation.’’ Id.
Respondent’s Counsel then argued that did a closing inventory. Id. at 471. She
‘‘it’s just for impeachment,’’ the ALJ then asked for the purchasing records Moving back to the audit, the DI
explained that while Respondent’s and the hard copy controlled substance testified that ‘‘we asked for purchasing
Counsel could impeach the witness, he prescriptions. Id. at 472. The DI testified records 43 and dispensing records, and
could not use documents which he did that she was familiar with patient that the hardcopy original
not provide ‘‘ahead of time’’ and that he profiles and that no patient profiles prescriptions 44 were used as the
had ‘‘an obligation to provide [the were obtained during the execution of dispensing record.’’ Id. at 477. As the
documents] as part of the response to the warrant. Id. at 473. starting point of the audit, the DI
the Pre-hearing Statement.’’ Id. at 394– The Government then asked the DI testified that she ‘‘asked when their last
95. about a number of Superior II’s schedule physical count was. And we used the
Respondent’s counsel then asserted II order forms. Id. at 473–74. Regarding July 31st, 2012. And the pharmacist got
that the documents were ‘‘not intended the orders forms in GX 6 (No. 15–07), the numbers from their perpetual
to be used as an exhibit’’ but ‘‘merely to the DI testified that the forms were not inventory.’’ Id. On cross-examination,
check the math.’’ Id. at 395. He further filled out properly, as ‘‘[t]hey are the DI reiterated her earlier testimony
asserted that when he went ‘‘through missing the number of packages that she ‘‘did not ask for perpetual
the DEA 222s on the [m]orphine received and date received on some of inventory numbers. I asked for an actual
[s]ulphate tabs and add them up, all the the lines on each form.’’ Id. at 474. With physical count of those seven drugs.’’
ones that were were returned . . . by respect to the first form in the exhibit, Id. at 491. She then explained that
the Government, I get to a number of which had two line entries, each for 12 Superior II’s employees ‘‘told me that
7,200. And what I’m trying to figure out packages of 100 count of oxycodone 30, they take physical counts very
is whether or not there are any she identified line two as not being frequently’’ and that she ‘‘asked them
supporting documents where we can see properly completed, apparently because when their most recent one was that
your math to see if you got it correct.’’ it did not list the number of packages was at least six months’’ old, ‘‘[a]nd
Id. After the Government objected that received and the date received. Id. these were the numbers I was given.’’ Id.
Respondent’s counsel was testifying and Turning to the second form, she also at 491–92. As for the closing inventory,
the ALJ expressed his agreement with identified the second line of the form as the DI testified that the pharmacist
the Government, Respondents’ counsel not being properly completed, ‘‘counted the pills, and I witnessed.’’ Id.
stated that he wanted to present the apparently because it did not list the at 477.
222s to the DI and ‘‘walk through the number of packages received and the
math together and see if Your Honor According to the DI, the audit found
date received. Id. However, the first two that Superior II was short 40 du of
comes to the same number that they forms have the same serial number, thus
[sic] do.’’ Id. at 396. The ALJ ruled that hydromorphone 4 mg and had an
establishing that one of them is a overage of 2,576 du of hydromorphone
because Respondent’s counsel ‘‘didn’t duplicate. Compare GX 6, at 1, with id.
[timely] present the 222s as evidence,’’ 8 mg. Id. at 479. As for the other drugs,
at 2. the audit found overages of 1,189 du of
he would not allow the question. Id. As for the next four forms, the DI
Then asked whether he did his oxycodone 30 mg, 896 du of methadone
testified that each was a copy and not 10 mg, 674 du of morphine sulfate 30
calculations ‘‘by hand’’ or by creating a the original and was thus a violation. Tr.
spreadsheet, the DI testified that he mg, 563 du of morphine sulfate 60 mg,
474–75; see also id. at 521. With respect
could not recall what procedure he used and 426 du of morphine sulfate 100 mg.
to several of the remaining forms in the
because he did the audit two years GX 12. According to the DI, ‘‘[a]n
exhibit, she identified that for several of
earlier. Id. at 396–97. Asked if he used overage indicates that all records either
the line items there was no notation that
only the hard copy 222s or also used the ‘‘no packages [were] received or date
electronic order records, the DI testified received.’’ Id. at 475; see also id. at 476.
43 On cross-examination, the DI testified that she
that he ‘‘used all the DEA 222s that were used both the paper and electronic 222 forms in
However, on cross-examination, the doing the audit. Tr. 504. She also testified that
there[] and there were some CSOS’’ DI testified that she relied on the entries ‘‘[w]e always ask if there’s been any theft or loss,
(electronic orders) as well. Id. at 397. on the forms maintained by Respondent returns, or if they have any outdated drugs.’’ Id. She
The DI subsequently explained that the and did not verify whether every line on then testified that she specifically recalled asking a
electronic orders were printed out and pharmacist for these records. Id. at 505.
the 222s had been actually shipped by
sradovich on DSK3TPTVN1PROD with NOTICES2
44 The DI testified that she asked for the hard
that he used the paper copy of these. Id. the distributors. Id. at 518. While the DI copy Schedule II prescriptions for the period of
at 401. Then asked whether he did acknowledged that sometimes January 1, 2011 through October 31, 2011, and from
anything to control for math errors, the distributors don’t ship an entire order at December 1, 2012 to the date of the warrant,
DI testified that he ‘‘reviewed [his] once, she then testified that ‘‘after 60
February 4, 2013. Tr. 515. She also testified that ‘‘I
counts on many occasions’’ and ‘‘did asked for specific date ranges, because there had
been a notice of inspection prior to the admin.
some cross checks’’ with ‘‘other 42 See 21 CFR 1304.33 (setting forth ARCOS inspection warrant. So I asked for different date
documents provided by the pharmacy.’’ reporting obligations imposed on manufacturers ranges.’’ Id. at 514. The DI then explained that she
Id. at 402. The DI also testified that he and distributors). did not participate in the prior inspection. Id.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/23.svg)
![31332 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
were not maintained or not provided.’’ counting the pills. Id. at 512. She then with a pharmacist (Mr. Majed) and
Tr. 480.45 identified another DI who was involved asked to see its primary records for the
On cross-examination, the DI testified in calculating the dispensing totals for receipt of controlled substances. Id. at
that she did not do any interviews and the audit, as well as the pharmacy’s 551. According to the DI, Mr. Majed
was not present during any interviews. receipts. Id. at 513. stated ‘‘that once he gets the orders he
Id. at 485. She further testified that she The Government’s final witness was a inputs it into the system[,] . . . places
did not notify Superior II of the audit DI from the Tampa office with 19 years the order[,] . . . then . . . prints out’’
results and did not know whether of experience as such, who was the lead the form, and upon receipt of ‘‘the
another DI had done so. Id. at 486. She investigator in the Superior II matter. Id. product, he jots it down where it says
also testified that she did not do any at 539–40; 558. She testified that on packages shipped and packages and
further investigation into Superior II November 30, 2012, she participated in dates shipped. So I said this is your
other than to review the records that a Notice of Inspection at Superior II, receipt. After you receive them
were obtained and to complete the which she explained involved ‘‘go[ing] manually,’’ at which point Respondent
audit. Id. at 487. on-site and advis[ing] the registrant that objected.49 Id. at 551–52. After the ALJ
On further cross, the DI testified that we’re going to be doing an audit of their overruled the objection, the DI testified
in performing the audit, she did not controlled substance records.’’ Id. at that when she asked Mr. Majed what he
compare the 222 forms she obtained 541. She further testified that during the did once he received product, Mr.
from Superior II with those its suppliers Notice of Inspection issued to Superior Majed said that ‘‘he notates [the receipt
provided to the Agency.46 Id. at 501. She II, ‘‘[w]e obtained records, purchase of product] on this paper form’’ and that
also testified that she could not recall if records, and dispensing records which he did not go back into the CSOS and
she obtained ARCOS data to verify consisted of the prescriptions.’’ Id. enter the receipt because ‘‘he wasn’t
whether the documents obtained The DI testified that she was not aware that he had to do that.’’ Id. at 554.
pursuant to the warrant contained present at Superior II when the AIW She then asked Mr. Majed if the paper
‘‘accurate information,’’ explaining that was executed. Id. at 542. However, she records were the ‘‘primary records’’ and
‘‘[w]hen we conduct [an] audit, it is the did review the records seized from was told ‘‘yes.’’ The DI then testified
registrant’s responsibility to provide all Superior II to include its purchases and that these were the records she used for
documents.’’ Id. at 502. Subsequently, dispensing records. Id. at 543. She also the audit. Id.
the lead investigator on the matter testified that no patient profiles were
Continuing, the Government asked
testified that she did not instruct anyone taken during the November 30
the DI whether a printout of an
working on the investigation to ‘‘consult inspection and that when she reviewed
electronic 222 form complied with DEA
ARCOS’’ or to look at either the paper the records obtained from Superior II
regulations. Id. at 555. According to the
or electronic 222 forms that had been pursuant to the AIW, she did not see
DI, the document ‘‘should have been
sent to the Agency.47 Id. at 583. any patient profiles. Id. at 544.
linked’’ and was the ‘‘supplier’s copy’’
The DI further testified that she kept Subsequently, she testified that the
and not the ‘‘purchaser’s copy.’’ Id. at
track of the serial numbers on the 222s records she told Mr. Parrado that he
556. The DI further explained that
by spreading them out on a desk but did could not review were the records she
obtained from the State’s Prescription ‘‘[y]ou see where it says packages
not ‘‘make a document.’’ Id. at 505. shipped? He’s not the supplier. He’s the
Respondent’s counsel then asked her if Drug Monitoring Program. Id. at 546–48.
And later, on cross-examination, she purchaser. So that should be packages
she had considered several orders received and date received. What he’s
which he identified by drug, quantity, clarified that Mr. Parrado did not get the
PDMP records. Id. at 559. She also showing me here is the supplier’s
date, and the order form number. Id. copy.’’ Id. Moreover, to the DI’s
The DI responded to these questions testified that she did not provide the
‘‘partial medical records’’ to Mr. knowledge, this record was not
stating that if the record was provided, included in any database. Id.
it was considered. Id. at 505–08. Parrado, id. at 577, and that the records
were provided by Government The DI further explained that in order
Subsequently, the DI acknowledged for a person to use the CSOS, the person
that pharmacy personnel filling a Counsel.48 Id. at 578.
Thereafter, the DI acknowledged that has to have a pass key. Id. at 556–57.
prescription could make an error when However, while Mr. Majed represented
various notations made on the Superior
45 Respondent objected to the admission of the II order forms were her initials and that that he had a key, the DI subsequently
computation chart, arguing that the opening she did not keep a clean copy of the determined that he did not, and that
inventory was based on Superior II’s perpetual documents. Id. at 549. According to the only Mr. Obi (the owner) and another
inventory, which it is not lawfully required to DI, when she reviews records, she ‘‘will
maintain. Tr. 483. The ALJ overruled the objection.
Id. While there is no requirement to maintain a
usually initial it in some way or the 49 Respondent objected on the grounds of hearsay
other just to let me know that I did and the lack of notice. As for the latter objection,
perpetual inventory, there is no requirement that this was based on the Government having been
the Government use only an actual hand counted review that record.’’ Id. She testified ‘‘aware of [Mr. Majed’s] participation in this and [it]
inventory in establishing the quantities on hand on that the 222s that were returned to gave us no notice in [its] pre-hearing statement that
the beginning date of the audit period. Indeed, at
times, a pharmacy is entirely missing the required
Respondent had her initials on them. Id. [it] intended to have this witness testify about
at 550. things that he said.’’ Tr. 552. Respondent did,
inventory and the DIs use zero as the opening however, have notice of the issue through the
inventory. Turning to Superior’s II ordering of Government’s disclosure of the DI’s testimony. ALJ
Most significantly, Respondent ignores that the DI controlled substances using the Ex. 6, at 6–7 (No. 15–7) (‘‘She will testify that
testified multiple times that she asked for an actual Controlled Substances Order System Respondent, as a purchaser of controlled substances
physical count which was at least six months old
sradovich on DSK3TPTVN1PROD with NOTICES2
(CSOS), the DI testified that during the via [the CSOS], failed to create an accurate record
and used what Superior II gave her. of the quantity of controlled substances received
46 Pursuant to 21 CFR 1305.13(d), ‘‘[t]he supplier November 30, 2012 inspection, she met and the date received. She will testify that
must retain Copy 1 of the DEA Form 222 for [its] Respondent failed to electronically archive and link
files and forward Copy 2 to the Special Agent in 48 Later, on re-direct, the Government asked the these records to the original order, as required by
Charge . . . in the area in which the supplier is DI if she had ‘‘ever subpoenaed any medical records the . . . [r]egulations.’’). As for Respondent’s
located.’’ from any clinics owned by Mr. Obi-Anaduime?’’ Tr. objection that the testimony was hearsay, hearsay
47 The evidence also showed that only the DI and 589–90. The DI testified that ‘‘[o]n the same day of is admissible in these proceedings and Respondent
the lead DI ‘‘handled the prescription records and the administrative inspection warrant, we issued made no argument as to why the testimony was
the 222s.’’ Id. at 584. subpoenas for the clinic, 21st [sic] Century.’’ Id. unreliable.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/24.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31333
pharmacist (Ms. Minozzi) had pass keys. notified the Government that it intended Id.50 The ALJ thus denied Respondents’
Id. at 557–58. to call ‘‘any and all witnesses identified motion. Id. at 606–07.
On cross-examination, the DI in the Government’s Pre-hearing Superior II’s counsel then sought to
acknowledged that because she had the Statement.’’ Id. at 597. As to the issues allow Mr. Obi to testify by asking and
PDMP records she could determine that Mr. Obi would testify to, Superior ‘‘answering the questions [himself] that
whether the patients were opioid II’s counsel argued that ‘‘the summary of are posed in the Government’s Pre-
tolerant or opioid naı̈ve. Id. at 559–60. [his] testimony’’ was ‘‘covered hearing Statement.’’ Id. at 608. The ALJ
The DI did not, however, use that sufficiently’’ by the Government in its denied the request. Id. Superior II’s
information. Id. at 560. Prehearing Statement and that ‘‘the counsel then sought to take an
The DI further testified that electronic Government has no prejudice with interlocutory appeal of the ALJ’s ruling.
222 forms found in Government Exhibit respect to this.’’ Id. at 597–98. Superior Id. The ALJ denied the motion. Id.
7 were obtained during the AIW, when II’s counsel then asserted that because Explaining that he wanted to
she was not present. Id. at 563. When Government counsel had represented in understand how the proffer would be
then asked whether her testimony its Prehearing Statement that it intended done, Superior II’s counsel then asked
regarding the statements made by Mr. to call Mr. Obi and had subpoenaed the ALJ if he wished for him ‘‘to proffer
Majed were based on her personal him, he should be allowed to testify. Id.
knowledge, the DI testified that they what would be said’’ by Mr. Obi. Id. at
Superior II’s counsel further argued that 609. The ALJ responded ‘‘no,’’ and
were made during the notice of
under section 555 of the Administrative explained that Superior II’s counsel had
inspection. Id.
The DI also testified that Mr. Majed Procedure Act, Mr. Obi was an given him the ‘‘substance of what that
told her that the handwritten notations interested person who had the right to information would be.’’ Id. Superior II’s
on printouts of the electronic 222 forms participate in the proceeding, and that counsel then argued that he should be
were of the packages that the pharmacy ‘‘fundamental fairness’’ required that he allowed ‘‘to put the full proffer . . . on
had actually received and the date be allowed to testify. Id. at 598–602. the record.’’ Id.
received. Id. at 567. The DI testified that After Superior II’s counsel In response, the ALJ stated that
if Superior II pharmacists had correctly represented that he was making the Superior II’s counsel had made ‘‘a
documented their receipts of drugs, same motion with respect to Superior I, sufficient proffer,’’ noting that he had
‘‘they would have printed out the the ALJ asked if he was relying on the sought to go ‘‘beyond the scope of what
receipt and the receipt date’’ on a Government’s Prehearing Statements as the Government covered and enter[] into
different form and not used the his proffer. Id. at 604. Superior II’s the area of acknowledgment and
supplier’s copy. Id. The DI then testified counsel advised that there was one remediation [which] would not be
that the receipt record must be additional matter that went beyond the permitted[,] [b]ecause you did not
electronically linked to the same record scope of the proposed testimony—‘‘the disclose it in advance.’’ Id. at 610. The
that the pharmacy used to place the acceptance of responsibility and ALJ then stated that this told him ‘‘the
order. Id. at 569. corrective action.’’ Id. at 604. Superior broad parameters’’ and that was all he
Respondent’s counsel further II’s counsel further represented that he needed ‘‘to preserve your client’s right.’’
attempted to ask the DI if she had had ‘‘submitted written information to Id.
investigated if Superior II had stopped [Government Counsel] with language of Superior II’s counsel then explained
ordering oxycodone after the AIW. Id. at proposed acceptance of responsibility that his ‘‘statements about the
574. While the Government objected and with specific corrective actions that Government’s Pre-hearing statement and
that the question was outside the scope, have already been taken, and those that the broader subject matters [was] not the
the ALJ initially overruled the objection. are being taken and those that will be proffer [and] that the proffer is
Id. However, after Respondent re-asked taken in the future.’’ Id. at 605. substantially broader [as] it addresses
the question with only an immaterial individual patients, because the
change in wording, the ALJ barred the The ALJ denied the motion, noting
Government’s Pre-hearing Statement
question, on the ground that that the proffer ‘‘clearly . . . exceed[ed]
called for those things.’’ Id. at 610–11.
Respondent had not acknowledged any what the Government presented in its
Superior II’s counsel then explained
misconduct in its Pre-hearing Pre-hearing Statement.’’ Id. at 606.
that he understood ‘‘that this may be a
Statement. Id. at 575–77. Continuing, the ALJ stated:
bifurcated issue where there’s a notice
Before the Government rested, it With all due respect to your colleagues, I issue on acceptance of responsibility
requested a ruling from the ALJ think these were well informed lawyers [and] corrective action,’’ but ‘‘no notice
clarifying whether Respondents would making strategic decisions to keep as little issue on what’s in the Government’s
be allowed to call any witnesses. Id. at information in the Pre-hearing Statements as Pre-hearing statement but [was] still
594. After the ALJ stated that he agreed possible. And I think it ill-served the course being excluded from the record.’’ Id. at
with the Government’s understanding of justice and makes this proceeding a much 611. Superior II’s counsel then
that Respondents would not be allowed more difficult process merely because of a represented that with respect to ‘‘the
to call any witnesses, Superior II’s strategic decision to keep me in the dark. matter of what is in the Government’s
counsel stated that he intended to call I’m not attributing that to you at all. And Pre-hearing Statement . . . Respondent
a witness. Id. I don’t expect a response, nor will I care to has an extensive proffer about that for
Asked by the ALJ to provide ‘‘the hear a response with respect to that. I’ve the record which would address a wide
legal basis for . . . Superior II to already given Mr. Sisco the opportunity to variety of things.’’ Id. Continuing,
sradovich on DSK3TPTVN1PROD with NOTICES2
produce any witnesses, given [his] prior explain why the record is as it is in Superior II’s counsel explained that his
orders,’’ Superior II’s counsel stated that documents that I’ve received from previous statements were his ‘‘legal
‘‘we have noticed witnesses in the Pre- Respondents. argument rather than the factual
hearing Statement,’’ including Mr. Obi- And that record will stand, I will address
proffer’’ and then asked that he ‘‘be
Anadiume. Id. at 595. Again asked to that at another time in another forum. But
explain the legal basis for calling any from what you’ve told me, I don’t see a legal 50 While the ALJ then offered the Government the
witnesses, Superior II’s counsel argued justification for allowing the Respondent to, opportunity to respond to the motion, the
that in its Prehearing Statement, it in either case . . . present testimony. Government chose not to. Tr. 607.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/25.svg)
![31334 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
permitted to actually make the detailed F.3d at 816 (quoting Volkman, 567 F.3d other violations, and that it has thus
proffer.’’ Id. at 611–12. at 222); see also Hoxie, 419 F.3d at established that Respondents have
The ALJ rejected the request, 482.51 committed acts which render their
explaining that ‘‘[y]ou were permitted to Under the Agency’s regulation, ‘‘[a]t registrations ‘‘inconsistent with the
do so. That’s what the Pre-hearing any hearing for the revocation or public interest.’’ 21 U.S.C. 824(a)(4).
Statement was for.’’ Id. at 612. suspension of a registration, the Because I further find that Respondents
Continuing, the ALJ explained that the Administration shall have the burden of did not properly disclose in advance of
record now reflected Respondent’s proving that the requirements for such the proceeding their proposed evidence
proffer and ‘‘that the detailed proffer revocation or suspension pursuant to as to any remedial measures, I conclude
that you’re describing was appropriate . . . 21 U.S.C. 824(a) . . . are satisfied.’’ that Respondents have not rebutted the
and was not provided to me in a timely 21 CFR 1301.44(e). In this matter, while Government’s prima facie showing. I
fashion. And I believe that was a I have considered all of the factors, the will therefore order that each
strategic decision of prior counsel.’’ Id. Government’s evidence in support of its Respondent’s registration be revoked
The Government then rested. Id. at prima facie case is confined to factors and that any pending application be
612–13. Thereafter, Superior II’s counsel two and four.52 For reasons explained denied.
sought to call Mr. Obi. Id. at 614. The below, I find the Government’s evidence
ALJ denied the request for the reasons insufficient to establish that Factors Two and Four—The
he had previously explained. Respondents’ pharmacists violated their Respondent’s Experience in Dispensing
corresponding responsibility when they Controlled Substances and Compliance
Discussion dispensed the prescriptions at issue. with Applicable Laws Related to
Under the CSA, ‘‘[a] registration However, I find that the Government Controlled Substances
pursuant to section 823 of this title to has established by substantial evidence The Dispensing Allegations
manufacture, distribute, or dispense a that Respondents have failed to
‘‘Except as authorized by’’ the CSA, it
controlled substance . . . may be maintain accurate records, as well as
is ‘‘unlawful for any person [to]
suspended or revoked by the Attorney knowingly or intentionally . . .
General upon a finding that the 51 In short, this is not a contest in which score
manufacture, distribute, or dispense, or
registrant . . . has committed such acts is kept; the Agency is not required to mechanically
count up the factors and determine how many favor possess with intent to manufacture,
as would render [its] registration under the Government and how many favor the registrant. distribute, or dispense, a controlled
section 823 of this title inconsistent Rather, it is an inquiry which focuses on protecting
substance.’’ 21 U.S.C. 841(a)(1). Under
with the public interest as determined the public interest; what matters is the seriousness
of the registrant’s or applicant’s misconduct. Jayam the Act, a pharmacy’s registration
under such section.’’ 21 U.S.C. Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, authorizes it ‘‘to dispense,’’ id. § 823(f),
824(a)(4). In the case of a retail as the Tenth Circuit has recognized, findings under which ‘‘means to deliver a controlled
pharmacy, which is deemed to be a a single factor can support the revocation of a
substance to an ultimate user . . . by, or
practitioner, see id. § 802(21), Congress registration. MacKay, 664 F.3d at 821. Likewise,
findings under a single factor can support the pursuant to the lawful order of, a
directed the Attorney General to denial of an application. practitioner.’’ Id. § 802(10).
consider the following factors in making 52 As to factor one, there is no evidence that the
The CSA’s implementing regulations
the public interest determination: Florida Department of Health has either made a set forth the standard for a lawful
recommendation to the Agency with respect to
(1) The recommendation of the appropriate either Respondent, or taken any disciplinary action controlled substance prescription. 21
State licensing board or professional against either Respondent. See 21 U.S.C. 823(f)(1). CFR 1306.04(a). Under the regulation,
disciplinary authority. However, even assuming that each Respondent ‘‘[a] prescription for a controlled
(2) The applicant’s experience in currently possesses authority to dispense controlled substance to be effective must be issued
dispensing or conducting research with substances under Florida law and thus meets a
prerequisite for maintaining its registration, this for a legitimate medical purpose by an
respect to controlled substances.
(3) The applicant’s conviction record under finding is not dispositive of the public interest individual practitioner acting in the
Federal or State laws relating to the inquiry. See Mortimer Levin, 57 FR 8680, 8681 usual course of his professional
(1992) (‘‘[T]he Controlled Substances Act requires practice.’’ Id. Continuing, the regulation
manufacture, distribution, or dispensing of that the Administrator . . . make an independent
controlled substances. determination [from that made by state officials] as provides that:
(4) Compliance with applicable State, to whether the granting of controlled substance [t]he responsibility for the proper
Federal, or local laws relating to controlled privileges would be in the public interest.’’). prescribing and dispensing of controlled
substances. Accordingly, this factor is not dispositive either for,
substances is upon the prescribing
(5) Such other conduct which may threaten or against, the revocation of each Respondent’s
registration. Paul Weir Battershell, 76 FR 44359, practitioner, but a corresponding
the public health and safety. responsibility rests with the pharmacist who
44366 (2011) (citing Edmund Chein, 72 FR 6580,
Id. 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 fills the prescription. An order purporting to
F.3d 828 (D.C. Cir. 2008)). be a prescription issued not in the usual
‘‘[T]hese factors are . . . considered course of professional treatment . . . is not
As to factor three, I acknowledge that there is no
in the disjunctive.’’ Robert A. Leslie, evidence that either of the Respondents, or Mr. Obi- a prescription within the meaning and intent
M.D., 68 FR 15227, 15230 (2003). It is Anadiume, or any of the Respondents’ pharmacists, of section 309 of the Act (21 U.S.C. 829) and
well settled that I ‘‘may rely on any one has been convicted of an offense under either the person knowingly filling such a purported
or a combination of factors, and may federal or Florida law ‘‘relating to the manufacture, prescription . . . shall be subject to the
distribution or dispensing of controlled
give each factor the weight [I] deem[] penalties provided for violations of the
substances.’’ 21 U.S.C. 823(f)(3). However, there are
appropriate in determining whether’’ to a number of reasons why even a person who has provisions of law relating to controlled
suspend or revoke an existing engaged in criminal misconduct may never have substances.53
been convicted of an offense under this factor, let
sradovich on DSK3TPTVN1PROD with NOTICES2
registration. Id.; see also MacKay v.
alone prosecuted for one. Dewey C. MacKay, 75 FR 53 As the Supreme Court has explained, ‘‘the
DEA, 664 F.3d 808, 816 (10th Cir. 2011); 49956, 49973 (2010), pet. for rev. denied MacKay v. prescription requirement . . . ensures patients use
Volkman v. DEA, 567 F.3d 215, 222 (6th DEA, 664 F.3d 808 (10th Cir. 2011). The Agency has controlled substances under the supervision of a
Cir. 2009); Hoxie v. DEA, 419 F.3d 477, therefore held that ‘‘the absence of such a doctor so as to prevent addiction and recreational
482 (6th Cir. 2005). Moreover, while I conviction is of considerably less consequence in abuse. As a corollary, the provision also bars
the public interest inquiry’’ and is therefore not doctors from peddling to patients who crave the
am required to consider each of the dispositive. Id. drugs for those prohibited uses.’’ Gonzales v.
factors, I ‘‘need not make explicit As to factor five, no evidence was offered with Oregon, 546 U.S. 243, 274 (2006) (citing United
findings as to each one.’’ MacKay, 664 respect to it. States v. Moore, 423 U.S. 122, 135, 143 (1975)).
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/26.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31335
Id. (emphasis added). which is resolved must be documented reasonable to draw an adverse inference
As the Agency has made clear, to and that the documentation should be that a pharmacist failed to resolve a red
prove a violation of the corresponding placed on the prescription itself.’’ Id. It flag (or flags) from the failure to
responsibility, the Government must further notes that the prescriptions document the resolution in any manner,
show that the pharmacist acted with the contained no notations showing that the the Government offered no evidence
requisite degree of scienter. See JM pharmacists resolved the red flags (with that the DIs even asked the pharmacists
Pharmacy Group, Inc., d/b/a Farmacia the exception of the address stickers at either Respondent if they
Nueva and Best Pharma Corp., 80 FR that were placed on the prescriptions). documented their resolution of red
28667, 28669 (2015). Thus, the It further contends that ‘‘[t]o the extent flags, and if so, where they did so.
Government can prove a violation by the Respondents may argue that [their] Here, a regulation of the Florida Board
showing either: (1) That pharmacist practice was to place such of Pharmacy (then in effect) specifically
filled a prescription notwithstanding documentation elsewhere, that required that ‘‘[a] patient record system
his/her actual knowledge that the argument flies in the face of evidence . . . be maintained by all pharmacies
prescription lacked a legitimate medical showing that [the pharmacies] for patients to whom new or refill
purpose; or (2) that the pharmacist was habitually corrected ‘mistakes’ related to prescriptions are dispensed’’ and that
willfully blind (or deliberately ignorant) prescriptions on the prescriptions the ‘‘system shall provide for the
to the fact that the prescription lacked themselves,’’ such as the missing patient immediate retrieval of information
a legitimate medical purpose. See id. at addresses and the instance in which a necessary for the dispensing pharmacist
28671–72. As to establishing that a pharmacist marked on the prescription to identify previously dispensed drugs
that it had only been partially filled. at the time a new or refill prescription
pharmacist acted with ‘‘willful
Id.at 17–18. is presented for dispensing.’’ Fla.
blindness, proof is required that: ‘(1) the
Here, I assume that the red flags with Admin. Code 64B–16–27.800. This rule
defendant must subjectively believe that
respect to each prescription or the also required that the pharmacy
there is a high probability that a fact
convergence of red flags—as there were maintain ‘‘[a] list of all new and refill
exists and (2) the defendant must take
typically multiple red flags associated prescriptions obtained by the patient at
deliberate actions to avoid learning of
with each prescription—establishes that the pharmacy . . . during the two years
that fact.’’ Id. at 28672 (quoting Global-
the pharmacists ‘‘subjectively believed immediately preceding the most recent
Tech Appliances, Inc., v. SEB S.A., 563
that there was a high probability’’ that entry’’ and include the ‘‘prescription
U.S. 754, 769 (2011)). the various prescriptions lacked a number, name and strength of the drug,
Here, the Government makes no claim legitimate medical purpose.54 I the quantity and date received, and the
that any of Respondents’ pharmacists nonetheless conclude that the name of the prescriber.’’ Id. The rule
dispensed the prescriptions having Government has failed to put forward further required that the record include
actual knowledge that the prescriptions sufficient evidence to establish that the the ‘‘[p]harmacist[’s] comments relevant
lacked a legitimate medical purpose. pharmacists failed to resolve the various to the individual’s drug therapy,
Instead, relying primarily on Holiday red flags (i.e., that they deliberately including any other information
CVS, L.L.C., d/b/a CVS/Pharmacy Nos. failed to avoid learning of the fact that peculiar to the specific patient or drug.’’
219 and 5195, 77 FR 62316, 62341 the prescriptions lacked a legitimate Id. And the rule also required that the
(2012), the Government argues that a medical purpose). pharmacist make ‘‘a reasonable effort
pharmacist violates the corresponding As noted above, as proof that the . . . to obtain from the patient . . . and
responsibility rule when he/she pharmacists failed to resolve the red record any known allergies, drug
dispenses a controlled substance flags, the Government relies solely on reactions, idiosyncrasies, and chronic
prescription ‘‘in the face of a red flag the absence of such documentation on conditions or disease states of the
(i.e.[,] a circumstance that does or the prescriptions themselves and the patient and the identity of any other
should raise a reasonable suspicion as to Expert’s testimony that it is the custom drugs . . . being used by the patient
the validity of a prescription) unless he in pharmacy practice to document the which may relate to prospective drug
. . . takes steps to resolve the red flag resolution of a red flag on the review.’’ Id. Finally, the rule required
and ensure that the prescription is prescription. Yet as the Expert that ‘‘[t]he pharmacist . . . record any
valid.’’ Gov. Post-Hrng. Br. 16. The conceded, no provision of the related information indicated by a
Government argues that each Controlled Substances Act, DEA licensed health care practitioner.’’ Id.56
Respondent’s pharmacists violated this regulations, Florida law, or the Florida
regulation by filling oxycodone Board of Pharmacy’s regulations to document the resolution someplace else.
prescriptions which presented various requires that a pharmacist document the Moreover, while evidence of a custom certainly has
‘‘red flags’’ which were never resolved. resolution of red flags on the probative value, it is not conclusive proof. See
Gov. Post-Hrng. Br. 15–18. Noting that Sorrels v. NCL (Bahamas) Ltd., 796 F.3d 1275, 1282
prescription itself.55 While it would be (11th Cir. 2015) (‘‘ ‘[E]vidence of custom within a
its pharmacy expert gave ‘‘unrefuted particular industry, group, or organization is
testimony,’’ the Government argues that 54 All red flags do not have the same hue, and as admissible as bearing on the standard of care in
‘‘[a]ll of the prescriptions discussed by the Supreme Court’s decision in Global-Tech makes determining negligence. Compliance or
[its Expert] we[re] for highly abused plain, proof that a pharmacist dispensed a noncompliance with such custom, though not
controlled substance prescription without resolving conclusive on the issue of negligence, is one of the
drugs such as oxycodone and a red flag which only created a ‘‘reasonable factors the trier of fact may consider in applying the
hydromorphone’’ and ‘‘contained one or suspicion’’ that the prescription lacked a legitimate standard of care.’ ’’) (emphasis added) (quoting
more of’’ some six ‘‘red flags.’’ Id. at 17. medical purpose, is not enough to establish that a Muncie Aviation Corp. v. Party Doll Fleet, Inc., 519
pharmacist acted with the requisite scienter. F.2d 1178, 1180–81 (5th Cir. 1975)); II Wigmore,
sradovich on DSK3TPTVN1PROD with NOTICES2
It further argues that the Expert
However, where there are multiple red flags, none Evidence, § 379, at 403 (Tillers rev. ed. 1983)
‘‘testified that no evidence could be of which alone would establish the requisite (explaining that with respect to evidence of custom
found to show the red flags had been scienter, the combination of red flags may well or usage of trade, ‘‘the question is not whether the
resolved prior to dispensing.’’ Id. create a subjective belief that there is a high offered instances fully prove the custom alleged,
As proof for its assertion that the red probability that a prescription lacks a legitimate but merely whether they are receivable as having
medical purpose. probative value’’).
flags were not resolved, the Government 55 While it may be customary in the profession to 56 This rule remains in effect today; however, the
points to its Expert’s testimony ‘‘that, in document the resolution of a red flag on the rule now requires that the information be
the practice of pharmacy, a red flag prescription itself, that does not make it improper Continued
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/27.svg)
![31336 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
Of further note, the Board of does no such thing. Indeed, the fundamental to conducting an adequate
Pharmacy’s rules require that a Government ignores that its own Expert investigation of the dispensing
pharmacist ‘‘review the patient record sought to review the patient profiles and allegations.
and each new and refill prescription that the Board of Pharmacy’s rules As further support for its contention
presented for dispensing in order to mandate that a pharmacist review the that the absence of documentation on
promote therapeutic appropriateness.’’ patient’s profile as part of the the prescriptions is proof that the red
Fla Admin Code r. 64B16–27.810. This prospective drug use review which is flags were not resolved, the Government
rule specifically requires that a required before filling a prescription. points to the evidence showing that
pharmacist identify such issues as: Unexplained by the Government is why
where the physicians failed to include
‘‘[o]ver-utilization,’’ ‘‘[t]herapeutic it would be improper for pharmacists to
the patients’ address, the pharmacists
duplication,’’ ‘‘[d]rug-drug document their resolution of a red flag
placed address stickers on the
interactions,’’ ‘‘[i]ncorrect drug dosage,’’ in the patient profile given that the
prescriptions. It also points to a single
and ‘‘[c]linical abuse/misuse.’’ Id. Board’s rules required (and still require)
that a pharmacist document his/her prescription, which was partially filled,
On cross-examination, the Expert and that the pharmacist documented
testified that he asked DEA ‘‘for ‘‘comments relevant to the individual’s
drug therapy, including any other this on the face of the prescription.
complete profiles on all these patients’’
but was told to look at only the information peculiar to the specific Yet Florida law expressly required
prescriptions. Tr. 247; see also id. at patient or drug,’’ as well as ‘‘any related (and still requires) that a patient’s
324–25 (testimony of Expert that he had information indicated by a licensed address ‘‘appear on the face of the
asked for patient profiles for the health care practitioner’’ in that record. prescription.’’ Fla. Sta. Ann. § 893.04(c);
Superior II patients and was told not Of further consequence, the see also 21 CFR 1306.05(a) (‘‘All
look at them, although it was unclear Government produced no evidence prescriptions for controlled substances
whether he actually received them). He establishing when the various patients . . . shall bear the full name and
further acknowledged that a patient first filled prescriptions at Respondents address of the patient[.]’’).58 As for the
profile would show a patient’s complete for the drugs in the prescriptions at partially filled prescription, a DEA
history of the prescriptions filled at the issue here. Unexplained by the regulation requires that the pharmacist
pharmacy during the period for which Government is why, if the red flags ‘‘make a notation of the quantity
it was run, as well as whether the associated with a specific patient and supplied on the face of the written
patient was opioid naı̈ve or tolerant. Id. prescription had been previously prescription . . . or in the electronic
at 325. While subsequent testimony resolved and this was documented in prescription record.’’ 21 CFR 1306.13(a).
suggests that the Agency’s Investigators the patient profile, the pharmacists were By contrast, no law or rule requires the
did not obtain the patient profiles (at nonetheless required to document this documentation of the resolution of a red
least with respect to Superior II) 57 but on subsequent prescriptions. flag to be placed on the prescription
I also reject the Government’s itself. Finally, it bears repeating that
only state PMP reports, both the Board’s
contention that it is entitled to an there is no evidence in the record that
regulation and the Expert’s testimony
adverse inference based on the failure of the Investigators even asked
establish that the patient profiles were
Respondents to produce any evidence Respondents’ pharmacists, as a general
relevant evidence in assessing whether
showing that they resolved the red flags. matter, if they resolved red flags
Respondents’ pharmacists had resolved
Under the adverse inference rule, if a presented by controlled substance
the red flags, whether they contained
party has evidence within its control
such proof or not.
that ‘‘would in fact strengthen [its] case,
The Government nonetheless argues [it] can be expected to introduce it even
58 Quoting 21 CFR 1306.05(a), the Government
that it had no obligation to produce the suggests that prescriptions were ‘‘[d]ispensed in an
if it is not subpoenaed.’’ Int’l Union, 459 [i]mproper manner.’’ Gov. Post-Hrng. Br. 18. The
patient profiles and that the F.2d at 1338. Be that as it may, while Government then states: ‘‘[a]s evidenced [b]y many
Respondents’ position would force the the patient profiles remained within of the prescriptions themselves for both Superior I
Government to ‘‘search the entire Respondents’ control, International
and II, prescriptions were repeatedly issued absent
universe for exculpatory evidence.’’ a patient address.’’ Id. The Government, however,
Union itself recognizes that ‘‘if a party offers no further explanation as to why Respondents
Gov. Mot. to Supplement the Record, has good reason to believe his opponent violated federal law by filling the prescriptions
Strike Respondent’s Untimely has failed to meet [its] burden of proof, given that they contain address stickers for the
Exceptions, . . . Or, In the Alternative, [it] may find no need to introduce his
patients.
Respond to Exceptions, at 15. It further Of note, the DEA Office of Diversion Control
strong evidence.’’ Id. maintains a Web page of ‘‘Questions & Answers’’
argues that it is entitled to an adverse Here, the Government has the burden pertaining to prescriptions. See http://
inference that Respondents’ pharmacists of proof. See 21 CFR 1301.44(d) & (e). www.deadiversion.usdoj.gov/faq/prescriptions.htm.
did not resolve the various red flags While it may be that there is nothing in One of the questions is: ‘‘What changes may a
because such evidence, if it does exist, pharmacist make to a prescription written for a
the patient profiles which would have controlled substance in schedule II?’’ Id. at 2. In its
is ‘‘under the complete control of the been favorable to Respondents, given answer, the Office of Diversion Control noted a
Respondent’’ and ‘‘not DEA’’ and that the Government’s Expert conflict between its previous policy and a statement
Respondent ‘‘fail[ed] to produce’’ it. Id. acknowledged the relevance of these made in a 2007 rulemaking entitled Issuance of
(citing Int’l Union, UAW v. NLRB, 459 Multiple Prescriptions for Schedule II Controlled
records and the scope of the information Substances; the answer further explained that the
F.2d 1329, 1336 (D.C. Cir. 1972)). required by the Board’s rule to be Agency ‘‘plans to resolve this matter through a
As for the contention that maintained in them, requiring the future rulemaking.’’ Id. The Answer then advised
Respondents’ position would force the
sradovich on DSK3TPTVN1PROD with NOTICES2
Government to put forward evidence as that ‘‘[u]ntil that time, pharmacists are instructed to
Government to ‘‘search the entire adhere to state regulations or policy regarding those
to whether the patient profiles show changes that a pharmacist may make to a schedule
universe for exculpatory evidence,’’ it that the various red flags were not II prescription after oral consultation with the
resolved, is not fairly described as prescriber.’’ Id. Because the Government has
maintained for a period of four years preceding the requiring it ‘‘to search the entire produced no evidence that Florida law, the Board
most recent entry. of Pharmacy’s regulations, or the Board’s policy
57 With respect to Superior I, a DI testified that universe for exculpatory evidence.’’ To prohibited the pharmacists from adding the
he believed that digital evidence was collected. Tr. the contrary, obtaining and reviewing patient’s address to the prescriptions, I reject the
372. patient profiles would seem to be Government’s suggestion.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/28.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31337
prescriptions, and if so, how they The Audits and Recordkeeping hearing Brief, Respondent did not
documented having done so.59 Allegations specifically identify this ruling as being
Accordingly, I find that the The evidence nonetheless shows that in error. Indeed, while in its Post-
Government’s allegations that hearing Brief, Superior I proposes as a
both Respondents violated the CSA by
Respondents’ pharmacists violated 21 factual finding that it ‘‘proffered
failing to maintain and/or properly
CFR 1306.04(a) and Fla. Stat. Ann. Exhibits 3 through 9 including invoices
maintain required records. With respect
§ 465.016(1)(s)) when they dispensed and other records that demonstrate
to Superior I, the evidence is
controlled substance prescriptions errors in the DEA audit which resolve
particularly egregious, as an audit
without resolving the red flags the alleged inventory overages,’’ Resp.
conducted by Agency Investigators
presented by the prescriptions are not Post-Hrng. Br. 9 (emphasis added), with
found that the pharmacy had shortages
supported by substantial evidence.60 respect to Superior I, the gravamen of
of 15,560 du of oxycodone 30 mg and
the Government’s audit allegation was
11,951 du of hydromorphone 8 mg. In
59 The Government also alludes to testimony by
that it had shortages of multiple drugs.61
its Expert to the effect that he was shown partial addition, Superior I was short 946 du of
Moreover, Exhibits 3 through 9, which
medical records for the patients and that he found hydromorphone 4 mg, 864 du of
no evidence in these records ‘‘that any conversation comprise nearly 1500 pages of assorted
methadone 10 mg, 474 du of morphine
had taken place between the prescriber and the documents, and which purportedly
Respondents’ pharmacist.’’ Gov. Post-Hrng. Br. 17 sulfate 100 mg ER, and 447 du of
include relevant records for each of the
n.10. None of these records are in evidence, and morphine sulfate 30 mg ER. Thus,
audited drugs, are just that—raw
thus, there is no evidence establishing when the Superior I was short more than 30,000
patients first saw the physicians and whether there documents, with no accompanying
du of highly abused controlled
was any communication between the pharmacists explanation or calculations showing
and prescribers at that time. In any event, there is substances. And while Superior II had
why the Government’s audit results are
no evidence in the record establishing that a only a small shortage of a single drug, in error.62
physician has an obligation under the standard of it had substantial overages in several
care to document phone calls from a pharmacist Respondent also questioned the
questioning his prescription. Accordingly, I place drugs, including 2,576 du of validity of the audits on the ground that
no weight on this testimony. hydromorphone 8 mg and 1,189 du of while the DIs could have verified their
60 As found above, on various occasions, the oxycodone 30 mg. calculations as to the level of
Government elicited testimony from its Expert, over ‘‘Recordkeeping is one of the CSA’s
Respondents’ objections, to the effect that some of Respondents’ purchases of the drugs by
the prescriptions presented red flags that could not
central features; a registrant’s accurate obtaining data from the Agency’s
be resolved. While the Government made no and diligent adherence to this obligation ARCOS database, they ‘‘willfully chose
argument based on this testimony in its Post- is absolutely essential to protect against to ignore that evidence which would
hearing Brief, the ALJ made multiple findings that the diversion of controlled substances.’’
several of the prescriptions presented red flags that have demonstrated the accuracy of the
could not be resolved. See R.D. 80–81 (FoF#s 9, 10).
Paul H. Volkman, 73 FR 30630, 30644 pharmacies’ records with respect to
Moreover, in its Response to Respondent’s (2008); see also Fred Samimi, 79 FR [their] purchases.’’ Id. at 20. Contrary to
Exceptions, the Government invokes this evidence. 18698, 18712 (2014) (finding where Respondent’s understanding, one of the
See Gov. Response to Resp.’s Exceptions, at 14 physician ‘‘had shortages totaling more
(‘‘Notwithstanding the fact that Mr. Parrado purposes of an audit is to determine
credibly testified that he discovered red flags than 40,000 dosage units’’ of various whether the audited party is
which, in his opinion, were unresolvable . . . drugs that his ‘‘inability to account for maintaining ‘‘a complete and accurate
Respondents are now arguing for a new rule that this significant number of dosage units
requires the Government to prove a negative.’’) creates a grave risk of diversion,’’ and 61 Likewise, even assuming the correctness of
(citing Tr. 145–46, 289–90).
While in the Show Cause Orders, the Government
that ‘‘even were there no other proven Superior I’s counsel’s representation that when he
violations, the audit results alone are added up the morphine sulfate orders, he got ‘‘a
made conclusory allegations to the effect that the
number of 7,200,’’ Tr. 395, he made no proffer as
Respondents’ ‘‘pharmacists dispensed controlled sufficient to . . . establish[] that to errors with respect to the audit results for
substances when they knew or should have known [physician’s] registration[] ‘would be oxycodone 30 mg and hydromorphone 8 mg, which
that the prescriptions were not issued in the usual
course of professional practice or for a legitimate inconsistent with the public interest’’’) found massive shortages.
62 It is noted that Respondents attached, as
medical purpose,’’ ALJ Ex. 1, at 2 (No. 15–6), which (citations omitted).
implies that the red flags could not be resolved, the During the hearing, Respondents supplements to their untimely filed Exceptions,
Government never identified a specific prescription charts which purport to show audit results for both
raised various challenges to the validity pharmacies which are dramatically different from
in either Show Cause Order or any of its Prehearing
Statements that could not be resolved. As explained of the audits. With respect to the those found by the Government. See Resp.
previously, while the ALJ overruled Respondents’ Superior I audit, Respondent’s counsel Exceptions, at Appendices A & B. Respondents
offered no foundation for consideration of the
objections, the correct standard is not whether the attempted to impeach the DI’s result by charts, and in any event, the charts are not properly
ALJ wanted to know the answer to the using a document he described as
Government’s question, Tr. 287, but whether considered as newly discovered evidence.
Respondents knew ‘‘what conduct was being ‘‘scratch paper’’ which, according to his Furthermore, while throughout the proceeding,
alleged and ha[d] a fair opportunity to present representation, had been included Respondents have argued that their due process
[their] defense.’’ Duane v. DOD, 275 F.3d 988, 995 among the documents returned to rights have been violated because the Agency’s
(10th Cir. 2002) (quoting Facet Enters., Inc., v. Lead Investigator ‘‘unlawfully retained’’ records
NLRB, 907 F.2d 963, 972 (10th Cir. 1990). See also
Respondents on the CD and which seized pursuant to the Administrative Inspection
Pergament United Sales, 920 F.2d at 135 (‘‘Notice listed the DEA 222 forms for Superior I’s Warrants for some 611 days, Resp. Post-Hrng. Br.
does not mean a complaint necessarily must state morphine sulfate orders; Respondent’s 18, Respondents were provided with the records on
the legal theory upon which the General Counsel or about the same day they were served with the
counsel further represented that when Show Cause Orders, which made specific
intends to proceed. Instead notice must inform the
respondent of the acts forming the basis of the
he added up the orders, he got a number allegations as to the audits. Thus, Respondents had
complaint.’’); see also id. (‘‘The primary function of of 7,200 du. Tr. 395. approximately 80 days from the date they were
notice is to afford [a] respondent an opportunity to I need not decide whether the ALJ informed of the allegations to the date on which
they were required to file their Prehearing
sradovich on DSK3TPTVN1PROD with NOTICES2
prepare a defense by investigating the basis of the erred when he barred Superior I’s
complaint and fashioning an explanation that Statements to investigate the allegations pertaining
refutes the charge of unlawful behavior.’’).
counsel from using this document to to the audits and prepare a defense.
Because the Government never alleged that any impeach the DI, Tr. 394–95, because While Respondents argue that ‘‘[t]he first access
of the prescriptions could not be resolved, and Respondent did not properly preserve [they] had to what may or may not be all of the
Respondents objected to this line of inquiry, there the claim of error. Notably, evidence was on the day that DEA served its Order
is no basis for a finding of litigation by consent. to Show Cause,’’ Resp. Post-Hrng. Br. 19, they did
Accordingly, I do not consider the testimony that
Respondent’s counsel did not seek to not identify any records that were necessary to
the some of the prescriptions presented submit the document even as a rejected complete their audits which were not provided to
unresolvable red flags. impeachment exhibit, and in its Post- them when their records were returned.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/29.svg)
![31338 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
record of each [controlled] substance should result in the form not being While the DI further identified other
. . . received, sold, delivered, or used,’’ the applicable regulation actually Order Forms in this Exhibit which she
otherwise disposed of by him.’’ See 21 states that the order ‘‘must not be filled alleged were not properly completed,
U.S.C. 827(a)(3); see also id. at if . . . [t]he order shows any alteration, she did not identify a single instance in
§ 827(a)(1) (requiring registrants to erasure, or change of any description.’’ which a line item had actually been
‘‘make a complete and accurate record 21 CFR 1305.15(a) (emphasis added). shipped to Respondent and the entry
of all stocks . . . on hand’’ when ‘‘first Thus, the regulation is not fairly read as had not been made. Indeed, with respect
engag[ing] in the . . . dispensing of imposing liability on Superior I for to the Exhibit, the only violations the DI
controlled substances, and every second changing the National Drug Code. identified were that the forms were
year thereafter’’). Putting aside that The DI also testified that a second copies and not the original. Tr. 474–75,
Respondents produced no evidence order form was not filled out properly, 521. Under a DEA regulation, ‘‘[t]he
showing discrepancies between the DIs’ because ‘‘information in regard to the purchaser must retain Copy 3 of each
calculations as to the quantities of the number of package[s] receive [sic] . . . executed DEA Form 222.’’ 21 CFR
drugs received by them and the was omitted.’’ Tr. 384. However, the 1305.13(a). Standing alone these
distributions as reported by their Government offered no evidence that violations would be of minimal
suppliers to the ARCOS system, the DIs any portion of the two orders listed on consequence.
were entitled to rely on the records the form were filled. While DEA’s The evidence further showed that
provided by Respondent in response to regulation states that ‘‘[t]he purchaser while Superior II used the electronic
the warrant. Given that ARCOS data is must record on Copy 3 of the . . . 222 Controlled Substances Ordering System
compiled from distribution reports the number of commercial or bulk to purchase controlled substances, it did
submitted by manufacturers and containers on each item and the dates not comply with 21 CFR 1305.22(g).
distributors, and Respondents were not on which the containers are received by Under this provision, ‘‘[w]hen a
required to file reports to ARCOS, see 21 the purchaser,’’ 21 CFR 1305.13(e), the purchaser receives a shipment, the
CFR 1304.33(c), the DIs had no Government points to no provision purchaser must create a record of the
obligation to cross-check their which requires, where no portion of a quantity of each item received and the
calculations with ARCOS data. line entry has been filled by the date received. The record must be
Respondent Superior II questioned expiration of the 60-day period in which electronically linked to the original
the validity of the audit pertaining to it, the Order Form is valid, id. § 1305.13(b), order and archived.’’ 21 CFR 1305.22(g).
on the ground that the DI based her the purchaser to notate on the form that The evidence shows that Respondent’s
initial inventory figures on a perpetual no portion of that entry was received.64 pharmacists would print out a copy of
inventory which Respondent is not The Government made similar claims the electronic order form and by hand,
lawfully required to maintain. However, with respect to Superior II. For example, notate in the boxes in which the
the DI testified multiple times that she it identified the first two pages of GX 6 Supplier is to list the ‘‘Packages
asked for an actual physical count (No. 15–7) as examples of Order Forms Shipped’’ and the ‘‘Date Shipped,’’ the
which was at least six months old and that were not properly completed number of packages received and the
used what Superior II gave her. Tr. 491– because the second entry on each form date received. See generally GXs 7 & 10;
92. I thus reject Respondent’s challenge did not list the number of packages Tr. 551. According to the DI, when she
received and the date received. Putting asked Mr. Majed (one of Superior II
to the findings of the audit of Superior
aside that these two documents bear the pharmacists), how he documented the
II, which establishes that it had overages
exact same serial number, here again, pharmacy’s receipt of the drugs, the
in several drugs.63
I thus find that both pharmacies failed the Government put forward no pharmacist explained that he did not go
evidence that any portion of the order back into the CSOS because ‘‘he wasn’t
to maintain complete and accurate
listed in the second line item was filled. aware that he had to do that.’’ Tr. 554.
records as required by 21 U.S.C.
While here too, this DI insisted that The record thus supports the
827(a)(1) & (3). While this finding alone
‘‘after 60 days, the 222 is invalid’’ and conclusion that Superior II’s receipts
supports the conclusion that each
that Respondent ‘‘should go back and were not documented electronically and
pharmacy has committed such acts as to
put a zero and the date they put the were not linked to the original order.
render its continued registration
zeros’’ on the form, as explained above, Thus, I conclude Superior II violated 21
‘‘inconsistent with the public interest,’’
the regulations do not so require. And CFR 1305.22(g) with respect to the
see 21 U.S.C. 824(a)(4), the scope of the
while the DI also asserted that the numerous electronic orders it placed.
shortages of oxycodone 30 mg and The DI also testified that Mr. Majed
Pharmacist’s Manual—which does not
hydromorphone 8 mg found during the represented that he had a key which is
have the force and effect of law
audit of Superior I supports a sanction required under the Agency’s regulations
anyway—instructs pharmacists to do
of revocation. See Samimi, 79 FR at for placing electronic orders through the
this, the Manual actually states that
18712. CSOS. Tr. 557–58. Under DEA’s
The Government further alleges that ‘‘[w]hen the items are received, the
pharmacist must document on the regulation, a person must ‘‘obtain a
Respondents failed to properly complete CSOS digital certificate from the DEA
various schedule II order forms. More purchaser’s copy (copy three) the actual
number of packages received and the Certification Authority to sign electronic
specifically, with respect to Superior I, orders for controlled substances.’’ 21
the Government’s evidence included an date received’’ and nothing more. DEA,
Pharmacist’s Manual—An CFR 1311.10. However, a person is
Order Form for oxycodone 30 on which eligible to obtain a CSOS digital
the National Drug Code was changed. Informational Outline of the Controlled
sradovich on DSK3TPTVN1PROD with NOTICES2
Substances Act 23 (Rev. ed. 2010). certificate only if he/she: (1) is the
GX 5, at 1 (No. 15–6). However, while person who ‘‘signed the most recent
the DI testified that ‘‘any alteration or 64 While the purchaser’s copy 3 of the form registration application or renewal
any erasure or change of description’’ includes columns ‘‘To Be Filled In By Purchaser’’ application,’’ (2) is ‘‘a person authorized
in which the purchaser lists the ‘‘No. of Packages to sign a registration application,’’ or (3)
63 While Superior II also argues that DEA failed Received’’ and the ‘‘Date Received’’ for each line
to consider ARCOS data in auditing it, I reject the item, see GX 5 (No. 15–6), if no packages of that
has been ‘‘granted power of attorney by
argument for the same reasons that I rejected the item have been received, then there is no date on [the] registrant to sign orders for one or
argument with respect to Superior I’s. which they were received. more schedules of controlled
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/30.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31339
substances.’’ Id. DEA’s regulations Pharmaceuticals, Inc., 72 FR 36487, ALJ was biased, they assert that he
further provide that ‘‘[o]nly the 36504 (2007). Obviously, the ‘‘refused to require the DEA to obey the
certificate holder may access or use his egregiousness and extent of a order of the Federal Magistrate Judge.’’
or her digital certificate and private registrant’s misconduct are significant Id. at 34.
key,’’ and ‘‘[a] certificate holder must factors in determining the appropriate As for their claim of bias, none of
ensure that no one else use the private sanction. See Jacobo Dreszer, 76 FR their assertions establish bias. As found
key’’ and ‘‘prevent unauthorized use of 19386, 19387–88 (2011) (explaining that above, while several of the ALJ’s rulings
that private key.’’ Id. § 1311.30. a respondent can ‘‘argue that even on objections were erroneous, many of
According to the DI, after her though the Government has made out a them were not, and some of
conversation with Mr. Majed, she prima facie case, his conduct was not so Respondents’ objections were clearly
determined that only Mr. Obi, egregious as to warrant revocation’’); lacking in merit. In any event, ‘‘judicial
Respondent’s owner, and Ms. Minozzi, Paul H. Volkman, 73 FR 30630, 30644 rulings alone almost never constitute a
another pharmacist, had been issued (2008); see also Paul Weir Battershell, valid basis for a bias or partiality
CSOS keys. Accordingly, I conclude that 76 FR 44359, 44369 (2011) (imposing motion.’’ Liteky v. United States, 510
Respondent violated 21 CFR 1311.30(a) six-month suspension, noting that the U.S. 540, 555–56 (1994) (citing United
and (c). evidence was not limited to security and States v. Grinnell Corp., 384 U.S. 563,
Accordingly, I conclude that the recordkeeping violations found at first 583 (1966)).
evidence with respect to factor four— inspection and ‘‘manifested a disturbing As for the contention that bias is
Respondents’ compliance with pattern of indifference on the part of established by the ALJ’s refusal to
applicable laws related to controlled [r]espondent to his obligations as a require the DI to obey the Federal
substances—establishes that each registrant’’); Gregory D. Owens, 74 FR Magistrate Judge’s order, Respondents
Respondent ‘‘has committed such acts 36751, 36757 n.22 (2009). point to no provision of law which
as would render [its] registration . . . The Agency has also held that grants an Administrative Law Judge
inconsistent with the public interest.’’ ‘‘ ‘[n]either Jackson, nor any other authority to order the Government to
21 U.S.C. 824(a)(4). agency decision, holds . . . that the comply with an order of a Federal
Agency cannot consider the deterrent Magistrate Judge.65 A Magistrate Judge
Sanction
value of a sanction in deciding whether has authority to ensure compliance with
Under Agency precedent, where, as a registration should be [suspended or] his orders, including the power to hold
here, ‘‘the Government has proved that revoked.’ ’’ Gaudio, 74 FR at 10094 a disobeying party in contempt. See 28
a registrant has committed acts (quoting Southwood, 72 FR at 36504); U.S.C. 636. Respondents offer no
inconsistent with the public interest, a see also Robert Raymond Reppy, 76 FR explanation for why they did not seek
registrant must ‘ ‘‘present sufficient 61154, 61158 (2011); Michael S. Moore,
mitigating evidence to assure the an order compelling the return of the
76 FR 45867, 45868 (2011). This is so, documents from the Magistrate Judge
Administrator that it can be entrusted both with respect to the respondent in
with the responsibility carried by such who approved the warrant. I thus reject
a particular case and the community of Respondents’ claim that the ALJ’s ruling
a registration.’’ ’ ’’ Medicine Shoppe- registrants. See Gaudio, 74 FR at 10095
Jonesborough, 73 FR 364, 387 (2008) on Mr. Obi’s testimony should be
(quoting Southwood, 71 FR at 36503). rejected on the ground of bias.66 Indeed,
(quoting Samuel S. Jackson, 72 FR Cf. McCarthy v. SEC, 406 F.3d 179, 188–
23848, 23853 (2007) (quoting Leo R. Respondents self-refute their claim of
89 (2d Cir. 2005) (upholding SEC’s
Miller, 53 FR 21931, 21932 (1988))). bias when they argue that ‘‘[t]he real
express adoptions of ‘‘deterrence, both
‘‘Moreover, because ‘past performance is reason that the ALJ refused to let Mr.
specific and general, as a component in
the best predictor of future Obi testify was because he felt like
analyzing the remedial efficacy of
performance,’ ALRA Labs, Inc. v. DEA, Respondents’ counsel had not
sanctions’’).
54 F.3d 450, 452 (7th Cir.1995), [DEA] Here, the record contains no evidence adequately complied with the
has repeatedly held that where a that the principals of either Respondent 65 Respondents do not identify what orders the DI
registrant has committed acts acknowledge its misconduct. So too, the violated. If Respondents mean the administrative
inconsistent with the public interest, the record contains no evidence that either inspection warrants, the language of the warrants
registrant must accept responsibility for Respondent has undertaken any only provided for a return of the warrant to the
its actions and demonstrate that it will remedial measures. court and an accounting of the property seized.
Resp.’s Post-Hrng. Br., at Attachments 1 and 2. The
not engage in future misconduct.’’ Respondents attribute this to the ALJ’s warrants contained no provision requiring the
Medicine Shoppe, 73 FR at 387; see also ruling barring Mr. Obi (Respondents’ return of the seized property, and Respondents
Jackson, 72 FR at 23853; John H. owner) from testifying. They argue that point to no further orders by the court to return the
Kennedy, 71 FR 35705, 35709 (2006); the ALJ’s ruling denied them their right records.
66 Respondents further assert that the ALJ’s
Prince George Daniels, 60 FR 62884, to due process and a fair hearing under
‘‘general bias . . . finds its roots in’’ what they
62887 (1995). See also Hoxie v. DEA, the Administrative Procedure Act. See characterize as ‘‘the Administrator’s public scolding
419 F.3d at 483 (‘‘admitting fault’’ is Resp. Post-Hrng. Br. 23 (citing, inter of the ALJ in Clair L. Pettinger, M.D., 78 [FR] 61591
‘‘properly consider[ed]’’ by DEA to be alia, Oshodi v. Holder, 729 F.3d 883, (2013), for requiring the DEA to follow the
an ‘‘important factor[ ]’’ in the public 889 (9th Cir. 2013) (en banc); Block v. procedural rules of the Agency and for his
interpretation of the law.’’ Id. at 35. Not only is
interest determination). SEC, 50 F.3d 1078, 1085 (D.C. Cir. Respondents’ explanation of Pettinger
While a registrant must accept 1995); 21 [sic] U.S.C. 556). Tallying up counterfactual (both the pleading burden imposed
responsibility and demonstrate that it the number of each party’s objections by the ALJ and his interpretation of factor two were
sradovich on DSK3TPTVN1PROD with NOTICES2
will not engage in future misconduct in which the ALJ overruled versus those he inconsistent with agency precedent), they cite no
authority for their theory. Beyond that, Respondents
order to establish that its continued sustained, as well as the number of ignore the extensive protections provided to ALJs
registration is consistent with the public times the ALJ, sua sponte, instructed a under federal law to ensure decisional
interest, DEA has repeatedly held these witness not to answer a question, they independence, including that they are not subject
are not the only factors that are relevant assert that ‘‘[t]his unmistakable pattern to performance appraisals, 5 U.S.C. 4301(2)(D), their
pay is set by OPM independent of any evaluation
in determining the appropriate sanction. reflects the [ALJ’s] clear bias against by the Agency, id. § 5372, and they are subject to
See, e.g., Joseph Gaudio, 74 FR 10083, Respondents.’’ Id. at 27. As additional discipline only upon a showing of good cause by
10094 (2009); Southwood grounds for their contention that the the MSPB. Id. § 3105.
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/31.svg)
![31340 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
disclosure requirements of the ALJ’s prejudice to the Government because Department of Labor, 601 F.3d 1013,
prehearing order.’’ Resp. Exceptions, at ‘‘the summary of Mr. Obi’s testimony’’ 1021 (10th Cir. 2010).
24 (emphasis added). was ‘‘covered sufficiently’’ by the Indeed, in their Post-Hearing Brief,
Respondents thus assert that the ALJ Government in its Prehearing Respondents argue that ‘‘Mr. Obi’s
erred in barring Mr. Obi from testifying Statements, the Government’s summary testimony could have been restricted to
because he was an interested person of Mr. Obi’s anticipated testimony was the issues discussed in the DEA’s
within the meaning of the APA. That confined to questioning him about past prehearing statement.’’ Resp. Post-Hrng.
Mr. Obi is an interested person is hardly acts. Tr. 597–98; see also ALJ Ex. 7, at Br. 24. However, as explained above, to
disputable. However, while an 6–7 (No. 15–6); ALJ Ex. 7, at 8–9 (No. rebut the Government’s prima facie
interested person has a right to 15–7). Indeed, Respondents’ Counsel case, Respondents bore the burden of
participate in a proceeding, that right is conceded that he intended to elicit producing evidence as to their remedial
subject to the reasonable procedural testimony from Mr. Obi as to the measures. Thus, even if Mr. Obi had
rules of the Agency and rulings of the corrective actions Respondents had testified to those issues identified in the
ALJ. See, e.g., 5 U.S.C. 556(c) (‘‘Subject undertaken and that this raised a notice Government’s Prehearing Statements
to published rules of the agency and issue. Id. at 611. Moreover, at no point and acknowledged Respondents’
within its powers, employees presiding prior to the hearing did Respondents misconduct (as to those violations
at hearings may . . . regulate the course provide notice to the Government that proven on the record), Respondents still
of the hearing.’’); 21 CFR 1316.58(a) any of their proposed witnesses would would have failed to rebut the
(‘‘The presiding officer may direct that testify regarding any corrective actions Government’s prima facie case.
summaries of the direct testimony of undertaken by the pharmacies.67 See ALJ Accordingly, even if it was error to bar
witnesses be prepared in writing and Ex. 9, at 4–6 (No. 15–6); ALJ Ex. 12, at Mr. Obi’s testimony as to the issues
served on all parties in advance of the 4–6 (No. 15–7). Thus, the ALJ did not discussed in the Government’s
hearing.’’). abuse his discretion when he barred Mr. Prehearing Statements, Respondents
Here, in his Orders for Prehearing Obi from testifying.68 See Gunderson v. have not shown prejudice. See
Statements, which were issued more Gunderson, 601 F.3d at 1021 (An ALJ’s
than one month before Respondents’ 67 Respondents’ reliance on Oshodi is not error in excluding evidence must
Prehearing Statements were due, the persuasive. Therein, the Ninth Circuit overturned a ‘‘ ‘prejudicially affect a substantial right
ALJ specifically warned Respondents decision of the Board of Immigration Appeals (BIA),
which affirmed a decision of an Immigration Judge
of a party’ ’’; ‘‘[a]n error is prejudicial
that if their ‘‘corporate representative that Oshodi, who was an applicant for asylum, was only ‘if it can be reasonably concluded
intends to testify, the representative not credible. 729 F.3d at 885. Specifically, the court that with . . . such evidence, there
must be listed as a witness, and a held that the Immigration Judge violated the would have been a contrary result.’’’)
summary of anticipated testimony as applicant’s right to due process ‘‘by cutting off his
testimony on the event of his alleged past
(quoting Sanjuan v. IBP, Inc., 160 F.3d
described below must be provided.’’ ALJ persecution . . . that [were] the foundation of his’’ 1291, 1296 (10th Cir. 1998)); see also Air
Ex. 5, at 2 (No. 15–6); ALJ Ex. 6, at 2 claims, and denied his claims ‘‘solely on the basis Canada v. Department of Trans., 148
(No. 15–7). The Orders for Prehearing of [an] adverse credibility finding.’’ Id. F.3d 1142, 1156 (D.C. Cir. 1998) (‘‘As
Statements also cautioned Respondents Respondents also cite to Kerciku v. INS, 314 F.3d incorporated into the APA, the harmless
913 (7th Cir. 2003), asserting that the ALJ violated
that their summaries of testimony must their rights to due process by precluding them from error rule requires the party asserting
‘‘indicate clearly each and every matter putting on any case. Resp. Post-Hrng. Br. 2. In error to demonstrate prejudice from the
as to which Respondent[s] intend[ ] to Kericku, the Seventh Circuit vacated a BIA decision error.’’) (citing 5 U.S.C. 706). I thus
introduce evidence in opposition’’ and which upheld an IJ’s denial of applications for reject Respondents’ contentions with
asylum, faulting the IJ for not allowing the
that ‘‘[t]he summaries are to state what applicants ‘‘to make any presentation.’’ 314 F.3d at respect to the ALJ’s ruling which barred
the testimony will be rather than merely 918. Mr. Obi’s testimony.69
listing the areas to be covered.’’ ALJ Ex. Neither case, however, raised the issue of
5, at 2 (No. 15–6); ALJ Ex. 6, at 2 (No. whether a party could be barred from putting on been disclosed in advance of the hearing. Just as in
15–7). And finally, the Orders for testimony when the party entirely failed to comply federal court, evidence that a respondent had
with an agency rule which requires disclosure of undertaken remedial measures is not proof that it
Prehearing Statements further warned the substance of that testimony in advance of the has engaged in culpable conduct. Cf. Fed. R. Evid.
‘‘that testimony not disclosed in the proceeding to prevent prejudice. While R.407.
prehearing statements or pursuant to Respondents also argue that the ALJ did not While a respondent retains the right to challenge
subsequent rulings is likely to be neutrally apply this rule, I have carefully reviewed the allegations at the proceeding, when the
the parties’ respective Prehearing Statements, and Government serves a party with a show cause order,
excluded at the hearing.’’ ALJ Ex. 5, at conclude otherwise. a respondent should assume that the Government
2 (No. 15–6); ALJ Ex. 6, at 2 (No. 15– 68 In Hatem M. Ataya, M.D., 81 FR 8221, 8243
has probable cause to support the allegations and
7). (2016), I held that while the Agency’s case law a good faith basis for seeking the action (revocation
Respondents thus had fair notice of requires a respondent to acknowledge its or suspension) it proposes. A wise respondent
misconduct and put on evidence of its remedial conducts its own investigation to determine
the steps they were obligated to take to measures to rebut the Government’s prima facie whether the allegations are true, and if they are, to
present Mr. Obi’s testimony. While case, the Agency’s cases do not require a then determine what measures are needed to correct
Respondents represented in their respondent ‘‘to admit to the allegations even before the violations or offending practices. Thus, while a
Prehearing Statements that they [it] even has the opportunity to challenge the respondent retains the right to challenge the
Government’s evidence.’’ Thus, in Attaya, I held Government’s evidence at the hearing, it is still
intended to call ‘‘[a]ny and all witnesses that a respondent’s failure to acknowledge his properly charged with the obligation to disclose the
identified in the Government’s misconduct in his prehearing statement could not remedial measures it has undertaken as a condition
Prehearing Statement[s] in th[ese] bar him from introducing evidence of his remedial of being able to present such evidence at the
matter[s],’’ and the Government measures. Id. at 8242. However, in Attaya, I also hearing. Of course, where the Government fails to
held that because the respondent had not
sradovich on DSK3TPTVN1PROD with NOTICES2
identified Mr. Obi as a potential witness prove an allegation at the hearing, a respondent
adequately disclosed ‘‘with sufficient particularity’’ need not put on evidence of any corrective
therein, Respondents entirely failed to his evidence of remedial measures, the testimony measures relevant to that allegation.
provide a summary of the testimony could nonetheless be barred. 69 As for Respondents’ arguments with respect to
they intended to elicit from him. ALJ Here, while Respondents failed to set forth any the ALJ’s ruling which precluded them from
Ex. 9, at 4 (No. 15–6); ALJ Ex. 12, at 4 proposed testimony by Mr. Obi on the issue of submitting their documentary evidence, see Resps.’
acceptance of responsibility in advance of the Post-Hrng. Br. at 30–32, the ALJ’s Prehearing Orders
(No. 15–7). hearing, this would not have been a bar to Mr. Obi’s were clear enough that the documents had to be
While at the hearing Respondents testimony as to Respondents’ corrective measures, submitted in hard copy. Moreover, my holding that
asserted that there would be no had such proposed testimony on the latter issue the Government has failed to prove any of the
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4703 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/32.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31341
Because Respondents failed to I acknowledge that Superior II’s Order
produce any evidence of remedial recordkeeping violations did not
measures undertaken to address the involve large shortages but rather Pursuant to the authority vested in me
numerous recordkeeping issues that I overages. However, the pharmacy by 21 U.S.C. 824(a)(4) and 823(f), as
find proven on the record, I conclude nonetheless failed to maintain complete well as 28 CFR 0.100(b), I order that
that Respondents have not rebutted the and accurate records as required by the DEA Certificates of Registration
Government’s prima facie showing they CSA, did not properly document its BS9255274 and BS9699731 issued to
have ‘‘committed such acts as [to] receipts on electronic order forms, and Superior Pharmacy, L.L.C., be, and they
render [their] registration[s] inconsistent allowed an unauthorized person to hereby are, revoked. I further order that
with the public interest.’’ 21 U.S.C. access the electronic ordering system. In any application of Superior Pharmacy,
824(a)(4). And based on the substantial addition, the pharmacies have common L.L.C., to renew or modify either
shortages found at Superior I, which ownership in that they are both owned registration, be, and it hereby is, denied.
supports the conclusion that it has by Mr. Obi. Thus, while the conduct This Order is effective June 17, 2016.
major recordkeeping issues and/or has proven with respect to Superior I is
engaged in diversion, I conclude that Dated: May 7, 2016.
more egregious than that proved with Chuck Rosenberg,
revocation of its registration is respect to Superior II, given that Mr. Obi
warranted to protect the public Acting Administrator.
owns and controls each pharmacy, I
interest.70 [FR Doc. 2016–11550 Filed 5–17–16; 8:45 am]
conclude that revocation is warranted
dispensing violations renders moot their with respect to Superior II as well.71 BILLING CODE 4410–09–P
contentions with respect to those exhibits that were
relevant to those allegations. 71 In numerous cases, DEA has held that where FR 71555, 71557 (2006) (denying application noting
As for the thousands of pages of exhibits that misconduct has previously been proved with evidence that ‘‘one of Respondent’s managing
include records of Respondents’ purchases and respect to the owners, officers, or key employees of members had previously operated a business which
dispensings of the controlled substances audited by a pharmacy, the Agency can deny an application or distributed List I chemicals without a valid
the Government, because Respondents failed to revoke a registration of a second or subsequent registration’’); Cf. 4 OTC, Inc., 77 FR 35031, 35035
make an adequate proffer as to their audit results pharmacy where the Government shows that such
(2012) (denying application for registration as List
prior to the hearing, the ALJ did not abuse his individuals have influence over the management or
discretion in declining to admit this evidence. control of the second pharmacy. See, e.g., Lawsons I chemical distributor where evidence showed that
70 Given the size of the shortages, the Agency’s & Sons Pharmacy and Fenwick Pharmacy, 48 FR a person holding a 10 percent interest in applicant
deterrence interests also support revocation. 16140, 16141 (1983); Orlando Wholesale, L.L.C., 71 had been found by Canadian regulatory agency to
have violated its List I regulations).
sradovich on DSK3TPTVN1PROD with NOTICES2
VerDate Sep<11>2014 17:28 May 17, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4701 Sfmt 9990 E:\FR\FM\18MYN2.SGM 18MYN2](https://thefederalregister.org/doc/81_FR_31405/page/33.svg)
Document Created: 2016-05-18 00:05:59
Document Modified: 2016-05-18 00:05:59
| 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 | |
| FR Citation | 81 FR 31309 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR