83 FR 10876 - Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 49 (March 13, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 49 (March 13, 2018)
| Page Range | 10876-10903 | |
| FR Document | 2018-05020 |
[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)] [Notices] [Pages 10876-10903] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05020] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15-17] Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and Order On February 23, 2015, the former Deputy Assistant Administrator of the then-Office of Diversion Control, Drug Enforcement Administration (hereinafter, DEA or Government) issued an Order to Show Cause to Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy (hereinafter, Respondent). ALJX 1. The Show Cause Order proposed the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f) on the ground that Respondent's registration is inconsistent with the public interest. ALJX 1, at 1. For the same reason, the Show Cause Order also proposed the denial of any pending application by Respondent for renewal or modification of its registration, and the denial of any application by Respondent for any other DEA registration. Id. (citing 21 U.S.C. 823(f)). As the jurisdictional basis for the proceeding, the Show Cause Order alleged that Respondent's DEA Certification of Registration No. FP1049546 authorized it to dispense controlled substances in schedules II through V as a retail pharmacy at the registered location of 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009. Id. Respondent's registration was to expire on March 31, 2017. Id. As the substantive grounds for the proceeding, the Show Cause Order contained seven categories of violations. First, it alleged that ``Zion dispensed controlled substances where it knew, or should have known, that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose and therefore failed to exercise its corresponding responsibility regarding the proper prescribing and dispensing of controlled substances.'' Id. (citing 21 CFR 1306.04(a)). The Show Cause Order stated that Respondent's failure to exercise its corresponding responsibility was evidenced by its ``dispensing of controlled substances despite the presence of red flags of diversion that Zion failed to clear prior to dispensing the drugs.'' Id. at 1-2. The Show Cause Order listed seven red flags of diversion that Respondent allegedly did not resolve prior to filling prescriptions. Id. at 2-7. It cited Holiday CVS, L.L.C., d/ b/a CVS/Pharmacy Nos. 219 and 5195, 77 FR 62,316 (2012) (hereinafter, Holiday CVS) as support for these allegations. The Show Cause Order listed 13 prescriptions, for customers who allegedly traveled long round-trip distances of approximately 166 to 661 miles from home to physician to Respondent and back home, and alleged that Respondent filled them without having resolved the long distance red flags of diversion. ALJX 1, at 2-3. Each of the 13 prescription examples was for a controlled substance written some time during the period of February 2012 through January 2013. Id.; see also Government Exhibit (hereinafter, GX) 8/8a. The Show Cause Order cited five prescriptions written by the same doctor on June 27, 2012 for five different customers for ``1 ML Testosterone Cypionate 210mg/mL IM,'' a controlled substance, that Respondent allegedly filled without first having resolved the red flags of diversion. ALJX 1, at 3-4; see also GX 10. The Show Cause Order referenced two prescriptions for Dilaudid 8 mg., a controlled substance, written by the same doctor on June 22, 2012 for two individuals with the same last name and the exact same street address that Respondent allegedly filled without first having resolved the red flags of diversion. ALJX 1, at 4; see also GX 11. The Show Cause Order alleged that Respondent filled the two prescriptions on July 13, 2012 at 2:35 p.m. and 2:39 p.m., respectively. ALJX 1, at 4. The Order to Show Cause alleged that Respondent filled two prescriptions for the same customer on the same day for the same immediate release controlled substance, but for different strengths, [[Page 10877]] without first having resolved the red flags of diversion. Id. The two pairs of prescriptions listed in the Show Cause Order to illustrate this allegation were issued for Dilaudid 8 mg. and Dilaudid 4 mg. Id.; see also GX 12. They were written during the period of September 2012 through November 2012. ALJX 1, at 4. The Show Cause Order alleged that Respondent filled opiate (hydromorphone) and benzodiazepine (alprazolam, clonazepam, diazepam, or lorazepam) prescriptions, a ``common `drug cocktail' popular with drug abusers,'' for the same customer on the same day at about the same time without first having resolved the red flags of diversion. Id. The Show Cause Order cited 14 prescriptions, or seven pairs of ``drug cocktail'' prescriptions, that Respondent allegedly filled during the period of October 2012 through January 2013. ALJX 1, at 4-5; see also GX 13. The Order to Show Cause alleged that ``[c]ustomers paying for their prescriptions with cash, where other red flags of diversion were present,'' were red flags of diversion that Respondent did not resolve prior to having filled the prescriptions. ALJX 1, at 5. The Show Cause Order listed 50 examples of prescriptions paid for with cash, costing as much as $1,008 for one prescription. Id.; see also GX 8, GX 10, GX 11, and GX 13. The Show Cause Order alleged that Respondent filled prescriptions for ``[c]ustomers [who] present[ed] new prescriptions for controlled substances when they should not have finished their previous prescription for that drug (`early fills' or `early refills')'' without first having resolved the red flags of diversion. ALJX 1, at 5. The Order to Show Cause provided seven sets of examples of prescriptions that Respondent allegedly filled as many as 15 days early. Id. at 5-7; see also GX 14. The Show Cause Order specifically cited Holiday CVS, 77 FR at 62,318 as precedent for this charge. ALJX 1, at 7. Next, the Order to Show Cause alleged that Respondent ``was unable to readily retrieve prescriptions it had dispensed.'' Id. (citing subsections (a) and (h)(3) and (4) of 21 CFR 1304.04). Specifically, the Show Cause Order alleged that, on April 11, 2013, DEA investigators conducted an on-site inspection of Respondent and requested specific prescriptions that Florida's Prescription Drug Monitoring Program showed Respondent had filled.\1\ Id. The Show Cause Order listed 12 testosterone prescriptions that Respondent filled from February 2012 through January 2013 and DEA investigators requested, but that Respondent's staff was allegedly ``unable to produce.'' Id. at 7-8. --------------------------------------------------------------------------- \1\ Florida's Prescription Drug Monitoring Program is called the Electronic-Florida Online Reporting of Controlled Substance Evaluation Program (hereinafter, E-FORCSE). --------------------------------------------------------------------------- The Show Cause Order further alleged that Respondent filled controlled substance prescriptions and shipped them to Alabama, Georgia, Illinois, Kentucky, Massachusetts, and Vermont without meeting the out-of-state pharmacy requirements of four of those states.\2\ Id. at 8. It detailed eight prescriptions that Respondent allegedly filled and shipped out-of-state, though it did not allege that all eight were shipped in violation of a State's non-resident pharmacy requirements. Id. at 8-9; see also GX 15. --------------------------------------------------------------------------- \2\ The Order to Show Cause cited the allegedly violated state legal requirements as Alabama: Rules of Ala. State Bd. of Pharm. Sec. 680-x-2-.07(2); Illinois: Ill. Admin Code tit. 68, Sec. 1330.550(a); Kentucky: Ky. Rev. Stat. Sec. 315.0351(1); and Vermont: Admin. Rules Vt. Bd. of Pharm., Part 16. --------------------------------------------------------------------------- The Order to Show Cause next alleged that Respondent filled controlled substance prescriptions that did not contain all of the required information, such as directions for use, patient address, prescriber name, prescriber address, prescriber DEA number, and prescriber signature. ALJX 1, at 9 (citing 21 CFR 1306.05(a) and (f)). It specified eight prescriptions and the required information each one allegedly lacked. Id. at 9-10; see also GX 16. Next, the Show Cause Order alleged that Respondent filled prescriptions written for ``office use'' in violation of 21 CFR 1306.04(b). ALJX 1, at 10. It provided two examples of such prescriptions. Id. at 10; see also GX 17. The Show Cause Order also alleged that Respondent filled prescriptions written by physicians for their personal use in violation of Florida law. ALJX 1, at 10 (citing Fla. Stat. Sec. 458.331(r)). It referenced six examples of prescriptions where the name of the prescribing physician was the same name as the patient. Id.; see also GX 18. And, lastly, the Order to Show Cause alleged that Respondent violated Florida law by ``failing to report some prescriptions to E- FORCSE, in violation of Fla. Stat. Sec. 893.055(4).'' ALJX 1, at 10. It listed six prescriptions that Respondent allegedly did not report to E-FORCSE. Id. at 11; see also GX 19. The Show Cause Order notified Registrant of its right to request a hearing on the allegations or to submit a written statement while waiving its right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. ALJX 1, at 11 (citing 21 CFR 1301.43). On February 25, 2015, the DEA Diversion Investigator (hereinafter, DI) assigned to the investigation of Respondent, personally served the Order to Show Cause on Respondent's owner and operator, Veronica Taran (hereinafter, Respondent's Owner and PIC).\3\ ALJX 5 (Government's Prehearing Statement dated March 27, 2015 (hereinafter, Govt. Prehearing Statement)), at 2; ALJX 7 (Respondent's Prehearing Statement dated April 10, 2015), at 2; see also Stipulation No. 4, ALJX 10, at 2. --------------------------------------------------------------------------- \3\ She variously testified that she was ``the owner of the respondent pharmacy'' and that she was ``an owner and a Pharmacist- in-Charge'' of Respondent. Transcript Page (hereinafter, Tr.) 795, 798 (respectively); see also Stipulation No. 2, ALJX 10, at 1. Her testimony cited in this Decision and Order is quoted verbatim from the hearing transcript, without correction or ``[sic]'' notations in addition to those already in the transcript. --------------------------------------------------------------------------- By letter from its attorneys dated March 12, 2015, Respondent timely requested a hearing and asked that a ``reasonable extension to respond to an Order to Show Cause'' be granted. ALJX 3 (Hearing Request dated March 12, 2015), at 1; ALJX 4 (Order for Prehearing Statements dated March 17, 2015), at 1. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). On March 17, 2015, the CALJ established the schedule for the filing of prehearing statements and granted Respondent's request for additional time ``to the extent that the hearing date set in the OSC . . . will be continued as directed at the prehearing conference scheduled by this order.'' ALJX 4 (Order for Prehearing Statements), at 1, 2. On March 27, 2015, the Government filed its Prehearing Statement. ALJX 5. On April 10, 2015, Respondent served its Prehearing Statement. ALJX 7. The April 14, 2015 Prehearing Ruling and Protective Order found that four ``stipulations have been mutually agreed to and are conclusively accepted as facts.'' ALJX 10, at 1. On May 6, 2015, the Government and Respondent filed Supplemental Prehearing Statements. ALJX 6 and ALJX 9, respectively. The parties' joint filing dated May 26, 2015 included their 11 additional joint stipulations. ALJX 20, at 1-2. On June 9 through 11, 2015 and on August 4, 2015, the CALJ conducted an evidentiary hearing in Miami, Florida. [[Page 10878]] Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge dated October 16, 2015 (hereinafter, R.D.), at 2. At the hearing, both parties called witnesses to testify and offered documents into evidence. Following the hearing, both parties submitted briefs containing proposed findings of fact, proposed conclusions of law, and argument. On October 16, 2015, the CALJ issued his Recommended Decision, including that all but two of the Show Cause Order's allegations, the sixth (prescriptions written for ``office use'') and the seventh (prescriptions written for the prescriber's personal use), be sustained. Id. at 33-36, 38-39 (respectively). Regarding those two allegations, the CALJ's recommendations were that there were substantive violations, but that the allegations should not be sustained ``based exclusively on the lack of adequate notice under current Agency precedent.'' Id. at 36, 39 (respectively). The CALJ found that the Government ``supplied sufficient evidence to make out a prima facie case.'' Id. at 57. He also found that Respondent's acceptance of responsibility was insufficient. Id. at 58. Concerning remedial steps, he explained that Respondent's ``intentional decision to decline to notice evidence of remedial steps resulted in their preclusion from consideration.'' Id. In sum, he concluded that the record supported imposition of a sanction. Id. The CALJ included in his R.D. an assessment of the degree and extent of Respondent's misconduct and concluded that Respondent had not ``accepted anything meaningful in terms of responsibility or learned anything.'' Id. at 59. ``Where no understanding is acquired about how the regulated conduct fell short of professional and federal and state legal standards,'' he wrote, ``it would be difficult (even illogical) to predict improvement.'' Id. He determined that the Registrant ``is likely to proceed in the future as it has in the past if not curtailed in its ability to do so.'' Id. He concluded that the ``sheer number of established transgressions of various types, coupled with the refusal to admit that issues existed, would render a sanction less than revocation as a message to the regulated community that due diligence is not a required condition precedent to operating as a registrant.'' Id. at 59. He recommended revocation of Registrant's registration and the denial of any pending applications for renewal. Id. at 60. On November 5, 2015, both parties filed Exceptions to the R.D. Respondent served supplemental Exceptions to the R.D. on November 16, 2015. By letter dated November 10, 2015, the record was forwarded to me for Final Agency Action.\4\ --------------------------------------------------------------------------- \4\ By correspondence dated February 29, 2016, Respondent's counsel gave notice of ``termination of legal representation and an attorney/client relationship with the Respondent.'' --------------------------------------------------------------------------- Having considered the record in its entirety, including all of the Exceptions filed by Respondent and the Government, I agree with the CALJ that Respondent's registration should be revoked and that any pending applications for its renewal or modification should be denied. I further agree with the CALJ's conclusions that Respondent dispensed controlled substances knowing that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose and, therefore, violated the corresponding responsibility rule of 21 CFR 1306.04(a). I agree with the CALJ that Respondent was unable to readily retrieve prescriptions it had dispensed and, therefore, violated 21 CFR 1304.04. I agree with the CALJ that Respondent filled controlled substance prescriptions and shipped them out-of-state in violation of four States' non-resident pharmacy requirements. I agree with the CALJ that Respondent violated 21 CFR 1306.05 by filling controlled substance prescriptions that did not contain all of the required information. Based on Respondent's admissions, I find that Respondent filled prescriptions written for ``office use,'' although I do not sustain this allegation due to the Government's failure to comply with the notice requirements for a Show Cause Order. 21 CFR 1301.37(c). I find that Respondent filled at least one controlled substance prescription written by a physician for the physician's personal use, although I do not sustain this allegation due to the Government's failure to comply with the notice requirements for a Show Cause Order. 21 CFR 1301.37(c). I agree with the CALJ's conclusion that Respondent failed to report controlled substance prescriptions to E- FORCSE in violation of Fla. Stat. Sec. 893.055(4) (2012). I agree with the CALJ that Respondent's acceptance of responsibility was insufficient and that Respondent did not provide sufficient notice of remedial measures. Accordingly, I find the record as a whole established by substantial evidence that Respondent committed acts which render its continued registration inconsistent with the public interest. I conclude that revocation of Respondent's registration and denial of any pending application to renew or modify Respondent's registration are appropriate sanctions. I make the following findings. Findings of Fact Respondent's DEA Registration Respondent is registered with the DEA as a retail pharmacy in schedules II through V under DEA Certificate of Registration No. FP1049546 at 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009. ALJX 1, at 1; see also Stipulation No. 1; ALJX 10, at 1. Respondent's registration was to expire on March 31, 2017. Stipulation No. 1; ALJX 10, at 1. According to DEA's registration records, however, on January 31, 2017, Respondent timely filed a renewal application. I take official notice of that pending registration renewal application. 5 U.S.C. 556(e).\5\ Respondent's registration, therefore, remains in effect pending the issuance of this Decision and Order. 5 U.S.C. 558(c). --------------------------------------------------------------------------- \5\ Under the Administrative Procedure Act, an agency ``may take official notice of facts at any stage in a proceeding--even in the final decision.'' United States Department of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.'' Accordingly, Respondent or the Government may dispute my finding by filing a properly supported motion for reconsideration within 10 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the other party; in the event either party files a motion, the other party shall have 10 calendar days to file a response. --------------------------------------------------------------------------- The Investigation of Respondent According to the testimony of the DI, he decided to investigate Respondent after learning that it had ordered 41,700 dosage units of hydromorphone in 2012. Tr. 28. This raised his suspicion because the average pharmacy in the United States ordered approximately 5,900 dosage units of hydromorphone in the same time period. Id. at 28. On April 11, 2013, the DI presented Ms. Veronica Taran, Respondent's Owner and PIC, with a Notice of Inspection. Id. at 38; see also Stipulation No. 3; ALJX 10, at 2. The DI testified that Respondent's Owner and PIC read the notice of inspection, did not have any questions for the DI about it, signed it, and consented to the inspection. Tr. 38. The DI then asked Respondent's Owner and PIC for various records, including order forms and prescriptions [[Page 10879]] filled for schedule II through V controlled substances. Id. The DI stated that ``I asked Mrs. Taran if we could take records for further review, so we boxed them up and took them with us. She consented to that.'' Id. at 52-53. When he left Respondent on the unannounced inspection day, he took with him ``2011 to 2013 Schedule II through V prescriptions, . . . any invoices or receipts covering the same timeframe, and executed DEA 222 forms and . . . [Respondent's] biennial inventory.'' Id. at 50. The DI also testified about approximately a dozen problematic prescriptions he had identified from E-FORCSE that Respondent's Owner and PIC ``was never able to locate . . . for me.'' Id. at 42, 43. ``They were written for different anabolic steroid substances to patients that were not in the State of Florida,'' he testified. Id. at 42. The DI testified that he asked Respondent's Owner and PIC questions, including how she would verify controlled substance prescriptions. Id. at 39. According to the DI, Respondent's Owner and PIC said that she used two forms, one to verify the prescription and a doctor-patient affidavit ``that she makes the patient fill out,'' and she checked the prescriber's DEA number on the DEA website and the prescriber's license on the Florida Department of Health website. Id. at 39-40. According to the DI, Respondent's Owner and PIC told him that she was familiar with her patients and visited the doctors and their offices. Id. at 40. The DI testified that Respondent's Owner and PIC had posted lists: ``[o]ne was for doctors she would fill prescriptions for, another list of doctors that she wouldn't fill prescriptions for, and ones that were pending verification.'' Id. at 40; see also id. at 41. The DI stated that Respondent's Owner and PIC specifically told him ``she does not check'' E-FORCSE, she had never shipped a controlled substance out of state, and ``the pharmacy was not licensed in any other state.'' Id. at 40-41, 44. Regarding E-FORCSE, the DI testified that he asked Respondent's Owner and PIC to ``go onto'' it to ``check a prescription for me'' and that ``she wasn't able to do that.'' Id. at 48-49. When asked for elaboration on the meaning of ``she wasn't able to do that,'' the DI responded that she did not have access. He testified, ``She had access to enter her data into, but not to query a patient. . . . I was standing next to her when she was logged onto the computer attempting to query a patient.'' Id. at 49. The Allegations of Dispensing and Non-Dispensing Violations The Order to Show Cause alleged seven bases for the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f). One of them had seven subparts. Witnesses Four witnesses testified at the hearing: The DI and Dr. Tracey J. Gordon for the Government, and Louis Fisher and Respondent's Owner and PIC called by Respondent. There was factual agreement among the witnesses on a number of issues. When there was factual disagreement, I applied the CALJ's credibility recommendations. See R.D., at 5-25. Regarding the DI, the CALJ stated that he ``presented as an objective regulator with no stake in the outcome of the proceedings'' and provided ``testimony [that] was sufficiently detailed, plausible, consistent, and cogent to be fully credited.'' R.D., at 8. I agree with the CALJ's assessment of the DI's credibility. At the hearing, the Government also offered testimony from Dr. Tracey Gordon, a pharmacist licensed in Florida who had practiced pharmacy for 21 years. Dr. Gordon testified to ``ten-plus years of retail'' experience in ``at least 200'' Florida retail pharmacies serving as a clerk, tech, intern, assistant manager, and manager. Tr. 282, 284. She testified to having experience dispensing controlled substances for the treatment of chronic pain. Id. at 289. She stated that she has served as a pharmacist-in-charge. Id. at 351. She testified to training in, and experience with, issues regarding the use and diversion of controlled substances, and to familiarity with the pharmaceutical practice aspects of the use and abuse of controlled substances. Id. at 289-90. She stated that she was a licensed Consultant Pharmacist and, at the time, was serving as a clinical Hospice pharmacist. Id. at 278-79. Dr. Gordon was accepted, without objection, ``as an expert in the practice of pharmacy in the [S]tate of Florida regarding the dispensing of controlled substance prescriptions.'' R.D., at 8; see also Tr. 294- 95.\6\ The CALJ found that Dr. Gordon's testimony was ``internally consistent and logically persuasive'' and her qualifications ``reflected a wide breadth of pharmacy experience, including working in many pharmacies as a line pharmacist and a pharmacist in charge,'' and as a consultant and teacher. R.D., at 11. I agree with the CALJ that Dr. Gordon's ``answers rang of sufficient clarity, authority, and candor to merit controlling weight in these proceedings regarding the practice of pharmacy in Florida.'' Id. at 11. --------------------------------------------------------------------------- \6\ On cross-examination, Respondent elicited that, although Dr. Gordon had helped her father in his store before she was a pharmacist, she never worked as a pharmacist in a small independent pharmacy. Tr. 477-78. Respondent further elicited that Dr. Gordon was ``never in charge of purchasing controlled substances for resale for a small independent pharmacy.'' Id. at 482. Respondent's first Exception to the R.D. also asserts ``[a]s evident from the record'' that ``Respondent challenged Dr. Gordon's qualifications to testify about dispensing patterns . . . for a small sized, independent pharmacy such as Respondent.'' Respondent's Exceptions to the ALJ's Recommended Ruling dated Nov. 5, 2015 (hereinafter, Resp. Exceptions), at 2. Respondent did not, however, provide a citation to the record for its assertion and my review found none. 21 CFR 1316.66(a). Regardless, given that the Show Cause Order did not raise ``dispensing patterns . . . for a small sized, independent pharmacy,'' Respondent's assertion is not germane to the resolution of this matter. --------------------------------------------------------------------------- Respondent offered the testimony of Louis Fisher, who graduated in 1971 from the Hampden College of Pharmacy and worked for DEA or its predecessor agency from 1971 to 2003. Tr. 565. Mr. Fisher testified that, during his government service, his positions included compliance investigator, quota operation staff assistant, diversion investigator, diversion program manager, and group supervisor. Id. at 565, 570. He stated that he was ``familiar with a procedure of dispensing controlled medications pursuant to prescriptions in Florida,'' even though he never practiced pharmacy, or was a licensed pharmacist, in Florida. Id. at 571-72, 574-75. He testified that he was a consultant in the field of ``controlled substances abuse and diversion'' at the time. Id. at 572. Respondent sought to qualify Mr. Fisher as a ``specialist in preventing drug diversion.'' Id. at 561. The CALJ accepted Mr. Fisher as an expert on the issue of dispensing in Florida. R.D., at 11 n.74, at 17. I agree with the CALJ that it is appropriate to ``afford . . . diminished weight [to Mr. Fisher's testimony] where it conflicts with other, more persuasive evidence of record, including the testimony of Dr. Gordon.'' \7\ Id. at 17; see also id. at 11 n.74. --------------------------------------------------------------------------- \7\ The CALJ explained that Mr. Fisher's ``discrepant testimony regarding his licensure and experience was disquieting. . . . On this record, the issue of Mr. Fisher's qualifications to render an expert opinion is uniquely dependent upon his own representations of his experience and, thus, his credibility. Either Mr. Fisher was careless . . . and reckless . . ., or he was engaged in an intentional effort to inflate his own qualifications. Either option undermines the weight that can be logically afforded to his opinions, and where these opinions conflict with other opinions or evidence, they cannot be relied upon.'' R.D., at 16 (footnote omitted). --------------------------------------------------------------------------- At the hearing, Respondent also offered testimony from Respondent's [[Page 10880]] Owner and PIC. Tr. 798. Respondent's Owner and PIC testified that she had been, at the time, a practicing pharmacist in Florida for about ten years. Id. at 798. She testified that she was familiar with the Florida provision specifically addressing the dispensing of controlled substances, and that she had taken ``[m]ultiple courses'' on ``red flag of diversions'' as well as ``read many articles online about the situation in Florida with the pain management.'' Id. at 799. Respondent's Owner and PIC also testified that she was a custodian of records for Respondent and supervised, at the time, one technician, one intern, and one student. Id. at 798-99. I agree with the CALJ's conclusion that, while ``[t]here were, undoubtedly, aspects of . . . [the testimony of Respondent's Owner and PIC] during which she presented as generally credible, . . . on the present record, her testimony was not sufficiently consistent or plausible to be afforded full credibility.'' R.D., at 25. Florida Pharmacists' Standard of Practice Dr. Gordon, Mr. Fisher, and Respondent's Owner and PIC testified about a Florida pharmacy's/pharmacist's standard of practice when presented with a controlled substance prescription.\8\ There were some areas of agreement by at least two of the three witnesses on some aspects of that standard. --------------------------------------------------------------------------- \8\ The DI also addressed the standard of practice. For example, he testified that his investigation identified issues concerning Respondent's compliance with the Controlled Substances Act and its implementing regulations. See, e.g., Tr. 51, 54, 68, 71, 73, 74-75, 76-77, 99, 102, and 124. --------------------------------------------------------------------------- According to Dr. Gordon, upon a customer's presentation of a controlled substance prescription, the pharmacist should protect the safety of the patient and the community by looking for red flags of diversion, or ``something that makes a pharmacist pause and think about'' whether the prescription was ``really for a legitimate medical purpose.'' Tr. 296, 303. She discussed red flags including the quantity and dosage of the controlled substance, the doctor and practice specialty, and the patient's geographic location, doctor/pharmacy patronage, and payment (insurance/cash) method. Id. at 295-97. Regarding the quantity and dosage of a controlled substance used for pain management, Dr. Gordon explained that ``I look . . . [for] a long-acting with the prescription . . . [because] [i]t helps the patient to be more adherent to therapy.'' Id. at 296. Regarding the doctor and practice specialty, Dr. Gordon explained that, ``I feel pretty comfortable filling a prescription for a large quantity of pain medication'' if an oncologist wrote it. Id. at 298. ``But if it's from a general practitioner or an ob-gyn,'' she continued, ``then that causes me to take pause and reevaluate the legitimacy of the prescription.'' Id. She testified that the National Provider Identification website showed physicians' specialties and helped the pharmacist evaluate prescriptions. Id. at 297-98, 345. She also testified that a pharmacist should routinely check the status of a controlled substance prescriber's State medical license and DEA registration. Id. at 301, 345. Regarding the patient, Dr. Gordon stated that a chain pharmacy's computer would show if the customer had filled the prescription at another branch, and Florida's prescription drug monitoring program, E- FORCSE, would show what other controlled substances the customer had received from other pharmacies or doctors. Id. at 301-02, 345. She explained that E-FORCSE ``gives you the date . . . [the prescription] was written, the date it was filled, the name of the drug, the quantity, the doctor, the pharmacy, and how the patron paid for the medication'' which would tell the pharmacy ``if the patient was either doctor-hopping or pharmacy-hopping.'' Id. at 302. Dr. Gordon testified about the importance of the customer's payment method, explaining that ``[a] lot of drug-seekers only want to pay for their medications in cash because . . . the insurance company will actually create your red flag for you to say if a prescription is refilled too soon, which means they've . . . obtained a prescription from another pharmacy.'' Id. at 297; see also id. at 298-99. Dr. Gordon stated that what constituted a red flag ``changed all the time. It's like the drug community gets smarter.'' Id. at 303. She indicated that, when confronted with a red flag, a pharmacist would make further inquiries of the doctor, the customer, or the caregiver. Id. at 305. She noted that ``some of the red flags really can't be resolved, especially if you see patterns.'' Id. at 304-05. She testified that, if she could not resolve a prescription's red flags, she would not fill it. Id. at 305. She would either give the prescription back to the customer or, with the doctor's authorization, shred it. Id. Dr. Gordon testified that, although there is no codified Florida rule specifying where a pharmacist must document resolution of a red flag, the standard practice in Florida was for the resolution of a red flag to be documented on the front of the prescription. Id. at 346-48. As a pharmacist-in-charge, she would check the face of the prescription to see if a subordinate pharmacist resolved a concern about the prescription. Id. at 351-52. She testified that any notes about the patient, as opposed to notes about a specific prescription, would appear in the patient profile. Id. at 350, 352. Mr. Fisher testified that red flags ``are part of the pharmacist's responsibility.'' Id. at 616. Regarding what a pharmacist should do to resolve a red flag, Mr. Fisher first stated that the pharmacist should ``[c]heck the state E-FORCSE system to see if this person is a doctor- shopper.'' Id. at 604; see also id. at 608-09. He also stated that he would check the doctor's license to make sure it was valid, check if the customer had any history in the pharmacy of previous prescriptions being filled, and ``then talk to the doctor and see . . . what the-- maybe the diagnosis is on this prescription.'' Id. at 604. When asked ``where would you see if these things were done, if they were documented,'' Mr. Fisher responded that the documentation could be written on the back of the prescription, in a notebook, in a logbook ``of any kind'' or ``whatever system they want to be put into effect.'' Id. at. 604-05. When asked whether the red flags ``would have to be documented someplace,'' Mr. Fisher responded affirmatively. Id. at 605; see also id. at 598-600 (Mr. Fisher's testimony that a pharmacist needs to resolve a red flag before dispensing the prescription, and resolution of the red flag must be documented somewhere.). Mr. Fisher testified that he did not know if the red flags he had identified on the prescriptions in the Government's exhibit had been resolved. Id. at 605; see also id. at 766 (Mr. Fisher's testimony that the prescriptions contained no notations evidencing that Respondent had resolved any of their red flags.). The testimony of Respondent's Owner and PIC about diversion and what a pharmacy needed to do when presented with a controlled substance prescription was largely inconsistent with the testimony of Dr. Gordon and Mr. Fisher. Further, her testimony admitted that Respondent did not even follow the steps she described. It also, though, evidenced her knowledge and awareness that schedule II controlled substances were prone to diversion. For example, Respondent's Owner and PIC testified that ``[e]ach prescription it comes with chronic nonmalignant pain, has to be addressed as a highly risky--high risk medication. It has to be addressed with proper steps.'' Id. at 1129. Also regarding prescriptions for [[Page 10881]] schedule II controlled substances, she testified that ``on schedule II, each time it's presented it has to be--there's a lot of diversion.'' Id. at 1116. Specifically, Respondent's Owner and PIC identified Dilaudid 8mg. and Dilaudid 4 mg. prescriptions as ``highly risky.'' Id. at 1129; GX 12, at 5 and 7. When asked whether she recalled identifying ``any red flags'' when she filled a prescription for 174 tablets of Dilaudid 8 mg., Respondent's Owner and PIC responded that ``the major red flag of that prescription is for Schedule II medication, Dilaudid, 8 milligram. Also, prescribed on the quantities.'' Tr. 880-81. According to Respondent's Owner and PIC, Respondent, and she as its PIC, needed to implement specific procedures unique to schedule II prescriptions due to the diversion associated with them. Her ``specific procedures'' consisted of a series of steps. See id. at 883-897 (using as an example GX 19, at 1). First, according to her testimony, she would ``talk to doctor on each [schedule II] prescription'' because ``there's a lot of diversion'' of schedule II controlled substances. Id. at 1116. Her testimony underlined the importance of talking to the prescribing doctor ``each time'' a schedule II prescription was presented by comparing the diversion of schedule II controlled substances with schedule III controlled substances: When all the schedule II prescriptions--I would talk to doctor on each prescription. On schedule III I would talk to doctor when there's initial prescriptions for it. But there's not that much schedule III situations. But on schedule II, each time it's presented it has to be--there's a lot of diversion. Id. Respondent's Owner and PIC described the conversation she had regarding the first prescription in GX 19, a prescription for 174 tablets of Dilaudid 8 mg. She stated that she called the office and asked to speak with the doctor. ``[H]onestly,'' she admitted, the ``doctor not always were available. But I spoke with the manager.'' Id. at 895. The ``honest'' admission of Respondent's Owner and PIC that she did not always speak with the prescribing doctor about a schedule II prescription contradicted other testimony she gave that she always spoke with the doctor regarding such prescriptions. See, e.g., id. at 1116. Respondent's Owner and PIC continued to describe her conversation with the doctor's office. She testified that she ``would ask a manager to tell me more what was happening with the patient; was he seen on that day?'' Id. at 895. So if the patient was seen on the day that the prescription was issued, and the quantity--the reason why he had prescribed that quantity this month? And they would tell me that he has diagnosis in the proper--that doctor has a note in his chart to consider alternative treatments . . . . I would ask them, What did you prescribe today for that patient? . . . So they have to spell out what did they write this day, the quantity, to make sure there is no alteration on the way--there is no forging of the prescription. Then I would say, Is it okay for me to fill it? And they would give me approval to fill. Id. at 896. Respondent's Owner and PIC testified that after these steps, including ``verify[ing] all the information, the address, the phone number, the complete date of birth, the doctor DEA number on the front, the quantities and the medications, the signature . . . [a]nd that medication was hand signed by the doctor,'' she filled the prescription. Id. at 897. Despite her testimony and her stated awareness of the high risk nature of schedule II prescriptions and the risk of diversion associated with them, including the ``red flag'' of schedule II controlled substances being prescribed in large quantities, Respondent's Owner and PIC again admitted that she did not always follow her first step. Instead, she testified that she would have to ``go one-by-one each [schedule II] prescription'' before answering questions about whether or not she spoke with the doctor about any of them. Id. at 1137; see also id. at 1133-39. Thus, Respondent's Owner and PIC admitted more than once to not implementing her own requirement of speaking to the prescriber of every schedule II prescription.\9\ In making this admission, she did not explain why she deviated from her own procedure. Nor did she justify that deviation. --------------------------------------------------------------------------- \9\ In the context of describing the uses of the ``approved'' stamp and the name/telephone number stamp, Respondent's Owner and PIC also testified she verified that the prescriptions were issued within the scope of the prescriber's practice when she talked ``to the [prescriber's] office.'' Tr. 1132. [The stamps mean that] I talk to the office and I spoke with the patient. And I fill out documentation appropriate for--I verified-- and most important, I verified this prescription was issued within scope of the doctor's practice. The doctor was allowed to treat chronic pain. It was the scope of his practice. He made the decision to write this prescription according to his practice. Id. at 1132-33; contra id. at 1225-27. It is noteworthy that Respondent's quoted testimony concerned her calling ``the office'' as opposed to her ``speak[ing] with the doctor.'' Id. at 1138, 1132, respectively. It was the further admission of the Respondent's Owner and PIC that she did not always ``speak with the doctor'' as she had testified was appropriate due to the high risk nature of schedule II prescriptions and the risk of diversion associated with them. Given her testimony that she did not necessarily speak with the ``doctor'' about schedule II prescriptions, it also raises the question of whether Respondent's Owner and PIC actually ``verified'' that prescriptions were ``issued within [the] scope of the doctor's practice.'' Id. at 1133. --------------------------------------------------------------------------- Second, Respondent's Owner and PIC testified that she made sure the prescriber's State medical license was active, and the prescription was within the scope of the prescriber's DEA registration. Regarding a prescriber's State license, she testified that she would make sure that ``the doctor actually licensed in the State of Florida to prescribe controlled substances.'' \10\ Id. at 894. Regarding a DEA registration, she testified that she ``was instructed . . . [by DEA] to go on the website--diversion site and verify the physician DEA number'' and ``[s]ince that instruction I religiously did that.'' Id. at 892; see also id. at 1131-32 (Pharmacies should ``make sure that . . . [the] doctor[ ] . . . [was] legitimate, I mean, . . . has a DEA license.''). --------------------------------------------------------------------------- \10\ Regarding the doctor who prescribed the first prescription in GX 19, Respondent's Owner and PIC testified that he was ``licensed in the State of Florida to prescribe medication for chronic pain management.'' Tr. 894-95. ``He was actually special trained in the pain management,'' she stated. Id. at 895. --------------------------------------------------------------------------- According to Respondent's Owner and PIC, ``[t]he decision of prescribing lies upon the physicians and the state who govern his practice.'' Id. at 1108. She elaborated, asserting that a pharmacy must fill a controlled substance prescription issued by a practitioner with the appropriate State and DEA licenses unless there is ``a very good reason not to fill it.'' Id. at 1168. The doctor tells you it's okay to fill, just by the filling--the filling prescription. When the patient comes to the office--to the doctor, he's seen by the doctor. Doctor asking how many pills you have, what are you taking? Then he decide to issue another prescription. Once he issue the prescription, it's an order for a pharmacy--keep in mind, we still working in the medical system here. The prescription is an order for the pharmacist to fill. For me not to fill that prescription, I have to have a very good reason not to fill it, because it's an order from the doctor to me to fill that prescription for that patient. Id. at 1167-68. Respondent's Owner and PIC did not explain what she meant by ``a very good reason not to fill it.'' Nevertheless, I found in the record evidence of numerous controlled substance prescriptions that Respondent's Owner and PIC admitted Respondent filled without having documented the existence or resolution of any of the red flags of diversion identified in the testimony of Dr. Gordon and Mr. Fisher. Third, Respondent's Owner and PIC testified that her ``main concern would be if this patient was checked and have relation with the doctor.'' Id. at 885. In the context of GX 19, the six Dilaudid [[Page 10882]] 8 mg. prescriptions the Show Cause Order alleged that Respondent did not report to E-FORCSE, Respondent's Owner and PIC testified about how she would establish the requisite doctor-patient relationship.\11\ She testified that she would ``ask . . . [the customers] to fill out the [``Pain Management Physician-Patient Relationship Affidavit,'' hereinafter, Relationship Affidavit] form, and sign . . . written affidavit'' and ``then I would call to the office and start questioning the office about whether this--to substantiate the truth about it.'' Id. at 885. She testified that the Relationship Affidavit was to be completed the ``first time only'' that a customer came to Respondent pharmacy. Id. at 1016. She testified as to what the Relationship Affidavit would ``do to alleviate . . . [her] concerns that this prescription was not diverted.'' Id. at 887. She stated that ``the major red flag at that time'' was ``whether patient actually be seen by doctor, not just come to the office and have the prescription ready for them.'' Id. She continued by stating that ``[i]t was not about . . . whether this prescription written for Dilaudid or prescription written for--or quantities, it was a concern, but not the main concern.'' Id. According to Respondent's Owner and PIC, ``[t]he main concern--the problem at the time was the patient going and the doctor's [sic] are not properly executing the practice that's reflected in the medical practice law.'' \12\ Id. Her testimony continued: ``So we would check, . . . would require for the patient has issues . . . [a]nd she has a medical history and there is a logical connection between her and the doctor, there's relationship, it's not just to get a prescription for major narcotics.'' Id. at 887-88. According to Respondent's Owner and PIC, the Relationship Affidavit ``resolve[d]'' these concerns. Id. at 889. She stated, ``That form would resolve . . . that he's not attempted to fraudulently--to illegally get access to the controlled pain medication.'' Id.; see also id. at 1149.\13\ --------------------------------------------------------------------------- \11\ The six Dilaudid 8 mg. prescriptions in GX 19 were written by the same doctor for six different customers in the July-August- November 2012 time period. Specifically, the six Dilaudid 8 mg. prescriptions were for: (1) 174 tablets for a customer from Pompano Beach at a cash price of $870; (2) 96 tablets for a customer from Fort Lauderdale at a cash price of $480; (3) 150 tablets for a customer from Miami at a cash price of $750; (4) 180 tablets for a customer from Pompano Beach at a cash price of $900; (5) 168 tablets for a customer from Pompano Beach at a cash price of $840; and (6) 168 tablets for a customer from Coral Springs at a cash price of $840. Respondent's Owner and PIC had identified the first prescription for 174 Dilaudid 8 mg. tablets as showing a ``major red flag'' because it was for a schedule II medication and for 174 tablets. Tr. 881. \12\ Apparently, the ``medical practice law'' Respondent's Owner and PIC referenced was the ``Ryan Act.'' She testified that the purpose of the Relationship Affidavit was to ``establish the patient-doctor relationships and the legitimate ill of the patients'' in compliance with the ``Ryan Act.'' Tr. 1015-16. According to Respondent's Owner and PIC, ``by that law is rely if the patient actually has a logical relation with the doctor.'' Id. at 1016. She testified further about the ``state statute and federal statutes'': ``For . . . me was most important thing was to go to references of the state statute and federal statutes. So federal statute says, has to be clear relationship to establish the legitimate medical purpose. You rely on the doctors to establish the appropriateness of therapies. It's not on the pharmacy to establish the appropriateness of pharmacy. . . , that's how I understood the law. The pharmacist is just to establish that the prescription was valid--the validity of prescription based that the prescription as a requirement, and the doctor allowed to prescribe, and the doctor actually see the patients. Unless there's some issues that arise with that, like, for instance, if the patient is--not that the doctor overly treated or the patient has issues -- or the doctor has issues with the patient, or I feel something suspicious, then I call the doctors. . . . Because standards only tell you that you have to actually establish the patient is not coming here for wrong reasons. That's only what the statute says. The statute says if the patient come for wrong reason you don't fill it. If the patient come from appropriate reason, you fill.'' Id. at 1018-19, 1021. \13\ She also testified that she interacted with Respondent's customers by asking them questions. I would talk to the patient, ask him about why did he come to my pharmacy? Where did he fill before? What is the reason he doesn't use previous pharmacy? And also, what is the reason for--how long has he been on that medication? And whether he was checked by--and then I would ask him to look at the affidavit form and sign the affidavit form for the patient. . . . I have not written those questions out. But they would be the same questions that I would ask to establish . . . the history of the patient. Tr. 882-83, 884. When asked whether she would ``essentially'' ask every customer the same questions, she responded affirmatively and identified other questions she asked. Id. at 884-85. Respondent's Owner and PIC, however, did not explain the purpose of these questions given her testimony that the signed Relationship Affidavits ``resolved'' the issue of whether customers were attempting to fraudulently or illegally get access to controlled pain medication. --------------------------------------------------------------------------- The Relationship Affidavit was a one-page form with Respondent's name at the top, and name and contact information at the bottom. See, e.g., Respondent Exhibit (hereinafter, RX) 5, at 2. Text on the Relationship Affidavit stated that individuals ``who are receiving medications to treat chronic intractable pain are required to be seen and examined by the physician on the same date the prescription for pain has been issued.'' Id. According to the Relationship Affidavit, a customer had to sign it before Respondent would fill a prescription. The Relationship Affidavit stated that: In order for prescriptions to be filled by . . . [Respondent] patients are required to sign this affidavit to ensure the following elements exist. By affirming and satisfying the conditions mentioned below . . . [Respondent] assumes that the prescription is valid pursuant to a legal Physician Patient Relationship.\14\ --------------------------------------------------------------------------- \14\ The referenced ``elements'' apparently were listed in the last section of the form, which stated: ``By signing below, I ________agree that the following elements of a legal Pain Management Physician-Patient Relationship exist: 1. There is no fraudulent representation to illegally gain access to controlled pain medications 2. There are no multiple doctors ``doctor shopping'' treating me for pain management 3. A physician has seen and conducted a physical examination 4. A physician has reviewed the patient's medical history 5. The patient has a medical complaint 6. MRI has been conducted within 24 months of the prescription 7. There is a logical correlation between the following a. Medical Complaint b. Medical History c. Physical Exam d. Prescriptions. __________Patient Name ________Date of Birth ________Signature ________Date.'' RX 5, at 2. Id. Notably, Respondent stated its ``assumption'' that a prescription was valid when customers affirmed and satisfied the Relationship Affidavit's ``conditions mentioned below,'' presumably the ``elements.'' Id. Also of note was the ``Warning'' on the Relationship Affidavit: ``In the event . . . [Respondent] has reasons to believe that prescriptions for pain medication have been prescribed and/or received fraudulently we have a legal responsibility to report such activity and individuals to local and federal authorities. These authorities will handle such individual in the manner prescribed by law.'' Id. Respondent's Owner and PIC discussed the Relationship Affidavit's ``warning'' in her testimony. She stated that ``it was actually warning that's in the case if I find something which would jeopardize or compromise my belief in the validity of the prescription, we have responsibility to report such activity to local and federal police. And the patient knew about it.'' Tr. 888. She testified that, ``I would say if I . . . find something . . .--. . . like Your Honor giving me the benefit of the doubt, I would give the patient the benefit of the doubt. If I find out that you have a problem, it's fraudulent, I will report you. So you better not start that process.'' Id. In sum, Respondent's Owner and PIC testified that (1) she assumed the legality of a prescription based on customers' completion of the Relationship Affidavit, (2) she gave customers ``the benefit of the doubt'' concerning their completion of the Relationship Affidavit, and (3) she warned customers to ``better not start'' the process of her ``find[ing] out'' that a prescription is ``fraudulent.'' She did not explain why it was reasonable to expect drug seekers to understand what they read, let alone be honest and [[Page 10883]] truthful as they completed and signed the Relationship Affidavit. She also did not explain how giving customers ``the benefit of the doubt'' was consistent with the requirements of the corresponding responsibility regulation. 21 CFR 1306.04(a). Fourth, Respondent's Owner and PIC testified that she ``validate[d] that . . . it's a signature . . . not rubber signed, . . . [the prescription] was actually signed by the physician.'' Tr. 892; see also id. at 1116-17 (``[T]he issue at the time was not the strength. The issue they were looking for was actually the prescription legitimate . . . , it's not fake . . . . Make sure the doctor actually issue it. He didn't buy it from--on the side, on the street. He didn't get his prescription from other sources, and actually get it from the doctor.''). Respondent's Owner and PIC testified that the concept of ``red flags'' stood in the way of getting medicine to deserving individuals. She testified that, ``by strictly following these red flags, it will prevent legitimate patient from obtaining the medication.'' Id. at 1108. She testified that she decided not to fill prescriptions for schedule II controlled substances altogether because ``following the red flags will prevent me from filling the . . . prescriptions for legitimate medical purposes . . . and be unfair to the patient.'' Id.\15\ --------------------------------------------------------------------------- \15\ She added, ``Except two instances when I had this overstock and the patient was patient of mine for other reasons, we decide to fill. . . . And I don't purchase them [schedule II controlled substances].'' Tr. 1108-09. --------------------------------------------------------------------------- Before the time she testified to having decided not to fill schedule II prescriptions, Respondent's Owner and PIC testified that her ``liability was to prevent the diversion the best that I can, considering it was very, very little guidelines was provided to us at that time. We tried to update it, it was confusing, the red flags was changing.'' Id. at 890. Apparently based on the individual perspective of Respondent's Owner and PIC concerning what pharmacies should do, Respondent designed its own forms ``to support the establishment of legitimate medical purpose to fill'' prescriptions. Id. at 981.\16\ --------------------------------------------------------------------------- \16\ See, e.g., RX 6 and RX 10. These exhibits include various items of documentation with respect to fourteen customers which Respondent represented were obtained to determine the validity of the prescriptions. Tr. 824. Each of the exhibits contains a copy of each customer's driver's license, and copies of the Pain Management Physician-Patient Relationship Affidavit for 11 of the customers. There are also copies of printouts from the DEA registration web page with respect to five of the customers. RX 6, at 3, 18, 35; RX 10, at 6, 12. There are also copies of a ``CII/CIII Rx Verification Form'' for four customers in these two exhibits. This was a one-page form on which Respondent would document the date and time of a phone call to a prescriber's office and list the name of the person providing the information. See RX 6, at 6. The form was then used to document ``yes'' or ``no'' as to whether: (1) The prescription was written by the prescriber, (2) whether the patient was seen by the prescriber at the prescriber's office, and (3) whether the patient was physically examined by the prescriber, after which the form provided a space for writing the diagnosis. Id. The form then included boxes to check whether the prescription was approved or denied, three lines for notes, and a line for the pharmacist to initial. While Respondent's Owner and PIC testified that she used this one-page form ``[i]nstead of writing scribbles on the back of the prescription,'' Tr. 1002, and on each of the four forms, checked ``yes'' with respect to each question, listed diagnoses codes, and indicated that each prescription was ``approve[d],'' none of the forms contains additional notes and only two of the forms were initialed by the pharmacist. See RX 6, at 6, 10, 21, 29. Finally, the exhibits contain copies of E-FORCSE printouts for five of the fourteen patients. See RX 6, at 4, 7, 17, 20, 30. Of note, three E-FORSCE printouts were not obtained until the middle of April 2013, see id. at 4, 7, 30, one was obtained on May 13, 2013, see id. at 20, and one was obtained on August 23, 2013. Id. at 17. As found above, the DI served the Notice of Inspection on Respondent on April 11, 2013. Respondent's Owner and PIC offered multiple comments about these timing issues: She ``would not necessarily print out every time,'' ``the record that I kept in the file obviously was the latest one,'' and ``every time I check, I would check with the PDMP--with the PMP report.'' Id. at 994. When questioned further by the CALJ about the E-FORCSE printout for patient G.A., Respondent's Owner and PIC testified that the State of Florida ``would not give us the access'' and ``for a while I relied on the physician offices to provide me that information. I would call the physician to run the PMP report until I actually were able to get the access myself . . . .'' Id. at 996. Respondent's Owner and PIC stated that she got access to E- FORCSE ``sometime during 2013.'' Id. at 997-98. Respondent's Owner and PIC testified that this information was important to her because it told her ``that this patient . . . was seen by the same doctor for over . . . [a] seven-month period. And so this patient requires therapy. And the doctor was a very local doctor . . . [a]nd he was going only to my pharmacy. So [the customer] relied on me to fill her prescription.'' Id. at 986-87. Yet, with respect to patient S.B., her E-FORCSE printout showed that she had filled her controlled substance prescriptions at three different pharmacies as well as through a mail order service, RX 6, at 7, and with respect to patient D.K., his E-FORSCE printout showed that he had filled his prescriptions for both oxycodone and hydromorphone at four pharmacies in addition to Respondent. Id. at 20. While Respondent's Owner and PIC also testified that G.A.'s ``established relationship'' with the doctor was ``one of the thing that you use--one of the tools that you use with--to establish legitimate medical purpose . . . [because] you can fairly assume that the patients are being taken [sic] by the physician properly,'' id. at 988-89, Dr. Gordon testified that ``[t]he first . . . [red flag] that is really bold to me is the doctor. I've worked on other cases, and I've seen this doctor [R.T.] write lots of illegitimate prescriptions.'' Id. at 360-61. Notably, each of the seven prescriptions listed on G.A.'s E-FORCSE printout was written by Dr. R.T., and each prescription was for 150 or 160 dosage units of hydromorphone 8 mg. RX 6, at 4. Dr. R.T. also wrote five of the prescriptions listed on S.B.'s E-FORCSE printout (including all four hydromorphone prescriptions, three of these being for 160 dosage units or more of the 8mg. dosage), see RX 6, at 7, and all four hydromorphone prescriptions listed on T.S.'s E-FORCSE printout, each of these being for 150 or more dosage units of the 8 mg. dosage. Id. at 30. Respondent submitted a further exhibit, RX 11, which contained documentation related to other customers. Respondent's Owner & PIC testified that this exhibit was ``generated . . . [t]o show in good faith that we are actually conducting best practices. . . . That we document good practice when we fill the patient--we're filling pain medication for sick patient.'' Tr. 1173-74. The exhibit consist of a photocopy of the driver's licenses of three of the six customers for whom the prescriptions in GX 14 were written; a Relationship Affidavit signed by two of the six customers; and a one page E- FORCSE printout dated months after the corresponding prescriptions in GX 14 were written and filled. --------------------------------------------------------------------------- I afford Dr. Gordon's statement of the pharmacy's/pharmacist's standard of practice regarding controlled substances controlling weight in this proceeding. I find that the requirements incumbent on pharmacies/pharmacists espoused by Respondent's Owner and PIC are only entitled to credit as I determine what actions Respondent took and Respondent's suitability to be a registrant. Essentially, the views of Respondent's Owner and PIC about a pharmacy's/pharmacist's obligations with respect to dispensing controlled substances reflect an abdication of her legal responsibility to a prescriber with a valid State license and whose DEA registration covered the schedule of the prescribed medication when the customer simply signed the Relationship Affidavit. Significant aspects of the pharmacy's/pharmacist's obligations espoused by Respondent's Owner and PIC were contrary to statute, regulation, and Agency precedent. I categorically reject them. Allegations That Respondent Failed To Exercise Its Corresponding Responsibility When It Dispensed Controlled Substances Pursuant to Prescriptions Not Issued in the Usual Course of Professional Practice or for a Legitimate Medical Purpose The Show Cause Order alleged that Respondent failed to exercise its corresponding responsibility under 21 CFR 1306.04(a) as evidenced by its having dispensed controlled substances without resolving ``red flags of diversion'' that were present. The Government alleged seven ``red flags of diversion'' in the Show Cause Order: Prescriptions presented by customers who traveled long distances to Respondent; multiple customers filling prescriptions written by the same prescriber, for the same drugs, in the same quantities, on the same day; multiple customers from the same address coming to Respondent at the same time with prescriptions from the same doctor for the same drug and [[Page 10884]] strength; customers presenting two prescriptions, both for the same immediate release controlled substance, but for different strengths; customers presenting prescriptions with a combination of an opiate and a benzodiazepine or ``drug cocktail'' popular among drug abusers; customers paying for their prescriptions with cash, when other red flags of diversion were present; and customers presenting new prescriptions for controlled substances when they should not have finished their previous prescription for that drug (``early fills'' or ``early refills''). Prescriptions Presented by Customers Who Traveled Long Distances to Respondent The Government alleged that customers traveling long distances to fill their prescriptions was a ``red flag of diversion,'' and that Respondent dispensed controlled substances to customers who traveled long round-trip distances, from their homes, to the prescribers, to Respondent, and then back home, without addressing or resolving the distance red flags. To support this allegation, the Government submitted 13 such prescriptions filled by Respondent. See GX 8/8a; \17\ see also Tr. 53 (DI testifying that GX 8 contained fair and accurate copies of the documents Respondent provided to him). Of the 13 prescriptions in GX 8/8a, nine were for Dilaudid 8mg.\18\ --------------------------------------------------------------------------- \17\ The materials in GX 8 and GX 8a, 13 prescriptions and corresponding prescription labels, were identical. There were driver's licenses associated with nine of the 13 prescriptions/ prescription labels. GX 8a contained better copies of most of the driver's licenses than GX 8. Tr. 793. Those better copies were added to GX 8 as GX 8a during the hearing on June 11, 2015. Id. at 794. \18\ The other four were for buprenorphine (2), Xanax, and testosterone. --------------------------------------------------------------------------- The DI testified that he initially identified the prescriptions in GX 8/8a as ``problematic'' because they showed ``[p]eople traveling long distance[s] to the pharmacy.'' Tr. 50-51. The parties stipulated to sets of round-trip (by road) miles within the State of Florida. ALJX 20, at 1-2. Those sets of round-trip miles corresponded to miles traveled by customers for whom Respondent filled prescriptions listed in the Show Cause Order and included in GX 8/8a. In sum, the round- trips ranged from 184 miles to 661 miles. I make the following findings:One bottle of Buprenorphine Hydrochloride 0.3 mg/mL issued to FW of Deltona by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Deltona to Hallandale Beach and back to Deltona is 504 miles. 150 tables of Dilaudid 8 mg. issued to GA of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles. 168 tablets of Dilaudid 8 mg. issued to SB of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles. 150 tablets of Dilaudid 8 mg. issued to CW of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles. One bottle of Buprenorphine Hydrochloride 0.3 mg/mL issued to MW of Hobe Sound by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Hobe Sound to Hallandale Beach and back to Hobe Sound is 166 miles. 140 tablets of Dilaudid 8 mg. issued to DK of Jensen Beach by Dr. NG of Hallandale Beach. The parties stipulated that the distance by road from Jensen Beach to Hallandale Beach and back to Jensen Beach is 195 miles. 56 tablets of Dilaudid 8 mg. issued to BS of Port St. Lucie by Dr. ML of Hollywood. The parties stipulated that the distance from Port Saint Lucie to Hollywood to Hallandale Beach and back to Port Saint Lucie is 201 miles. 150 tablets of Dilaudid 8 mg. issued to TS of Sebastian by Dr. RT of Miami. The parties stipulated that the distance from Sebastian to Miami to Hallandale Beach and back to Sebastian is 318 miles. One bottle of testosterone cypionate 210 mg/mL issued to RV of Sebring by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Sebring to Hallandale Beach and back to Sebring is 312 miles. 112 tablets of Dilaudid 8 mg. issued to BR of St. Pete Beach by Dr. DJ of Deerfield Beach. The parties stipulated that the distance by road from Saint Pete Beach to Deerfield Beach to Hallandale Beach and back to Saint Pete Beach is 538 miles. 112 tablets of Dilaudid 8 mg. issued to WP of Stuart by Dr. GF of Pembroke Park. The parties stipulated that the distance by road from Stuart to Pembroke Park to Hallandale Beach and back to Stuart is 184 miles. GX 8/8a. Dr. Gordon testified that the long distances the customers traveled in connection with obtaining and filling all of the prescriptions in GX 8/8a were red flags. Tr. 353-62, 365, 368, 370, 372, 374-77, 380-82, 384-85, 387-92. She explained: ``Pharmacies that dispense prescriptions that are not for legitimate medical purpose, they have a tendency to develop a reputation. And then the other drug seekers find out about it, and they'll go to any distance to get what they need for their--to satisfy their addiction.'' Id. at 355. For 12 of the 13 prescriptions, Dr. Gordon was asked to look for notations on the prescriptions evidencing that the filling pharmacist had taken steps to attempt to resolve the prescriptions' red flags, or she looked for notations herself. She found none. Id. at 356, 364, 369, 371, 373, 374, 377, 381-82, 384, 387-88, 389-90, 391. On cross examination, Dr. Gordon testified to the absence of documentation on the other prescription. Id. at 494. Dr. Gordon was asked whether the distance red flags on 12 of the prescriptions were resolvable. She testified they were not. Id. at 355, 367, 369, 371, 373, 374, 377-78, 382, 384, 388, 390, 391. She was not asked about the resolvability of the distance red flag on the other prescription, but said that its red flag had not been ``resolved.'' Id. at 364. Of that prescription, she also stated: ``That's a very long distance [261 miles from Fort Pierce to Miami to Hallandale Beach to Fort Pierce] for somebody that has pain to be driving--sitting in a car for that long to obtain Dilaudid 8, which is the highest milligrams it comes in.'' Id. at 361. In sum, Dr. Gordon concluded that none of the 13 prescriptions was legitimate and that the pharmacist who filled the prescriptions had not exercised her corresponding responsibility to make sure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 357, 364-65, 367-78, 370, 371, 373, 375, 378, 382, 385, 388, 390, 391-92. Mr. Fisher's testimony about whether distance was a red flag was inconsistent. At one point, Mr. Fisher testified that the prescriptions included in GX 8 evidenced distance red flags, and that he believed they could have been resolved. Id. at 596-97. ``Usually,'' he stated, ``a prescription is going to be filled close to where the physician is or close to where the person lives.'' Id. at 597; see also id. at 601 (Mr. Fisher's testimony that Fort Pierce is a ``distance from the area.''). At another point, however, Mr. Fisher appeared to testify that distance was a red flag only when Respondent was asked to fill prescriptions for intrastate customers, as opposed to out-of-state customers, even though out-of-state customers would be located further from Respondent than intrastate customers. Id. at 745. The CALJ sought clarification, asking: ``[I]f a person was a long distance but they were in Florida, that would be a red flag. But if a person was living a long distance . . . in Georgia, that's not a red flag? . . . So what's your final answer; that it is a distance red flag or it's not.'' Id. at 745-46. Mr. Fisher responded: ``It's a distance red flag, which is [[Page 10885]] resolvable.'' \19\ Id. at 746; see also id. at 754. Thus, Mr. Fisher eventually agreed with the testimony of the Government's expert that customers who traveled long distances to fill controlled substance prescriptions were red flags. --------------------------------------------------------------------------- \19\ When Respondent's counsel argued that Mr. Fisher ``did not testify in all other cases that the distance was a factor and testified in this case--. . . I'm talking about as out-of-state prescriptions, that distance is not a factor'' and that ``[t]he method of delivery is completely different . . . [s]o those two are not even analogous,'' the CALJ responded: ``The record will stand as it is.'' Tr. 746-47. --------------------------------------------------------------------------- Respondent's Owner and PIC admitted that Respondent filled the prescriptions in GX 8/8a. Id. at 979. She testified that it was not a red flag ``by itself'' for customers within the State of Florida to come over 100 miles from their homes to fill a controlled substance prescription at her pharmacy. Id. at 1028; see also id. at 1021-22 (In 2012 and 2013, ``the fact that a patient traveled a long distance . . . was not a major red flag, no.'' There were ``other red flags that I was concentrating on.''). Respondent submitted CII/CIII Rx Verification Forms for four of the 13 prescriptions in GX 8/8a.\20\ RX 6, at 6, 10, 21, and 29. According to Respondent's Owner and PIC, these four forms were part of Respondent's ``patient files,'' the ``documents--prescriptions, prescription labels, and corresponding documents which assisted me to resolve the red flags made by . . . [Respondent] and kept in the regular course of business.'' Tr. 824-25. She asserted that the CII/ CIII Rx Verification Form was a ``step ahead,'' and ``above and beyond'' the ``general practice of most of the pharmacies in the State of Florida.'' Id. at 1001. She further testified that ``[i]nstead of writing scribbles on the back of the prescription, . . . you have, more or less, here on form.'' Id. at 1002. --------------------------------------------------------------------------- \20\ The CII/CIII Rx Verification Forms concern the prescriptions in GX 8/8a written for SB, CW, DK, and TS. --------------------------------------------------------------------------- While the forms contained diagnosis codes, only two of the forms were initialed by the pharmacist, and none of the forms contained any notes explaining how Respondent's pharmacist resolved whatever prompted her to call the prescriber even though the form contained three lines for this purpose. RX 6, at 6, 10, 21, 29. Regarding the incompletions, Respondent's Owner and PIC testified both that: (1) ``Sometime we get busy, I know the office is called'' and ``I did look at the paper, because I would not fill the prescription unless I look at the paper;'' and (2) ``[i]f it's a routine patient who comes--who's been already established by me, . . . same prescription that's filled before, we would just--probably would be a little bit more routine in the call.'' Id. at 1004, 1005-06 (respectively). This testimony of Respondent's Owner and PIC was inconsistent with her testimony that ``When all the schedule II prescriptions--I would talk to doctor on each prescription.'' Id. at 1116. Respondent's Owner and PIC stated that she did not document all her conversations with doctors because ``it's my kind of internal--I did it to make a proper, sound clinical judgment whether this patient appropriate to get . . . these filled prescriptions.'' Id. at 1010. Notably, she stated that, ``I do accept responsibility for that and I don't do it any more. Now I document every little thing that it's concerned to the conversation and the dispensing of controlled substances.'' Id. She also said that, ``again, like I said, I accept responsibility for that and I improve my practice now. I do document everything that's possible to. However, like I said, this happens all the time.'' Id. at 1011. She added that ``we cannot have 100 percent even if it's red flag. . . . You try to do the best that you can, but sometimes it happens.'' Id. at 1012. The CALJ noted that ``it seems to me that on the form that you're giving me, the place that that should have been noted is down at the bottom where it says `notes,' and also the pharmacist's initials if you had made the call.'' \21\ Id. at 1013. Respondent's Owner and PIC, correlating the exercise of her corresponding responsibility with her practice in school of ``taking very little notes,'' admitted that ``I do have a tendency not to take too many notes'' and confirmed that ``I should learn how to take better notes.'' Id. at 1014. She said that she ``took remedial steps for it'' by ``hir[ing] new person who actually specifically look if I leaving the notes . . . and everything is properly taken right now.'' Id. Further, Respondent's Owner and PIC admitted that red flags identified from E-FORCSE were not noted, nor was their resolution documented, on the corresponding CII/CIII Rx Verification Form. Id. at 1010. --------------------------------------------------------------------------- \21\ Two of the forms' ``Pharmacist's Initials'' sections were completed. No form's ``Notes'' section contained a note. --------------------------------------------------------------------------- Based on the testimony of both Dr. Gordon and Mr. Fisher, I reject the testimony of Respondent's Owner and PIC that ``the fact that a patient traveled a long distance . . . was not a major red flag.'' I further find not credible the testimony of Respondent's Owner and PIC that she did not consider a controlled substance prescription presented by a customer who travelled a long distance to be a red flag and conclude the exact opposite to be the case. I find that each of the prescriptions in GX 8/8a raised at least one red flag that required resolution in that customers traveled long distances to obtain controlled substances, including schedule II controlled substances that even Respondent's Owner and PIC admitted were ``highly risky'' and subject to ``a lot of diversion.'' Id. at 1129, 1116, respectively. I find that Respondent admitted filling the prescriptions in GX 8/8a. Based on the testimony of both Dr. Gordon and Mr. Fisher, I find that, at a minimum, the distances the patients traveled to present the prescriptions in GX 8/8a required Respondent to resolve the distance red flags before dispensing controlled substances. I further find that Respondent did not address or resolve the red flags before filling the prescriptions in GX 8/8a. Multiple Customers Filling Prescriptions Written by the Same Prescriber, for the Same Drugs, in the Same Quantities, on the Same Day The Government alleged that prescriptions written by the same prescriber, for the same drugs, in the same quantities, and on the same day was a ``red flag of diversion,'' and that Respondent filled such prescriptions without resolving that red flag. As support for this allegation, the Government submitted five prescriptions that were written by the same doctor (Dr. A.F.) on the same day (June 27, 2012), and for the same strength of the same medication (testosterone cypionate). See GX 10; see also Tr. 394 (testimony of Dr. Gordon), Tr. 67 (DI testifying that GX 10 contained fair and accurate copies of documents he obtained from Respondent on April 11, 2013), and Tr. 68. Respondent filled them all on June 28, 2012, between 11:24 a.m. and 12:56 p.m., a period of about an hour and a half. GX 10. In Dr. Gordon's view, ``[t]hese prescriptions present a big red flag.'' Tr. 394. ``[I]t's odd,'' she testified, ``that a compounded script would be made exactly the same for each of these patients, which means there's not individualized therapy.'' Id. The lack of individualized treatment meant to Dr. Gordon that ``the prescriptions were not written for a legitimate medical purpose.'' Id. at 396. She testified that she did not see any notations on the prescriptions evidencing that a pharmacist attempted to address the red flags. Id.; see also R.D., at 49 (Respondent's Owner and PIC ``conceded that the paperwork furnished [[Page 10886]] to the DIs at the April 11th Inspection did not memorialize any attempts to resolve this red flag and agreed that she did not have any paperwork documenting her identification or resolution of the issue.''). Dr. Gordon's testimony was that this red flag was not resolvable. Tr. 396. She testified that the pharmacist who filled the prescriptions did not exercise her corresponding responsibility to ensure that the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 396-97. At first, the ``only comment'' that Mr. Fisher had about the prescriptions in GX 10 was that ``there doesn't seem to be a quantity that's identifiable.'' Id. at 618. When asked specifically about the fact that the prescriptions came from the same doctor and for the same drug, Mr. Fisher testified that, ``[i]f the doctor is specializing in men's health . . . , he could have multiple patients on the same regimen of drugs.'' Id. at 619. On cross examination, however, Mr. Fisher admitted that the five prescriptions were an example of ``pattern prescribing,'' or when ``a doctor . . . writes the same thing for every single patient that comes in.'' Id. at 769. Mr. Fisher then testified that pattern prescribing was a ``red flag for diversion.'' Id. Respondent's Owner and PIC testified that the prescriptions raised a red flag because they were for a ``schedule [sic] medication, testosterone.'' \22\ Id. at 1084. She testified that she resolved this red flag by asking the prescribing doctor ``if she knows the purpose of this . . . treatment, and if the patient are . . . taking it for an appropriate use.'' Id. --------------------------------------------------------------------------- \22\ Respondent's Owner and PIC testified that the red flag for the testosterone prescription on page 3 of GX 10 was the customer's age, 27 years old. Tr. 1086. She stated that she spoke with the doctor about this prescription and the ``doctor assured me that this patient has low testosterone and he needs because he feels very tired and he's not going to use it for athletic purposes. He was not an athlete.'' Id. --------------------------------------------------------------------------- Respondent's Owner and PIC also testified that these five prescriptions raised red flags because ``[t]hey came on the same day with the same medication at the same . . . dose . . . [a]nd the same doctor.'' Id. at 1092. At this juncture, her testimony about how she resolved the red flags was that she spoke with the doctor. Id. at 1092- 93. She testified that, ``The reason . . . they come on the same day, because the doctor designated that day to see patients who need hormonal replacement. . . . [I]t helps her to keep the records straight . . . . [T]hey start out on the same dose. This way it's easier to achieve the day to day concentration of the dose.'' Id. In response to whether she had any notes ``anywhere'' documenting her conversation with the physician, Respondent's Owner and PIC replied, ``Not here, no.'' Id. at 1094. Based on all of the evidence in the record, I find that Respondent filled prescriptions that raised the red flag of multiple customers presenting prescriptions written by the same prescriber on the same day for the same medication in the same quantity. I further find that, even if these red flags were resolvable, there was no credible evidence that Respondent addressed or resolved them before filling the prescriptions. I cannot, and do not, place any weight on the testimony of Respondent's Owner and PIC that she resolved these red flags because she produced no documentary evidence to support her claim that she attempted to and, in fact, did resolve them before filling the prescriptions. Multiple Customers From the Same Address Coming to Respondent at the Same Time With Prescriptions From the Same Doctor for the Same Drug and Strength The Government alleged that multiple customers from the same address coming to Respondent at the same time with prescriptions written by the same doctor for the same drug and strength was a ``red flag of diversion,'' and that Respondent filled such prescriptions without resolving that red flag. To support this allegation, the Government submitted two prescriptions for Dilaudid 8 mg. that Respondent filled within five minutes of each other. See GX 11. The prescriptions were written by the same doctor on the same day with the same use directions to two individuals with the same last name and street address in Hollywood, Florida. See Tr. 397-98; see also id. at 70 (DI testifying that GX 11 consisted of true and accurate copies of prescriptions and labels he took from Respondent on April 11, 2013) and id. at 71 (DI testifying that the prescriptions in GX 11 were for two customers living at the same address, who saw the same doctor, were prescribed the exact same drug and strength, and then took those prescriptions to Respondent at the same time). The difference between the two prescriptions was that one was for 80 tablets and the other was for 85 tablets. Id. at 397; see also GX 11, at 1, 3. In Dr. Gordon's opinion, these prescriptions raised multiple red flags that were not resolvable. Tr. 397-98. She testified that: ``This to me is what's called rubber-stamping from a physician, and is not individualized therapy. . . . It's unusual that two patients that live at the same address would receive the same exact therapy. There's always an exception to the rule, but this is common in the drug-seeking community . . . .'' Id. Dr. Gordon also testified that there were no notations on the prescriptions addressing the red flags. Id. at 398. Her opinion was that the prescriptions were not legitimate and that the pharmacist who filled the prescriptions had not exercised her corresponding responsibility to ensure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 398-99. Mr. Fisher agreed with Dr. Gordon that the prescriptions raised red flags. He testified that the ``same address for two different people'' and the ``same drug'' were red flags associated with these prescriptions. Id. at 620. He considered it ``very possible'' that the prescriptions were for husband and wife who had a reason for going to the same doctor at the same time. Id. He suggested that ``[s]peaking to the physician would be the easiest way'' to resolve those red flags. Id. On cross-examination, Mr. Fisher agreed that a pharmacist's ``due diligence . . . [and] the standard way to try to prevent diversion of drugs'' required the pharmacist to ``check the other things available . . . [l]ike the E-FORCSE system, . . . the doctor's license number, and all that. The routine things you do with a Schedule II prescription.'' Id. at 771. He also contradicted his earlier testimony when he admitted that, in this situation, a ``simple phone call to the doctor'' might not achieve the level of satisfaction concerning the prescriptions' legitimacy the ``pharmacist has to get . . . before they can fill the prescription,'' because ``the doctor, himself, may not have issued . . . [the prescriptions] for legitimate medical purpose[s] in the course of his professional practice.'' Id. at 771-72. According to Respondent's Owner and PIC, the fact that the prescriptions were written by the same doctor, for the same drug and dosage, for individuals living at the same address who had the same last name and presented the prescriptions on the same day did not raise a red flag. Id. at 1097-98. She testified that she ``would treat . . . [the prescriptions] the same way I treat every other schedule II medication.'' Id. at 1098. She also stated that she filled the prescriptions because, at the time, ``I thought the circumstances of the prescriptions were understandable.'' Id. at 1103-04. She then stated that, as of 2015, she would not fill them ``[b]ecause the DEA have restriction on filling those [[Page 10887]] prescriptions[,] . . . [n]ot because the patient are not legitimate and not because of doctor not legitimate or not legitimate medical purpose. Only because DEA said do not fill those prescriptions.'' Id. at 1104. When asked if someone at DEA told her not to fill schedule II prescriptions, Respondent's Owner and PIC responded: ``Obviously, if they bring me that case, that what they saying to me. They will try to take--intend to revoke my license for filling those prescriptions. . . . The[y] didn't tell me--not until they come with this order to show cause.'' Id. at 1104-05. Based on all of the evidence in the record, I find that the prescriptions in GX 11 raised red flags because customers with the same last name and street address presented them, and they were written on the same day by the same doctor for the same drug and strength. Further, I find that Respondent admitted filling the prescriptions even though these red flags were not resolvable, according to Dr. Gordon's testimony. I find that, even if these red flags were resolvable, there was no credible evidence in the record that Respondent addressed or resolved them before it filled the prescriptions. Respondent's Owner and PIC offered no evidence to substantiate her testimony that the circumstances of the prescriptions were ``understandable'' and did not raise red flags. I afford her testimony no weight. Customers Presenting Two Prescriptions, Both for the Same Immediate Release Controlled Substance, but for Different Strengths The Government alleged that a ``red flag of diversion'' was raised when customers presented two prescriptions for the same immediate release controlled substance, but for different strengths, and that Respondent filled such prescriptions without addressing or resolving the red flag. As support for this allegation, the Government submitted four such prescriptions filled by Respondent. See GX 12. The four prescriptions consisted of two prescriptions each for Dilaudid 8 mg. and Dilaudid 4 mg. written for two different people. Tr. 399, 405-06; see also id. at 72 (DI testifying that GX 12 contained true and accurate copies of documents he took from Respondent on April 11, 2013) and id. at 73 (DI testifying that the prescriptions in GX 12 belonged to two patients for the same immediate-release drugs and strengths). Dr. Gordon testified that the prescriptions raised red flags. Id. at 399-400, 403-04. The first red flag she identified was that the two prescriptions were written for the same immediate release controlled substance, but for different strengths. Id. at 399. The second red flag she identified was the diagnosis of ``lumbar radiculopathy.'' Id. at 400. Dr. Gordon explained that giving one person two prescriptions for two immediate release opioids was not necessary because the Dilaudid 8 mg. could be broken in half to get a 4-milligram dose. Id. at 399. She pointed out that there was no long-acting medication accompanying the prescriptions in GX 12 and that ``[t]wo immediate-release opioids is . . . a common red flag for diverted prescriptions.'' Id.; see also id. at 399-400. She explained: ``In pain management . . . you start out with a short-acting. Then based on the amount of short-acting, you prescribe a long-acting, because if you were in pain, I wouldn't want you to have to take something every four hours. . . . So what we do is we recommend . . . a long-acting . . . with a break-through.'' Id. at 401. Her testimony further explained that ``it looks like the practitioner was trying to say that you could only take Dilaudid, 4 milligrams, one, three times a day . . . [but] [i]t won't last eight hours. So that's the first red flag.'' Id. at 403. She continued, asking rhetorically ``why would you take a higher dose of a break- through? It doesn't make any sense.'' Id. Drawing from her experience, she testified that ``it would have made more sense for him to schedule the eight[;] . . . it's usually the same dose for break-through.'' Id. Dr. Gordon also testified that the diagnosis of ``lumbar radiculopathy'' was ``a red flag to take pause for any reasonable pharmacist to make sure the prescriptions are legit.'' Id. at 400. See GX 12, at 1-2. She explained that, ``on prescriptions that are not legit, that's the pattern I've seen--lumbago is big on illegitimate prescriptions--and most of my colleagues as well.'' Tr. 404. When asked if she would ``reach out to the prescriber'' if she ``were in a retail pharmacy and . . . saw a prescription like this coming in with two short-actings,'' Dr. Gordon responded ``[n]o. . . . I would give the prescriptions back to the patron.'' Id. at 402. She stated that the red flags raised by the prescriptions were not resolvable. Id. at 405, 406. Dr. Gordon testified that there were no notations on the prescriptions addressing the red flags, and gave her opinion that the prescriptions were not legitimate and that the pharmacist who filled the prescriptions did not exercise her corresponding responsibility to ensure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 404-05, 406-07; see GX 12, at 1-8. Mr. Fisher agreed that ``two prescriptions written for the same person for the same drug but different strengths'' was a red flag. Tr. 620-21. He testified that he would speak to the doctor to resolve it because it's ``[c]ommonly done'' to ``try[ ] to achieve a certain therapeutic level by combining the two doses . . . [because] [t]he 8 milligrams is not enough for the patient, so they do 12.'' Id. at 621. Mr. Fisher testified that a consistent therapeutic level would be achieved if the medication were taken as directed during a 24-hour cycle. See id. at 624. He stated that ``three times a day, you're going to take it probably . . . . You're not taking it in the middle of the night. You're probably going to take it morning, noontime, and suppertime. And then he goes to work and he needs something stronger and he takes the stronger dose. . . . It is common.'' Id. at 624-25. Respondent's Owner and PIC testified that the only red flag she associated with the prescriptions in GX 12 was that they were for schedule II controlled substances. Id. at 1115, 1129. When asked if ``the fact that there was two different strengths of the same medication, issued to the same patient on the same day by the same doctor . . . constitutes a red flag,'' Respondent's Owner and PIC replied in the negative ``because there is a logical explanation to it.'' Id. at 1115. ``That's done . . . to achieve certain dosage variance,'' she stated. Id. After further questioning on the subject, Respondent's Owner and PIC stated that she ``spoke with the doctor about it and doctor approved the dose.'' Id. at 1121; see also id. at 1132-33. She added that the doctor was ``still practicing . . . [a]nd the patient tells me that's how he benefits the most.'' Id. at 1121. She testified similarly regarding the prescriber of the other prescriptions in GX 12. Id. at 1126. When asked whether she had, for these prescriptions, ``the same documentation that you've shown before . . . [l]ike . . . the patient agreement and the PMP report and a note that somebody checked with the doctor,'' Respondent's Owner and PIC answered affirmatively. Id. at 1121-22. She admitted that she had not, however, provided the same documentation. Instead, she stated that the existence of the ``approved'' stamp and ``my personal stamp with my signature on it'' meant that ``I spoke with the doctors. . . . And documents were obviously generated when he comes--visiting the [[Page 10888]] pharmacy, otherwise I would not dispense it.'' Id. at 1122. When asked, however, whether ``[e]very time you see that stamp, you spoke with the doctor,'' Respondent's Owner and PIC declined to respond in the affirmative. Id. at 1136-37. She stated, ``I have to go each prescription by--let's go one-by-one each prescription, I tell you each one I spoke with.'' Id. at 1137. She testified that, ``I called--as far as I remember, on each prescription, every time it's presented to me, I called the office. Not necessarily I would speak every time with the doctor. . . . But the practice was at the pharmacy, we verify every prescription.'' Id. at 1138. During cross-examination, Respondent's Owner and PIC testified that the absence of the stamps would not mean that a prescription was not valid ``[b]ecause, again, there's sometimes human distractions and errors, some paper can be missed. . . . Again, I was not obligated by either the State or law to stamp those prescriptions.'' Id. at 1226. She testified that, ``I did my best attempt to make sure there's no fraudulent prescription I fill there. Or there's no valid DEA numbers or there's, like, no major violation or diversion with the prescriptions.'' Id. at 1227. Respondent's Owner and PIC was satisfied, she testified, when she filled the prescriptions in GX 12 that each ``prescription was filled for medical purpose within the scope of a physician practice.'' Id. at 1139. Based on all of the evidence in the record, I find that Respondent, without addressing or resolving the red flags, filled prescriptions that raised the red flag of customers presenting two prescriptions for the same immediate release controlled substance but for different strengths. The testimony of Respondent's Owner and PIC, including her testimony that she filled each prescription in GX 12 only after being satisfied they were for a medical purpose within the scope of a physician practice, was not credible. First, it directly conflicted with her original testimony denying that the circumstances raised a red flag and, second, she did not produce any documentary evidence to corroborate her statements. Customers Presenting Prescriptions With a Combination of an Opiate and a Benzodiazepine or ``Drug Cocktail'' Popular with Drug Abusers The Government alleged that prescriptions with a combination of an opiate and a benzodiazepine are ``drug cocktails'' popular with drug abusers and, therefore, raise ``red flags of diversion,'' and that Respondent filled such prescriptions without addressing or resolving those red flags. To support this allegation, the Government submitted seven sets of prescriptions (a total of 14 prescriptions) that Respondent filled and dispensed to its customers containing an opiate and a benzodiazepine. Id. at 407, 412, 414-15, 417, 421, 422-23, 424; see GX 13; see also Tr. 73-74 (DI testifying that GX 13 consisted of true and accurate copies of documents he took from Respondent during the unannounced inspection) and Tr. 74-75 (DI testifying that the prescriptions in GX 13 were for a common drug cocktail of a narcotic pain reliever and a benzodiazepine, both at their highest strengths). ---------------------------------------------------------------------------------------------------------------- Drug Number of tablets Date written Customer's initials ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg............................... 116 11/20/12 D.C. Xanax 2 mg.................................. 43 11/20/12 D.C. Dilaudid 8 mg............................... 140 12/27/12 D.C. Xanax 2 mg.................................. 42 12/27/12 D.C. Dilaudid 8 mg............................... 140 1/24/13 D.C. Xanax 2 mg.................................. 42 1/24/13 D.C. Dilaudid 8 mg............................... 162 10/26/12 L.F. clonazepam 2 mg............................. 30 10/26/12 L.F. Dilaudid 8 mg............................... 162 12/21/12 L.F. clonazepam 2 mg............................. 30 12/21/12 L.F. Dilaudid 8 mg............................... 70 10/12/12 B.K. Valium 10 mg................................ 42 10/12/12 B.K. Dilaudid 8 mg............................... 35 11/9/12 B.K. Valium 10 mg................................ 42 11/9/12 B.K. ---------------------------------------------------------------------------------------------------------------- According to Dr. Gordon, these seven pairings of prescriptions were considered ``cocktail medications,'' red flags, because they were multiple drugs that suppressed the central nervous system and, when taken together, could give euphoria. Tr. 408, 412, 414-15 (maximum strength of Dilaudid and Xanax), 417, 421, 422 (highest Valium dose available), 424 (highest doses available), 546, 547. She elaborated on what makes a drug cocktail by testifying that it consisted of ``drugs that cause you to have a high.'' Id. at 547. ``So it could be an opioid, it could be an upper and a downer,'' she stated. Id. She explained that the ``person could be taking the drugs to get a high during the day and then a low at night. . . . ``[I]t's not being used for what it's intended to be used for.'' \23\ Id. She explained that ``these two drugs are very highly sought after on the street.'' Id. at 409. In her opinion, the drug pairings were ``surrounded by diversion.'' \24\ Id. at 410; see also id. at 413-14. --------------------------------------------------------------------------- \23\ Dr. Gordon testified that the prescriptions would not raise a red flag for her if they were written by a ``Hospice doctor [or] oncologist.'' Tr. 545. \24\ Dr. Gordon identified additional red flags regarding the prescriptions in GX 13: First, the prescriptions on pages 13 and 15 were written for a male (LF) living in Davie and traveling a long distance to Miami to see an OB/GYN (Dr. R.T.); second, the diagnosis written on the prescription on page 13 was lumbago, a common diagnosis that doctors used on diverted prescriptions; and third, the repeat customer (LF) for the prescriptions on pages 13 through 19 written by Dr. R.T. was receiving the same cocktail medications with no long-acting medication present. Tr. 16-17, 418, 420-21. --------------------------------------------------------------------------- Dr. Gordon addressed whether a muscle relaxant had to be present to constitute a drug cocktail. She stated that, ``Cocktail medications usually . . . are a combination of an opioid plus or minus a benzo plus or minus a muscle relaxant.'' Id. at 408. Then she explained: ``But what I've seen . . . lately is the doctors have stopped the Soma, and they are just doing, now, high doses of Dilaudid, high doses of benzos. It used to be Oxys. Now they've switched to hydromorphone. So you see . . . the flags change.'' Id. She added that, ``I see the physicians and drug diverters trying to eliminate one of the components of the cocktail to try to get away with diverted drugs.'' Id. at 538. Dr. Gordon testified that she saw no notations by the pharmacist on the prescriptions attempting to resolve the [[Page 10889]] red flags and, in her opinion, the ``cocktail'' red flags were not resolvable. Id. at 411, 414, 416, 418, 421, 423, 424-25. She specifically testified that the prescriptions were not legitimate and that the pharmacist who filled the prescription pairings did not exercise her corresponding responsibility to ensure that the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 411-12, 414, 416, 418-19, 421-22, 423, 425. Mr. Fisher stated that he did not consider the drugs in the prescriptions in GX 13 to be cocktails. Id. at 629, 631, 632, 633. He elaborated: ``To me a cocktail is when you have a combination of three drugs: alprazolam, oxycodone or hydrocodone, and carisoprodol. This to me looks like a simple case of a patient getting pain medication and some Xanax for anxiety.'' Id. 629; see also id. at 630 (``[I]n everything I have read and have seen and talked to and have heard at meetings, it's a combination of the three drugs represents the cocktail.''). Mr. Fisher agreed that ``[a]s things have changed, yes, other drugs have been added like the hydromorphone that's come into play.'' Id. at 629-30. He testified that what makes a cocktail is ``more the street value of the drugs.'' Id. at 630. On cross-examination, Mr. Fisher reaffirmed his opinion that a cocktail involves an opioid, a benzodiazepine, and carisoprodol. Id. at 772. He acknowledged that a customer could obtain the opioid and the benzodiazepine from one pharmacy and the carisoprodol from a second pharmacy. Id. at 772-73. He agreed that ``the only way to check for that would be through use of . . . E-FORCSE.'' Id. at 773. Mr. Fisher also agreed that Respondent, ``not having access to query E-FORCSE, would not be able to . . . check for that, those instances of drug seekers using other pharmacies or doctors to obtain a third drug that could be used in this cocktail.'' Id. On re-direct, Mr. Fisher stated that, beside using E-FORCSE, other ways to resolve any red flags associated with GX 13 were ``[c]all the physician, discuss their treatment modality for the patient, [c]heck the patient's profile if you maintain one[,] . . . [and] [i]f you have a computer system you could check and see if there's a history of the patient getting other prescriptions filled.'' Id. at 779. Respondent's Owner and PIC did not agree that the prescriptions in GX 13 constituted a drug cocktail because, in her view, a drug cocktail had four components: two opioids, carisoprodol, and a benzodiazepine. Id. at 1142. ``It's multiple--it's two--for instance, oxycodone and Vicodin together with Soma and benzodiazepine,'' she stated. Id. According to Respondent's Owner and PIC, she ``didn't fill those prescriptions for the Soma, benzodiazepine, carisoprodol,'' and she did not recall ever filling a benzodiazepine, Soma, and opiate combination for any patients. Id. at 1144, 1145. Respondent produced an exhibit containing various documents concerning the three customers who asked Respondent to fill the prescriptions in GX 13. RX 10. According to the testimony of Respondent's Owner and PIC, Respondent compiled or generated the documents in RX 10 ``at that time in 2013'' because ``[w]e tried to implement as much possible steps and follow them through as much as possible to make sure that . . . steps are taken . . . that's preventing. . . . Also, . . . that's why . . . when the patient knows the pharmacy takes extra steps and scrutinize the prescriptions, people who has non-valid prescription not come to me.'' Tr. 1157-58. Page 2 of RX 10 was the Relationship Affidavit signed by DC, the same DC associated with six prescriptions in GX 13 (pages 1 through 12). See id. at 1145-46. Similarly, the Relationship Affidavit on page 5 of RX 10 was signed by LF, the same LF associated with pages 13 through 20 of GX 13.\25\ See id. at 1148-49. --------------------------------------------------------------------------- \25\ LF did not complete the Relationship Affidavit in full. --------------------------------------------------------------------------- Respondent also provided registration validation pages purportedly printed from DEA's website. According to Respondent's Owner and PIC, the DEA registration validation website satisfied her that, on the day she filled LF's Dilaudid and clonazepam prescriptions, the prescribing physician was ``allowed to prescribe the pain medications.'' Id. at 1149; see RX 10, at 6; GX 13, at 17, 19. Likewise, according to Respondent's Owner and PIC, the DEA registration validation website showed her that the physician who prescribed prescriptions for BK ``was actually scheduled to prescribe schedule II narcotics.'' Tr. 1156; see RX 10, at 12; GX 13, at 21-27. Respondent also submitted a hand-written note on a piece of prescription paper belonging to the doctor who issued Dilaudid and Valium prescriptions for BK. See RX 10, at 10; GX 13, at 21, 23, 25, and 27. The note was not addressed to anyone. It showed BK's name in the ``patient'' space, and an age, partial address, and date in the lines of the prescription paper calling for that information. It did not include a diagnosis. The note contained a signature which, according to Respondent's Owner and PIC, was the prescribing doctor's signature. Tr. 1152. The note stated that ``the patient cannot tolerate for long periods of kneel, more than 20 minutes of sitting or standing.'' Id. Significantly, the date on the note (August 9, 2011) was more than a year and two months before the date on the earliest prescription issued to BK and included in GX 13 as filled by Respondent (October 12, 2012). Compare RX 10, at 10 with GX 13, at 21. Yet, Respondent's Owner and PIC testified that: ``Because I've been calling to the doctor and asking about this patient few times . . .[,] [w]e make sure the doctor just write a note.'' \26\ Tr. 1152. She continued, stating, ``[T]his patient has such a difficult time to fill his prescriptions. . . . This patient could not fill prescription anywhere, and then he come to me.'' Id. She did not explain how this note led her to conclude that the prescriptions issued to BK were legitimate. --------------------------------------------------------------------------- \26\ She did not address the timing of how Respondent could have ``made sure'' the doctor wrote a note more than a year before Respondent filled the earliest prescription in the record. --------------------------------------------------------------------------- Respondent also submitted a ``Verification of legitimate purpose of prescribing CII-CV medications To establish legitimate Physician- patient relationship.'' RX 10, at 11. It purported to be signed by BK, the individual for whom the Dilaudid and Valium prescriptions on pages 21, 23, 25, and 27 of GX 13 were written. This one-page sheet had space for the customer's name, signature, birth date, and appointment date, for the physician's name and address, and for ``yes'' or ``no'' responses to whether the physician or ``qualified medical professional'' conducted a medical examination, took a blood sample, and had an ``MRI on file.'' Id. I find, based on Dr. Gordon's testimony and consistent with my credibility determinations giving Dr. Gordon's testimony regarding the practice of pharmacy in Florida more weight than any other witness's testimony in these proceedings, that the prescriptions in GX 13 were ``drug cocktails'' popular with drug abusers. Based on all of the evidence in the record, I find that Respondent filled prescriptions without having resolved the red flags of customers presenting prescriptions with a combination of an opiate and a benzodiazepine which is a [[Page 10890]] common ``drug cocktail'' popular with drug abusers. Customers Paying for Their Prescriptions With Cash, When Other Red Flags of Diversion Were Present The Government alleged that customers paying cash for their prescriptions when other red flags of diversion were present was a ``red flag of diversion,'' and that Respondent dispensed controlled substances to customers without resolving the red flags those prescriptions presented. As support for this allegation, the Government listed 50 prescriptions in the Show Cause Order. ALJX 1, at 5. No testimony disputed the allegations that Respondent filled the 50 prescriptions and that those prescriptions were purchased with cash. I reviewed those 50 prescriptions. Thirty-two of them were for Dilaudid 8 mg. GX 8, 11, 12, 13, 14. ---------------------------------------------------------------------------------------------------------------- Number of Drug tablets Date written Cash paid Customer ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg.......................... 150 12/10/12 $750.00 G.A. Dilaudid 8 mg.......................... 168 11/20/12 840.00 S.B. Dilaudid 8 mg.......................... 150 12/19/12 750.00 C.W. Dilaudid 8 mg.......................... 56 7/9/12 280.00 J.S. Dilaudid 8 mg.......................... 140 1/21/13 840.00 D.K. Dilaudid 8 mg.......................... 56 9/6/12 40.00 B.S. Dilaudid 8 mg.......................... 150 12/28/12 750.00 T.S. Dilaudid 8 mg.......................... 112 4/26/12 560.00 B.R. Dilaudid 8 mg.......................... 112 11/14/12 560.00 W.P. Dilaudid 8 mg.......................... 80 6/22/12 400.00 D.S. Dilaudid 8 mg.......................... 85 6/22/12 425.00 B.S. Dilaudid 8 mg.......................... 75 9/27/12 375.00 J.F. Dilaudid 8 mg.......................... 168 11/29/12 840.00 B.M. Dilaudid 8 mg.......................... 116 11/20/12 580.00 D.C. Dilaudid 8 mg.......................... 140 12/27/12 28.00 D.C. Dilaudid 8 mg.......................... 140 1/24/13 840.00 D.C. Dilaudid 8 mg.......................... 162 10/26/12 810.00 L.F. Dilaudid 8 mg.......................... 162 12/21/12 810.00 L.F. Dilaudid 8 mg.......................... 70 10/12/12 320.00 B.K. Dilaudid 8 mg.......................... 35 11/9/12 175.00 B.K. Dilaudid 8 mg.......................... 128 10/5/12 640.00 B.K. Dilaudid 8 mg.......................... 40 11/2/12 200.00 B.K. Dilaudid 8 mg.......................... 180 8/15/12 900.00 J.B. Dilaudid 8 mg.......................... 150 9/6/12 750.00 J.B. Dilaudid 8 mg.......................... 180 8/30/12 900.00 J.F. Dilaudid 8 mg.......................... 150 9/27/12 750.00 J.F. Dilaudid 8 mg.......................... 168 3/13/13 1,008.00 L.B. Dilaudid 8 mg.......................... 168 4/10/13 1,008.00 L.B. Dilaudid 8 mg.......................... 168 12/28/12 840.00 J.S. Dilaudid 8 mg.......................... 168 1/23/13 1,008.00 J.S. Dilaudid 8 mg.......................... 180 9/7/12 900.00 H.H. Dilaudid 8 mg.......................... 180 10/5/12 900.00 H.H. ---------------------------------------------------------------------------------------------------------------- The evidence shows that customers paid as much as $1,008.00 for a month's worth of Dilaudid 8 mg. Dr. Gordon's testimony explained that payment in cash for a controlled substance was always a red flag, even if a significant sector of the public did not have health insurance. Tr. 363. Paying in cash was a red flag, she testified, because it enabled evasion of processes established to alert a pharmacy that a prescription was being filled too soon. She stated, ``A lot of drug-seekers only want to pay for their medications in cash because . . . the computer systems, the insurance company will actually create your red flag for you to say if a prescription is refilled too soon, which means they've gone--obtained a prescription from another pharmacy.'' Id. at 297. She elaborated and provided a specific example: ``[T]he insurance company will give you that red flag. Because they'll have a claim . . . and they'll . . . say, . . . the patient just got this prescription yesterday from Walgreen's . . . . So . . . the patrons will say, `I don't want you to charge my insurance company.' That way it kind of eliminates that flag.'' Id. at 298-99. In Dr. Gordon's opinion, the cash prices that Respondent charged its customers were as high as five times the cost Dr. Gordon would have expected. Id. at 362; see also id. at 417, 424, 502, 512. As Dr. Gordon concluded, ``that to me means that maybe the pharmacist knew what was going on, and they were taking advantage of these patrons that were drug seeking.'' Id. at 362; see also id. at 464-65 (Concerning Respondent's initial charge of $840 for a prescription and subsequent charge of $1,008 for the same exact prescription on the next visit, Dr. Gordon suggested that ``the pharmacist actually knew the prescriptions were diverted and . . . was taking advantage of that patron . . . [b]ecause they knew they would pay whatever they needed to pay . . . .''). She explained that ``the cost of that medication is high compared to what I've seen out in the field. That's a very high cost. And between Fort Pierce, Miami, and Hallandale, you pass like a zillion pharmacies. . . . It doesn't make sense.'' Id. at 362. According to Dr. Gordon, there was no notation made by the pharmacist on the prescriptions showing any attempt to resolve the red flags. See, e.g., id. at 364, 369, 371, 373, 374, 377, 389-90, 398, 404-05, 406, 411, 416, 421, 423, 424-25, 467; see also id. at 133 (DI testimony that he did not see notations on the prescriptions from Respondent ``clearing'' any red flags). Mr. Fisher agreed that ``[c]ustomers paying for their prescriptions with cash where other red flags of diversion are present'' was a red flag. Id. at 756. Respondent challenged Dr. Gordon's cash price-level testimony based on her not having been in charge of purchasing controlled substances for resale for a small independent pharmacy. Id. at 502. [[Page 10891]] Yet, I find Dr. Gordon's testimony to be credible because she ``actually looked up the national . . . price.'' Id. at 503. Respondent also challenged Dr. Gordon by stating that pharmacies where Dr. Gordon worked ``like Walgreens, are getting discounts from the supplier on purchasing controlled medication.'' Id. at 502. However, Dr. Gordon testified she was ``99 percent sure'' that discounts are not available for generic opioids. Id. at 503. Respondent presented no pricing data or other evidence refuting Dr. Gordon's characterization of the higher- than-expected level of cash prices Respondent's customers paid for controlled substance prescriptions. Further, Respondent did not present evidence to establish that its cash prices for controlled substances were consistent with the prices charged by other pharmacies similar to Respondent. Nor did it present evidence to establish that it set the level of its cash prices for controlled substances for a reason other than that its customers were willing to pay those prices. Thus, I find no reason to reject Dr. Gordon's testimony. Rather, I shall credit it consistent with the CALJ's credibility determinations. Based on all of the evidence in the record, I find that Respondent, without resolving the red flags, filled prescriptions that raised the red flag of customers paying cash for their prescriptions when other red flags were present. I further find that Respondent's customers were charged, and paid, exorbitantly high prices for their controlled substance prescriptions. Customers Presenting New Prescriptions for Controlled Substances When They Should Not Have Finished Their Previous Prescription for That Drug (``Early Fills'' or ``Early Refills'') The last red flag the Government alleged in the Show Cause Order concerned early fills. According to the Government, Respondent filled prescriptions for controlled substances that the customers presented before the customers' previous prescription for that controlled substance should have been consumed. To support this allegation, the Government submitted 22 prescriptions. GX 14, at 1-33, 37-47.\27\ Twelve of the prescriptions concerned one customer. The other ten prescriptions concerned five different customers. All 22 prescriptions were for Dilaudid 8 mg. --------------------------------------------------------------------------- \27\ GX 14 included 24 prescriptions, but there were two copies of two of the prescriptions. --------------------------------------------------------------------------- I reviewed the prescriptions the Government submitted and analyzed them according to the standard Dr. Gordon described in her testimony. GX 14; Tr. 436 (``[W]hat most pharmacies do . . . [to determine whether a prescription is an early fill is] they start at when the first prescription was filled.''); see also Tr. 429-67 (Dr. Gordon's testimony concerning GX 14), Tr. 75-76 (DI testifying that GX 14 consisted of true and accurate copies of documents he took from Respondent during the unannounced inspection), and Tr. 76-77 (DI testifying that GX 14 showed Respondent filled new schedule II controlled substance prescriptions before the customers' previous prescriptions should have been exhausted). I make these findings. First, Respondent filled 12 prescriptions for BK, dispensing a total of 840 Dilaudid 8 mg. tablets, from July 26, 2012 through November 8, 2012. GX 14, at 1-33, 37-47. Customer B.K. ---------------------------------------------------------------------------------------------------------------- Drug Number of tablets/SIG Date written Date filled ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg................................. 168--1 every 4 hrs. for pain.... 7/16/12 7/26/12 Dilaudid 8 mg................................. 168--1 every 4 hrs. for pain.... 8/13/12 8/13/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain..... 9/7/12 9/10/12 Dilaudid 8 mg................................. 128--1 every 4 hrs. for pain.... 9/7/12 9/13/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain.... 10/12/12 10/12/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain.... 10/12/12 10/15/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain..... 10/12/12 10/17/12 Dilaudid 8 mg................................. 8--1 every 4 hrs. for pain..... 10/12/12 10/17/12 Dilaudid 8 mg................................. 128--1 every 4 hrs. for pain.... 10/5/12 10/22/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain..... 11/2/12 11/2/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain..... 11/2/12 11/5/12 Dilaudid 8 mg................................. 40--1 every 4 hrs. for pain..... 11/2/12 11/9/12 ---------------------------------------------------------------------------------------------------------------- I note that Respondent filled all four of the prescriptions that were written on the same day, October 12, 2012. Further, one prescription for ``chronic pain due to trauma,'' among other things, was written on July 16, 2012, yet BK did not have it filled until July 26, 2012. GX 14, at 1-2. Similarly, BK waited up to 16 days before filling another prescription for ``chronic pain due to trauma,'' among other things. GX 14, at 17-18. BK's delay in filling such Dilaudid 8 mg. prescriptions casts doubt on the prescriptions' legitimacy. Based on the dosing instructions, six tablets each day, 840 tablets should have lasted 140 days. The number of days from July 26, 2012 through November 8, 2012, the day before BK filled the last prescription in GX 14, was 105 days. Thus, in this period, Respondent dispensed to BK a 140-day supply of Dilaudid 8 mg. in 105 days. According to my analysis, Respondent filled all but one of them significantly early, from about at least 6 days early to up to about at least 29 days early. Id. Second, concerning the two Dilaudid 8 mg. prescriptions in GX 14 issued to JB, Respondent filled the second prescription at least one week early. Id. at 25-28. Customer J.B. ---------------------------------------------------------------------------------------------------------------- Drug Number of tablets/SIG Date written Date filled ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg................................. 180--1 every 3 hrs. as needed... 8/15/12 8/22/12 Dilaudid 8 mg................................. 150--1 every 3 hrs. as needed... 9/6/12 9/6/12 ---------------------------------------------------------------------------------------------------------------- [[Page 10892]] Third, concerning the two Dilaudid 8 mg. prescriptions in GX 14 issued to LB, Respondent filled the second prescription at least 5 days early. Customer L.B. ---------------------------------------------------------------------------------------------------------------- Drug Number of tablets/SIG Date written Date filled ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg................................. 168--1 every 4 hrs. as needed.. 3/13/13 3/18/13 Dilaudid 8 mg................................. 168--1 every 4 hrs. as needed... 4/10/13 4/10/13 ---------------------------------------------------------------------------------------------------------------- Fourth, Respondent filled the second Dilaudid 8 mg. prescription in GX for JS at least 5 days early. Customer J.S. ---------------------------------------------------------------------------------------------------------------- Drug Number of tablets/SIG Date written Date filled ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg................................. 168--1 every 4 hrs. as needed.. 12/28/12 12/31/12 Dilaudid 8 mg................................. 168--1 every 4 hrs. as needed... 1/23/13 1/23/13 ---------------------------------------------------------------------------------------------------------------- Fifth, Respondent filled the second Dilaudid 8 mg. prescription in GX 14 for HH at least six days early. Customer H.H. ---------------------------------------------------------------------------------------------------------------- Drug Number of tablets/SIG Date written Date filled ---------------------------------------------------------------------------------------------------------------- Dilaudid 8 mg................................. 180--1 every 4-6 hrs. as needed. 9/7/12 9/14/12 Dilaudid 8 mg................................. 180--1 every 4-6 hrs. as needed. 10/5/12 10/8/12 ---------------------------------------------------------------------------------------------------------------- According to Dr. Gordon, the prescriptions in GX 14 exhibited multiple red flags, yet Respondent filled them all. Tr. 429-67. For none of the prescriptions in GX 14 did Dr. Gordon testify that it included any notation recognizing or addressing red flags, that its red flags were resolvable, that it was a legitimate prescription, or that the pharmacist had exercised her corresponding responsibility to ensure that the prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 437-38, 441, 442, 445-46, 446-47, 448-49, 450-51, 456, 458-59, 460- 61, 464, 467. Regarding these prescriptions and labels, Dr. Gordon testified that ``the pharmacist was not exercising her corresponding responsibility, that most of these prescriptions should not have been filled or at least held until it was due to be filled.'' Id. at 450. ``However,'' Dr. Gordon continued, ``I wouldn't have filled any of these to begin with.'' Id. at 451. She explained: ``The multiple red flags would alert any pharmacist that none of these prescriptions were legit because of the distance, that certain physician is a well-known pill mill writer, the Dilaudid 8, the odd quantities, . . . the diagnosis of lumbago . . . and paying cash . . . And the early fills.'' Id. Specifically regarding the multiple prescriptions for BK that Respondent filled on October 17, 2012 and why, in Dr. Gordon's experience, a patient would present two prescriptions for the same drug but different quantities on the same day, she testified: ``I have no idea. That's very unusual. I would not fill either one of these scripts. . . . It's a huge red flag for any pharmacist to get the same exact Dilaudid 8 from the same doctor on the same date. Huge red flag. No reasonable pharmacist would fill this.'' Id. at 443. Mr. Fisher agreed that an early fill was a red flag for diversion. Id. at 774. He identified early fill red flags in GX 14 on at least 13 occasions. Id. at 635-36, 637-38, 685, 692-93, 696 (two prescriptions filled on the same day), 698, 703, 704, 711, 714, 718, 721, 725, 727. Mr. Fisher testified that filling the two prescriptions on October 17, 2012 was ``highly unusual.'' Id. at 696. His testimony was that it was ``reasonable'' to fill a prescription two to three days early and that a pharmacy can do so. Id. at 700. In Mr. Fisher's view, early fill red flags were ``resolvable,'' meaning ``there's a number of explanations for an early fill.'' Id. at 686; see also id. at 693, 704-05, 711, 715, 719, 722-23, 725-26. Being ``honest,'' as he prefaced his statement, he acknowledged that an attempt to secure more drugs was one of those explanations. Id. at 687. Regarding the prescriptions for BK, he testified: ``A patient taking this medicine . . . is not going to want to run out . . . [T]he pharmacy might . . . only have 40 tablets . . . on the twelfth, and they got some more in so they call the patient . . . It also--. . . to be honest, . . . could be an attempt by a patient to secure more drugs.'' Id. at 686-87. When asked if an early fill ``can be reasonably explained where there is diversion or where there is no diversion,'' Mr. Fisher responded that, ``It could be either way.'' Id. at 687. Mr. Fisher did not explain, however, why the physician would write all four of the prescriptions on the same day, let alone break them up into smaller quantities. Mr. Fisher also suggested that ``the patient . . . [may] only come down to that area once in a while for shopping, and they fill their prescriptions whenever they get down there.'' Id. at 711. Mr. Fisher agreed that resolution of an early fill red flag ``could be'' and ``should be'' documented. Id. at 688. Respondent's Owner and PIC testified that an ``early refill'' is a red flag that ``requires definite investigation.'' Id. at 1165. She then stated, however, that the term ``early refill'' does not apply to a [[Page 10893]] schedule II controlled substance and stated, regardless, that pharmacies are ``obligated by the physician order.'' Id. at 1167, 1170. She testified, ``[T]here are two issues here, because why . . . the patient is prevented early prescriptions? It's not a refill on schedule IIs, so it's not early refill, it's an early fill. . . . The doctor fills [sic] the order, you have to fill it. You're obligated by the physician order.'' Id. In sum, both Dr. Gordon and Mr. Fisher identified about the same number of early fills in GX 14. They disagreed on how many days early a pharmacy could fill a controlled substance prescription without needing to resolve the suspicion. They also disagreed about the resolvability of early fills in general and in GX 14. Dr. Gordon testified that an early fill was not legitimate and was not resolvable. Mr. Fisher testified that red flags due to early fills were resolvable, but admitted that an attempt to secure more drugs was one of the reasons for early fill requests. Mr. Fisher agreed that a pharmacist's resolution of an early fill should be documented. Based on the testimony of Dr. Gordon and Mr. Fisher, I find that Respondent, without resolving the red flags, filled prescriptions early on at least 13 occasions. I find that the early fill-related testimony of Respondent's owner and PIC, that a prescription is a doctor's order and a pharmacist is ``obligated'' to fill a doctor's order, was Respondent's admission to an abdication of her corresponding responsibility. Allegation That Respondent Was Unable to Readily Retrieve Prescriptions It Had Dispensed The Show Cause Order alleged that Respondent committed six other violations, including that Respondent was unable to readily retrieve prescriptions it had dispensed. ALJX 1, at 7. As already discussed, the DI testified that he conducted an unannounced inspection of Respondent on April 11, 2013. Tr. 36. At that time, he stated, he asked Respondent to retrieve 12 ``problematic prescriptions'' he had identified from a Florida Prescription Drug Monitoring Program query. Id. at 41-42. Those dozen prescriptions were for ``anabolic steroid substances to patients that were not in the State of Florida.'' Id. at 42. The Show Cause Order alleged that the prescriptions were filled from February 15, 2012 to April 11, 2013, or less than two years before the date of the unannounced inspection. ALJX 1, at 7-8. The DI testified that GX 21 consisted of Respondent's daily prescription log reports he obtained on the day of the unannounced inspection. Tr. 128. According to the DI, pages 1, 4, 6, 9, 13, and 16 of Respondent's daily prescription logs showed that Respondent had dispensed nine of the 12 prescriptions referenced in the Show Cause Order. Id. at 129-131; GX 21, at 1, 4, 6, 9, 13, and 16; ALJX 1, at 7- 8. The DI further testified that the other three prescriptions appeared in the E-FORCSE report. Tr. 131; see also GX 20 (E-FORCSE query results). The DI testified that Respondent ``was never able to locate these prescriptions for me.'' Tr. 42; see also id. at 49, 125. Instead, he testified that he learned of Respondent's having located many of the missing prescriptions when he saw them in Respondent's exhibits. Id. at 270-71; see also RX 12. Two of the requested prescriptions, he testified, were never located. Tr. 1185. According to Respondent's Owner and PIC, ``[t]hey was misfiled.'' Id. at 1189. She testified that ``if the number is assigned, it means that was prescription presented to the pharmacy. . . . I know across the board, that it's common that some prescriptions do get misfiled in pharmacies.'' Id. at 1189-90. The testimony of Respondent's Owner and PIC confirmed Respondent's failure to retrieve and provide the requested prescriptions to the DI on April 11, 2013. See id. at 846; see also id. at 1186 (The first time the prescriptions were provided to the Government was as an exhibit in this proceeding.). Respondent's Owner and PIC offered excuses for that failure. Id. at 847-850. I find that Respondent never provided the 12 requested prescriptions to the DI. I find that Respondent included ten of the 12 prescriptions in an exhibit for the hearing in this proceeding more than two years after they were requested during the unannounced inspection. I find that Respondent has still not provided the Government with two of the prescriptions that the DI requested on April 11, 2013. Allegation That Respondent Shipped Controlled Substances Out-of-State Without Complying With Those States' Non-Resident Pharmacy Requirements Next, the Show Cause Order alleged that Respondent shipped controlled substances to four States (Alabama, Illinois, Kentucky, and Vermont) without complying with those States' non-resident pharmacy requirements. ALJX 1, at 8. As support for the allegation, the Government submitted prescriptions for schedule III controlled substances (testosterone cypionate, testosterone cream, and stanozolol) that Respondent filled for seven customers whose addresses were in Alabama, Georgia, Illinois, Kentucky, Massachusetts, or Vermont. See GX 15; see also Tr. 87-88 (DI), Tr. 392-93 (Dr. Gordon), Tr. 731-32, 734 (Mr. Fisher). The Government also submitted seven FedEx shipping reports showing that Respondent shipped the prescriptions to customers outside the State of Florida. GX 15. In further support of the allegation, the Government obtained certifications from Alabama, Illinois, Kentucky, and Vermont that Respondent had not complied with those States' out-of-state pharmacy requirements. See GX 24 (Alabama Board of Pharmacy Certification of Non-Licensure of Respondent for the period July 1, 1989 through April 29, 2015), GX 25 (Certification of the Division of Professional Regulation of the Illinois Department of Financial and Professional Regulation that Respondent ``does not now hold nor has ever held a license under the Pharmacy Practice Act of 1987'' dated April 16, 2015), GX 26 (Kentucky Board of Pharmacy Executive Director letter dated April 14, 2015 stating that, ``I have searched the Board records and do not find that . . . [Respondent] has or ever has been issued a license/permit''), and GX 27 (Vermont Board of Pharmacy's Licensing Board Specialist Certification of Non-Licensure of Respondent for the period July 1, 1989 through April 13, 2015). Respondent's Owner and PIC asserted that ``out-of-state patients was out of question. That was for me,'' indicating that she would not have filled out-of-state prescriptions ``[u]nder any circumstances, even the patient was really, really sick.'' Tr. 1023; see also id. at 44, 88-89 (DI's testimony that Respondent's Owner and PIC told him that Respondent never shipped a controlled substance out-of-state.). Yet, Respondent's Proposed Findings of Fact and Conclusions of Law admitted that ``[f]actually, . . . Respondent was not registered in Alabama, Illinois, Kentucky and Vermont when it shipped control [sic] substances to these states.'' Respondent's Proposed Findings of Fact and Conclusions of Law dated August 28, 2015 (hereinafter, Resp. Br.), at 4. Based on the uncontroverted documentary evidence, which I find to be more persuasive than the testimony and statements of Respondent's Owner and PIC to the contrary, and Respondent's admission, I find that Respondent shipped controlled substances out-of-state to customers in Alabama, Illinois, Kentucky, and Vermont. Further, I find that, when Respondent shipped those controlled [[Page 10894]] substances to out-of-state customers, it was not licensed or permitted to do so by the States of Alabama, Illinois, Kentucky, or Vermont. Allegation That Respondent Filled Controlled Substance Prescriptions Not Containing All of the Information Required By 21 CFR 1306.05(a) and (f) Next, the Show Cause Order alleged that Respondent filled controlled substance prescriptions that did not contain all of the information required by 21 CFR 1306.05(a). ALJX 1, at 9. As support for the allegation, the Government submitted nine prescriptions. GX 16. The DI testified that the patient's full address was missing from six of the prescriptions. Tr. 99-101; see also GX 16, at 1, 3, 5, 7, 9, and 15. He testified that the prescriber's DEA registration number was missing from four of the prescriptions. Tr. 99-101; see also GX 16, at 1, 11, 13, and 15. The DI testified that the directions for use were missing from one of the prescriptions. Tr. 99; see also GX 16, at 1. He testified that the prescriber's address was missing from four of the prescriptions. Tr. 100-01; see also GX 16, at 7, 9, 11, and 13. The DI testified that the prescriber's name was missing from two of the prescriptions, and that the prescriber's signature was missing from one of them. Tr. 100-01; see also GX 16, at 11, 13, and 15, respectively. My review and analysis of the 13 prescriptions in GX 8/8a identified information missing from prescriptions and discrepancies between information on some of the prescriptions and/or prescription labels and information on the customers' driver's licenses. See, e.g., GX 8, at 15 and 17 (missing information in customer address); id. at 3- 4 and 5-6 (discrepancies between the customer's address shown on the driver's license and shown on the prescription label); id. at 9-10 (discrepancies between the customer's address shown on the prescription and shown on the prescription label and driver's license); see also Tr. 614-15 (testimony of Mr. Fisher concerning missing information), Tr. 761-65 (testimony of Mr. Fisher concerning information discrepancies). In Mr. Fisher's opinion, Respondent did not exercise due care in entering customer addresses. Tr. 766. Respondent's Owner and PIC admitted that Respondent filled the prescriptions in GX 16. Id. at 1196. She admitted that the patient's address was missing from five prescriptions. Id. at 1194-96; see also GX 16, at 3, 5, 7, 9, and 15. Respondent's Owner and PIC testified that the prescriber's DEA registration number was missing from three prescriptions, but that those numbers appeared on the prescription fill labels. Tr. 1195-96; see also GX 16, at 11, 13, and 15, and GX 16, at 14 and 16, respectively. Respondent did not dispute the facts underlying this allegation. See, e.g., Resp. Exceptions, at 18 (``[I]t is true that twelve out of many hundreds of scripts lacked some of the information required.''). Having examined the prescriptions and all of the other evidence in the record concerning this allegation, I find the Respondent filled controlled substance prescriptions that did not contain all of the information required by 21 CFR 1306.05(a). I also find that Respondent's Owner and PIC admitted Respondent filled prescriptions not containing all of the information required by 21 CFR 1306.05(a). Allegation That Respondent Filled Prescriptions Written for ``Office Use'' in Violation of 21 CFR 1306.04(b) Next, the Show Cause Order alleged that Respondent filled prescriptions written for ``office use'' in violation of 21 CFR 1306.04(b). ALJX 1, at 10. To support this allegation, the Government submitted two Respondent ``RX Order Forms,'' one for testosterone and one for testosterone propionate, for which ``Office Use'' was written on the line designated for the patient name. See GX 17. The DI testified that these pages were controlled substance prescriptions written for ``office use.'' Tr. 252-53. Respondent's Owner and PIC testified that page 1 of GX 17 was a ``prescription'' for testosterone. Id. at 1200. She agreed that page 3 of GX 17 was a ``copy of a prescription'' for testosterone. Id. at 1202; see also Resp. Br., at 10 (``Factually, Respondent did fill the prescriptions alleged in OSC ] 6 for `office use.' ''). Respondent's Owner and PIC further testified that the entity that completed and submitted the ``RX Order Forms'' was engaged in hormone replacement therapy and wanted to ``see how the patient responds'' and ``make sure that the patient don't have allergic reaction on the prescription before they dispense it.'' Tr. 1199; see also id. at 1201. Her testimony acknowledged that Respondent ``delivered'' the testosterone ``prescribed'' on page 1 of GX 17. Id. at 1200. Regarding the prescription depicted on page 3 of GX 17, however, Respondent's Owner and PIC testified to having ``a flashback,'' stating that, ``I really remember that I don't give them that cypionate.'' Id. at 1203. I find that Respondent admitted filling at least two controlled substance ``prescriptions'' for ``office use'' and delivering at least one of them to an entity engaged in hormone replacement therapy for the purpose of allergy testing. Allegation That Respondent Filled Prescriptions Written by Physicians for the Physicians' Personal Use in Violation of Florida Statute Sec. 458.331(r) Next, the Show Cause Order alleged that Respondent filled prescriptions written by physicians for the physicians' personal use in violation of Florida Statute Sec. 458.331(r). ALJX 1, at 10. As support for this allegation, the Government submitted 12 documents that, according to the DI, included ``controlled substance prescriptions'' which doctors wrote ``to themselves.'' Tr. 106; see also GX 18. One prescription was written on Respondent's ``RX Order Form'' and had nothing written in the ``patient'' information boxes. GX 18, at 3. The labels associated with this ``prescription'' showed the same name for the patient and the prescriber. Id. at 4. Respondent admitted that, ``Factually, Respondent did fill the prescriptions alleged in OSC, ] 7 written by physicians for the physicians' personal use.'' Resp. Br., at 16. I find that Respondent admitted filling six ``prescriptions'' which doctors wrote ``to themselves,'' and that the ``prescriptions'' were for controlled substances. Allegation That Respondent Violated Florida State Law by Failing To Report Some Prescriptions to E-FORCSE in Violation of Florida Statute Sec. 893.055(4) Finally, the Show Cause Order alleged that Respondent failed to comply with Florida law by failing to report some prescriptions to E- FORCSE. ALJX 1, at 10-11; see Fla. Stat. Sec. 893.055(4) (2012). In support of this allegation, the Government submitted six Dilaudid 8 mg. prescriptions written by the same doctor from July through November of 2012. See GX 19. The DI obtained these prescriptions during his unannounced inspection of Respondent. Tr. 107; ALJX 1, at 11. The DI testified that none of these six prescriptions was reported to E-FORCSE according to his analysis of the results of his E-FORCSE query for the period February 14, 2012 to February 4, 2013. Tr. 108-10, 115; see also GX 20 (E-FORCSE query results). Further, in addition to doing his own query, the DI explained that he asked the E-FORCSE program manager to ``do a back-end query to see if these prescriptions were ever uploaded or any errors or . . . any attempts were made for these prescriptions.'' Tr. 109; see also id. at 119. As further support for this allegation, the Government [[Page 10895]] introduced the certified response the DI received from the program manager stating that, ``I certify, none of the prescriptions . . . were uploaded.'' GX 23, at 1 (Letter from E-FORCSE Program Manager to DI dated April 2, 2015); see also Tr. 118. The Program Manager's letter, the DI explained, ``shows . . . that . . . [the six prescriptions] were never uploaded'' to E-FORCSE and that there were no uploading attempts that failed due to an error. Tr. 118. The DI also testified that the second page of GX 23 ``shows the uploads that . . . [Respondent] did in that timeframe, and where those [six] prescriptions should have fallen into if . . . [Respondent] had, in fact, uploaded them.'' Id. The DI concluded from this evidence that ``these [six] prescriptions were never entered'' into E-FORCSE. Id. at 123. Respondent's Owner and PIC did not challenge the Government's contention that the six prescriptions in GX 19 did not appear in E- FORCSE. Her testimony included that ``I fully believe it was actually entered''; ``I do not know. I did the fair attempt to provide all Schedule prescriptions, and if other prescription was in E-FORCSE, this prescription should be in E-FORCSE''; ``I know that I made a fair attempt to submit this prescription along with other prescription that was accumulated for that week. That was in a compiled file''; and ``I can fairly testify that I did the best effort to submit the prescription to the E-FORCSE.'' Id. at 898, 914-15, 922-23, 935, respectively. I find that Respondent did not present evidence contesting the Government's allegation that six of the controlled substance prescriptions it filled did not appear in E-FORCSE. I find that Respondent filled, but did not report to E-FORCSE, six controlled substance prescriptions for Dilaudid 8 mg. written by the same doctor from July through November of 2012. Discussion Under Section 304 of the Controlled Substances Act (hereinafter, CSA or Act), ``[a] registration . . . to . . . 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 his registration under section 823 of this title inconsistent with the public interest as determined by such section.'' 21 U.S.C. 824(a)(4). In the case of a retail pharmacy, which is a ``practitioner'' under 21 U.S.C. 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 . . . controlled substances. (3) The applicant's conviction record under Federal or State laws relating to the . . . 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. 21 U.S.C. 823(f). [T]hese factors are . . . considered in the disjunctive. Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (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 revoke a registration. Id.; see also MacKay v. Drug Enforcement Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enforcement Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enforcement Admin., 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. ``In short, . . . 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 misconduct.'' Jayam Krishna-Iyer, M.D., 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. Under DEA's regulation, ``[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e). In this matter, while I have considered all of the factors, the Government's evidence in support of its prima facie case was confined to Factors Two and Four.\28\ I find that the Government's evidence with respect to Factors Two and Four satisfies its prima facie burden of showing that Respondent's continued registration would be ``inconsistent with the public interest.'' 21 U.S.C. 823(f). I further find that Respondent failed to produce sufficient evidence to rebut the Government's prima facie case. --------------------------------------------------------------------------- \28\ As to Factor One, there is no evidence that the Florida Department of Health or the Florida Board of Pharmacy made a recommendation concerning Respondent and the matter before me. Respondent provided several filings, from administrative proceedings and from Respondent's lawsuit against the Florida Department of Health, involving its permit to function as a community pharmacy and the compounding side of its business at its registered location and elsewhere in Florida. According to Respondent's cover letter, it provided this material due to an Order during the Prehearing Conference on April 14, 2015. ALJX 12, at 1. Material in Respondent's submission indicated that the Florida Board of Pharmacy (1) found Respondent had waived the right to request a hearing by failing to respond in a timely manner to the Administrative Complaint against it, (2) approved, adopted, and incorporated the Administrative Complaint's factual allegations, and (3) disciplined Respondent, placing it on probation for two years and requiring quarterly inspections. Id. at 20-21. The materials do not establish that Respondent lacks State authority or contain a recommendation one way or another. While there is no evidence that Florida has revoked Respondent's license, DEA has held repeatedly that a registrant's possession of a valid State license is not dispositive of the public interest inquiry. Lon F. Alexander, M.D., 82 FR 49,704, 49,724 n.42 (2017) (citing Mortimer Levin, D.O., 57 FR 8680, 8681 (1992)). As DEA has long held, ``[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.'' Alexander, 82 FR at 49,724 n.42 (citing Levin, 57 FR at 8681). As to Factor Three, there is no evidence that Respondent has a ``conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, as the Agency has noted, there are any number of reasons why 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, M.D., 75 FR 49,956, 49,973 (2010), pet. for rev. denied, MacKay v. Drug Enforcement Admin., 664 F.3d 808 (10th Cir. 2011). The DEA 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. --------------------------------------------------------------------------- Specifically, I find that the record contains substantial evidence that Respondent's pharmacists violated their corresponding responsibility when they dispensed multiple prescriptions. I also find there is substantial evidence in the record that Respondent was unable to readily retrieve prescriptions it had dispensed, shipped controlled substances out-of-state without complying with States' non-resident pharmacy requirements, and filled controlled substance prescriptions that did not contain all the information required by 21 CFR 1306.05. Accordingly, I agree with the CALJ that Respondent's registration should be revoked. Further, I agree with the CALJ's conclusions concerning Respondent's non-acceptance of responsibility and the appropriate disposition of Respondent's efforts to [[Page 10896]] show its remedial measures. R.D., at 58. For the reasons set out below, I will order that Respondent's registration be revoked and that any pending application of Respondent be denied. Factors Two and/or Four--The Registrant's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances Allegations That Respondent Failed To Exercise Its Corresponding Responsibility When It Dispensed Controlled Substances Pursuant to Prescriptions Not Issued in the Usual Course of Professional Practice or for a Legitimate Medical Purpose Under the CSA, it is ``unlawful for any person knowingly or intentionally . . . to . . . distribute[ ] or dispense, or possess with intent to . . . distribute[ ] or dispense, a controlled substance'' ``[e]xcept as authorized'' by the Act. 21 U.S.C. 841(a)(1). A pharmacy's registration authorizes it to ``dispense,'' or ``deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of . . . a practitioner.'' 21 U.S.C. 802(10). According to the CSA's implementing regulations, a lawful controlled substance order or prescription is one that is ``issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.'' 21 CFR 1306.04(a). While the ``responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, . . . a corresponding responsibility rests with the pharmacist who fills the prescription.'' Id. The regulations establish the parameters of the pharmacy's corresponding responsibility. 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. [Sec. ] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. Id. As the Supreme Court has explained in the context of the Act's requirement that schedule II controlled substances may be dispensed only by written prescription, ``the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . . [and] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006). The Government must show that the pharmacist acted with the requisite degree of scienter to prove a violation of the corresponding responsibility regulation.\29\ See Hills Pharmacy, LLC, 81 FR 49,816, 49,835 (2016). According to Agency precedent, the Government may prove a violation by showing either that: (1) The pharmacist filled a prescription notwithstanding her actual knowledge that the prescription lacked a legitimate medical purpose; or (2) the pharmacist was willfully blind or deliberately ignorant to the fact that the prescription lacked a legitimate medical purpose. Id. To establish that a pharmacist acted with willful blindness, the Government must prove that the pharmacist had a subjective belief that there was a high probability that a fact existed and she took deliberate actions to avoid learning of that fact. Id. (quoting Global-Tech Applications, Inc., v. SEB S.A., 563 U.S. 754, 769 (2011)); see also United States v. Henry, 727 F.2d 1373, 1378 (5th Cir. 1984) (citing United States v. Hayes, 595 F.2d 258 (5th Cir.), cert. denied, 444 U.S. 866 (1979) (rejecting challenge that the regulation was unconstitutionally vague)) (``What is required by him [the pharmacist] is the responsibility not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows that the issuing practitioner issued it outside the scope of medical practice. . . . [A] pharmacist can know that prescriptions are issued for no legitimate medical purpose without his needing to know anything about medical science.''). --------------------------------------------------------------------------- \29\ The Show Cause Order alleged that ``Respondent'' violated its corresponding responsibility. Respondent and the Government stipulated that: ``The Respondent is owned and operated by Veronica Taran.'' Further, Respondent's Owner and PIC admitted that she is Respondent's pharmacist-in-charge and Respondent's only pharmacist. Tr. 1012 (``[I]n this particular practice, because there's only me, there's nobody else there, like, there's no other pharmacist there.''). When asked by her counsel whose responsibility it was to resolve any red flags, she testified that ``[u]ltimate responsibility lies up me as the pharmacist and pharmacist-in- charge.'' Id. at 1045. Thus, for purposes of finding and attributing liability in this case, I find that the actions and inactions of Respondent's Owner and PIC were the actions and inactions of Respondent. --------------------------------------------------------------------------- The Government did not allege that Respondent dispensed the prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, the Government alleged that Respondent violated the corresponding responsibility regulation as ``evidenced'' by its ``dispensing of controlled substances despite the presence of red flags of diversion that . . . [it] failed to clear prior to dispensing the drugs.'' ALJX 1, at 1-2 (citing Holiday CVS); see also Government's Proposed Findings of Fact and Conclusions of Law dated August 28, 2015 (hereinafter, Govt. Br.), at 15-16. As discussed above, the testimony of Dr. Gordon, as well as testimony offered by Respondent's own witness, Mr. Fisher, supported the Government's allegations that the seven different factual circumstances the Government alleged to be ``red flags of diversion'' existed as alleged, and that Respondent did not resolve them before dispensing controlled substances.\30\ See also R.D., at 9 (``Dr. Gordon testified that she will not dispense a controlled medication in the face of an unresolved red flag . . ..'') and at 13 (``Mr. Fisher acknowledged that none of the Respondent's pharmacy paperwork reflected any documentation that red flags were resolved prior to dispensing and that he did not know whether they were ever resolved.''). Further, as discussed above, the CALJ recommended crediting that documentary and testimonial evidence. I find credible the testimony of Dr. Gordon and, to the extent he agreed with Dr. Gordon, Mr. Fisher that Respondent filled controlled substance prescriptions that raised ``red flags'' without resolving, and documenting the resolution of, those red flags. --------------------------------------------------------------------------- \30\ For example, Respondent's Owner and PIC even testified that it was not a red flag ``by itself'' for a customer to travel over 100 miles from their Florida home to Respondent to fill a controlled substance prescription. Tr. 1028. Indeed, regarding red flags, her testimony was that red flags were a stumbling block. Respondent's Owner and PIC said that ``just by strictly following these red flags, it will prevent legitimate patient from obtaining the medication.'' Id. at 1108. --------------------------------------------------------------------------- Prior Agency decisions found that prescriptions with the same ``red flags'' at issue here were so suspicious as to support a finding that the pharmacists who filled them violated the Agency's corresponding responsibility rule due to actual knowledge of, or willful blindness to, the prescriptions' illegitimacy.\31\ 21 CFR 1306.04(a). See, e.g., Hills Pharmacy, 81 FR at 49,836-39 (multiple customers filling prescriptions written by the same prescriber for the same drugs in the same quantities; customers with the [[Page 10897]] same last name and street address presenting similar prescriptions on the same day; two short-acting opiates prescribed together; long distances; drug cocktails; payment by cash); The Medicine Shoppe, 79 FR 59,504, 59,507, 59,512-13 (2014) (unusually large quantity of a controlled substance; pattern prescribing; irregular dosing instructions; drug cocktails); Holiday CVS, 77 FR 62,316, 62,317-22 (2012) (long distances; multiple customers filling prescriptions written by the same prescriber for the same drugs in the same quantities; customers with the same last name and street address presenting virtually the same prescriptions within a short time span; payment by cash); East Main Street Pharmacy, 75 FR 66,149, 66,163-65 (2010) (long distances; lack of individualized therapy or dosing; drug cocktails; early fills/refills; other pharmacies' refusals to fill the prescriptions). --------------------------------------------------------------------------- \31\ Agency precedent has defined the term ``red flag'' to mean ``a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription.'' Hills Pharmacy, 81 FR at 49,839. This precedent, in conjunction with the terms of the corresponding responsibility regulation, means that the suspicious circumstances presented by the red flags must rise to the level necessary to support a finding that the pharmacist acted with willful blindness. --------------------------------------------------------------------------- Agency precedent has made clear that, when presented with a prescription clearly not issued for a legitimate medical purpose, a pharmacist may not intentionally close her eyes and thereby avoid positive knowledge of the real purpose of the prescription. JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 FR 28,667, 28,670 (2015). Yet, that is exactly what Respondent's Owner and PIC did. As I detailed above, the testimony of Respondent's Owner and PIC acknowledged that schedule II controlled substances are highly risky and are subject to ``a lot of diversion.'' Tr. 1129, 1116 (respectively). She also specifically testified that a prescription for a large quantity of a schedule II controlled substance raised red flags. Id. at 881, 882, 887. Yet, she admitted failing to address such schedule II prescriptions presented to her pharmacy in a fashion consistent with her testimony. Id. at 1132-39. She did not explain or justify her conscious and deliberate choice to avoid learning legitimacy-related information about schedule II prescriptions that she knew were ``highly risky,'' prone to diversion, and raised red flags. These acknowledgements and failures clearly show her subjective belief of a high probability that the various schedule II prescriptions presented to her were not legitimate and her deliberate actions to avoid learning of their illegitimacy. Further, although Respondent challenged Dr. Gordon's expertise to testify that it charged exorbitantly high prices for controlled substances, Respondent did not offer any price-related evidence disputing Dr. Gordon's testimony. The evidence in the record that Respondent charged exorbitantly high prices for controlled substance prescriptions is further proof that Respondent knew or subjectively believed that there was a high probability that its customers were either abusing or diverting those controlled substances. See also id. at 362 (Dr. Gordon's testimony that ``maybe the pharmacist knew what was going on, and they were taking advantage of these patrons that were drug seeking.'') and id. at 465 (Dr. Gordon's testimony suggesting that Respondent ``knew . . . prescriptions were [being] diverted'' and ``was taking advantage of that patron . . . [b]ecause they knew they would pay whatever they needed to pay'' to fill the prescription.) The so-called ``proper steps'' for handling schedule II prescriptions that Respondent's Owner and PIC constructed were actually abdications of her corresponding responsibility. According to Respondent's Owner and PIC, her responsibility, when presented with a controlled substance prescription, was limited to (1) making sure the prescriber's medical license was current; (2) checking the prescriber's DEA registration against the controlled substance in the prescription; (3) obtaining the patient's signature on the Relationship Affidavit as alleged verification of a bona fide doctor-patient relationship; and (4) validating that the prescriber actually signed the prescription, as opposed to its having been rubber stamped. These steps, however, do not constitute an independent exercise of professional judgment by a pharmacist evaluating the legitimacy of highly suspicious controlled substance prescriptions such as those at issue here. They were clearly insufficient to determine the legitimacy of schedule II prescriptions that Respondent's Owner and PIC herself characterized as ``highly risky'' and prone to diversion. Instead, they constituted a pharmacist's abdication of responsibility for a legitimacy assessment. As for checking the currency of the prescriber's medical license and DEA registration, this is not enough as a prescriber must generally hold both a license and registration to even issue a prescription under the CSA. 21 CFR 1306.03(a). The fact that a practitioner possesses the requisite authority does not, however, mean that he/she acted in the usual course of professional practice in issuing any particular prescription and that the prescription was issued for a legitimate medical purpose. Cf. Krishna-Iyer, 74 FR at 463. As for the ``proper step'' of having a customer sign the Relationship Affidavit, Respondent's Owner and PIC did not explain why it was reasonable for her to expect customers who were drug seekers to understand the content of that document. Moreover, even if the customers did understand the document, she offered no explanation as to why her customers would be honest and truthful in answering the questions if they were seeking controlled substances to either personally abuse or divert to others.\32\ --------------------------------------------------------------------------- \32\ Further, I find that the high prices Respondent charged for controlled substances, as discussed above, suggest that Respondent knew its customers were either abusing or diverting them. --------------------------------------------------------------------------- Lastly, the ``proper step'' of ensuring that the prescription was not ``signed'' by a rubber stamp might have showed that the prescription was not an outright fraud, but it did nothing to ensure that the prescription was issued for a legitimate medical purpose. 21 CFR 1306.04(a). Respondent's Owner and PIC also testified regarding the five CII/ CIII Rx Verification Forms which were part of Respondent's ``patient files'' (see RXs 6 and 10) and ``kept in the regular course of business.'' \33\ Tr. 824-25. She also stated that they ``assisted . . . [her] to resolve the red flags.'' Id. at 824. Yet, neither she nor Respondent explained why Respondent submitted only five such forms from its ``patient files'' when the Government's evidence included 60 prescriptions and 29 patients. Moreover, while the forms indicated that the prescriptions were actually written by a physician, that the physician saw and physically examined the patient, and that there were diagnosis codes, the forms contained no additional documentation as to what circumstance prompted Respondent to contact the physician and what information the physician's office provided which led the pharmacist to approve and fill the prescription. Thus, at most, the forms establish with respect to these five patients that Respondent verified each prescription with its issuer. However, long-standing case law has explained that ``[v]erification by the issuing practitioner on request of the pharmacist . . . is not an insurance policy against a fact finder's concluding that the pharmacist had the requisite knowledge despite a purported but false verification.'' United States v. Henry, 727 F.2d at 1378 (quoting United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979)). In sum, Respondent's CII/CIII Rx Verification Forms are insufficient and do not alter my finding that Respondent [[Page 10898]] violated the corresponding responsibility regulation. --------------------------------------------------------------------------- \33\ Respondent submitted one other CII/CIII Rx Verification Form. RX 5, at 9. --------------------------------------------------------------------------- The Government also submitted prescriptions, in support of the Show Cause Order's corresponding responsibility allegation, that did not involve schedule II controlled substances. As discussed above, the controlled substance was testosterone cypionate and the same doctor wrote all of the prescriptions on the same day. GX 10. Respondent filled all of those prescriptions within the period of about an hour and a half. Id. Dr. Gordon, Mr. Fisher, and Respondent's Owner and PIC agreed that these prescriptions raised red flags. Although Respondent's Owner and PIC stated that she resolved the red flags, she did not produce any documentary evidence to support her statement and, thus, I did not afford her statement any weight. As discussed above, I found that Respondent also filled these prescriptions in the face of their red flags. The fact that Respondent's Owner and PIC acknowledged these prescriptions' red flags clearly evidenced her subjective belief of a high probability that these schedule III prescriptions were not legitimate. The fact that she simply filled them showed that she took deliberate actions to avoid learning of their illegitimacy. Accordingly, I find the Government has proved by substantial evidence that controlled substance prescriptions Respondent, by Respondent's Owner and PIC, filled were not prescriptions issued in the usual course of professional treatment, yet Respondent, by Respondent's Owner and PIC, knowingly filled, or filled with willful blindness, those prescriptions in violation of the corresponding responsibility regulation. 21 CFR 1306.04(a); see also Hills Pharmacy, 81 FR at 49,835; Superior Pharmacy I and Superior Pharmacy II, 81 FR 31,310, 31,335 (2016); The Medicine Shoppe, 79 FR at 59,515-16; East Main Street Pharmacy, 75 FR at 66,163-65.\34\ --------------------------------------------------------------------------- \34\ This case is different from Superior Pharmacy I and Superior Pharmacy II where the Government's evidence was insufficient to establish a corresponding responsibility violation even though Respondent dispensed controlled substance prescriptions in the face of unresolved red flags such as long distances, multiple people presenting identical or very similar prescriptions from the same prescriber on the same day, drug cocktails, two people in the same household or with the same address needing the exact same drugs, and payment by cash. 81 FR at 31,336. The Government's evidence in that case consisted only of the prescriptions allegedly dispensed without documentation of the resolution of red flags. As explained in that decision, there was no applicable law or rule requiring that documentation of the resolution of a red flag be placed on the prescription. Here, by contrast, the documentary and testimonial evidence made abundantly clear that Respondent did not carry out its corresponding responsibility. --------------------------------------------------------------------------- I considered Respondent's claim that Dr. Gordon's testimony should not be credited because ``she never worked as a pharmacist in an independent pharmacy'' such as Respondent and, therefore, ``her dispensing, managing and purchasing experience is not comparable to those of [Respondent's Owner and PIC].'' Resp. Br., at 37-38. I reject this claim. I have already set out my credibility determinations, which are based on the credibility recommendations of the CALJ. Those determinations afford Dr. Gordon's testimony the appropriate weight in these proceedings regarding the practice of pharmacy in Florida. Further, Respondent's claim is simply incorrect. The corresponding responsibility of a pharmacist is the same whether the pharmacist practices at an independent pharmacy or in a chain pharmacy. In other words, the size or corporate status of the pharmacy in which a pharmacist practices does not dictate the scope of a pharmacist's obligation under federal law. I reject Respondent's claim that the Government arbitrarily designated customers as having travelled long distances ``since it is not relying on any statutory enactment, federal or state to make such a designation.'' Id. at 33. Even Respondent's witness, Mr. Fisher, agreed that customers traveling long distances to fill prescriptions is a red flag. Tr. 754; see also R.D., at 47. I considered Respondent's claim that Dr. Gordon's testimony about pattern prescribing created ``an unrecognized standard under, both, case law and the Florida statutory law.'' Resp. Br., at 38. I find that Respondent's claim is without merit. Numerous agency and court cases have recognized that pattern prescribing is a red flag. See, e.g., The Medicine Shoppe, 79 FR at 59,512; see also United States v. Durante, No. 11-277, 2011 WL 6372775, at *3 (D.N.J. Dec. 20, 2011) (``This is sufficient to establish probable cause to believe that Defendant was engaged in an extensive pattern of prescribing controlled substances without a legitimate medical purpose to a broad group of patients in his medical practice.''). Further, as already discussed, even Respondent and Respondent's own witness, Mr. Fisher, eventually admitted that pattern prescribing was a red flag of diversion. During the hearing, Dr. Gordon testified about the level of the cash price Respondent charged for some prescriptions, including in comparison to what another pharmacy might charge. See, e.g., Tr. 400, 406, 410-11, 413, 415, 417-18. Respondent's Counsel objected, stating that ``the expert is testifying in price difference against what a normal pharmacist, quote, unquote, would charge versus what . . . [Respondent] charged for certain drugs, drug being Dilaudid.'' Id. at 419. He continued his objection by stating that, ``I just reviewed the prehearing statement provided by the Government, and there is no mention that their expert is going to get into the price . . . differentiation . . . between a normal pharmacy and . . . [Respondent].'' Id. at 419-20. Respondent's Counsel subsequently elicited from Dr. Gordon that she was ``never in charge of purchasing controlled substances for resale for a small independent pharmacy.'' Id. at 482; see also Resp. Exceptions, at 2. The CALJ's recommendation was that ``the Government did not adequately notice the relative price charged for the medication . . . [because] [t]he Agency recently imposed an increasingly rigorous standard of notice.'' R.D., at 10 n.60. I reject the Exception. As to the issue of notice, for reasons previously explained, the Agency has rejected the notion that the ``Agency recently imposed an increasingly rigorous standard of notice on its administrative prosecutors.'' See, e.g., Wesley Pope, M.D., 82 FR 14,944, 14,946 n.4 (2017). Here, the Government in its Prehearing Statement gave notice that Dr. Gordon would testify about ``patients willing to pay exorbitant prices'' as well as the relative price charged for the medication by Respondent. ALJX 5 (Govt. Prehearing Statement), at 11. Accordingly, I find that the Government provided adequate notice that the prices charged by Respondent would be at issue in the proceeding. To the extent Respondent argues that I should give no weight to Dr. Gordon's testimony, I reject its argument that I should reject her testimony because she has never purchased controlled substances for a small pharmacy. Indeed, Dr. Gordon specifically testified that she ``actually looked up the national . . . price.'' Id. at 503. In its Exceptions, Respondent argues that the ``absence of Respondent's corresponding exhibit should not be interpreted as an absence of records,'' and that ``it simply means that . . . the records in Respondent's possession are the same records as contained in a corresponding Government's exhibit.'' Resp. Exceptions, at 8 n.10. In this Exception, Respondent indicates its dispute with the Government's allegation that ``Respondent failed to exercise its corresponding responsibility [[Page 10899]] under the regulations by failing to acknowledge and resolve red flags related to a pattern of a doctor prescribing the exact same medication in a cookie-cutter fashion to multiple patients on the same day.'' Resp. Exceptions, at 8. As the CALJ noted, however, Respondent's Owner and PIC ``conceded that the paperwork furnished to the DIs at the April 11th Inspection did not memorialize any attempts to resolve this red flag and agreed that she did not have any paperwork documenting her identification or resolution of the issue.'' R.D., at 49 (citing Tr. 1094). While Respondent's Exception purports to correlate its ``corresponding exhibit'' with the Government's evidence, Respondent fails to explain the many instances in which Respondent simply did not offer documentary evidence to support the bald assertions of Respondent's Owner and PIC that Respondent complied with the corresponding responsibility regulation. See, e.g., R.D., at 49-50 (``[I]t is difficult to reconcile the multiple areas where the Respondent's recordkeeping system . . . had the capacity to note details such as red flag resolution with the absence of any documented indication that this, or any other red flags, were analyzed and resolved.''). Further, this Agency has applied, and I apply here, the ``adverse inference rule.'' As the DC Circuit explained, ``Simply stated, the rule provides that when a party has relevant evidence within his control which he fails to produce, that failure gives rise to an inference that the evidence is unfavorable to him.'' Int'l Union, United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v. Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (DC Cir. 1972). The Court reiterated this rule in Huthnance v. District of Columbia, 722 F.3d 371, 378 (DC Cir. 2013). According to this legal principle, Respondent's decision not to provide records gives rise to an inference that any such evidence is unfavorable to Respondent. In any event, as explained above, the records Respondent did provide concerning the Government's allegations were insufficient to rebut those allegations. Respondent suggested throughout the hearing and in its briefs that the Government's case was deficient. See, e.g., Resp. Exceptions, at 9- 10, 11, 13, 14, 15, and 16-17. Having reviewed and considered all of Respondent's claims and arguments, I find that none of them has merit. Adoption of any of them would undermine this Agency's regulatory mission, and I decline to rule against long-standing precedent. For example, in its Exceptions, Respondent argues that the Government's Expert ``admitted that she has no evidence that . . . any of the prescriptions . . . were diverted or somehow used for or with illicit purposes.'' Resp. Exceptions, at 11. Notwithstanding the Government's Expert's testimony, there is ample circumstantial evidence that the prescriptions at issue in this proceeding were issued by a physician acting outside of the usual course of professional practice. The circumstantial evidence includes that the prescriptions were for large quantities of Dilaudid 8 mg., a highly abused narcotic; that customers were traveling long distances; and that many of the customers were paying cash and exorbitantly high prices. In other instances, the evidence showed that customers were obtaining early fills of prescriptions. Second, Respondent suggests that the Government's failure to prove the prescribing doctors were not licensed or registered at the relevant time, or otherwise ``unable to lawfully issue the prescription[s],'' somehow exonerated Respondent. See, e.g., Resp. Exceptions, at 13. Respondent cites no legal authority for this Exception. Indeed, it is fatally flawed because it suggests that Respondent's corresponding responsibility is alleviated by the prescriber's medical license, controlled substances registration, or other credential. As the language of the regulation makes clear, while the prescribing practitioner is responsible for the proper prescribing and dispensing of a controlled substance, a corresponding responsibility rests with the pharmacist who fills a controlled substance prescription, and the pharmacist who knowingly fills a ``purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.'' 21 CFR 1306.04(a). Thus, contrary to Respondent's suggestion, the good order of the prescribing practitioner's license, registration, or other credential does not alleviate the pharmacist's corresponding responsibility or exonerate the pharmacist in any way. I reject Respondent's Exception. Third, Respondent claims that the Government failed to prove the existence of any indicator of controlled substance abuse specified in Fla. Admin. Code r. 64K-1.007 (adopted May 21, 2012).\35\ See, e.g., Resp. Exceptions, at 14-17. Respondent cites no legal basis for its claim that the provisions of this State Administrative Code section, that were not even in effect during the entire period covered by the Show Cause Order, are determinative of liability under Federal law. I reject Respondent's Exception. --------------------------------------------------------------------------- \35\ According to this provision, the E-FORCSE Program Manager ``may provide relevant information to the identified health care practitioners who have prescribed or dispensed controlled substances'' to an individual ``who within a 90-day time period . . . obtains a prescription for a controlled substance . . . from more than one prescriber . . . and . . . is dispensed a controlled substance . . . from five or more pharmacies.'' --------------------------------------------------------------------------- Finally, Respondent suggested that the Government's case must fail because the DI did not meet with any prescriber or speak with any customer. See, e.g., Resp. Br., at 35, 37. Respondent did not elaborate on its argument or cite any legal precedent for it. Again, Agency precedent has made clear that Respondent's argument is mistaken.\36\ Accordingly, I reject it. --------------------------------------------------------------------------- \36\ ``While it is true that a pharmacist cannot violate his corresponding responsibility if a prescription was nonetheless issued for a legitimate medical purpose, Respondent ignores that the invalidity of a prescription can be proved by circumstantial evidence.'' Hills Pharmacy, 81 FR at 49,836, n.33. --------------------------------------------------------------------------- Allegation That Respondent Filled Controlled Substance Prescriptions Not Containing All of the Information Required by 21 CFR 1306.05(a) and (f) The Show Cause Order alleged that Respondent filled controlled substance prescriptions that did not contain all the information required by 21 CFR 1306.05(a) and (f). According to that regulation, a ``corresponding liability rests upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.'' 21 CFR 1306.05(f). Among other things, those DEA regulations require that controlled substance prescriptions be ``dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.'' 21 CFR 1306.05(a). As found above, Respondent filled controlled substance prescriptions that did not contain all of the information required by 21 CFR 1306.05. As discussed above, the uncontroverted evidence is not only that Respondent violated this regulation, but that Respondent admitted violating this regulation. I find, based on all of the evidence in the record, that Respondent violated 21 CFR 1306.05(a) by filling multiple controlled substance prescriptions that were not prepared in the form prescribed by DEA regulation. [[Page 10900]] Allegation That Respondent Filled Prescriptions Written for ``Office Use'' in Violation of 21 CFR 1306.04(b) The Show Cause Order alleged that Respondent violated 21 CFR 1306.04(b) when it filled prescriptions issued for ``an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.'' ALJX 1, at 10. As explained above, GX 17 included two ``RX Order Forms'' that Respondent referred to as ``prescriptions'' and, pursuant to at least one of them, admitted delivering controlled substances to an entity engaged in hormone replacement therapy for the purpose of allergy testing. Based on Respondent's admissions, I find that Respondent filled prescriptions issued in violation of 21 CFR 1306.04(b).\37\ I note, however, that 21 CFR 1306.04(b), the provision the Government cited in the Show Cause Order, prohibits the issuance, not the filling, of prescriptions. --------------------------------------------------------------------------- \37\ After admitting that it filled ``the prescriptions alleged'' in the Show Cause Order, Respondent argued that its actions were ``legal and proper'' under 21 CFR 1307.11(a), the so- called 5% Rule. Resp. Br., at 15-16. Since I find that the Government did not allege a legal basis for the ``office use'' allegation, I need not address Respondent's argument concerning 21 CFR 1307.11(a). --------------------------------------------------------------------------- Neither the Show Cause Order nor the Government Prehearing Statement cited a statutory or regulatory provision that prohibited the filling of a prescription issued in violation of 21 CFR 1306.04(b). In addition, the Government did not discuss the ``office use'' allegation, let alone address the legal sufficiency of this allegation in the Show Cause Order or in the Government Prehearing Statement. I find that the Government did not allege a legal basis for the revocation or suspension of Registrant's registration upon a finding that Registrant ``filled'' prescriptions issued in violation of 21 CFR 1306.04(b). Thus, while I find that Respondent admitted filling prescriptions issued in violation of 21 CFR 1306.04(b), I also find that the Government did not comply with the requirement that the Show Cause Order ``contain a statement of the legal basis for . . . the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.'' 21 CFR 1301.37(c). Thus, I will not give any weight in the public interest assessment to Respondent's admission that it filled prescriptions issued in violation of 21 CFR 1306.04(b). Allegation That Respondent Filled Prescriptions Written by Physicians for the Physicians' Personal Use in Violation of Florida Statute Sec. 458.331(r) According to the Show Cause Order, Respondent ``filled prescriptions written by physicians for the physicians' personal use, in violation of Fla. Stat. Sec. 458.331(r) which prohibits `[p]rescribing, dispensing, or administering any medicinal drug appearing in any schedule set forth in chapter 893 by the physician to himself or herself.''' ALJX 1, at 10. The Show Cause Order also alleged that Respondent ``violated Florida law by dispensing controlled substances pursuant to these invalid prescriptions.'' Id. Neither it nor the Government Prehearing Statement, however, specified the provision of the allegedly violated Florida law. The CALJ referenced the corresponding responsibility provision of 21 CFR 1306.04(a) but that, of course, cannot be the provision of ``Florida law'' that the Show Cause Order referenced. During the time period covered by the Show Cause Order, Florida law required that a pharmacist, before dispensing a controlled substance listed in schedules II through IV, first determine ``in the exercise of her or his professional judgment . . . that the order is valid.'' Fla. Stat. Sec. 893.04(2)(a) (2009). The substances that Respondent admitted dispensing to physicians for their personal use, testosterone and phentermine, were listed in Florida law as controlled substances under schedules III and IV, respectively. Fla. Stat. Sec. 893.03 (2011) (``Standards and schedules''). See also Fla. Stat. Sec. 893.02(22) (2011) (defining a ``prescription'' as an order for drugs ``issued in good faith and in the course of professional practice . . . and meeting the requirements of s. 893.04.''). The Respondent's argument against liability was that the Florida statute referenced in the Order to Show Cause was not sufficiently related to preventing the diversion of controlled substances. Resp. Br., at 17-18. According to Respondent, the ``primary purpose behind Sec. 458.331 . . . is to regulate the practice of medicine and discipline physicians that have engaged in unethical and/or unprofessional behavior.'' Id. at 17. It argued that ``[c]learly, the primary purpose behind Sec. 458.331 . . . in general and Sec. 458.331(r) specifically is not `control[ling] the supply and demand of controlled substances in both lawful and unlawful drug markets' . . . or preventing drug diversion, but disciplinary actions and remedies against offending physicians.'' Id. at 18 (quoting Gonzales v. Raich, 545 U.S. 1, 19 (2005)). Respondent's argument fails as does its similar argument concerning its admitted interstate shipment of controlled substances in violation of four States' non-resident pharmacy requirements. The Florida statutes at issue concerned exactly what Respondent argued they did not. As the CALJ stated, the Florida provision cited in the Show Cause Order ``prohibits an activity that `increases the opportunity for those persons who are self-abusing or engaged in diversion to obtain controlled substances.''' R.D., at 38 n.159 (citing Fred Samimi, M.D., 79 FR 18,698, 18,710 (2014)). Further, Chapter 893, referenced in the Florida statute listed in the Show Cause Order, is entitled ``Drug Abuse Prevention and Control.'' These provisions of Florida law concern much more than physician discipline; by their very title, they go to the heart of the controlled substance anti-diversion mission--drug abuse prevention and control. The dilemma posed by this Show Cause Order allegation is whether it, in its and the hearing record's brevity concerning this charge, sufficiently noticed Respondent of the charge being levied against it. The CALJ thought not. See R.D., at 39. However, Respondent defended against this charge and, in doing so, purported to understand the charge being levied against it. I find that neither the Show Cause Order nor the Government Prehearing Statement specified a statutory provision that Respondent allegedly violated.\38\ 21 CFR 1301.37(c). Thus, even though there is evidence in the record that Respondent violated Florida law when it filled prescriptions for the personal use of the prescriptions' prescribers, I did not consider this evidence when I conducted the public interest analysis of 21 U.S.C. 823(f).\39\ --------------------------------------------------------------------------- \38\ Neither did the Government Brief specify a statutory provision that Respondent allegedly violated. \39\ Fla. Stat. Sec. 458.331(r) (which prohibited ``[p]rescribing, dispensing, or administering any medicinal drug appearing in any schedule set forth in chapter 893 by the physician to himself or herself'') in conjunction with Fla. Stat. Sec. 893.04(2)(a) (which prohibited a pharmacist from dispensing a controlled substance without first determining, in the exercise of her professional judgment, that the order was valid). --------------------------------------------------------------------------- Other Allegations Allegation That Respondent Was Unable To Readily Retrieve Prescriptions It Had Dispensed The Show Cause Order alleged that Respondent was unable to ``readily retrieve prescriptions it had dispensed'' [[Page 10901]] in violation of 21 CFR 1304.04(h)(3) and (4). ALJX 1, at 7-8. The Show Cause Order cited 12 examples of prescriptions that Respondent allegedly did not retrieve and provide to the DI as required by law. According to the regulation, which is applicable to inventories and records of controlled substances in schedules III through V, ``[p]aper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered location . . . in such form that they are readily retrievable from the other prescription records of the pharmacy.'' 21 CFR 1304.04(h)(4). The regulatory definition of ``readily retrievable'' calls for locating the records ``in a reasonable time.'' 21 CFR 1300.01(b). Agency precedent states that ``what constitutes `a reasonable time' necessarily depends on the circumstances.'' Edmund Chein, M.D., 72 FR 6580, 6593 (2007), pet. for rev. denied, Chein v. Drug Enforcement Admin., 533 F.3d 828, 832 n.6 (DC Cir 2008), cert. denied, 555 U.S. 1139 (2009). According to that precedent, ``under normal circumstances if a practice is open for business, it should be capable of producing a complete set of records within several hours of the request.'' Id. The decision explained that ``[t]o allow a registrant an even greater period of time to produce the records would create an incentive for those who are engaged in illegal activity to obstruct investigations by stalling for time in the hopes that DEA personnel would eventually give up and leave.'' Id. As found above, Respondent never provided the 12 requested prescriptions to the DI. Respondent included ten of the 12 prescriptions in an exhibit for the hearing in this proceeding more than two years after the unannounced inspection, but this is insufficient to comply with the ``readily retrievable'' requirement. As of the final day of the hearing in this proceeding, or about 28 months after the unannounced inspection, Respondent still had not provided the Government with two of the prescriptions. Accordingly, I find that the Government has proved by substantial evidence that Registrant failed to comply with the requirements of 21 CFR 1304.04(h)(3) and (4). Allegation That Respondent Shipped Controlled Substances Out-of-State Without Complying With Those States' Non-Resident Pharmacy Requirements The Order to Show Cause alleged that Respondent shipped controlled substances to customers in Alabama, Illinois, Kentucky, and Vermont without complying with those States' non-resident pharmacy requirements.\40\ As found above, Respondent shipped controlled substances to customers in Alabama, Illinois, Kentucky, and Vermont without being licensed in, or permitted by, those States to do so. Accordingly, I find that the Government has proved by substantial evidence that Registrant failed to comply with the non-resident pharmacy requirements of four States. --------------------------------------------------------------------------- \40\ Alabama (prescription shipped Jan. 14, 2013): Ala. Admin. Code r. 680-X-2-.07(2) (2005) (``No nonresident pharmacy shall ship, mail or deliver prescription drugs and/or devices to a patient in this state unless registered by the Alabama State Board of Pharmacy.''); Illinois (prescription shipped Jan. 27, 2012): Ill. Admin. Code tit. 68 Sec. 1330.550(a) (2012) (``The Division shall require and provide for an annual nonresident special pharmacy registration for all pharmacies located outside of this State that dispense medications for Illinois residents and mail, ship or deliver prescription medications into this State. . . .''); Kentucky (prescription shipped March 19, 2012): Ky. Rev. Stat. Sec. 315.0351(1) (2007) (``Every person or pharmacy located outside this Commonwealth which does business, physically or by means of the internet, facsimile, phone, mail, or any other means, inside this Commonwealth . . . shall hold a current pharmacy permit . . . issued by the Kentucky Board of Pharmacy.''); and Vermont (prescription shipped Jan. 10, 2013): Vt. Stat. Ann. tit. 26 Sec. 2061(a) (2013) (``All drug outlets shall biennially register with the board of pharmacy.''); Vt. Stat. Ann. tit. 26 Sec. 2022(7) (2013) (`` Drug outlet' means all pharmacies, . . . and mail order vendors which are engaged in dispensing, delivery, or distribution of prescription drugs.''); see also 20-4-1400 Vt. Code R. Sec. 16.1 et seq. (2013) (`` Non-resident pharmacy' means a drug outlet . . . located outside of Vermont which dispenses prescription drugs . . . for Vermont residents . . . and which mails, ships, or delivers such prescription drugs . . . into this state. . . .''). --------------------------------------------------------------------------- Respondent admitted that it was not in compliance with any of these four States' non-resident pharmacy requirements when it shipped controlled substances to customers at addresses in those States. Further, Respondent did not challenge the Government's contention that it violated these four States' non-resident pharmacy requirements when it argued that ``[i]t should be note [sic] that other than the out-of- state dispensing instances . . . [alleged], there was no evidence that . . . [Respondent] is engaged in shipping medications to states where it does not hold a Non-resident pharmacy license.'' Resp. Br., at 9. Instead, Respondent argued that its noncompliance with these four States' non-resident pharmacy statutes was insufficiently related to preventing the diversion of controlled substances to be considered under Factor Four of 21 U.S.C. 823(f). Id. at 4-9 (citing Fred Samimi, 79 FR at 18,710). The CALJ disagreed and concluded that the out-of- state pharmacy provisions had a ``sufficient nexus'' to the Act's ``core purpose of preventing drug abuse and diversion to warrant consideration under the Public Interest Factors.'' R.D., at 43. I agree with the result the CALJ recommended. The second public interest factor is ``experience in dispensing . . . controlled substances.'' 21 U.S.C. 823(f)(2). ``Dispense,'' according to 21 U.S.C. 802(10), means ``deliver a controlled substance to an ultimate user . . . pursuant to the lawful order of . . . a practitioner.'' Despite the testimony of Respondent's Owner and PIC and her statements to the DI, Respondent admitted that it ``dispensed'' controlled substances in violation of four States' legal requirements. Thus, I find that Respondent's experience in dispensing controlled substances includes the dispensing of controlled substances to customers living in four States in which Respondent was not licensed or legally authorized to dispense those controlled substances. Id. This result is consistent with Agency precedent. Sun & Lake Pharmacy, Inc.; d/b/a the Medicine Shoppe, 76 FR 24,523, 24,532 (2011) (finding that Respondent committed actionable misconduct when it dispensed prescriptions to residents of States in which it was not licensed.). See also 21 U.S.C. 802(21) (defining ``practitioner'' as meaning, in relevant part, a ``pharmacy . . . licensed, registered or otherwise permitted . . . by the . . . jurisdiction in which . . . [it] practices . . . to . . . dispense a controlled substance''). Allegation That Respondent Violated Florida State Law by Failing To Report Some Prescriptions to E-FORCSE in Violation of Florida Statute Sec. 893.055(4) The Show Cause Order alleged that Respondent failed to comply with Florida State law by not reporting specified prescriptions to E-FORCSE. As discussed above, I found that Respondent did not challenge the Government's assertion that six controlled substance prescriptions it dispensed did not appear in E-FORCSE. The CALJ found ``not persuasive'' Respondent's argument that the non-reportings ``had their genesis in a good-faith technical glitch.'' R.D., at 46 n.184. He recommended finding the testimony of Respondent's Owner and PIC on this allegation ``wholly unpersuasive,'' ``even if assumed, arguendo, to be credible.'' Id. The Florida statute that the Respondent allegedly violated required the reporting to E-FORCSE of each controlled substance dispensed ``as soon thereafter as possible, but not more than 7 days after the date the controlled substance is dispensed unless an extension is approved.'' Fla. Stat. [[Page 10902]] Sec. 893.055(4) (2012). Respondent, a covered ``dispenser'' under the provision, did not claim that it had been granted an extension under the statute. Fla. Stat. Sec. 893.055(1)(c) (`` `Dispenser' means a pharmacy . . . [or] dispensing pharmacist. . . .''). I disagree with Respondent's claim that the Florida Statute did ``not provide for any penalties for non-compliance, partial compliance or reporting errors.'' Resp. Br., at 25. To the contrary, the Florida Statute contained a criminal sanction for a willful and knowing failure to report the dispensing of controlled substances. Fla. Stat. Sec. 893.055(9) (2011) (``Any person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this section commits a misdemeanor of the first degree.''); see also Fla. Stat. Sec. 893.13(7)(a)(2) and (c) (2011) (A person who refuses or fails to keep any required record commits a misdemeanor of the first degree for a first violation and a felony of the third degree for a second or subsequent violation). Based on all of the evidence in the record, I find that Respondent did not comply with the controlled substance reporting requirements of Fla. Stat. 893.055(4). Respondent's non-compliance is appropriate for consideration under Factor Four. In this case, due to the overwhelming egregiousness of other violations that Respondent committed, my consideration of Respondent's non-compliance with the controlled substance reporting requirements of Fla. Stat. 893.055(4) did not have a determinative impact on my public interest assessment. Summary of Factors Two and Four As discussed above, the Government presented a prima facie case that Respondent, with a subjective belief of a high probability that controlled substance prescriptions were not legitimate and while taking deliberate actions to avoid learning of their illegitimacy, filled multiple prescriptions for controlled substances which lacked a legitimate medical purpose. The Government also presented a prima facie case that Respondent was unable to readily retrieve prescriptions it had dispensed, filled controlled substance prescriptions and shipped them without meeting the out-of-state pharmacy requirements of four States, filled controlled substance prescriptions that did not contain all of the required information, and failed to report controlled substance prescriptions to E-FORCSE in violation of Florida law. Thus, I conclude that Respondent engaged in egregious misconduct which supports the revocation of its registration. See Wesley Pope, 82 FR 14,944, 14,985 (2017) (collecting cases). I therefore hold that the Government has established a prima facie case that Respondent's continued registration ``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). Sanction Where, as here, the Government has met its prima facie burden of showing that Respondent's continued registration is inconsistent with the public interest due to its numerous violations pertaining to its dispensing and recordkeeping practices and its non-compliance with State laws, the burden shifts to the Respondent to show why its continued registration would nonetheless be consistent with the public interest. Medicine Shoppe-Jonesborough, 73 FR 364, 387, pet. for rev. denied sub nom. Medicine Shoppe-Jonesborough v. Drug Enforcement Admin., 300 F. App'x 409 (6th Cir. 2008). Under Agency precedent, the Respondent must ``present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility carried by such a registration.'' Hills Pharmacy, 81 FR at 49,845 (citing Medicine Shoppe-Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007)) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988))). Moreover, because past performance is the best predictor of future performance, DEA has repeatedly held that when a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for those actions and demonstrate that it will not engage in future misconduct. East Main Street Pharmacy, 75 FR at 66,162 (quoting Medicine Shoppe-Jonesborough, 73 FR at 387); see also MacKay, 664 F.3d at 820 (DEA may properly consider whether a physician admits fault in determining if the physician's registration should be revoked.). That acceptance of responsibility must be unequivocal. Lon F. Alexander, M.D., 82 FR 49,704, 49,728 (2017) (collecting cases). Moreover, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19,386, 19,387-88 (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 30,630, 30,644 (2008); see also Paul Weir Battershell, 76 FR 44,359, 44,369 (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 36,751, 36,757 n.22 (2009). Finally, 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' '' or an application should be denied. Wesley Pope, 82 FR 14,944, 14,985 (2017) (quoting Joseph Gaudio, 74 FR 10,083, 10,094 (2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36,487, 36,504 (2007))). See also Robert Raymond Reppy, 76 FR 61,154, 61,158 (2011); Michael S. Moore, 76 FR 45,867, 45,868 (2011). This is so both with respect to the respondent in a particular case and the community of registrants. See Pope, 82 FR at 14,985 (quoting Gaudio, 74 FR at 10,095 (quoting Southwood, 71 FR at 36,503)). 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''). In this case, the CALJ found that Respondent's acceptance of responsibility was ``limited in scope and can be fairly characterized as minimal.'' R.D., at 58. Specifically, the CALJ found that Respondent's Owner and PIC, on behalf of Respondent, accepted responsibility in ``only three carefully circumscribed'' areas: (1) that she did not document every single conversation with every single prescriber; (2) that she, as the pharmacist-in-charge, shouldered ultimate responsibility for ensuring required documentation was properly completed; and (3) that Respondent filled controlled substance prescriptions for patients who lived a significant distance from the pharmacy. R.D., at 58. At the hearing, Respondent's counsel asked Respondent's Owner and PIC ``[w]hat is it that you're accepting responsibility for in this case?'' Tr. 1025. Respondent's Owner and PIC testified: ``That I don't have any intention to violate DEA rules.'' Tr. 1025. This is in no sense a meaningful acknowledgement of Respondent's misconduct. In its Exceptions, Respondent contends that it ``accepted responsibility for filling long-distance prescriptions [[Page 10903]] and, as remedial measures, stopped dispensing schedule II substances all together.'' Resp. Exceptions, at 8. Respondent also argues that, through Respondent's Owner and PIC, it ``accepted the responsibility for not documenting in every instance, its efforts in resolving the red flags and as [a] remedial measure stated that it `document[s] everything that's possible.' '' Id. It further contends that, ``[a]lthough . . . [Respondent's Owner and PIC] accepted responsibility for the misfiling of the prescriptions, it is easily deuced [sic] from the record and from the instituted corrective measures that the Respondent accepted the responsibility for the missing information as well.'' Id. at 18 n.19. I reject Respondent's contentions. Most significantly, Respondent's Owner and PIC has entirely failed to acknowledge that Respondent violated the CSA when it knowingly dispensed numerous controlled substance prescriptions which were clearly issued outside of the usual course of professional practice and which lacked a legitimate medical purpose. And even as to the factual matters for which the CALJ found she accepted responsibility, such as failing to adequately document her conversations with prescribers, Respondent's Owner and PIC immediately equivocated by making excuses for not doing so in the future. She stated, ``Now I document every little thing that it's concerned to the conversation and the dispensing of controlled substances. However, there's a lot of conversation going on on a daily basis between doctors and offices.'' Tr. 1010-11. Similarly, after acknowledging that she filled controlled substance prescriptions for patients who lived a significant distance from the pharmacy, Respondent's Owner and PIC justified her filling of the prescriptions, asserting, without any evidence to corroborate her claim, that ``some of them are working locally and they all had a local doctor.'' Id. at 1026. Respondent's Owner and PIC also testified that, ``If the DEA provide me, do not fill for 100 miles, like--that's why I said, I accepted my responsibility, I took remedial measures. I do not fill schedule II prescriptions in my pharmacy because of these conflicting red flags. Because it's a practice of Florida to travel.'' Id. at 1023- 24. Respondent characterized this testimony as meaning that Respondent's Owner and PIC accepted responsibility for filling long- distance prescriptions. Resp. Br., at 36; see also Resp. Exceptions, at 8. I specifically reject Respondent's argument. Notably, this testimony began with the word ``if'' and in any event, it does not constitute an acceptance of responsibility for violating the corresponding responsibility rule. Further, the testimony was not offered in the context of addressing Respondent's filling prescriptions from its Florida customers who travelled long distances to patronize Respondent. Rather, the testimony was offered to address Respondent's filling of prescriptions for out-of-state customers, specifically customers from Kentucky about whom Respondent's Owner and PIC testified she had been ``clearly instructed'' by DEA. Tr. 1023. Notably, at no point in the hearing did Respondent's Owner and PIC accept responsibility, let alone accept responsibility unequivocally, for violating the corresponding responsibility regulation. Notably, the testimony of Respondent's Owner and PIC manifests that she still does not acknowledge the scope of a pharmacist's obligation under 21 CFR 1306.04(a). As one example, she testified that ``[t]he prescription is an order for the pharmacist to fill. For me not to fill that prescription, I have to have a very good reason not to fill it, because it's an order from the doctor to me to fill that prescription for that patient.'' Id. at 1168. As the Agency has previously recognized, a registrant cannot accept responsibility for its misconduct when it does not even understand what the law requires of it. Alexander, 82 FR at 49,729. I agree with the CALJ's conclusion that ``there is no unequivocal acceptance of responsibility on this record that would be particularly helpful to the Respondent's efforts to avoid a sanction.'' R.D., at 58. Here, the CALJ concluded that ``the paltry nature of the Respondent's acceptance of responsibility would have rendered remedial measure evidence largely irrelevant.'' Id. In addition, Respondent's misconduct included an egregious abdication of the corresponding responsibility requirement involving the dispensing of controlled substances such as Dilaudid 8 mg., a most potent and highly abused schedule II drug; the evidence also shows that Respondent committed extensive violations of other Federal and State legal requirements. Thus, due to the Respondent's ``paltry'' acceptance of responsibility and its ``intentional decision to decline to notice evidence of remedial steps'' leading to the preclusion of that evidence from consideration, the CALJ recommended that ``the record supports the imposition of a sanction.'' Id. I find that this is the appropriate result on the record in this case. I agree with the CALJ's assessment that, ``[w]here no understanding is acquired about how the regulated conduct fell short of professional and federal and state legal standards, it would be difficult (even illogical) to predict improvement.'' Id. at 59. I also agree with the CALJ's prediction that Respondent ``is likely to proceed in the future as it has in the past if not curtailed in its ability to do so.'' Id. I further agree with the CALJ that the ``sheer number of established transgressions of various types, coupled with the refusal to admit that issues existed, would render a sanction less than revocation as a message to the regulated community that due diligence is not a required condition precedent to operating as a registrant.'' Id. Respondent has not rebutted the Government's prima facie showing that its continued registration is ``inconsistent with the public interest.'' 21 U.S.C. 823(f). I will therefore order that Respondent's registration be revoked and that any pending applications be denied. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration FP1049546 issued to Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy be, and it hereby is, revoked. I further order that any pending application of Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy for renewal or modification of this registration be, and it hereby is, denied. This order is effective April 12, 2018. Dated: February 28, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-05020 Filed 3-12-18; 8:45 am] BILLING CODE 4410-09-P
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Conference.—The Commission’s of these or related investigations or contained seven categories of violations.
Director of Investigations has scheduled reviews, or (b) in internal investigations, First, it alleged that ‘‘Zion dispensed
a conference in connection with these audits, reviews, and evaluations relating controlled substances where it knew, or
investigations for 9:30 a.m. on to the programs, personnel, and should have known, that the
Wednesday, March 28, 2018, at the U.S. operations of the Commission including prescriptions were not issued in the
International Trade Commission under 5 U.S.C. Appendix 3; or (ii) by usual course of professional practice or
Building, 500 E Street SW, Washington, U.S. government employees and for a legitimate medical purpose and
DC. Requests to appear at the conference contract personnel, solely for therefore failed to exercise its
should be emailed to cybersecurity purposes. All contract corresponding responsibility regarding
preliminaryconferences@usitc.gov (DO personnel will sign appropriate the proper prescribing and dispensing of
NOT FILE ON EDIS) on or before March nondisclosure agreements. controlled substances.’’ Id. (citing 21
26, 2018. Parties in support of the Authority: These investigations are CFR 1306.04(a)). The Show Cause Order
imposition of countervailing and being conducted under authority of title stated that Respondent’s failure to
antidumping duties in these VII of the Tariff Act of 1930; this notice exercise its corresponding responsibility
investigations and parties in opposition is published pursuant to section 207.12 was evidenced by its ‘‘dispensing of
to the imposition of such duties will of the Commission’s rules. controlled substances despite the
each be collectively allocated one hour By order of the Commission. presence of red flags of diversion that
within which to make an oral Zion failed to clear prior to dispensing
Dated: March 7, 2018.
presentation at the conference. A the drugs.’’ Id. at 1–2. The Show Cause
Lisa R. Barton, Order listed seven red flags of diversion
nonparty who has testimony that may
aid the Commission’s deliberations may Secretary to the Commission. that Respondent allegedly did not
request permission to present a short [FR Doc. 2018–04973 Filed 3–12–18; 8:45 am] resolve prior to filling prescriptions.
statement at the conference. BILLING CODE 7020–02–P Id. at 2–7. It cited Holiday CVS, L.L.C.,
Written submissions.—As provided in d/b/a CVS/Pharmacy Nos. 219 and
sections 201.8 and 207.15 of the 5195, 77 FR 62,316 (2012) (hereinafter,
Commission’s rules, any person may DEPARTMENT OF JUSTICE Holiday CVS) as support for these
submit to the Commission on or before allegations.
April 2, 2018, a written brief containing Drug Enforcement Administration The Show Cause Order listed 13
information and arguments pertinent to [Docket No. 15–17] prescriptions, for customers who
the subject matter of the investigations. allegedly traveled long round-trip
Parties may file written testimony in Pharmacy Doctors Enterprises d/b/a distances of approximately 166 to 661
connection with their presentation at Zion Clinic Pharmacy; Decision and miles from home to physician to
the conference. All written submissions Order Respondent and back home, and alleged
must conform with the provisions of that Respondent filled them without
section 201.8 of the Commission’s rules; On February 23, 2015, the former having resolved the long distance red
any submissions that contain BPI must Deputy Assistant Administrator of the flags of diversion. ALJX 1, at 2–3. Each
also conform with the requirements of then-Office of Diversion Control, Drug of the 13 prescription examples was for
sections 201.6, 207.3, and 207.7 of the Enforcement Administration a controlled substance written some
Commission’s rules. The Commission’s (hereinafter, DEA or Government) time during the period of February 2012
Handbook on E-Filing, available on the issued an Order to Show Cause to through January 2013. Id.; see also
Commission’s website at https:// Pharmacy Doctors Enterprises d/b/a Government Exhibit (hereinafter, GX) 8/
edis.usitc.gov, elaborates upon the Zion Clinic Pharmacy (hereinafter, 8a.
Commission’s rules with respect to Respondent). ALJX 1. The Show Cause The Show Cause Order cited five
electronic filing. Order proposed the revocation of prescriptions written by the same doctor
In accordance with sections 201.16(c) Respondent’s registration pursuant to 21 on June 27, 2012 for five different
and 207.3 of the rules, each document U.S.C. 824(a)(4) and 823(f) on the customers for ‘‘1 ML Testosterone
filed by a party to the investigations ground that Respondent’s registration is Cypionate 210mg/mL IM,’’ a controlled
must be served on all other parties to inconsistent with the public interest. substance, that Respondent allegedly
the investigations (as identified by ALJX 1, at 1. For the same reason, the filled without first having resolved the
either the public or BPI service list), and Show Cause Order also proposed the red flags of diversion. ALJX 1, at 3–4;
a certificate of service must be timely denial of any pending application by see also GX 10.
filed. The Secretary will not accept a Respondent for renewal or modification The Show Cause Order referenced
document for filing without a certificate of its registration, and the denial of any two prescriptions for Dilaudid 8 mg., a
of service. application by Respondent for any other controlled substance, written by the
Certification.—Pursuant to section DEA registration. Id. (citing 21 U.S.C. same doctor on June 22, 2012 for two
207.3 of the Commission’s rules, any 823(f)). individuals with the same last name and
person submitting information to the As the jurisdictional basis for the the exact same street address that
Commission in connection with these proceeding, the Show Cause Order Respondent allegedly filled without first
investigations must certify that the alleged that Respondent’s DEA having resolved the red flags of
information is accurate and complete to Certification of Registration No. diversion. ALJX 1, at 4; see also GX 11.
the best of the submitter’s knowledge. In FP1049546 authorized it to dispense The Show Cause Order alleged that
making the certification, the submitter controlled substances in schedules II Respondent filled the two prescriptions
amozie on DSK30RV082PROD with NOTICES
will acknowledge that any information through V as a retail pharmacy at the on July 13, 2012 at 2:35 p.m. and 2:39
that it submits to the Commission registered location of 205 E. Hallandale p.m., respectively. ALJX 1, at 4.
during these investigations may be Beach Blvd., Hallandale Beach, Florida The Order to Show Cause alleged that
disclosed to and used: (i) By the 33009. Id. Respondent’s registration was Respondent filled two prescriptions for
Commission, its employees and Offices, to expire on March 31, 2017. Id. the same customer on the same day for
and contract personnel (a) for As the substantive grounds for the the same immediate release controlled
developing or maintaining the records proceeding, the Show Cause Order substance, but for different strengths,
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without first having resolved the red Show Cause Order listed 12 testosterone electing each option, and the
flags of diversion. Id. The two pairs of prescriptions that Respondent filled consequences for failing to elect either
prescriptions listed in the Show Cause from February 2012 through January option. ALJX 1, at 11 (citing 21 CFR
Order to illustrate this allegation were 2013 and DEA investigators requested, 1301.43).
issued for Dilaudid 8 mg. and Dilaudid but that Respondent’s staff was On February 25, 2015, the DEA
4 mg. Id.; see also GX 12. They were allegedly ‘‘unable to produce.’’ Id. at 7– Diversion Investigator (hereinafter, DI)
written during the period of September 8. assigned to the investigation of
2012 through November 2012. ALJX 1, The Show Cause Order further alleged Respondent, personally served the
at 4. that Respondent filled controlled Order to Show Cause on Respondent’s
The Show Cause Order alleged that substance prescriptions and shipped owner and operator, Veronica Taran
Respondent filled opiate them to Alabama, Georgia, Illinois, (hereinafter, Respondent’s Owner and
(hydromorphone) and benzodiazepine Kentucky, Massachusetts, and Vermont PIC).3 ALJX 5 (Government’s Prehearing
(alprazolam, clonazepam, diazepam, or without meeting the out-of-state Statement dated March 27, 2015
lorazepam) prescriptions, a ‘‘common pharmacy requirements of four of those (hereinafter, Govt. Prehearing
‘drug cocktail’ popular with drug states.2 Id. at 8. It detailed eight Statement)), at 2; ALJX 7 (Respondent’s
abusers,’’ for the same customer on the prescriptions that Respondent allegedly Prehearing Statement dated April 10,
same day at about the same time filled and shipped out-of-state, though it 2015), at 2; see also Stipulation No. 4,
without first having resolved the red did not allege that all eight were ALJX 10, at 2.
flags of diversion. Id. The Show Cause shipped in violation of a State’s non- By letter from its attorneys dated
Order cited 14 prescriptions, or seven resident pharmacy requirements. Id. at March 12, 2015, Respondent timely
pairs of ‘‘drug cocktail’’ prescriptions, 8–9; see also GX 15. requested a hearing and asked that a
that Respondent allegedly filled during The Order to Show Cause next alleged ‘‘reasonable extension to respond to an
the period of October 2012 through that Respondent filled controlled Order to Show Cause’’ be granted. ALJX
January 2013. ALJX 1, at 4–5; see also substance prescriptions that did not 3 (Hearing Request dated March 12,
GX 13. contain all of the required information, 2015), at 1; ALJX 4 (Order for Prehearing
The Order to Show Cause alleged that such as directions for use, patient Statements dated March 17, 2015), at 1.
‘‘[c]ustomers paying for their address, prescriber name, prescriber The matter was placed on the docket of
prescriptions with cash, where other red address, prescriber DEA number, and the Office of Administrative Law Judges
flags of diversion were present,’’ were prescriber signature. ALJX 1, at 9 (citing and assigned to Chief Administrative
red flags of diversion that Respondent 21 CFR 1306.05(a) and (f)). It specified Law Judge John J. Mulrooney, II
did not resolve prior to having filled the eight prescriptions and the required (hereinafter, CALJ). On March 17, 2015,
prescriptions. ALJX 1, at 5. The Show information each one allegedly lacked. the CALJ established the schedule for
Cause Order listed 50 examples of Id. at 9–10; see also GX 16. the filing of prehearing statements and
Next, the Show Cause Order alleged granted Respondent’s request for
prescriptions paid for with cash, costing
that Respondent filled prescriptions additional time ‘‘to the extent that the
as much as $1,008 for one prescription.
written for ‘‘office use’’ in violation of hearing date set in the OSC . . . will be
Id.; see also GX 8, GX 10, GX 11, and
21 CFR 1306.04(b). ALJX 1, at 10. It continued as directed at the prehearing
GX 13.
provided two examples of such conference scheduled by this order.’’
The Show Cause Order alleged that prescriptions. Id. at 10; see also GX 17.
Respondent filled prescriptions for ALJX 4 (Order for Prehearing
The Show Cause Order also alleged Statements), at 1, 2.
‘‘[c]ustomers [who] present[ed] new that Respondent filled prescriptions
prescriptions for controlled substances On March 27, 2015, the Government
written by physicians for their personal filed its Prehearing Statement. ALJX 5.
when they should not have finished use in violation of Florida law. ALJX 1,
their previous prescription for that drug On April 10, 2015, Respondent served
at 10 (citing Fla. Stat. § 458.331(r)). It its Prehearing Statement. ALJX 7. The
(‘early fills’ or ‘early refills’)’’ without referenced six examples of prescriptions
first having resolved the red flags of April 14, 2015 Prehearing Ruling and
where the name of the prescribing Protective Order found that four
diversion. ALJX 1, at 5. The Order to physician was the same name as the
Show Cause provided seven sets of ‘‘stipulations have been mutually agreed
patient. Id.; see also GX 18. to and are conclusively accepted as
examples of prescriptions that And, lastly, the Order to Show Cause
Respondent allegedly filled as many as facts.’’ ALJX 10, at 1.
alleged that Respondent violated Florida On May 6, 2015, the Government and
15 days early. Id. at 5–7; see also GX 14. law by ‘‘failing to report some
The Show Cause Order specifically Respondent filed Supplemental
prescriptions to E–FORCSE, in violation Prehearing Statements. ALJX 6 and
cited Holiday CVS, 77 FR at 62,318 as of Fla. Stat. § 893.055(4).’’ ALJX 1, at 10.
precedent for this charge. ALJX 1, at 7. ALJX 9, respectively. The parties’ joint
It listed six prescriptions that filing dated May 26, 2015 included their
Next, the Order to Show Cause Respondent allegedly did not report to 11 additional joint stipulations. ALJX
alleged that Respondent ‘‘was unable to E–FORCSE. Id. at 11; see also GX 19. 20, at 1–2.
readily retrieve prescriptions it had The Show Cause Order notified
On June 9 through 11, 2015 and on
dispensed.’’ Id. (citing subsections (a) Registrant of its right to request a
August 4, 2015, the CALJ conducted an
and (h)(3) and (4) of 21 CFR 1304.04). hearing on the allegations or to submit
evidentiary hearing in Miami, Florida.
Specifically, the Show Cause Order a written statement while waiving its
alleged that, on April 11, 2013, DEA right to a hearing, the procedures for 3 She variously testified that she was ‘‘the owner
investigators conducted an on-site of the respondent pharmacy’’ and that she was ‘‘an
amozie on DSK30RV082PROD with NOTICES
inspection of Respondent and requested Controlled Substance Evaluation Program owner and a Pharmacist-in-Charge’’ of Respondent.
specific prescriptions that Florida’s (hereinafter, E–FORCSE). Transcript Page (hereinafter, Tr.) 795, 798
2 The Order to Show Cause cited the allegedly (respectively); see also Stipulation No. 2, ALJX 10,
Prescription Drug Monitoring Program at 1.
violated state legal requirements as Alabama: Rules
showed Respondent had filled.1 Id. The of Ala. State Bd. of Pharm. § 680–x–2–.07(2); Her testimony cited in this Decision and Order
Illinois: Ill. Admin Code tit. 68, § 1330.550(a); is quoted verbatim from the hearing transcript,
1 Florida’s Prescription Drug Monitoring Program Kentucky: Ky. Rev. Stat. § 315.0351(1); and without correction or ‘‘[sic]’’ notations in addition
is called the Electronic-Florida Online Reporting of Vermont: Admin. Rules Vt. Bd. of Pharm., Part 16. to those already in the transcript.
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Recommended Rulings, Findings of On November 5, 2015, both parties registration inconsistent with the public
Fact, Conclusions of Law, and Decision filed Exceptions to the R.D. Respondent interest. I conclude that revocation of
of the Administrative Law Judge dated served supplemental Exceptions to the Respondent’s registration and denial of
October 16, 2015 (hereinafter, R.D.), at R.D. on November 16, 2015. By letter any pending application to renew or
2. At the hearing, both parties called dated November 10, 2015, the record modify Respondent’s registration are
witnesses to testify and offered was forwarded to me for Final Agency appropriate sanctions. I make the
documents into evidence. Following the Action.4 following findings.
hearing, both parties submitted briefs Having considered the record in its
Findings of Fact
containing proposed findings of fact, entirety, including all of the Exceptions
proposed conclusions of law, and filed by Respondent and the Respondent’s DEA Registration
argument. Government, I agree with the CALJ that Respondent is registered with the
On October 16, 2015, the CALJ issued Respondent’s registration should be DEA as a retail pharmacy in schedules
his Recommended Decision, including revoked and that any pending II through V under DEA Certificate of
that all but two of the Show Cause applications for its renewal or Registration No. FP1049546 at 205 E.
Order’s allegations, the sixth modification should be denied. I further Hallandale Beach Blvd., Hallandale
(prescriptions written for ‘‘office use’’) agree with the CALJ’s conclusions that Beach, Florida 33009. ALJX 1, at 1; see
and the seventh (prescriptions written Respondent dispensed controlled also Stipulation No. 1; ALJX 10, at 1.
for the prescriber’s personal use), be substances knowing that the Respondent’s registration was to expire
sustained. Id. at 33–36, 38–39 prescriptions were not issued in the on March 31, 2017. Stipulation No. 1;
(respectively). Regarding those two usual course of professional practice or ALJX 10, at 1. According to DEA’s
allegations, the CALJ’s for a legitimate medical purpose and, registration records, however, on
recommendations were that there were therefore, violated the corresponding January 31, 2017, Respondent timely
substantive violations, but that the responsibility rule of 21 CFR 1306.04(a). filed a renewal application. I take
allegations should not be sustained I agree with the CALJ that Respondent official notice of that pending
‘‘based exclusively on the lack of was unable to readily retrieve registration renewal application. 5
adequate notice under current Agency prescriptions it had dispensed and, U.S.C. 556(e).5 Respondent’s
precedent.’’ Id. at 36, 39 (respectively). therefore, violated 21 CFR 1304.04. I registration, therefore, remains in effect
The CALJ found that the Government agree with the CALJ that Respondent pending the issuance of this Decision
‘‘supplied sufficient evidence to make filled controlled substance prescriptions and Order. 5 U.S.C. 558(c).
out a prima facie case.’’ Id. at 57. He and shipped them out-of-state in
violation of four States’ non-resident The Investigation of Respondent
also found that Respondent’s acceptance
of responsibility was insufficient. Id. at pharmacy requirements. I agree with the According to the testimony of the DI,
58. Concerning remedial steps, he CALJ that Respondent violated 21 CFR he decided to investigate Respondent
explained that Respondent’s 1306.05 by filling controlled substance after learning that it had ordered 41,700
‘‘intentional decision to decline to prescriptions that did not contain all of dosage units of hydromorphone in 2012.
notice evidence of remedial steps the required information. Based on Tr. 28. This raised his suspicion because
resulted in their preclusion from Respondent’s admissions, I find that the average pharmacy in the United
consideration.’’ Id. In sum, he Respondent filled prescriptions written States ordered approximately 5,900
concluded that the record supported for ‘‘office use,’’ although I do not dosage units of hydromorphone in the
imposition of a sanction. Id. sustain this allegation due to the same time period. Id. at 28.
The CALJ included in his R.D. an Government’s failure to comply with the On April 11, 2013, the DI presented
assessment of the degree and extent of notice requirements for a Show Cause Ms. Veronica Taran, Respondent’s
Respondent’s misconduct and Order. 21 CFR 1301.37(c). I find that Owner and PIC, with a Notice of
concluded that Respondent had not Respondent filled at least one controlled Inspection. Id. at 38; see also Stipulation
‘‘accepted anything meaningful in terms substance prescription written by a No. 3; ALJX 10, at 2. The DI testified
of responsibility or learned anything.’’ physician for the physician’s personal that Respondent’s Owner and PIC read
Id. at 59. ‘‘Where no understanding is use, although I do not sustain this the notice of inspection, did not have
acquired about how the regulated allegation due to the Government’s any questions for the DI about it, signed
conduct fell short of professional and failure to comply with the notice it, and consented to the inspection. Tr.
federal and state legal standards,’’ he requirements for a Show Cause Order. 38. The DI then asked Respondent’s
wrote, ‘‘it would be difficult (even 21 CFR 1301.37(c). I agree with the Owner and PIC for various records,
illogical) to predict improvement.’’ Id. CALJ’s conclusion that Respondent including order forms and prescriptions
He determined that the Registrant ‘‘is failed to report controlled substance
likely to proceed in the future as it has prescriptions to E–FORCSE in violation 5 Under the Administrative Procedure Act, an
of Fla. Stat. § 893.055(4) (2012). I agree agency ‘‘may take official notice of facts at any stage
in the past if not curtailed in its ability in a proceeding—even in the final decision.’’
to do so.’’ Id. He concluded that the with the CALJ that Respondent’s United States Department of Justice, Attorney
‘‘sheer number of established acceptance of responsibility was General’s Manual on the Administrative Procedure
transgressions of various types, coupled insufficient and that Respondent did not Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
provide sufficient notice of remedial 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
with the refusal to admit that issues agency decision rests on official notice of a material
existed, would render a sanction less measures. fact not appearing in the evidence in the record, a
than revocation as a message to the Accordingly, I find the record as a party is entitled, on timely request, to an
whole established by substantial opportunity to show the contrary.’’ Accordingly,
amozie on DSK30RV082PROD with NOTICES
regulated community that due diligence Respondent or the Government may dispute my
is not a required condition precedent to evidence that Respondent committed
finding by filing a properly supported motion for
operating as a registrant.’’ Id. at 59. He acts which render its continued reconsideration within 10 calendar days of the date
recommended revocation of Registrant’s of this Order. Any such motion shall be filed with
4 By correspondence dated February 29, 2016, the Office of the Administrator and a copy shall be
registration and the denial of any Respondent’s counsel gave notice of ‘‘termination of served on the other party; in the event either party
pending applications for renewal. Id. at legal representation and an attorney/client files a motion, the other party shall have 10
60. relationship with the Respondent.’’ calendar days to file a response.
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filled for schedule II through V The Allegations of Dispensing and Non- Dr. Gordon’s testimony was ‘‘internally
controlled substances. Id. The DI stated Dispensing Violations consistent and logically persuasive’’ and
that ‘‘I asked Mrs. Taran if we could The Order to Show Cause alleged her qualifications ‘‘reflected a wide
take records for further review, so we seven bases for the revocation of breadth of pharmacy experience,
boxed them up and took them with us. Respondent’s registration pursuant to 21 including working in many pharmacies
She consented to that.’’ Id. at 52–53. U.S.C. 824(a)(4) and 823(f). One of them as a line pharmacist and a pharmacist in
When he left Respondent on the had seven subparts. charge,’’ and as a consultant and
unannounced inspection day, he took teacher. R.D., at 11. I agree with the
with him ‘‘2011 to 2013 Schedule II Witnesses CALJ that Dr. Gordon’s ‘‘answers rang of
through V prescriptions, . . . any Four witnesses testified at the sufficient clarity, authority, and candor
invoices or receipts covering the same hearing: The DI and Dr. Tracey J. to merit controlling weight in these
timeframe, and executed DEA 222 forms Gordon for the Government, and Louis proceedings regarding the practice of
and . . . [Respondent’s] biennial Fisher and Respondent’s Owner and PIC pharmacy in Florida.’’ Id. at 11.
Respondent offered the testimony of
inventory.’’ Id. at 50. called by Respondent. There was factual
Louis Fisher, who graduated in 1971
The DI also testified about agreement among the witnesses on a
from the Hampden College of Pharmacy
approximately a dozen problematic number of issues. When there was
and worked for DEA or its predecessor
prescriptions he had identified from E– factual disagreement, I applied the
agency from 1971 to 2003. Tr. 565. Mr.
FORCSE that Respondent’s Owner and CALJ’s credibility recommendations.
Fisher testified that, during his
PIC ‘‘was never able to locate . . . for See R.D., at 5–25.
government service, his positions
me.’’ Id. at 42, 43. ‘‘They were written Regarding the DI, the CALJ stated that included compliance investigator, quota
for different anabolic steroid substances he ‘‘presented as an objective regulator operation staff assistant, diversion
to patients that were not in the State of with no stake in the outcome of the investigator, diversion program
proceedings’’ and provided ‘‘testimony manager, and group supervisor. Id. at
Florida,’’ he testified. Id. at 42.
[that] was sufficiently detailed, 565, 570. He stated that he was ‘‘familiar
The DI testified that he asked plausible, consistent, and cogent to be
Respondent’s Owner and PIC questions, with a procedure of dispensing
fully credited.’’ R.D., at 8. I agree with controlled medications pursuant to
including how she would verify the CALJ’s assessment of the DI’s prescriptions in Florida,’’ even though
controlled substance prescriptions. Id. credibility. he never practiced pharmacy, or was a
at 39. According to the DI, Respondent’s At the hearing, the Government also licensed pharmacist, in Florida. Id. at
Owner and PIC said that she used two offered testimony from Dr. Tracey 571–72, 574–75. He testified that he was
forms, one to verify the prescription and Gordon, a pharmacist licensed in a consultant in the field of ‘‘controlled
a doctor-patient affidavit ‘‘that she Florida who had practiced pharmacy for substances abuse and diversion’’ at the
makes the patient fill out,’’ and she 21 years. Dr. Gordon testified to ‘‘ten- time. Id. at 572. Respondent sought to
checked the prescriber’s DEA number plus years of retail’’ experience in ‘‘at qualify Mr. Fisher as a ‘‘specialist in
on the DEA website and the prescriber’s least 200’’ Florida retail pharmacies preventing drug diversion.’’ Id. at 561.
license on the Florida Department of serving as a clerk, tech, intern, assistant The CALJ accepted Mr. Fisher as an
Health website. Id. at 39–40. According manager, and manager. Tr. 282, 284. She expert on the issue of dispensing in
to the DI, Respondent’s Owner and PIC testified to having experience Florida. R.D., at 11 n.74, at 17. I agree
told him that she was familiar with her dispensing controlled substances for the with the CALJ that it is appropriate to
patients and visited the doctors and treatment of chronic pain. Id. at 289. ‘‘afford . . . diminished weight [to Mr.
their offices. Id. at 40. She stated that she has served as a Fisher’s testimony] where it conflicts
The DI testified that Respondent’s pharmacist-in-charge. Id. at 351. She with other, more persuasive evidence of
Owner and PIC had posted lists: ‘‘[o]ne testified to training in, and experience record, including the testimony of Dr.
with, issues regarding the use and Gordon.’’ 7 Id. at 17; see also id. at 11
was for doctors she would fill
diversion of controlled substances, and n.74.
prescriptions for, another list of doctors
to familiarity with the pharmaceutical At the hearing, Respondent also
that she wouldn’t fill prescriptions for,
practice aspects of the use and abuse of offered testimony from Respondent’s
and ones that were pending
controlled substances. Id. at 289–90.
verification.’’ Id. at 40; see also id. at 41.
She stated that she was a licensed patterns . . . for a small sized, independent
The DI stated that Respondent’s Owner pharmacy such as Respondent.’’ Respondent’s
Consultant Pharmacist and, at the time,
and PIC specifically told him ‘‘she does was serving as a clinical Hospice
Exceptions to the ALJ’s Recommended Ruling dated
not check’’ E–FORCSE, she had never Nov. 5, 2015 (hereinafter, Resp. Exceptions), at 2.
pharmacist. Id. at 278–79. Respondent did not, however, provide a citation to
shipped a controlled substance out of Dr. Gordon was accepted, without the record for its assertion and my review found
state, and ‘‘the pharmacy was not objection, ‘‘as an expert in the practice none. 21 CFR 1316.66(a). Regardless, given that the
licensed in any other state.’’ Id. at 40– Show Cause Order did not raise ‘‘dispensing
of pharmacy in the [S]tate of Florida patterns . . . for a small sized, independent
41, 44. Regarding E–FORCSE, the DI regarding the dispensing of controlled pharmacy,’’ Respondent’s assertion is not germane
testified that he asked Respondent’s substance prescriptions.’’ R.D., at 8; see to the resolution of this matter.
Owner and PIC to ‘‘go onto’’ it to ‘‘check also Tr. 294–95.6 The CALJ found that
7 The CALJ explained that Mr. Fisher’s
a prescription for me’’ and that ‘‘she ‘‘discrepant testimony regarding his licensure and
experience was disquieting. . . . On this record,
wasn’t able to do that.’’ Id. at 48–49. 6 On cross-examination, Respondent elicited that,
the issue of Mr. Fisher’s qualifications to render an
When asked for elaboration on the although Dr. Gordon had helped her father in his expert opinion is uniquely dependent upon his own
store before she was a pharmacist, she never
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meaning of ‘‘she wasn’t able to do that,’’ representations of his experience and, thus, his
worked as a pharmacist in a small independent credibility. Either Mr. Fisher was careless . . . and
the DI responded that she did not have pharmacy. Tr. 477–78. Respondent further elicited reckless . . ., or he was engaged in an intentional
access. He testified, ‘‘She had access to that Dr. Gordon was ‘‘never in charge of purchasing effort to inflate his own qualifications. Either option
enter her data into, but not to query a controlled substances for resale for a small undermines the weight that can be logically
independent pharmacy.’’ Id. at 482. Respondent’s afforded to his opinions, and where these opinions
patient. . . . I was standing next to her first Exception to the R.D. also asserts ‘‘[a]s evident conflict with other opinions or evidence, they
when she was logged onto the computer from the record’’ that ‘‘Respondent challenged Dr. cannot be relied upon.’’ R.D., at 16 (footnote
attempting to query a patient.’’ Id. at 49. Gordon’s qualifications to testify about dispensing omitted).
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Owner and PIC. Tr. 798. Respondent’s feel pretty comfortable filling a prescription. Id. at 346–48. As a
Owner and PIC testified that she had prescription for a large quantity of pain pharmacist-in-charge, she would check
been, at the time, a practicing medication’’ if an oncologist wrote it. Id. the face of the prescription to see if a
pharmacist in Florida for about ten at 298. ‘‘But if it’s from a general subordinate pharmacist resolved a
years. Id. at 798. She testified that she practitioner or an ob-gyn,’’ she concern about the prescription. Id. at
was familiar with the Florida provision continued, ‘‘then that causes me to take 351–52. She testified that any notes
specifically addressing the dispensing of pause and reevaluate the legitimacy of about the patient, as opposed to notes
controlled substances, and that she had the prescription.’’ Id. She testified that about a specific prescription, would
taken ‘‘[m]ultiple courses’’ on ‘‘red flag the National Provider Identification appear in the patient profile. Id. at 350,
of diversions’’ as well as ‘‘read many website showed physicians’ specialties 352.
articles online about the situation in and helped the pharmacist evaluate Mr. Fisher testified that red flags ‘‘are
Florida with the pain management.’’ Id. prescriptions. Id. at 297–98, 345. She part of the pharmacist’s responsibility.’’
at 799. Respondent’s Owner and PIC also testified that a pharmacist should Id. at 616. Regarding what a pharmacist
also testified that she was a custodian of routinely check the status of a should do to resolve a red flag, Mr.
records for Respondent and supervised, controlled substance prescriber’s State Fisher first stated that the pharmacist
at the time, one technician, one intern, medical license and DEA registration. should ‘‘[c]heck the state E–FORCSE
and one student. Id. at 798–99. Id. at 301, 345. system to see if this person is a doctor-
I agree with the CALJ’s conclusion Regarding the patient, Dr. Gordon shopper.’’ Id. at 604; see also id. at 608–
that, while ‘‘[t]here were, undoubtedly, stated that a chain pharmacy’s computer 09. He also stated that he would check
aspects of . . . [the testimony of would show if the customer had filled the doctor’s license to make sure it was
Respondent’s Owner and PIC] during the prescription at another branch, and valid, check if the customer had any
which she presented as generally Florida’s prescription drug monitoring history in the pharmacy of previous
credible, . . . on the present record, her program, E–FORCSE, would show what prescriptions being filled, and ‘‘then
testimony was not sufficiently other controlled substances the talk to the doctor and see . . . what
consistent or plausible to be afforded customer had received from other the—maybe the diagnosis is on this
full credibility.’’ R.D., at 25. pharmacies or doctors. Id. at 301–02, prescription.’’ Id. at 604. When asked
345. She explained that E–FORCSE ‘‘where would you see if these things
Florida Pharmacists’ Standard of
‘‘gives you the date . . . [the were done, if they were documented,’’
Practice
prescription] was written, the date it Mr. Fisher responded that the
Dr. Gordon, Mr. Fisher, and was filled, the name of the drug, the documentation could be written on the
Respondent’s Owner and PIC testified quantity, the doctor, the pharmacy, and back of the prescription, in a notebook,
about a Florida pharmacy’s/ how the patron paid for the medication’’ in a logbook ‘‘of any kind’’ or ‘‘whatever
pharmacist’s standard of practice when which would tell the pharmacy ‘‘if the system they want to be put into effect.’’
presented with a controlled substance patient was either doctor-hopping or Id. at. 604–05. When asked whether the
prescription.8 There were some areas of pharmacy-hopping.’’ Id. at 302. red flags ‘‘would have to be documented
agreement by at least two of the three Dr. Gordon testified about the someplace,’’ Mr. Fisher responded
witnesses on some aspects of that importance of the customer’s payment affirmatively. Id. at 605; see also id. at
standard. method, explaining that ‘‘[a] lot of drug- 598–600 (Mr. Fisher’s testimony that a
According to Dr. Gordon, upon a seekers only want to pay for their pharmacist needs to resolve a red flag
customer’s presentation of a controlled medications in cash because . . . the before dispensing the prescription, and
substance prescription, the pharmacist insurance company will actually create resolution of the red flag must be
should protect the safety of the patient your red flag for you to say if a documented somewhere.). Mr. Fisher
and the community by looking for red prescription is refilled too soon, which testified that he did not know if the red
flags of diversion, or ‘‘something that means they’ve . . . obtained a flags he had identified on the
makes a pharmacist pause and think prescription from another pharmacy.’’ prescriptions in the Government’s
about’’ whether the prescription was Id. at 297; see also id. at 298–99. exhibit had been resolved. Id. at 605; see
‘‘really for a legitimate medical Dr. Gordon stated that what also id. at 766 (Mr. Fisher’s testimony
purpose.’’ Tr. 296, 303. She discussed constituted a red flag ‘‘changed all the that the prescriptions contained no
red flags including the quantity and time. It’s like the drug community gets notations evidencing that Respondent
dosage of the controlled substance, the smarter.’’ Id. at 303. She indicated that, had resolved any of their red flags.).
doctor and practice specialty, and the when confronted with a red flag, a The testimony of Respondent’s Owner
patient’s geographic location, doctor/ pharmacist would make further and PIC about diversion and what a
pharmacy patronage, and payment inquiries of the doctor, the customer, or pharmacy needed to do when presented
(insurance/cash) method. Id. at 295–97. the caregiver. Id. at 305. She noted that with a controlled substance prescription
Regarding the quantity and dosage of ‘‘some of the red flags really can’t be was largely inconsistent with the
a controlled substance used for pain resolved, especially if you see patterns.’’ testimony of Dr. Gordon and Mr. Fisher.
management, Dr. Gordon explained that Id. at 304–05. She testified that, if she Further, her testimony admitted that
‘‘I look . . . [for] a long-acting with the could not resolve a prescription’s red Respondent did not even follow the
prescription . . . [because] [i]t helps the flags, she would not fill it. Id. at 305. steps she described. It also, though,
patient to be more adherent to therapy.’’ She would either give the prescription evidenced her knowledge and
Id. at 296. back to the customer or, with the awareness that schedule II controlled
Regarding the doctor and practice doctor’s authorization, shred it. Id. substances were prone to diversion. For
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specialty, Dr. Gordon explained that, ‘‘I Dr. Gordon testified that, although example, Respondent’s Owner and PIC
there is no codified Florida rule testified that ‘‘[e]ach prescription it
8 The DI also addressed the standard of practice. specifying where a pharmacist must comes with chronic nonmalignant pain,
For example, he testified that his investigation document resolution of a red flag, the has to be addressed as a highly risky—
identified issues concerning Respondent’s
compliance with the Controlled Substances Act and
standard practice in Florida was for the high risk medication. It has to be
its implementing regulations. See, e.g., Tr. 51, 54, resolution of a red flag to be addressed with proper steps.’’ Id. at
68, 71, 73, 74–75, 76–77, 99, 102, and 124. documented on the front of the 1129. Also regarding prescriptions for
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schedule II controlled substances, she So if the patient was seen on the day that from her own procedure. Nor did she
testified that ‘‘on schedule II, each time the prescription was issued, and the justify that deviation.
it’s presented it has to be—there’s a lot quantity—the reason why he had prescribed Second, Respondent’s Owner and PIC
that quantity this month? And they would testified that she made sure the
of diversion.’’ Id. at 1116. Specifically, tell me that he has diagnosis in the proper—
Respondent’s Owner and PIC identified that doctor has a note in his chart to consider
prescriber’s State medical license was
Dilaudid 8mg. and Dilaudid 4 mg. alternative treatments . . . . I would ask active, and the prescription was within
prescriptions as ‘‘highly risky.’’ Id. at them, What did you prescribe today for that the scope of the prescriber’s DEA
1129; GX 12, at 5 and 7. When asked patient? . . . So they have to spell out what registration. Regarding a prescriber’s
whether she recalled identifying ‘‘any did they write this day, the quantity, to make State license, she testified that she
red flags’’ when she filled a prescription sure there is no alteration on the way—there would make sure that ‘‘the doctor
for 174 tablets of Dilaudid 8 mg., is no forging of the prescription. Then I actually licensed in the State of Florida
Respondent’s Owner and PIC responded would say, Is it okay for me to fill it? And to prescribe controlled
they would give me approval to fill.
that ‘‘the major red flag of that substances.’’ 10 Id. at 894. Regarding a
prescription is for Schedule II Id. at 896. Respondent’s Owner and PIC DEA registration, she testified that she
medication, Dilaudid, 8 milligram. Also, testified that after these steps, including ‘‘was instructed . . . [by DEA] to go on
prescribed on the quantities.’’ Tr. 880– ‘‘verify[ing] all the information, the the website—diversion site and verify
81. address, the phone number, the the physician DEA number’’ and
According to Respondent’s Owner complete date of birth, the doctor DEA ‘‘[s]ince that instruction I religiously did
and PIC, Respondent, and she as its PIC, number on the front, the quantities and that.’’ Id. at 892; see also id. at 1131–
needed to implement specific the medications, the signature . . . 32 (Pharmacies should ‘‘make sure that
procedures unique to schedule II [a]nd that medication was hand signed . . . [the] doctor[ ] . . . [was] legitimate,
prescriptions due to the diversion by the doctor,’’ she filled the I mean, . . . has a DEA license.’’).
associated with them. Her ‘‘specific prescription. Id. at 897. According to Respondent’s Owner
procedures’’ consisted of a series of Despite her testimony and her stated and PIC, ‘‘[t]he decision of prescribing
steps. See id. at 883–897 (using as an awareness of the high risk nature of lies upon the physicians and the state
example GX 19, at 1). First, according to schedule II prescriptions and the risk of who govern his practice.’’ Id. at 1108.
her testimony, she would ‘‘talk to doctor diversion associated with them, She elaborated, asserting that a
on each [schedule II] prescription’’ including the ‘‘red flag’’ of schedule II pharmacy must fill a controlled
because ‘‘there’s a lot of diversion’’ of controlled substances being prescribed substance prescription issued by a
schedule II controlled substances. Id. at in large quantities, Respondent’s Owner practitioner with the appropriate State
1116. Her testimony underlined the and PIC again admitted that she did not and DEA licenses unless there is ‘‘a very
importance of talking to the prescribing always follow her first step. Instead, she good reason not to fill it.’’ Id. at 1168.
doctor ‘‘each time’’ a schedule II testified that she would have to ‘‘go one- The doctor tells you it’s okay to fill, just
prescription was presented by by-one each [schedule II] prescription’’ by the filling—the filling prescription. When
comparing the diversion of schedule II before answering questions about the patient comes to the office—to the doctor,
controlled substances with schedule III whether or not she spoke with the he’s seen by the doctor. Doctor asking how
controlled substances: doctor about any of them. Id. at 1137; many pills you have, what are you taking?
Then he decide to issue another prescription.
When all the schedule II prescriptions—I see also id. at 1133–39. Thus,
Once he issue the prescription, it’s an order
would talk to doctor on each prescription. On Respondent’s Owner and PIC admitted for a pharmacy—keep in mind, we still
schedule III I would talk to doctor when more than once to not implementing her working in the medical system here. The
there’s initial prescriptions for it. But there’s own requirement of speaking to the prescription is an order for the pharmacist to
not that much schedule III situations. But on prescriber of every schedule II fill. For me not to fill that prescription, I have
schedule II, each time it’s presented it has to prescription.9 In making this admission, to have a very good reason not to fill it,
be—there’s a lot of diversion. because it’s an order from the doctor to me
she did not explain why she deviated
Id. to fill that prescription for that patient.
Respondent’s Owner and PIC 9 In the context of describing the uses of the Id. at 1167–68. Respondent’s Owner and
described the conversation she had ‘‘approved’’ stamp and the name/telephone number PIC did not explain what she meant by
regarding the first prescription in GX 19, stamp, Respondent’s Owner and PIC also testified
she verified that the prescriptions were issued
‘‘a very good reason not to fill it.’’
a prescription for 174 tablets of Dilaudid Nevertheless, I found in the record
within the scope of the prescriber’s practice when
8 mg. She stated that she called the she talked ‘‘to the [prescriber’s] office.’’ Tr. 1132. evidence of numerous controlled
office and asked to speak with the [The stamps mean that] I talk to the office and substance prescriptions that
doctor. ‘‘[H]onestly,’’ she admitted, the I spoke with the patient. And I fill out Respondent’s Owner and PIC admitted
‘‘doctor not always were available. But documentation appropriate for—I verified—and
most important, I verified this prescription was
Respondent filled without having
I spoke with the manager.’’ Id. at 895. issued within scope of the doctor’s practice. The documented the existence or resolution
The ‘‘honest’’ admission of doctor was allowed to treat chronic pain. It was the of any of the red flags of diversion
Respondent’s Owner and PIC that she scope of his practice. He made the decision to write identified in the testimony of Dr.
did not always speak with the this prescription according to his practice.
Gordon and Mr. Fisher.
prescribing doctor about a schedule II Id. at 1132–33; contra id. at 1225–27. It is
noteworthy that Respondent’s quoted testimony Third, Respondent’s Owner and PIC
prescription contradicted other concerned her calling ‘‘the office’’ as opposed to her testified that her ‘‘main concern would
testimony she gave that she always ‘‘speak[ing] with the doctor.’’ Id. at 1138, 1132, be if this patient was checked and have
spoke with the doctor regarding such respectively. It was the further admission of the relation with the doctor.’’ Id. at 885. In
prescriptions. See, e.g., id. at 1116. Respondent’s Owner and PIC that she did not
always ‘‘speak with the doctor’’ as she had testified the context of GX 19, the six Dilaudid
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Respondent’s Owner and PIC was appropriate due to the high risk nature of
continued to describe her conversation schedule II prescriptions and the risk of diversion 10 Regarding the doctor who prescribed the first
with the doctor’s office. She testified associated with them. Given her testimony that she prescription in GX 19, Respondent’s Owner and PIC
that she ‘‘would ask a manager to tell did not necessarily speak with the ‘‘doctor’’ about testified that he was ‘‘licensed in the State of
schedule II prescriptions, it also raises the question Florida to prescribe medication for chronic pain
me more what was happening with the of whether Respondent’s Owner and PIC actually management.’’ Tr. 894–95. ‘‘He was actually special
patient; was he seen on that day?’’ Id. ‘‘verified’’ that prescriptions were ‘‘issued within trained in the pain management,’’ she stated. Id. at
at 895. [the] scope of the doctor’s practice.’’ Id. at 1133. 895.
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8 mg. prescriptions the Show Cause ‘‘So we would check, . . . would the conditions mentioned below . . .
Order alleged that Respondent did not require for the patient has issues . . . [Respondent] assumes that the prescription is
report to E–FORCSE, Respondent’s [a]nd she has a medical history and valid pursuant to a legal Physician Patient
Relationship.14
Owner and PIC testified about how she there is a logical connection between
would establish the requisite doctor- her and the doctor, there’s relationship, Id. Notably, Respondent stated its
patient relationship.11 She testified that it’s not just to get a prescription for ‘‘assumption’’ that a prescription was
she would ‘‘ask . . . [the customers] to major narcotics.’’ Id. at 887–88. valid when customers affirmed and
fill out the [‘‘Pain Management According to Respondent’s Owner and satisfied the Relationship Affidavit’s
Physician-Patient Relationship PIC, the Relationship Affidavit ‘‘conditions mentioned below,’’
Affidavit,’’ hereinafter, Relationship ‘‘resolve[d]’’ these concerns. Id. at 889. presumably the ‘‘elements.’’ Id.
Affidavit] form, and sign . . . written She stated, ‘‘That form would resolve Also of note was the ‘‘Warning’’ on
affidavit’’ and ‘‘then I would call to the . . . that he’s not attempted to the Relationship Affidavit: ‘‘In the event
office and start questioning the office fraudulently—to illegally get access to . . . [Respondent] has reasons to believe
about whether this—to substantiate the the controlled pain medication.’’ Id.; see that prescriptions for pain medication
truth about it.’’ Id. at 885. She testified also id. at 1149.13 have been prescribed and/or received
that the Relationship Affidavit was to be The Relationship Affidavit was a one- fraudulently we have a legal
completed the ‘‘first time only’’ that a page form with Respondent’s name at responsibility to report such activity
customer came to Respondent the top, and name and contact and individuals to local and federal
pharmacy. Id. at 1016. She testified as information at the bottom. See, e.g., authorities. These authorities will
to what the Relationship Affidavit Respondent Exhibit (hereinafter, RX) 5, handle such individual in the manner
would ‘‘do to alleviate . . . [her] at 2. Text on the Relationship Affidavit prescribed by law.’’ Id. Respondent’s
concerns that this prescription was not stated that individuals ‘‘who are Owner and PIC discussed the
diverted.’’ Id. at 887. She stated that receiving medications to treat chronic Relationship Affidavit’s ‘‘warning’’ in
‘‘the major red flag at that time’’ was intractable pain are required to be seen her testimony. She stated that ‘‘it was
‘‘whether patient actually be seen by and examined by the physician on the actually warning that’s in the case if I
doctor, not just come to the office and same date the prescription for pain has find something which would jeopardize
have the prescription ready for them.’’ been issued.’’ Id. According to the or compromise my belief in the validity
Id. She continued by stating that ‘‘[i]t Relationship Affidavit, a customer had of the prescription, we have
was not about . . . whether this to sign it before Respondent would fill responsibility to report such activity to
prescription written for Dilaudid or a prescription. The Relationship local and federal police. And the patient
prescription written for—or quantities, Affidavit stated that: knew about it.’’ Tr. 888. She testified
it was a concern, but not the main In order for prescriptions to be filled by that, ‘‘I would say if I . . . find
concern.’’ Id. According to Respondent’s . . . [Respondent] patients are required to something . . .—. . . like Your Honor
Owner and PIC, ‘‘[t]he main concern— sign this affidavit to ensure the following giving me the benefit of the doubt, I
the problem at the time was the patient elements exist. By affirming and satisfying would give the patient the benefit of the
going and the doctor’s [sic] are not doubt. If I find out that you have a
properly executing the practice that’s pharmacy. . . , that’s how I understood the law. problem, it’s fraudulent, I will report
The pharmacist is just to establish that the you. So you better not start that
reflected in the medical practice prescription was valid—the validity of prescription
law.’’ 12 Id. Her testimony continued: based that the prescription as a requirement, and
process.’’ Id.
the doctor allowed to prescribe, and the doctor In sum, Respondent’s Owner and PIC
11 The six Dilaudid 8 mg. prescriptions in GX 19 actually see the patients. Unless there’s some issues testified that (1) she assumed the
were written by the same doctor for six different that arise with that, like, for instance, if the patient legality of a prescription based on
customers in the July-August-November 2012 time is—not that the doctor overly treated or the patient
has issues — or the doctor has issues with the
customers’ completion of the
period. Specifically, the six Dilaudid 8 mg.
prescriptions were for: (1) 174 tablets for a customer patient, or I feel something suspicious, then I call Relationship Affidavit, (2) she gave
from Pompano Beach at a cash price of $870; (2) the doctors. . . . Because standards only tell you customers ‘‘the benefit of the doubt’’
96 tablets for a customer from Fort Lauderdale at that you have to actually establish the patient is not concerning their completion of the
a cash price of $480; (3) 150 tablets for a customer coming here for wrong reasons. That’s only what
the statute says. The statute says if the patient come
Relationship Affidavit, and (3) she
from Miami at a cash price of $750; (4) 180 tablets
for a customer from Pompano Beach at a cash price for wrong reason you don’t fill it. If the patient warned customers to ‘‘better not start’’
of $900; (5) 168 tablets for a customer from come from appropriate reason, you fill.’’ Id. at the process of her ‘‘find[ing] out’’ that a
Pompano Beach at a cash price of $840; and (6) 168 1018–19, 1021. prescription is ‘‘fraudulent.’’ She did
tablets for a customer from Coral Springs at a cash 13 She also testified that she interacted with
not explain why it was reasonable to
price of $840. Respondent’s Owner and PIC had Respondent’s customers by asking them questions.
identified the first prescription for 174 Dilaudid 8 I would talk to the patient, ask him about why
expect drug seekers to understand what
mg. tablets as showing a ‘‘major red flag’’ because did he come to my pharmacy? Where did he fill they read, let alone be honest and
it was for a schedule II medication and for 174 before? What is the reason he doesn’t use previous
tablets. Tr. 881. pharmacy? And also, what is the reason for—how 14 The referenced ‘‘elements’’ apparently were
12 Apparently, the ‘‘medical practice law’’ long has he been on that medication? And whether listed in the last section of the form, which stated:
Respondent’s Owner and PIC referenced was the he was checked by—and then I would ask him to ‘‘By signing below, I ________agree that the
‘‘Ryan Act.’’ She testified that the purpose of the look at the affidavit form and sign the affidavit form following elements of a legal Pain Management
Relationship Affidavit was to ‘‘establish the patient- for the patient. . . . I have not written those Physician-Patient Relationship exist: 1. There is no
doctor relationships and the legitimate ill of the questions out. But they would be the same fraudulent representation to illegally gain access to
patients’’ in compliance with the ‘‘Ryan Act.’’ Tr. questions that I would ask to establish . . . the controlled pain medications 2. There are no
1015–16. According to Respondent’s Owner and history of the patient. multiple doctors ‘‘doctor shopping’’ treating me for
PIC, ‘‘by that law is rely if the patient actually has Tr. 882–83, 884. When asked whether she would pain management 3. A physician has seen and
a logical relation with the doctor.’’ Id. at 1016. ‘‘essentially’’ ask every customer the same conducted a physical examination 4. A physician
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She testified further about the ‘‘state statute and questions, she responded affirmatively and has reviewed the patient’s medical history 5. The
federal statutes’’: ‘‘For . . . me was most important identified other questions she asked. Id. at 884–85. patient has a medical complaint 6. MRI has been
thing was to go to references of the state statute and Respondent’s Owner and PIC, however, did not conducted within 24 months of the prescription 7.
federal statutes. So federal statute says, has to be explain the purpose of these questions given her There is a logical correlation between the following
clear relationship to establish the legitimate testimony that the signed Relationship Affidavits a. Medical Complaint b. Medical History c. Physical
medical purpose. You rely on the doctors to ‘‘resolved’’ the issue of whether customers were Exam d. Prescriptions. __________Patient Name __
establish the appropriateness of therapies. It’s not attempting to fraudulently or illegally get access to ______Date of Birth ________Signature ________
on the pharmacy to establish the appropriateness of controlled pain medication. Date.’’ RX 5, at 2.
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truthful as they completed and signed exhibits. This was a one-page form on which
I afford Dr. Gordon’s statement of the
the Relationship Affidavit. She also did Respondent would document the date and time of pharmacy’s/pharmacist’s standard of
not explain how giving customers ‘‘the a phone call to a prescriber’s office and list the practice regarding controlled substances
benefit of the doubt’’ was consistent name of the person providing the information. See controlling weight in this proceeding. I
with the requirements of the RX 6, at 6. The form was then used to document find that the requirements incumbent on
‘‘yes’’ or ‘‘no’’ as to whether: (1) The prescription
corresponding responsibility regulation. was written by the prescriber, (2) whether the pharmacies/pharmacists espoused by
21 CFR 1306.04(a). patient was seen by the prescriber at the Respondent’s Owner and PIC are only
Fourth, Respondent’s Owner and PIC prescriber’s office, and (3) whether the patient was entitled to credit as I determine what
testified that she ‘‘validate[d] that . . . physically examined by the prescriber, after which actions Respondent took and
the form provided a space for writing the diagnosis.
it’s a signature . . . not rubber signed, Id. The form then included boxes to check whether
Respondent’s suitability to be a
. . . [the prescription] was actually the prescription was approved or denied, three registrant. Essentially, the views of
signed by the physician.’’ Tr. 892; see lines for notes, and a line for the pharmacist to Respondent’s Owner and PIC about a
also id. at 1116–17 (‘‘[T]he issue at the initial. While Respondent’s Owner and PIC testified pharmacy’s/pharmacist’s obligations
time was not the strength. The issue that she used this one-page form ‘‘[i]nstead of with respect to dispensing controlled
writing scribbles on the back of the prescription,’’
they were looking for was actually the Tr. 1002, and on each of the four forms, checked substances reflect an abdication of her
prescription legitimate . . . , it’s not ‘‘yes’’ with respect to each question, listed legal responsibility to a prescriber with
fake . . . . Make sure the doctor diagnoses codes, and indicated that each a valid State license and whose DEA
actually issue it. He didn’t buy it from— prescription was ‘‘approve[d],’’ none of the forms registration covered the schedule of the
contains additional notes and only two of the forms
on the side, on the street. He didn’t get were initialed by the pharmacist. See RX 6, at 6, 10,
prescribed medication when the
his prescription from other sources, and 21, 29. customer simply signed the
actually get it from the doctor.’’). Finally, the exhibits contain copies of E–FORCSE Relationship Affidavit. Significant
Respondent’s Owner and PIC testified printouts for five of the fourteen patients. See RX aspects of the pharmacy’s/pharmacist’s
that the concept of ‘‘red flags’’ stood in 6, at 4, 7, 17, 20, 30. Of note, three E–FORSCE obligations espoused by Respondent’s
printouts were not obtained until the middle of
the way of getting medicine to deserving April 2013, see id. at 4, 7, 30, one was obtained on
Owner and PIC were contrary to statute,
individuals. She testified that, ‘‘by May 13, 2013, see id. at 20, and one was obtained regulation, and Agency precedent. I
strictly following these red flags, it will on August 23, 2013. Id. at 17. As found above, the categorically reject them.
prevent legitimate patient from DI served the Notice of Inspection on Respondent
on April 11, 2013. Allegations That Respondent Failed To
obtaining the medication.’’ Id. at 1108.
Respondent’s Owner and PIC offered multiple Exercise Its Corresponding
She testified that she decided not to fill comments about these timing issues: She ‘‘would Responsibility When It Dispensed
prescriptions for schedule II controlled not necessarily print out every time,’’ ‘‘the record Controlled Substances Pursuant to
substances altogether because that I kept in the file obviously was the latest one,’’
and ‘‘every time I check, I would check with the Prescriptions Not Issued in the Usual
‘‘following the red flags will prevent me
PDMP—with the PMP report.’’ Id. at 994. When Course of Professional Practice or for a
from filling the . . . prescriptions for questioned further by the CALJ about the E– Legitimate Medical Purpose
legitimate medical purposes . . . and be FORCSE printout for patient G.A., Respondent’s
unfair to the patient.’’ Id.15 Owner and PIC testified that the State of Florida The Show Cause Order alleged that
Before the time she testified to having ‘‘would not give us the access’’ and ‘‘for a while I Respondent failed to exercise its
decided not to fill schedule II relied on the physician offices to provide me that corresponding responsibility under 21
information. I would call the physician to run the
prescriptions, Respondent’s Owner and PMP report until I actually were able to get the
CFR 1306.04(a) as evidenced by its
PIC testified that her ‘‘liability was to access myself . . . .’’ Id. at 996. Respondent’s having dispensed controlled substances
prevent the diversion the best that I can, Owner and PIC stated that she got access to E– without resolving ‘‘red flags of
considering it was very, very little FORCSE ‘‘sometime during 2013.’’ Id. at 997–98. diversion’’ that were present. The
Respondent’s Owner and PIC testified that this Government alleged seven ‘‘red flags of
guidelines was provided to us at that information was important to her because it told her
time. We tried to update it, it was ‘‘that this patient . . . was seen by the same doctor diversion’’ in the Show Cause Order:
confusing, the red flags was changing.’’ for over . . . [a] seven-month period. And so this Prescriptions presented by customers
Id. at 890. Apparently based on the patient requires therapy. And the doctor was a very who traveled long distances to
local doctor . . . [a]nd he was going only to my Respondent; multiple customers filling
individual perspective of Respondent’s pharmacy. So [the customer] relied on me to fill her
Owner and PIC concerning what prescription.’’ Id. at 986–87. Yet, with respect to prescriptions written by the same
pharmacies should do, Respondent patient S.B., her E–FORCSE printout showed that prescriber, for the same drugs, in the
designed its own forms ‘‘to support the she had filled her controlled substance same quantities, on the same day;
prescriptions at three different pharmacies as well multiple customers from the same
establishment of legitimate medical as through a mail order service, RX 6, at 7, and with
purpose to fill’’ prescriptions. Id. at respect to patient D.K., his E–FORSCE printout address coming to Respondent at the
981.16 showed that he had filled his prescriptions for both same time with prescriptions from the
oxycodone and hydromorphone at four pharmacies same doctor for the same drug and
15 She added, ‘‘Except two instances when I had in addition to Respondent. Id. at 20.
this overstock and the patient was patient of mine While Respondent’s Owner and PIC also testified see RX 6, at 7, and all four hydromorphone
for other reasons, we decide to fill. . . . And I don’t that G.A.’s ‘‘established relationship’’ with the prescriptions listed on T.S.’s E–FORCSE printout,
purchase them [schedule II controlled substances].’’ doctor was ‘‘one of the thing that you use—one of each of these being for 150 or more dosage units of
Tr. 1108–09. the tools that you use with—to establish legitimate the 8 mg. dosage. Id. at 30.
16 See, e.g., RX 6 and RX 10. These exhibits medical purpose . . . [because] you can fairly
Respondent submitted a further exhibit, RX 11,
include various items of documentation with assume that the patients are being taken [sic] by the
which contained documentation related to other
respect to fourteen customers which Respondent physician properly,’’ id. at 988–89, Dr. Gordon
customers. Respondent’s Owner & PIC testified that
represented were obtained to determine the validity testified that ‘‘[t]he first . . . [red flag] that is really
this exhibit was ‘‘generated . . . [t]o show in good
of the prescriptions. Tr. 824. Each of the exhibits bold to me is the doctor. I’ve worked on other cases,
faith that we are actually conducting best practices.
contains a copy of each customer’s driver’s license, and I’ve seen this doctor [R.T.] write lots of
. . . That we document good practice when we fill
amozie on DSK30RV082PROD with NOTICES
and copies of the Pain Management Physician- illegitimate prescriptions.’’ Id. at 360–61. Notably,
the patient—we’re filling pain medication for sick
Patient Relationship Affidavit for 11 of the each of the seven prescriptions listed on G.A.’s E–
patient.’’ Tr. 1173–74. The exhibit consist of a
customers. There are also copies of printouts from FORCSE printout was written by Dr. R.T., and each
photocopy of the driver’s licenses of three of the six
the DEA registration web page with respect to five prescription was for 150 or 160 dosage units of
customers for whom the prescriptions in GX 14
of the customers. RX 6, at 3, 18, 35; RX 10, at 6, hydromorphone 8 mg. RX 6, at 4. Dr. R.T. also
were written; a Relationship Affidavit signed by
12. wrote five of the prescriptions listed on S.B.’s E–
two of the six customers; and a one page E–FORCSE
FORCSE printout (including all four
There are also copies of a ‘‘CII/CIII Rx printout dated months after the corresponding
hydromorphone prescriptions, three of these being
Verification Form’’ for four customers in these two prescriptions in GX 14 were written and filled.
for 160 dosage units or more of the 8mg. dosage),
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strength; customers presenting two parties stipulated that the distance by road attempt to resolve the prescriptions’ red
prescriptions, both for the same from Fort Pierce to Miami to Hallandale flags, or she looked for notations herself.
immediate release controlled substance, Beach and back to Fort Pierce is 261 miles. She found none. Id. at 356, 364, 369,
• 168 tablets of Dilaudid 8 mg. issued to
but for different strengths; customers SB of Fort Pierce by Dr. RT of Miami. The 371, 373, 374, 377, 381–82, 384, 387–88,
presenting prescriptions with a parties stipulated that the distance by road 389–90, 391. On cross examination, Dr.
combination of an opiate and a from Fort Pierce to Miami to Gordon testified to the absence of
benzodiazepine or ‘‘drug cocktail’’ Hallandale Beach and back to Fort Pierce documentation on the other
popular among drug abusers; customers is 261 miles. prescription. Id. at 494. Dr. Gordon was
paying for their prescriptions with cash, • 150 tablets of Dilaudid 8 mg. issued to asked whether the distance red flags on
when other red flags of diversion were CW of Fort Pierce by Dr. RT of Miami. The 12 of the prescriptions were resolvable.
present; and customers presenting new parties stipulated that the distance by road
from Fort Pierce to Miami to Hallandale She testified they were not. Id. at 355,
prescriptions for controlled substances 367, 369, 371, 373, 374, 377–78, 382,
Beach and back to Fort Pierce is 261 miles.
when they should not have finished • One bottle of Buprenorphine 384, 388, 390, 391. She was not asked
their previous prescription for that drug Hydrochloride 0.3 mg/mL issued to MW of about the resolvability of the distance
(‘‘early fills’’ or ‘‘early refills’’). Hobe Sound by Dr. AF of Hallandale Beach. red flag on the other prescription, but
The parties stipulated that the distance by said that its red flag had not been
Prescriptions Presented by Customers
road from Hobe Sound to Hallandale Beach ‘‘resolved.’’ Id. at 364. Of that
Who Traveled Long Distances to and back to Hobe Sound is 166 miles.
Respondent • 140 tablets of Dilaudid 8 mg. issued to
prescription, she also stated: ‘‘That’s a
DK of Jensen Beach by Dr. NG of Hallandale very long distance [261 miles from Fort
The Government alleged that
customers traveling long distances to fill Beach. The parties stipulated that the Pierce to Miami to Hallandale Beach to
their prescriptions was a ‘‘red flag of distance by road from Jensen Beach to Fort Pierce] for somebody that has pain
diversion,’’ and that Respondent Hallandale Beach and back to Jensen Beach to be driving—sitting in a car for that
is 195 miles. long to obtain Dilaudid 8, which is the
dispensed controlled substances to • 56 tablets of Dilaudid 8 mg. issued to BS
customers who traveled long round-trip highest milligrams it comes in.’’ Id. at
of Port St. Lucie by Dr. ML of Hollywood.
distances, from their homes, to the 361.
The parties stipulated that the distance from
prescribers, to Respondent, and then Port Saint Lucie to Hollywood to Hallandale In sum, Dr. Gordon concluded that
back home, without addressing or Beach and back to Port Saint Lucie is 201 none of the 13 prescriptions was
resolving the distance red flags. To miles. legitimate and that the pharmacist who
support this allegation, the Government • 150 tablets of Dilaudid 8 mg. issued to filled the prescriptions had not
TS of Sebastian by Dr. RT of Miami. The
submitted 13 such prescriptions filled exercised her corresponding
parties stipulated that the distance from
by Respondent. See GX 8/8a; 17 see also Sebastian to Miami to Hallandale Beach and responsibility to make sure the
Tr. 53 (DI testifying that GX 8 contained back to Sebastian is 318 miles. prescriptions were issued for a
fair and accurate copies of the • One bottle of testosterone cypionate 210 legitimate medical purpose by a
documents Respondent provided to mg/mL issued to RV of Sebring by Dr. AF of practitioner acting in the usual course of
him). Of the 13 prescriptions in GX Hallandale Beach. The parties stipulated that professional practice. Id. at 357, 364–65,
8/8a, nine were for Dilaudid 8mg.18 the distance by road from Sebring to 367–78, 370, 371, 373, 375, 378, 382,
The DI testified that he initially Hallandale Beach and back to Sebring is 312 385, 388, 390, 391–92.
identified the prescriptions in GX 8/8a miles.
• 112 tablets of Dilaudid 8 mg. issued to Mr. Fisher’s testimony about whether
as ‘‘problematic’’ because they showed BR of St. Pete Beach by Dr. DJ of Deerfield distance was a red flag was inconsistent.
‘‘[p]eople traveling long distance[s] to Beach. The parties stipulated that the At one point, Mr. Fisher testified that
the pharmacy.’’ Tr. 50–51. The parties distance by road from Saint Pete Beach to the prescriptions included in GX 8
stipulated to sets of round-trip (by road) Deerfield Beach to Hallandale Beach and evidenced distance red flags, and that
miles within the State of Florida. ALJX back to Saint Pete Beach is 538 miles.
• 112 tablets of Dilaudid 8 mg. issued to he believed they could have been
20, at 1–2. Those sets of round-trip
WP of Stuart by Dr. GF of Pembroke Park. resolved. Id. at 596–97. ‘‘Usually,’’ he
miles corresponded to miles traveled by
The parties stipulated that the distance by stated, ‘‘a prescription is going to be
customers for whom Respondent filled
prescriptions listed in the Show Cause road from Stuart to Pembroke Park to filled close to where the physician is or
Hallandale Beach and back to Stuart is 184 close to where the person lives.’’ Id. at
Order and included in GX 8/8a. In sum, miles.
the round-trips ranged from 184 miles to 597; see also id. at 601 (Mr. Fisher’s
GX 8/8a. testimony that Fort Pierce is a ‘‘distance
661 miles. I make the following
findings: Dr. Gordon testified that the long from the area.’’). At another point,
distances the customers traveled in however, Mr. Fisher appeared to testify
• One bottle of Buprenorphine that distance was a red flag only when
Hydrochloride 0.3 mg/mL issued to FW of connection with obtaining and filling all
Deltona by Dr. AF of Hallandale Beach. The of the prescriptions in GX 8/8a were red Respondent was asked to fill
parties stipulated that the distance by road flags. Tr. 353–62, 365, 368, 370, 372, prescriptions for intrastate customers, as
from Deltona to Hallandale Beach and back 374–77, 380–82, 384–85, 387–92. She opposed to out-of-state customers, even
to Deltona is 504 miles. explained: ‘‘Pharmacies that dispense though out-of-state customers would be
• 150 tables of Dilaudid 8 mg. issued to prescriptions that are not for legitimate located further from Respondent than
GA of Fort Pierce by Dr. RT of Miami. The medical purpose, they have a tendency intrastate customers. Id. at 745. The
to develop a reputation. And then the CALJ sought clarification, asking: ‘‘[I]f a
17 The materials in GX 8 and GX 8a, 13
other drug seekers find out about it, and person was a long distance but they
prescriptions and corresponding prescription
amozie on DSK30RV082PROD with NOTICES
labels, were identical. There were driver’s licenses they’ll go to any distance to get what were in Florida, that would be a red
associated with nine of the 13 prescriptions/ they need for their—to satisfy their flag. But if a person was living a long
prescription labels. GX 8a contained better copies addiction.’’ Id. at 355. distance . . . in Georgia, that’s not a red
of most of the driver’s licenses than GX 8. Tr. 793. For 12 of the 13 prescriptions, Dr. flag? . . . So what’s your final answer;
Those better copies were added to GX 8 as GX 8a
during the hearing on June 11, 2015. Id. at 794. Gordon was asked to look for notations that it is a distance red flag or it’s not.’’
18 The other four were for buprenorphine (2), on the prescriptions evidencing that the Id. at 745–46. Mr. Fisher responded:
Xanax, and testosterone. filling pharmacist had taken steps to ‘‘It’s a distance red flag, which is
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resolvable.’’ 19 Id. at 746; see also id. at would just—probably would be a little conclude the exact opposite to be the
754. Thus, Mr. Fisher eventually agreed bit more routine in the call.’’ Id. at 1004, case.
with the testimony of the Government’s 1005–06 (respectively). This testimony I find that each of the prescriptions in
expert that customers who traveled long of Respondent’s Owner and PIC was GX 8/8a raised at least one red flag that
distances to fill controlled substance inconsistent with her testimony that required resolution in that customers
prescriptions were red flags. ‘‘When all the schedule II traveled long distances to obtain
Respondent’s Owner and PIC prescriptions—I would talk to doctor on controlled substances, including
admitted that Respondent filled the each prescription.’’ Id. at 1116. schedule II controlled substances that
prescriptions in GX 8/8a. Id. at 979. She Respondent’s Owner and PIC stated even Respondent’s Owner and PIC
testified that it was not a red flag ‘‘by that she did not document all her admitted were ‘‘highly risky’’ and
itself’’ for customers within the State of conversations with doctors because ‘‘it’s subject to ‘‘a lot of diversion.’’ Id. at
Florida to come over 100 miles from my kind of internal—I did it to make a 1129, 1116, respectively. I find that
their homes to fill a controlled proper, sound clinical judgment Respondent admitted filling the
substance prescription at her pharmacy. whether this patient appropriate to get prescriptions in GX 8/8a. Based on the
Id. at 1028; see also id. at 1021–22 (In . . . these filled prescriptions.’’ Id. at testimony of both Dr. Gordon and Mr.
2012 and 2013, ‘‘the fact that a patient 1010. Notably, she stated that, ‘‘I do Fisher, I find that, at a minimum, the
traveled a long distance . . . was not a accept responsibility for that and I don’t distances the patients traveled to
major red flag, no.’’ There were ‘‘other do it any more. Now I document every present the prescriptions in GX 8/8a
red flags that I was concentrating on.’’). little thing that it’s concerned to the required Respondent to resolve the
Respondent submitted CII/CIII Rx conversation and the dispensing of distance red flags before dispensing
Verification Forms for four of the 13 controlled substances.’’ Id. She also said controlled substances. I further find that
prescriptions in GX 8/8a.20 RX 6, at 6, that, ‘‘again, like I said, I accept Respondent did not address or resolve
10, 21, and 29. According to responsibility for that and I improve my the red flags before filling the
Respondent’s Owner and PIC, these four practice now. I do document everything prescriptions in GX 8/8a.
forms were part of Respondent’s that’s possible to. However, like I said,
‘‘patient files,’’ the ‘‘documents— Multiple Customers Filling Prescriptions
this happens all the time.’’ Id. at 1011. Written by the Same Prescriber, for the
prescriptions, prescription labels, and She added that ‘‘we cannot have 100
corresponding documents which Same Drugs, in the Same Quantities, on
percent even if it’s red flag. . . . You the Same Day
assisted me to resolve the red flags made try to do the best that you can, but
by . . . [Respondent] and kept in the sometimes it happens.’’ Id. at 1012. The Government alleged that
regular course of business.’’ Tr. 824–25. The CALJ noted that ‘‘it seems to me prescriptions written by the same
She asserted that the CII/CIII Rx that on the form that you’re giving me, prescriber, for the same drugs, in the
Verification Form was a ‘‘step ahead,’’ the place that that should have been same quantities, and on the same day
and ‘‘above and beyond’’ the ‘‘general noted is down at the bottom where it was a ‘‘red flag of diversion,’’ and that
practice of most of the pharmacies in says ‘notes,’ and also the pharmacist’s Respondent filled such prescriptions
the State of Florida.’’ Id. at 1001. She initials if you had made the call.’’ 21 Id. without resolving that red flag. As
further testified that ‘‘[i]nstead of at 1013. Respondent’s Owner and PIC, support for this allegation, the
writing scribbles on the back of the correlating the exercise of her Government submitted five
prescription, . . . you have, more or corresponding responsibility with her prescriptions that were written by the
less, here on form.’’ Id. at 1002. practice in school of ‘‘taking very little same doctor (Dr. A.F.) on the same day
While the forms contained diagnosis notes,’’ admitted that ‘‘I do have a (June 27, 2012), and for the same
codes, only two of the forms were tendency not to take too many notes’’ strength of the same medication
initialed by the pharmacist, and none of and confirmed that ‘‘I should learn how (testosterone cypionate). See GX 10; see
the forms contained any notes to take better notes.’’ Id. at 1014. She also Tr. 394 (testimony of Dr. Gordon),
explaining how Respondent’s said that she ‘‘took remedial steps for it’’ Tr. 67 (DI testifying that GX 10
pharmacist resolved whatever prompted by ‘‘hir[ing] new person who actually contained fair and accurate copies of
her to call the prescriber even though specifically look if I leaving the notes documents he obtained from
the form contained three lines for this . . . and everything is properly taken Respondent on April 11, 2013), and Tr.
purpose. RX 6, at 6, 10, 21, 29. 68. Respondent filled them all on June
right now.’’ Id. Further, Respondent’s
Regarding the incompletions, 28, 2012, between 11:24 a.m. and 12:56
Owner and PIC admitted that red flags
Respondent’s Owner and PIC testified p.m., a period of about an hour and a
identified from E–FORCSE were not
both that: (1) ‘‘Sometime we get busy, I half. GX 10.
noted, nor was their resolution
know the office is called’’ and ‘‘I did In Dr. Gordon’s view, ‘‘[t]hese
documented, on the corresponding CII/
look at the paper, because I would not prescriptions present a big red flag.’’ Tr.
CIII Rx Verification Form. Id. at 1010.
fill the prescription unless I look at the 394. ‘‘[I]t’s odd,’’ she testified, ‘‘that a
Based on the testimony of both Dr.
paper;’’ and (2) ‘‘[i]f it’s a routine patient compounded script would be made
Gordon and Mr. Fisher, I reject the
who comes—who’s been already exactly the same for each of these
testimony of Respondent’s Owner and
established by me, . . . same patients, which means there’s not
PIC that ‘‘the fact that a patient traveled
prescription that’s filled before, we individualized therapy.’’ Id. The lack of
a long distance . . . was not a major red
individualized treatment meant to Dr.
flag.’’ I further find not credible the
19 When Respondent’s counsel argued that Mr. Gordon that ‘‘the prescriptions were not
Fisher ‘‘did not testify in all other cases that the testimony of Respondent’s Owner and
written for a legitimate medical
distance was a factor and testified in this case—. . . PIC that she did not consider a
amozie on DSK30RV082PROD with NOTICES
purpose.’’ Id. at 396. She testified that
I’m talking about as out-of-state prescriptions, that controlled substance prescription
distance is not a factor’’ and that ‘‘[t]he method of she did not see any notations on the
presented by a customer who travelled
delivery is completely different . . . [s]o those two prescriptions evidencing that a
are not even analogous,’’ the CALJ responded: ‘‘The a long distance to be a red flag and
pharmacist attempted to address the red
record will stand as it is.’’ Tr. 746–47.
20 The CII/CIII Rx Verification Forms concern the 21 Two of the forms’ ‘‘Pharmacist’s Initials’’ flags. Id.; see also R.D., at 49
prescriptions in GX 8/8a written for SB, CW, DK, sections were completed. No form’s ‘‘Notes’’ section (Respondent’s Owner and PIC
and TS. contained a note. ‘‘conceded that the paperwork furnished
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to the DIs at the April 11th Inspection concentration of the dose.’’ Id. In therapy. . . . It’s unusual that two
did not memorialize any attempts to response to whether she had any notes patients that live at the same address
resolve this red flag and agreed that she ‘‘anywhere’’ documenting her would receive the same exact therapy.
did not have any paperwork conversation with the physician, There’s always an exception to the rule,
documenting her identification or Respondent’s Owner and PIC replied, but this is common in the drug-seeking
resolution of the issue.’’). Dr. Gordon’s ‘‘Not here, no.’’ Id. at 1094. community . . . .’’ Id. Dr. Gordon also
testimony was that this red flag was not Based on all of the evidence in the testified that there were no notations on
resolvable. Tr. 396. She testified that the record, I find that Respondent filled the prescriptions addressing the red
pharmacist who filled the prescriptions prescriptions that raised the red flag of flags. Id. at 398. Her opinion was that
did not exercise her corresponding multiple customers presenting the prescriptions were not legitimate
responsibility to ensure that the prescriptions written by the same and that the pharmacist who filled the
prescriptions were issued for a prescriber on the same day for the same prescriptions had not exercised her
legitimate medical purpose by a medication in the same quantity. I corresponding responsibility to ensure
practitioner acting in the usual course of further find that, even if these red flags the prescriptions were issued for a
professional practice. Id. at 396–97. were resolvable, there was no credible legitimate medical purpose by a
At first, the ‘‘only comment’’ that Mr. evidence that Respondent addressed or practitioner acting in the usual course of
Fisher had about the prescriptions in resolved them before filling the professional practice. Id. at 398–99.
GX 10 was that ‘‘there doesn’t seem to prescriptions. I cannot, and do not, Mr. Fisher agreed with Dr. Gordon
be a quantity that’s identifiable.’’ Id. at place any weight on the testimony of that the prescriptions raised red flags.
618. When asked specifically about the Respondent’s Owner and PIC that she He testified that the ‘‘same address for
fact that the prescriptions came from the resolved these red flags because she two different people’’ and the ‘‘same
same doctor and for the same drug, Mr. produced no documentary evidence to drug’’ were red flags associated with
Fisher testified that, ‘‘[i]f the doctor is support her claim that she attempted to these prescriptions. Id. at 620. He
specializing in men’s health . . . , he and, in fact, did resolve them before considered it ‘‘very possible’’ that the
could have multiple patients on the filling the prescriptions. prescriptions were for husband and wife
same regimen of drugs.’’ Id. at 619. On who had a reason for going to the same
Multiple Customers From the Same
cross examination, however, Mr. Fisher doctor at the same time. Id. He
Address Coming to Respondent at the
admitted that the five prescriptions suggested that ‘‘[s]peaking to the
Same Time With Prescriptions From the
were an example of ‘‘pattern physician would be the easiest way’’ to
Same Doctor for the Same Drug and
prescribing,’’ or when ‘‘a doctor . . . resolve those red flags. Id. On cross-
Strength
writes the same thing for every single examination, Mr. Fisher agreed that a
patient that comes in.’’ Id. at 769. Mr. The Government alleged that multiple pharmacist’s ‘‘due diligence . . . [and]
Fisher then testified that pattern customers from the same address the standard way to try to prevent
prescribing was a ‘‘red flag for coming to Respondent at the same time diversion of drugs’’ required the
diversion.’’ Id. with prescriptions written by the same pharmacist to ‘‘check the other things
Respondent’s Owner and PIC testified doctor for the same drug and strength available . . . [l]ike the E–FORCSE
that the prescriptions raised a red flag was a ‘‘red flag of diversion,’’ and that system, . . . the doctor’s license
because they were for a ‘‘schedule [sic] Respondent filled such prescriptions number, and all that. The routine things
medication, testosterone.’’ 22 Id. at 1084. without resolving that red flag. To you do with a Schedule II prescription.’’
She testified that she resolved this red support this allegation, the Government Id. at 771. He also contradicted his
flag by asking the prescribing doctor ‘‘if submitted two prescriptions for earlier testimony when he admitted
she knows the purpose of this . . . Dilaudid 8 mg. that Respondent filled that, in this situation, a ‘‘simple phone
treatment, and if the patient are . . . within five minutes of each other. See call to the doctor’’ might not achieve the
taking it for an appropriate use.’’ Id. GX 11. The prescriptions were written level of satisfaction concerning the
Respondent’s Owner and PIC also by the same doctor on the same day prescriptions’ legitimacy the
testified that these five prescriptions with the same use directions to two ‘‘pharmacist has to get . . . before they
raised red flags because ‘‘[t]hey came on individuals with the same last name and can fill the prescription,’’ because ‘‘the
the same day with the same medication street address in Hollywood, Florida. doctor, himself, may not have issued
at the same . . . dose . . . [a]nd the See Tr. 397–98; see also id. at 70 (DI . . . [the prescriptions] for legitimate
same doctor.’’ Id. at 1092. At this testifying that GX 11 consisted of true medical purpose[s] in the course of his
juncture, her testimony about how she and accurate copies of prescriptions and professional practice.’’ Id. at 771–72.
resolved the red flags was that she spoke labels he took from Respondent on April According to Respondent’s Owner
with the doctor. Id. at 1092–93. She 11, 2013) and id. at 71 (DI testifying that and PIC, the fact that the prescriptions
testified that, ‘‘The reason . . . they the prescriptions in GX 11 were for two were written by the same doctor, for the
come on the same day, because the customers living at the same address, same drug and dosage, for individuals
doctor designated that day to see who saw the same doctor, were living at the same address who had the
patients who need hormonal prescribed the exact same drug and same last name and presented the
replacement. . . . [I]t helps her to keep strength, and then took those prescriptions on the same day did not
the records straight . . . . [T]hey start prescriptions to Respondent at the same raise a red flag. Id. at 1097–98. She
out on the same dose. This way it’s time). The difference between the two testified that she ‘‘would treat . . . [the
easier to achieve the day to day prescriptions was that one was for 80 prescriptions] the same way I treat every
tablets and the other was for 85 tablets. other schedule II medication.’’ Id. at
amozie on DSK30RV082PROD with NOTICES
22 Respondent’s Owner and PIC testified that the Id. at 397; see also GX 11, at 1, 3. 1098. She also stated that she filled the
red flag for the testosterone prescription on page 3 In Dr. Gordon’s opinion, these prescriptions because, at the time, ‘‘I
of GX 10 was the customer’s age, 27 years old. Tr. prescriptions raised multiple red flags thought the circumstances of the
1086. She stated that she spoke with the doctor that were not resolvable. Tr. 397–98. prescriptions were understandable.’’ Id.
about this prescription and the ‘‘doctor assured me
that this patient has low testosterone and he needs
She testified that: ‘‘This to me is what’s at 1103–04. She then stated that, as of
because he feels very tired and he’s not going to use called rubber-stamping from a 2015, she would not fill them ‘‘[b]ecause
it for athletic purposes. He was not an athlete.’’ Id. physician, and is not individualized the DEA have restriction on filling those
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prescriptions[,] . . . [n]ot because the were written for the same immediate a legitimate medical purpose by a
patient are not legitimate and not release controlled substance, but for practitioner acting in the usual course of
because of doctor not legitimate or not different strengths. Id. at 399. The professional practice. Id. at 404–05,
legitimate medical purpose. Only second red flag she identified was the 406–07; see GX 12, at 1–8.
because DEA said do not fill those diagnosis of ‘‘lumbar radiculopathy.’’ Id. Mr. Fisher agreed that ‘‘two
prescriptions.’’ Id. at 1104. When asked at 400. prescriptions written for the same
if someone at DEA told her not to fill Dr. Gordon explained that giving one person for the same drug but different
schedule II prescriptions, Respondent’s person two prescriptions for two strengths’’ was a red flag. Tr. 620–21. He
Owner and PIC responded: ‘‘Obviously, immediate release opioids was not testified that he would speak to the
if they bring me that case, that what necessary because the Dilaudid 8 mg. doctor to resolve it because it’s
they saying to me. They will try to could be broken in half to get a 4- ‘‘[c]ommonly done’’ to ‘‘try[ ] to achieve
take—intend to revoke my license for milligram dose. Id. at 399. She pointed a certain therapeutic level by combining
filling those prescriptions. . . . The[y] out that there was no long-acting the two doses . . . [because] [t]he 8
didn’t tell me—not until they come with medication accompanying the milligrams is not enough for the patient,
this order to show cause.’’ Id. at 1104– prescriptions in GX 12 and that ‘‘[t]wo so they do 12.’’ Id. at 621. Mr. Fisher
05. immediate-release opioids is . . . a testified that a consistent therapeutic
Based on all of the evidence in the common red flag for diverted level would be achieved if the
record, I find that the prescriptions in prescriptions.’’ Id.; see also id. at 399– medication were taken as directed
GX 11 raised red flags because 400. She explained: ‘‘In pain during a 24-hour cycle. See id. at 624.
customers with the same last name and management . . . you start out with a He stated that ‘‘three times a day, you’re
street address presented them, and they short-acting. Then based on the amount going to take it probably . . . . You’re
were written on the same day by the of short-acting, you prescribe a long- not taking it in the middle of the night.
same doctor for the same drug and acting, because if you were in pain, I You’re probably going to take it
strength. Further, I find that Respondent wouldn’t want you to have to take morning, noontime, and suppertime.
admitted filling the prescriptions even something every four hours. . . . So And then he goes to work and he needs
though these red flags were not what we do is we recommend . . . a something stronger and he takes the
resolvable, according to Dr. Gordon’s long-acting . . . with a break-through.’’ stronger dose. . . . It is common.’’ Id. at
testimony. I find that, even if these red Id. at 401. Her testimony further 624–25.
flags were resolvable, there was no explained that ‘‘it looks like the Respondent’s Owner and PIC testified
credible evidence in the record that practitioner was trying to say that you that the only red flag she associated
Respondent addressed or resolved them could only take Dilaudid, 4 milligrams, with the prescriptions in GX 12 was that
before it filled the prescriptions. one, three times a day . . . [but] [i]t they were for schedule II controlled
Respondent’s Owner and PIC offered no won’t last eight hours. So that’s the first substances. Id. at 1115, 1129. When
evidence to substantiate her testimony red flag.’’ Id. at 403. She continued, asked if ‘‘the fact that there was two
that the circumstances of the asking rhetorically ‘‘why would you different strengths of the same
prescriptions were ‘‘understandable’’ take a higher dose of a break-through? medication, issued to the same patient
and did not raise red flags. I afford her It doesn’t make any sense.’’ Id. Drawing on the same day by the same doctor . . .
testimony no weight. from her experience, she testified that constitutes a red flag,’’ Respondent’s
‘‘it would have made more sense for Owner and PIC replied in the negative
Customers Presenting Two ‘‘because there is a logical explanation
him to schedule the eight[;] . . . it’s
Prescriptions, Both for the Same to it.’’ Id. at 1115. ‘‘That’s done . . . to
usually the same dose for break-
Immediate Release Controlled achieve certain dosage variance,’’ she
through.’’ Id.
Substance, but for Different Strengths Dr. Gordon also testified that the stated. Id. After further questioning on
The Government alleged that a ‘‘red diagnosis of ‘‘lumbar radiculopathy’’ the subject, Respondent’s Owner and
flag of diversion’’ was raised when was ‘‘a red flag to take pause for any PIC stated that she ‘‘spoke with the
customers presented two prescriptions reasonable pharmacist to make sure the doctor about it and doctor approved the
for the same immediate release prescriptions are legit.’’ Id. at 400. See dose.’’ Id. at 1121; see also id. at 1132–
controlled substance, but for different GX 12, at 1–2. She explained that, ‘‘on 33. She added that the doctor was ‘‘still
strengths, and that Respondent filled prescriptions that are not legit, that’s the practicing . . . [a]nd the patient tells me
such prescriptions without addressing pattern I’ve seen—lumbago is big on that’s how he benefits the most.’’ Id. at
or resolving the red flag. As support for illegitimate prescriptions—and most of 1121. She testified similarly regarding
this allegation, the Government my colleagues as well.’’ Tr. 404. the prescriber of the other prescriptions
submitted four such prescriptions filled When asked if she would ‘‘reach out in GX 12. Id. at 1126.
by Respondent. See GX 12. The four to the prescriber’’ if she ‘‘were in a retail When asked whether she had, for
prescriptions consisted of two pharmacy and . . . saw a prescription these prescriptions, ‘‘the same
prescriptions each for Dilaudid 8 mg. like this coming in with two short- documentation that you’ve shown
and Dilaudid 4 mg. written for two actings,’’ Dr. Gordon responded ‘‘[n]o. before . . . [l]ike . . . the patient
different people. Tr. 399, 405–06; see . . . I would give the prescriptions back agreement and the PMP report and a
also id. at 72 (DI testifying that GX 12 to the patron.’’ Id. at 402. She stated that note that somebody checked with the
contained true and accurate copies of the red flags raised by the prescriptions doctor,’’ Respondent’s Owner and PIC
documents he took from Respondent on were not resolvable. Id. at 405, 406. Dr. answered affirmatively. Id. at 1121–22.
April 11, 2013) and id. at 73 (DI Gordon testified that there were no She admitted that she had not, however,
amozie on DSK30RV082PROD with NOTICES
testifying that the prescriptions in GX notations on the prescriptions provided the same documentation.
12 belonged to two patients for the same addressing the red flags, and gave her Instead, she stated that the existence of
immediate-release drugs and strengths). opinion that the prescriptions were not the ‘‘approved’’ stamp and ‘‘my
Dr. Gordon testified that the legitimate and that the pharmacist who personal stamp with my signature on it’’
prescriptions raised red flags. Id. at 399– filled the prescriptions did not exercise meant that ‘‘I spoke with the doctors.
400, 403–04. The first red flag she her corresponding responsibility to . . . And documents were obviously
identified was that the two prescriptions ensure the prescriptions were issued for generated when he comes—visiting the
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pharmacy, otherwise I would not valid DEA numbers or there’s, like, no Customers Presenting Prescriptions
dispense it.’’ Id. at 1122. When asked, major violation or diversion with the With a Combination of an Opiate and a
however, whether ‘‘[e]very time you see prescriptions.’’ Id. at 1227. Benzodiazepine or ‘‘Drug Cocktail’’
that stamp, you spoke with the doctor,’’ Respondent’s Owner and PIC was Popular with Drug Abusers
Respondent’s Owner and PIC declined satisfied, she testified, when she filled
to respond in the affirmative. Id. at the prescriptions in GX 12 that each The Government alleged that
1136–37. She stated, ‘‘I have to go each ‘‘prescription was filled for medical prescriptions with a combination of an
prescription by—let’s go one-by-one purpose within the scope of a physician opiate and a benzodiazepine are ‘‘drug
each prescription, I tell you each one I practice.’’ Id. at 1139. cocktails’’ popular with drug abusers
spoke with.’’ Id. at 1137. She testified Based on all of the evidence in the and, therefore, raise ‘‘red flags of
that, ‘‘I called—as far as I remember, on record, I find that Respondent, without diversion,’’ and that Respondent filled
each prescription, every time it’s addressing or resolving the red flags, such prescriptions without addressing
presented to me, I called the office. Not filled prescriptions that raised the red or resolving those red flags. To support
necessarily I would speak every time flag of customers presenting two this allegation, the Government
with the doctor. . . . But the practice prescriptions for the same immediate submitted seven sets of prescriptions (a
was at the pharmacy, we verify every release controlled substance but for total of 14 prescriptions) that
prescription.’’ Id. at 1138. During cross- different strengths. The testimony of Respondent filled and dispensed to its
examination, Respondent’s Owner and Respondent’s Owner and PIC, including customers containing an opiate and a
PIC testified that the absence of the her testimony that she filled each benzodiazepine. Id. at 407, 412, 414–15,
stamps would not mean that a prescription in GX 12 only after being 417, 421, 422–23, 424; see GX 13; see
prescription was not valid ‘‘[b]ecause, satisfied they were for a medical also Tr. 73–74 (DI testifying that GX 13
again, there’s sometimes human purpose within the scope of a physician consisted of true and accurate copies of
distractions and errors, some paper can practice, was not credible. First, it documents he took from Respondent
be missed. . . . Again, I was not directly conflicted with her original during the unannounced inspection)
obligated by either the State or law to testimony denying that the and Tr. 74–75 (DI testifying that the
stamp those prescriptions.’’ Id. at 1226. circumstances raised a red flag and, prescriptions in GX 13 were for a
She testified that, ‘‘I did my best attempt second, she did not produce any common drug cocktail of a narcotic pain
to make sure there’s no fraudulent documentary evidence to corroborate reliever and a benzodiazepine, both at
prescription I fill there. Or there’s no her statements. their highest strengths).
Customer’s
Drug Number of tablets Date written initials
Dilaudid 8 mg ......................................................................................................................... 116 11/20/12 D.C.
Xanax 2 mg ........................................................................................................................... 43 11/20/12 D.C.
Dilaudid 8 mg ......................................................................................................................... 140 12/27/12 D.C.
Xanax 2 mg ........................................................................................................................... 42 12/27/12 D.C.
Dilaudid 8 mg ......................................................................................................................... 140 1/24/13 D.C.
Xanax 2 mg ........................................................................................................................... 42 1/24/13 D.C.
Dilaudid 8 mg ......................................................................................................................... 162 10/26/12 L.F.
clonazepam 2 mg .................................................................................................................. 30 10/26/12 L.F.
Dilaudid 8 mg ......................................................................................................................... 162 12/21/12 L.F.
clonazepam 2 mg .................................................................................................................. 30 12/21/12 L.F.
Dilaudid 8 mg ......................................................................................................................... 70 10/12/12 B.K.
Valium 10 mg ......................................................................................................................... 42 10/12/12 B.K.
Dilaudid 8 mg ......................................................................................................................... 35 11/9/12 B.K.
Valium 10 mg ......................................................................................................................... 42 11/9/12 B.K.
According to Dr. Gordon, these seven be used for.’’ 23 Id. She explained that Dr. Gordon addressed whether a
pairings of prescriptions were ‘‘these two drugs are very highly sought muscle relaxant had to be present to
considered ‘‘cocktail medications,’’ red after on the street.’’ Id. at 409. In her constitute a drug cocktail. She stated
flags, because they were multiple drugs opinion, the drug pairings were that, ‘‘Cocktail medications usually . . .
that suppressed the central nervous ‘‘surrounded by diversion.’’ 24 Id. at 410; are a combination of an opioid plus or
system and, when taken together, could see also id. at 413–14. minus a benzo plus or minus a muscle
give euphoria. Tr. 408, 412, 414–15 relaxant.’’ Id. at 408. Then she
(maximum strength of Dilaudid and
23 Dr. Gordon testified that the prescriptions explained: ‘‘But what I’ve seen . . .
would not raise a red flag for her if they were lately is the doctors have stopped the
Xanax), 417, 421, 422 (highest Valium written by a ‘‘Hospice doctor [or] oncologist.’’ Tr.
dose available), 424 (highest doses 545.
Soma, and they are just doing, now,
available), 546, 547. She elaborated on 24 Dr. Gordon identified additional red flags high doses of Dilaudid, high doses of
what makes a drug cocktail by testifying regarding the prescriptions in GX 13: First, the benzos. It used to be Oxys. Now they’ve
prescriptions on pages 13 and 15 were written for switched to hydromorphone. So you see
that it consisted of ‘‘drugs that cause a male (LF) living in Davie and traveling a long . . . the flags change.’’ Id. She added
you to have a high.’’ Id. at 547. ‘‘So it distance to Miami to see an OB/GYN (Dr. R.T.);
amozie on DSK30RV082PROD with NOTICES
second, the diagnosis written on the prescription on that, ‘‘I see the physicians and drug
could be an opioid, it could be an upper diverters trying to eliminate one of the
page 13 was lumbago, a common diagnosis that
and a downer,’’ she stated. Id. She doctors used on diverted prescriptions; and third, components of the cocktail to try to get
explained that the ‘‘person could be the repeat customer (LF) for the prescriptions on away with diverted drugs.’’ Id. at 538.
taking the drugs to get a high during the pages 13 through 19 written by Dr. R.T. was
Dr. Gordon testified that she saw no
receiving the same cocktail medications with no
day and then a low at night. . . . ‘‘[I]t’s long-acting medication present. Tr. 16–17, 418, notations by the pharmacist on the
not being used for what it’s intended to 420–21. prescriptions attempting to resolve the
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red flags and, in her opinion, the components: two opioids, carisoprodol, BK’s name in the ‘‘patient’’ space, and
‘‘cocktail’’ red flags were not resolvable. and a benzodiazepine. Id. at 1142. ‘‘It’s an age, partial address, and date in the
Id. at 411, 414, 416, 418, 421, 423, 424– multiple—it’s two—for instance, lines of the prescription paper calling
25. She specifically testified that the oxycodone and Vicodin together with for that information. It did not include
prescriptions were not legitimate and Soma and benzodiazepine,’’ she stated. a diagnosis. The note contained a
that the pharmacist who filled the Id. According to Respondent’s Owner signature which, according to
prescription pairings did not exercise and PIC, she ‘‘didn’t fill those Respondent’s Owner and PIC, was the
her corresponding responsibility to prescriptions for the Soma, prescribing doctor’s signature. Tr. 1152.
ensure that the prescriptions were benzodiazepine, carisoprodol,’’ and she The note stated that ‘‘the patient cannot
issued for a legitimate medical purpose did not recall ever filling a tolerate for long periods of kneel, more
by a practitioner acting in the usual benzodiazepine, Soma, and opiate than 20 minutes of sitting or standing.’’
course of professional practice. Id. at combination for any patients. Id. at Id. Significantly, the date on the note
411–12, 414, 416, 418–19, 421–22, 423, 1144, 1145. (August 9, 2011) was more than a year
425. Respondent produced an exhibit and two months before the date on the
Mr. Fisher stated that he did not containing various documents earliest prescription issued to BK and
consider the drugs in the prescriptions concerning the three customers who included in GX 13 as filled by
in GX 13 to be cocktails. Id. at 629, 631, asked Respondent to fill the Respondent (October 12, 2012).
632, 633. He elaborated: ‘‘To me a prescriptions in GX 13. RX 10. Compare RX 10, at 10 with GX 13, at 21.
cocktail is when you have a According to the testimony of Yet, Respondent’s Owner and PIC
combination of three drugs: alprazolam, Respondent’s Owner and PIC, testified that: ‘‘Because I’ve been calling
oxycodone or hydrocodone, and Respondent compiled or generated the to the doctor and asking about this
carisoprodol. This to me looks like a documents in RX 10 ‘‘at that time in patient few times . . .[,] [w]e make sure
simple case of a patient getting pain 2013’’ because ‘‘[w]e tried to implement the doctor just write a note.’’ 26 Tr. 1152.
medication and some Xanax for as much possible steps and follow them She continued, stating, ‘‘[T]his patient
anxiety.’’ Id. 629; see also id. at 630 through as much as possible to make has such a difficult time to fill his
(‘‘[I]n everything I have read and have sure that . . . steps are taken . . . that’s prescriptions. . . . This patient could
seen and talked to and have heard at preventing. . . . Also, . . . that’s why not fill prescription anywhere, and then
meetings, it’s a combination of the three . . . when the patient knows the he come to me.’’ Id. She did not explain
drugs represents the cocktail.’’). Mr. pharmacy takes extra steps and how this note led her to conclude that
Fisher agreed that ‘‘[a]s things have scrutinize the prescriptions, people who the prescriptions issued to BK were
changed, yes, other drugs have been has non-valid prescription not come to legitimate.
added like the hydromorphone that’s me.’’ Tr. 1157–58. Respondent also submitted a
come into play.’’ Id. at 629–30. He Page 2 of RX 10 was the Relationship ‘‘Verification of legitimate purpose of
testified that what makes a cocktail is Affidavit signed by DC, the same DC prescribing CII–CV medications To
‘‘more the street value of the drugs.’’ Id. associated with six prescriptions in GX establish legitimate Physician-patient
at 630. 13 (pages 1 through 12). See id. at 1145– relationship.’’ RX 10, at 11. It purported
On cross-examination, Mr. Fisher 46. Similarly, the Relationship Affidavit to be signed by BK, the individual for
reaffirmed his opinion that a cocktail on page 5 of RX 10 was signed by LF, whom the Dilaudid and Valium
involves an opioid, a benzodiazepine, the same LF associated with pages 13 prescriptions on pages 21, 23, 25, and
and carisoprodol. Id. at 772. He through 20 of GX 13.25 See id. at 1148– 27 of GX 13 were written. This one-page
acknowledged that a customer could 49. sheet had space for the customer’s
obtain the opioid and the Respondent also provided registration name, signature, birth date, and
benzodiazepine from one pharmacy and validation pages purportedly printed appointment date, for the physician’s
the carisoprodol from a second from DEA’s website. According to name and address, and for ‘‘yes’’ or
pharmacy. Id. at 772–73. He agreed that Respondent’s Owner and PIC, the DEA ‘‘no’’ responses to whether the
‘‘the only way to check for that would registration validation website satisfied physician or ‘‘qualified medical
be through use of . . . E–FORCSE.’’ Id. her that, on the day she filled LF’s professional’’ conducted a medical
at 773. Mr. Fisher also agreed that Dilaudid and clonazepam prescriptions, examination, took a blood sample, and
Respondent, ‘‘not having access to query the prescribing physician was ‘‘allowed had an ‘‘MRI on file.’’ Id.
E–FORCSE, would not be able to . . . to prescribe the pain medications.’’ Id. I find, based on Dr. Gordon’s
check for that, those instances of drug at 1149; see RX 10, at 6; GX 13, at 17, testimony and consistent with my
seekers using other pharmacies or 19. Likewise, according to Respondent’s credibility determinations giving Dr.
doctors to obtain a third drug that could Owner and PIC, the DEA registration Gordon’s testimony regarding the
be used in this cocktail.’’ Id. On re- validation website showed her that the practice of pharmacy in Florida more
direct, Mr. Fisher stated that, beside physician who prescribed prescriptions weight than any other witness’s
using E–FORCSE, other ways to resolve for BK ‘‘was actually scheduled to testimony in these proceedings, that the
any red flags associated with GX 13 prescribe schedule II narcotics.’’ Tr.
were ‘‘[c]all the physician, discuss their prescriptions in GX 13 were ‘‘drug
1156; see RX 10, at 12; GX 13, at 21– cocktails’’ popular with drug abusers.
treatment modality for the patient, 27.
[c]heck the patient’s profile if you Based on all of the evidence in the
Respondent also submitted a hand- record, I find that Respondent filled
maintain one[,] . . . [and] [i]f you have written note on a piece of prescription
a computer system you could check and prescriptions without having resolved
paper belonging to the doctor who the red flags of customers presenting
amozie on DSK30RV082PROD with NOTICES
see if there’s a history of the patient issued Dilaudid and Valium
getting other prescriptions filled.’’ Id. at prescriptions with a combination of an
prescriptions for BK. See RX 10, at 10; opiate and a benzodiazepine which is a
779. GX 13, at 21, 23, 25, and 27. The note
Respondent’s Owner and PIC did not was not addressed to anyone. It showed 26 She did not address the timing of how
agree that the prescriptions in GX 13 Respondent could have ‘‘made sure’’ the doctor
constituted a drug cocktail because, in 25 LF did not complete the Relationship Affidavit wrote a note more than a year before Respondent
her view, a drug cocktail had four in full. filled the earliest prescription in the record.
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common ‘‘drug cocktail’’ popular with prescriptions when other red flags of the Show Cause Order. ALJX 1, at 5. No
drug abusers. diversion were present was a ‘‘red flag testimony disputed the allegations that
of diversion,’’ and that Respondent Respondent filled the 50 prescriptions
Customers Paying for Their
dispensed controlled substances to and that those prescriptions were
Prescriptions With Cash, When Other
customers without resolving the red purchased with cash. I reviewed those
Red Flags of Diversion Were Present
flags those prescriptions presented. As 50 prescriptions. Thirty-two of them
The Government alleged that support for this allegation, the were for Dilaudid 8 mg. GX 8, 11, 12,
customers paying cash for their Government listed 50 prescriptions in 13, 14.
Number of
Drug Date written Cash paid Customer
tablets
Dilaudid 8 mg ......................................................................................................... 150 12/10/12 $750.00 G.A.
Dilaudid 8 mg ......................................................................................................... 168 11/20/12 840.00 S.B.
Dilaudid 8 mg ......................................................................................................... 150 12/19/12 750.00 C.W.
Dilaudid 8 mg ......................................................................................................... 56 7/9/12 280.00 J.S.
Dilaudid 8 mg ......................................................................................................... 140 1/21/13 840.00 D.K.
Dilaudid 8 mg ......................................................................................................... 56 9/6/12 40.00 B.S.
Dilaudid 8 mg ......................................................................................................... 150 12/28/12 750.00 T.S.
Dilaudid 8 mg ......................................................................................................... 112 4/26/12 560.00 B.R.
Dilaudid 8 mg ......................................................................................................... 112 11/14/12 560.00 W.P.
Dilaudid 8 mg ......................................................................................................... 80 6/22/12 400.00 D.S.
Dilaudid 8 mg ......................................................................................................... 85 6/22/12 425.00 B.S.
Dilaudid 8 mg ......................................................................................................... 75 9/27/12 375.00 J.F.
Dilaudid 8 mg ......................................................................................................... 168 11/29/12 840.00 B.M.
Dilaudid 8 mg ......................................................................................................... 116 11/20/12 580.00 D.C.
Dilaudid 8 mg ......................................................................................................... 140 12/27/12 28.00 D.C.
Dilaudid 8 mg ......................................................................................................... 140 1/24/13 840.00 D.C.
Dilaudid 8 mg ......................................................................................................... 162 10/26/12 810.00 L.F.
Dilaudid 8 mg ......................................................................................................... 162 12/21/12 810.00 L.F.
Dilaudid 8 mg ......................................................................................................... 70 10/12/12 320.00 B.K.
Dilaudid 8 mg ......................................................................................................... 35 11/9/12 175.00 B.K.
Dilaudid 8 mg ......................................................................................................... 128 10/5/12 640.00 B.K.
Dilaudid 8 mg ......................................................................................................... 40 11/2/12 200.00 B.K.
Dilaudid 8 mg ......................................................................................................... 180 8/15/12 900.00 J.B.
Dilaudid 8 mg ......................................................................................................... 150 9/6/12 750.00 J.B.
Dilaudid 8 mg ......................................................................................................... 180 8/30/12 900.00 J.F.
Dilaudid 8 mg ......................................................................................................... 150 9/27/12 750.00 J.F.
Dilaudid 8 mg ......................................................................................................... 168 3/13/13 1,008.00 L.B.
Dilaudid 8 mg ......................................................................................................... 168 4/10/13 1,008.00 L.B.
Dilaudid 8 mg ......................................................................................................... 168 12/28/12 840.00 J.S.
Dilaudid 8 mg ......................................................................................................... 168 1/23/13 1,008.00 J.S.
Dilaudid 8 mg ......................................................................................................... 180 9/7/12 900.00 H.H.
Dilaudid 8 mg ......................................................................................................... 180 10/5/12 900.00 H.H.
The evidence shows that customers this prescription yesterday from She explained that ‘‘the cost of that
paid as much as $1,008.00 for a month’s Walgreen’s . . . . So . . . the patrons medication is high compared to what
worth of Dilaudid 8 mg. will say, ‘I don’t want you to charge my I’ve seen out in the field. That’s a very
Dr. Gordon’s testimony explained that insurance company.’ That way it kind of high cost. And between Fort Pierce,
payment in cash for a controlled eliminates that flag.’’ Id. at 298–99. Miami, and Hallandale, you pass like a
substance was always a red flag, even if In Dr. Gordon’s opinion, the cash zillion pharmacies. . . . It doesn’t make
a significant sector of the public did not prices that Respondent charged its sense.’’ Id. at 362. According to Dr.
have health insurance. Tr. 363. Paying customers were as high as five times the Gordon, there was no notation made by
in cash was a red flag, she testified, cost Dr. Gordon would have expected. the pharmacist on the prescriptions
because it enabled evasion of processes Id. at 362; see also id. at 417, 424, 502, showing any attempt to resolve the red
established to alert a pharmacy that a 512. As Dr. Gordon concluded, ‘‘that to flags. See, e.g., id. at 364, 369, 371, 373,
374, 377, 389–90, 398, 404–05, 406, 411,
prescription was being filled too soon. me means that maybe the pharmacist
416, 421, 423, 424–25, 467; see also id.
She stated, ‘‘A lot of drug-seekers only knew what was going on, and they were
at 133 (DI testimony that he did not see
want to pay for their medications in taking advantage of these patrons that
notations on the prescriptions from
cash because . . . the computer were drug seeking.’’ Id. at 362; see also
Respondent ‘‘clearing’’ any red flags).
systems, the insurance company will id. at 464–65 (Concerning Respondent’s
actually create your red flag for you to initial charge of $840 for a prescription Mr. Fisher agreed that ‘‘[c]ustomers
say if a prescription is refilled too soon, and subsequent charge of $1,008 for the paying for their prescriptions with cash
where other red flags of diversion are
amozie on DSK30RV082PROD with NOTICES
which means they’ve gone—obtained a same exact prescription on the next
prescription from another pharmacy.’’ visit, Dr. Gordon suggested that ‘‘the present’’ was a red flag. Id. at 756.
Id. at 297. She elaborated and provided pharmacist actually knew the Respondent challenged Dr. Gordon’s
a specific example: ‘‘[T]he insurance prescriptions were diverted and . . . cash price-level testimony based on her
company will give you that red flag. was taking advantage of that patron . . . not having been in charge of purchasing
Because they’ll have a claim . . . and [b]ecause they knew they would pay controlled substances for resale for a
they’ll . . . say, . . . the patient just got whatever they needed to pay . . . .’’). small independent pharmacy. Id. at 502.
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Yet, I find Dr. Gordon’s testimony to be I shall credit it consistent with the concerned one customer. The other ten
credible because she ‘‘actually looked CALJ’s credibility determinations. prescriptions concerned five different
up the national . . . price.’’ Id. at 503. Based on all of the evidence in the customers. All 22 prescriptions were for
Respondent also challenged Dr. Gordon record, I find that Respondent, without Dilaudid 8 mg.
by stating that pharmacies where Dr. resolving the red flags, filled I reviewed the prescriptions the
Gordon worked ‘‘like Walgreens, are prescriptions that raised the red flag of Government submitted and analyzed
getting discounts from the supplier on customers paying cash for their them according to the standard Dr.
purchasing controlled medication.’’ Id. prescriptions when other red flags were Gordon described in her testimony. GX
at 502. However, Dr. Gordon testified present. I further find that Respondent’s 14; Tr. 436 (‘‘[W]hat most pharmacies
she was ‘‘99 percent sure’’ that customers were charged, and paid, do . . . [to determine whether a
discounts are not available for generic exorbitantly high prices for their prescription is an early fill is] they start
opioids. Id. at 503. Respondent controlled substance prescriptions.
at when the first prescription was
presented no pricing data or other Customers Presenting New Prescriptions filled.’’); see also Tr. 429–67 (Dr.
evidence refuting Dr. Gordon’s for Controlled Substances When They Gordon’s testimony concerning GX 14),
characterization of the higher-than- Should Not Have Finished Their Tr. 75–76 (DI testifying that GX 14
expected level of cash prices Previous Prescription for That Drug consisted of true and accurate copies of
Respondent’s customers paid for (‘‘Early Fills’’ or ‘‘Early Refills’’) documents he took from Respondent
controlled substance prescriptions. The last red flag the Government during the unannounced inspection),
Further, Respondent did not present alleged in the Show Cause Order and Tr. 76–77 (DI testifying that GX 14
evidence to establish that its cash prices concerned early fills. According to the showed Respondent filled new schedule
for controlled substances were Government, Respondent filled II controlled substance prescriptions
consistent with the prices charged by prescriptions for controlled substances before the customers’ previous
other pharmacies similar to Respondent. that the customers presented before the prescriptions should have been
Nor did it present evidence to establish customers’ previous prescription for exhausted). I make these findings.
that it set the level of its cash prices for that controlled substance should have First, Respondent filled 12
controlled substances for a reason other been consumed. To support this prescriptions for BK, dispensing a total
than that its customers were willing to allegation, the Government submitted of 840 Dilaudid 8 mg. tablets, from July
pay those prices. Thus, I find no reason 22 prescriptions. GX 14, at 1–33, 26, 2012 through November 8, 2012. GX
to reject Dr. Gordon’s testimony. Rather, 37–47.27 Twelve of the prescriptions 14, at 1–33, 37–47.
CUSTOMER B.K.
Drug Number of tablets/SIG Date written Date filled
Dilaudid 8 mg ............................................................... 168—1 every 4 hrs. for pain ........................................ 7/16/12 7/26/12
Dilaudid 8 mg ............................................................... 168—1 every 4 hrs. for pain ........................................ 8/13/12 8/13/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 9/7/12 9/10/12
Dilaudid 8 mg ............................................................... 128—1 every 4 hrs. for pain ........................................ 9/7/12 9/13/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 10/12/12 10/12/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 10/12/12 10/15/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 10/12/12 10/17/12
Dilaudid 8 mg ............................................................... 8—1 every 4 hrs. for pain ............................................ 10/12/12 10/17/12
Dilaudid 8 mg ............................................................... 128—1 every 4 hrs. for pain ........................................ 10/5/12 10/22/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 11/2/12 11/2/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 11/2/12 11/5/12
Dilaudid 8 mg ............................................................... 40—1 every 4 hrs. for pain .......................................... 11/2/12 11/9/12
I note that Respondent filled all four 14, at 17–18. BK’s delay in filling such supply of Dilaudid 8 mg. in 105 days.
of the prescriptions that were written on Dilaudid 8 mg. prescriptions casts doubt According to my analysis, Respondent
the same day, October 12, 2012. on the prescriptions’ legitimacy. filled all but one of them significantly
Further, one prescription for ‘‘chronic Based on the dosing instructions, six early, from about at least 6 days early to
pain due to trauma,’’ among other tablets each day, 840 tablets should up to about at least 29 days early. Id.
things, was written on July 16, 2012, yet have lasted 140 days. The number of
BK did not have it filled until July 26, days from July 26, 2012 through Second, concerning the two Dilaudid
2012. GX 14, at 1–2. Similarly, BK November 8, 2012, the day before BK 8 mg. prescriptions in GX 14 issued to
waited up to 16 days before filling filled the last prescription in GX 14, was JB, Respondent filled the second
another prescription for ‘‘chronic pain 105 days. Thus, in this period, prescription at least one week early. Id.
due to trauma,’’ among other things. GX Respondent dispensed to BK a 140-day at 25–28.
CUSTOMER J.B.
Drug Number of tablets/SIG Date written Date filled
amozie on DSK30RV082PROD with NOTICES
Dilaudid 8 mg ............................................................... 180—1 every 3 hrs. as needed .................................... 8/15/12 8/22/12
Dilaudid 8 mg ............................................................... 150—1 every 3 hrs. as needed .................................... 9/6/12 9/6/12
27 GX 14 included 24 prescriptions, but there
were two copies of two of the prescriptions.
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Third, concerning the two Dilaudid 8 Respondent filled the second
mg. prescriptions in GX 14 issued to LB, prescription at least 5 days early.
CUSTOMER L.B.
Drug Number of tablets/SIG Date written Date filled
Dilaudid 8 mg ............................................................... 168—1 every 4 hrs. as needed .................................... 3/13/13 3/18/13
Dilaudid 8 mg ............................................................... 168—1 every 4 hrs. as needed .................................... 4/10/13 4/10/13
Fourth, Respondent filled the second
Dilaudid 8 mg. prescription in GX for JS
at least 5 days early.
CUSTOMER J.S.
Drug Number of tablets/SIG Date written Date filled
Dilaudid 8 mg ............................................................... 168—1 every 4 hrs. as needed .................................... 12/28/12 12/31/12
Dilaudid 8 mg ............................................................... 168—1 every 4 hrs. as needed .................................... 1/23/13 1/23/13
Fifth, Respondent filled the second
Dilaudid 8 mg. prescription in GX 14 for
HH at least six days early.
CUSTOMER H.H.
Drug Number of tablets/SIG Date written Date filled
Dilaudid 8 mg ............................................................... 180—1 every 4–6 hrs. as needed ................................ 9/7/12 9/14/12
Dilaudid 8 mg ............................................................... 180—1 every 4–6 hrs. as needed ................................ 10/5/12 10/8/12
According to Dr. Gordon, the the early fills.’’ Id. Specifically statement, he acknowledged that an
prescriptions in GX 14 exhibited regarding the multiple prescriptions for attempt to secure more drugs was one of
multiple red flags, yet Respondent filled BK that Respondent filled on October those explanations. Id. at 687. Regarding
them all. Tr. 429–67. For none of the 17, 2012 and why, in Dr. Gordon’s the prescriptions for BK, he testified: ‘‘A
prescriptions in GX 14 did Dr. Gordon experience, a patient would present two patient taking this medicine . . . is not
testify that it included any notation prescriptions for the same drug but going to want to run out . . . [T]he
recognizing or addressing red flags, that different quantities on the same day, she pharmacy might . . . only have 40
its red flags were resolvable, that it was testified: ‘‘I have no idea. That’s very tablets . . . on the twelfth, and they got
a legitimate prescription, or that the unusual. I would not fill either one of some more in so they call the patient
pharmacist had exercised her these scripts. . . . It’s a huge red flag . . . It also—. . . to be honest, . . .
corresponding responsibility to ensure for any pharmacist to get the same exact could be an attempt by a patient to
that the prescription was issued for a Dilaudid 8 from the same doctor on the secure more drugs.’’ Id. at 686–87.
legitimate medical purpose by a same date. Huge red flag. No reasonable When asked if an early fill ‘‘can be
practitioner acting in the usual course of pharmacist would fill this.’’ Id. at 443. reasonably explained where there is
professional practice. Id. at 437–38, 441, Mr. Fisher agreed that an early fill diversion or where there is no
442, 445–46, 446–47, 448–49, 450–51, was a red flag for diversion. Id. at 774. diversion,’’ Mr. Fisher responded that,
456, 458–59, 460–61, 464, 467. He identified early fill red flags in GX ‘‘It could be either way.’’ Id. at 687. Mr.
Regarding these prescriptions and 14 on at least 13 occasions. Id. at 635– Fisher did not explain, however, why
labels, Dr. Gordon testified that ‘‘the 36, 637–38, 685, 692–93, 696 (two the physician would write all four of the
pharmacist was not exercising her prescriptions filled on the same day), prescriptions on the same day, let alone
corresponding responsibility, that most 698, 703, 704, 711, 714, 718, 721, 725, break them up into smaller quantities.
of these prescriptions should not have 727. Mr. Fisher testified that filling the Mr. Fisher also suggested that ‘‘the
been filled or at least held until it was two prescriptions on October 17, 2012 patient . . . [may] only come down to
due to be filled.’’ Id. at 450. ‘‘However,’’ was ‘‘highly unusual.’’ Id. at 696. His that area once in a while for shopping,
Dr. Gordon continued, ‘‘I wouldn’t have testimony was that it was ‘‘reasonable’’ and they fill their prescriptions
filled any of these to begin with.’’ Id. at to fill a prescription two to three days whenever they get down there.’’ Id. at
451. She explained: ‘‘The multiple red early and that a pharmacy can do so. Id. 711. Mr. Fisher agreed that resolution of
an early fill red flag ‘‘could be’’ and
amozie on DSK30RV082PROD with NOTICES
flags would alert any pharmacist that at 700.
none of these prescriptions were legit In Mr. Fisher’s view, early fill red ‘‘should be’’ documented. Id. at 688.
because of the distance, that certain flags were ‘‘resolvable,’’ meaning Respondent’s Owner and PIC testified
physician is a well-known pill mill ‘‘there’s a number of explanations for an that an ‘‘early refill’’ is a red flag that
writer, the Dilaudid 8, the odd early fill.’’ Id. at 686; see also id. at 693, ‘‘requires definite investigation.’’ Id. at
quantities, . . . the diagnosis of 704–05, 711, 715, 719, 722–23, 725–26. 1165. She then stated, however, that the
lumbago . . . and paying cash . . . And Being ‘‘honest,’’ as he prefaced his term ‘‘early refill’’ does not apply to a
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schedule II controlled substance and reports he obtained on the day of the whose addresses were in Alabama,
stated, regardless, that pharmacies are unannounced inspection. Tr. 128. Georgia, Illinois, Kentucky,
‘‘obligated by the physician order.’’ Id. According to the DI, pages 1, 4, 6, 9, 13, Massachusetts, or Vermont. See GX 15;
at 1167, 1170. She testified, ‘‘[T]here are and 16 of Respondent’s daily see also Tr. 87–88 (DI), Tr. 392–93 (Dr.
two issues here, because why . . . the prescription logs showed that Gordon), Tr. 731–32, 734 (Mr. Fisher).
patient is prevented early prescriptions? Respondent had dispensed nine of the The Government also submitted seven
It’s not a refill on schedule IIs, so it’s not 12 prescriptions referenced in the Show FedEx shipping reports showing that
early refill, it’s an early fill. . . . The Cause Order. Id. at 129–131; GX 21, at Respondent shipped the prescriptions to
doctor fills [sic] the order, you have to 1, 4, 6, 9, 13, and 16; ALJX 1, at 7–8. customers outside the State of Florida.
fill it. You’re obligated by the physician The DI further testified that the other GX 15.
order.’’ Id. three prescriptions appeared in the E– In further support of the allegation,
In sum, both Dr. Gordon and Mr. FORCSE report. Tr. 131; see also GX 20 the Government obtained certifications
Fisher identified about the same number (E–FORCSE query results). from Alabama, Illinois, Kentucky, and
of early fills in GX 14. They disagreed The DI testified that Respondent ‘‘was Vermont that Respondent had not
on how many days early a pharmacy never able to locate these prescriptions complied with those States’ out-of-state
could fill a controlled substance for me.’’ Tr. 42; see also id. at 49, 125. pharmacy requirements. See GX 24
prescription without needing to resolve Instead, he testified that he learned of (Alabama Board of Pharmacy
the suspicion. They also disagreed about Respondent’s having located many of Certification of Non-Licensure of
the resolvability of early fills in general the missing prescriptions when he saw Respondent for the period July 1, 1989
and in GX 14. Dr. Gordon testified that them in Respondent’s exhibits. Id. at through April 29, 2015), GX 25
an early fill was not legitimate and was 270–71; see also RX 12. Two of the (Certification of the Division of
not resolvable. Mr. Fisher testified that requested prescriptions, he testified, Professional Regulation of the Illinois
red flags due to early fills were were never located. Tr. 1185. According Department of Financial and
resolvable, but admitted that an attempt to Respondent’s Owner and PIC, ‘‘[t]hey Professional Regulation that Respondent
to secure more drugs was one of the was misfiled.’’ Id. at 1189. She testified ‘‘does not now hold nor has ever held
reasons for early fill requests. Mr. Fisher that ‘‘if the number is assigned, it means a license under the Pharmacy Practice
agreed that a pharmacist’s resolution of that was prescription presented to the Act of 1987’’ dated April 16, 2015), GX
an early fill should be documented. pharmacy. . . . I know across the 26 (Kentucky Board of Pharmacy
Based on the testimony of Dr. Gordon board, that it’s common that some Executive Director letter dated April 14,
and Mr. Fisher, I find that Respondent, prescriptions do get misfiled in 2015 stating that, ‘‘I have searched the
without resolving the red flags, filled pharmacies.’’ Id. at 1189–90. Board records and do not find that . . .
prescriptions early on at least 13 The testimony of Respondent’s Owner [Respondent] has or ever has been
occasions. I find that the early fill- and PIC confirmed Respondent’s failure issued a license/permit’’), and GX 27
related testimony of Respondent’s to retrieve and provide the requested (Vermont Board of Pharmacy’s
owner and PIC, that a prescription is a prescriptions to the DI on April 11, Licensing Board Specialist Certification
doctor’s order and a pharmacist is 2013. See id. at 846; see also id. at 1186 of Non-Licensure of Respondent for the
‘‘obligated’’ to fill a doctor’s order, was (The first time the prescriptions were period July 1, 1989 through April 13,
Respondent’s admission to an provided to the Government was as an 2015).
abdication of her corresponding exhibit in this proceeding.). Respondent’s Owner and PIC asserted
responsibility. Respondent’s Owner and PIC offered that ‘‘out-of-state patients was out of
excuses for that failure. Id. at 847–850. question. That was for me,’’ indicating
Allegation That Respondent Was I find that Respondent never provided that she would not have filled out-of-
Unable to Readily Retrieve Prescriptions the 12 requested prescriptions to the DI. state prescriptions ‘‘[u]nder any
It Had Dispensed I find that Respondent included ten of circumstances, even the patient was
The Show Cause Order alleged that the 12 prescriptions in an exhibit for the really, really sick.’’ Tr. 1023; see also id.
Respondent committed six other hearing in this proceeding more than at 44, 88–89 (DI’s testimony that
violations, including that Respondent two years after they were requested Respondent’s Owner and PIC told him
was unable to readily retrieve during the unannounced inspection. I that Respondent never shipped a
prescriptions it had dispensed. ALJX 1, find that Respondent has still not controlled substance out-of-state.). Yet,
at 7. provided the Government with two of Respondent’s Proposed Findings of Fact
As already discussed, the DI testified the prescriptions that the DI requested and Conclusions of Law admitted that
that he conducted an unannounced on April 11, 2013. ‘‘[f]actually, . . . Respondent was not
inspection of Respondent on April 11, registered in Alabama, Illinois,
2013. Tr. 36. At that time, he stated, he Allegation That Respondent Shipped Kentucky and Vermont when it shipped
asked Respondent to retrieve 12 Controlled Substances Out-of-State control [sic] substances to these states.’’
‘‘problematic prescriptions’’ he had Without Complying With Those States’ Respondent’s Proposed Findings of Fact
identified from a Florida Prescription Non-Resident Pharmacy Requirements and Conclusions of Law dated August
Drug Monitoring Program query. Id. at Next, the Show Cause Order alleged 28, 2015 (hereinafter, Resp. Br.), at 4.
41–42. Those dozen prescriptions were that Respondent shipped controlled Based on the uncontroverted
for ‘‘anabolic steroid substances to substances to four States (Alabama, documentary evidence, which I find to
patients that were not in the State of Illinois, Kentucky, and Vermont) be more persuasive than the testimony
Florida.’’ Id. at 42. The Show Cause without complying with those States’ and statements of Respondent’s Owner
amozie on DSK30RV082PROD with NOTICES
Order alleged that the prescriptions non-resident pharmacy requirements. and PIC to the contrary, and
were filled from February 15, 2012 to ALJX 1, at 8. As support for the Respondent’s admission, I find that
April 11, 2013, or less than two years allegation, the Government submitted Respondent shipped controlled
before the date of the unannounced prescriptions for schedule III controlled substances out-of-state to customers in
inspection. ALJX 1, at 7–8. substances (testosterone cypionate, Alabama, Illinois, Kentucky, and
The DI testified that GX 21 consisted testosterone cream, and stanozolol) that Vermont. Further, I find that, when
of Respondent’s daily prescription log Respondent filled for seven customers Respondent shipped those controlled
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substances to out-of-state customers, it registration number was missing from entity engaged in hormone replacement
was not licensed or permitted to do so three prescriptions, but that those therapy for the purpose of allergy
by the States of Alabama, Illinois, numbers appeared on the prescription testing.
Kentucky, or Vermont. fill labels. Tr. 1195–96; see also GX 16,
Allegation That Respondent Filled
at 11, 13, and 15, and GX 16, at 14 and
Allegation That Respondent Filled Prescriptions Written by Physicians for
16, respectively. Respondent did not
Controlled Substance Prescriptions Not the Physicians’ Personal Use in
dispute the facts underlying this
Containing All of the Information Violation of Florida Statute § 458.331(r)
allegation. See, e.g., Resp. Exceptions, at
Required By 21 CFR 1306.05(a) and (f) Next, the Show Cause Order alleged
18 (‘‘[I]t is true that twelve out of many
Next, the Show Cause Order alleged hundreds of scripts lacked some of the that Respondent filled prescriptions
that Respondent filled controlled information required.’’). written by physicians for the
substance prescriptions that did not Having examined the prescriptions physicians’ personal use in violation of
contain all of the information required and all of the other evidence in the Florida Statute § 458.331(r). ALJX 1, at
by 21 CFR 1306.05(a). ALJX 1, at 9. As record concerning this allegation, I find 10. As support for this allegation, the
support for the allegation, the the Respondent filled controlled Government submitted 12 documents
Government submitted nine substance prescriptions that did not that, according to the DI, included
prescriptions. GX 16. The DI testified contain all of the information required ‘‘controlled substance prescriptions’’
that the patient’s full address was by 21 CFR 1306.05(a). I also find that which doctors wrote ‘‘to themselves.’’
missing from six of the prescriptions. Respondent’s Owner and PIC admitted Tr. 106; see also GX 18. One
Tr. 99–101; see also GX 16, at 1, 3, 5, Respondent filled prescriptions not prescription was written on
7, 9, and 15. He testified that the containing all of the information Respondent’s ‘‘RX Order Form’’ and had
prescriber’s DEA registration number required by 21 CFR 1306.05(a). nothing written in the ‘‘patient’’
was missing from four of the information boxes. GX 18, at 3. The
prescriptions. Tr. 99–101; see also GX Allegation That Respondent Filled labels associated with this
16, at 1, 11, 13, and 15. The DI testified Prescriptions Written for ‘‘Office Use’’ in ‘‘prescription’’ showed the same name
that the directions for use were missing Violation of 21 CFR 1306.04(b) for the patient and the prescriber. Id. at
from one of the prescriptions. Tr. 99; see Next, the Show Cause Order alleged 4. Respondent admitted that, ‘‘Factually,
also GX 16, at 1. He testified that the that Respondent filled prescriptions Respondent did fill the prescriptions
prescriber’s address was missing from written for ‘‘office use’’ in violation of alleged in OSC, ¶ 7 written by
four of the prescriptions. Tr. 100–01; see 21 CFR 1306.04(b). ALJX 1, at 10. To physicians for the physicians’ personal
also GX 16, at 7, 9, 11, and 13. The DI support this allegation, the Government use.’’ Resp. Br., at 16.
testified that the prescriber’s name was submitted two Respondent ‘‘RX Order I find that Respondent admitted
missing from two of the prescriptions, Forms,’’ one for testosterone and one for filling six ‘‘prescriptions’’ which doctors
and that the prescriber’s signature was testosterone propionate, for which wrote ‘‘to themselves,’’ and that the
missing from one of them. Tr. 100–01; ‘‘Office Use’’ was written on the line ‘‘prescriptions’’ were for controlled
see also GX 16, at 11, 13, and 15, designated for the patient name. See GX substances.
respectively. 17. The DI testified that these pages
My review and analysis of the 13 were controlled substance prescriptions Allegation That Respondent Violated
prescriptions in GX 8/8a identified written for ‘‘office use.’’ Tr. 252–53. Florida State Law by Failing To Report
information missing from prescriptions Respondent’s Owner and PIC testified Some Prescriptions to E–FORCSE in
and discrepancies between information that page 1 of GX 17 was a Violation of Florida Statute § 893.055(4)
on some of the prescriptions and/or ‘‘prescription’’ for testosterone. Id. at Finally, the Show Cause Order alleged
prescription labels and information on 1200. She agreed that page 3 of GX 17 that Respondent failed to comply with
the customers’ driver’s licenses. See, was a ‘‘copy of a prescription’’ for Florida law by failing to report some
e.g., GX 8, at 15 and 17 (missing testosterone. Id. at 1202; see also Resp. prescriptions to E–FORCSE. ALJX 1, at
information in customer address); id. at Br., at 10 (‘‘Factually, Respondent did 10–11; see Fla. Stat. § 893.055(4) (2012).
3–4 and 5–6 (discrepancies between the fill the prescriptions alleged in OSC ¶ 6 In support of this allegation, the
customer’s address shown on the for ‘office use.’ ’’). Respondent’s Owner Government submitted six Dilaudid 8
driver’s license and shown on the and PIC further testified that the entity mg. prescriptions written by the same
prescription label); id. at 9–10 that completed and submitted the ‘‘RX doctor from July through November of
(discrepancies between the customer’s Order Forms’’ was engaged in hormone 2012. See GX 19. The DI obtained these
address shown on the prescription and replacement therapy and wanted to ‘‘see prescriptions during his unannounced
shown on the prescription label and how the patient responds’’ and ‘‘make inspection of Respondent. Tr. 107; ALJX
driver’s license); see also Tr. 614–15 sure that the patient don’t have allergic 1, at 11. The DI testified that none of
(testimony of Mr. Fisher concerning reaction on the prescription before they these six prescriptions was reported to
missing information), Tr. 761–65 dispense it.’’ Tr. 1199; see also id. at E–FORCSE according to his analysis of
(testimony of Mr. Fisher concerning 1201. Her testimony acknowledged that the results of his E–FORCSE query for
information discrepancies). In Mr. Respondent ‘‘delivered’’ the testosterone the period February 14, 2012 to
Fisher’s opinion, Respondent did not ‘‘prescribed’’ on page 1 of GX 17. Id. at February 4, 2013. Tr. 108–10, 115; see
exercise due care in entering customer 1200. Regarding the prescription also GX 20 (E–FORCSE query results).
addresses. Tr. 766. depicted on page 3 of GX 17, however, Further, in addition to doing his own
Respondent’s Owner and PIC Respondent’s Owner and PIC testified to query, the DI explained that he asked
amozie on DSK30RV082PROD with NOTICES
admitted that Respondent filled the having ‘‘a flashback,’’ stating that, ‘‘I the E–FORCSE program manager to ‘‘do
prescriptions in GX 16. Id. at 1196. She really remember that I don’t give them a back-end query to see if these
admitted that the patient’s address was that cypionate.’’ Id. at 1203. prescriptions were ever uploaded or any
missing from five prescriptions. Id. at I find that Respondent admitted errors or . . . any attempts were made
1194–96; see also GX 16, at 3, 5, 7, 9, filling at least two controlled substance for these prescriptions.’’ Tr. 109; see
and 15. Respondent’s Owner and PIC ‘‘prescriptions’’ for ‘‘office use’’ and also id. at 119. As further support for
testified that the prescriber’s DEA delivering at least one of them to an this allegation, the Government
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introduced the certified response the DI (1) The recommendation of the appropriate Government’s evidence with respect to
received from the program manager State licensing board or professional Factors Two and Four satisfies its prima
stating that, ‘‘I certify, none of the disciplinary authority. facie burden of showing that
prescriptions . . . were uploaded.’’ GX (2) The applicant’s experience in Respondent’s continued registration
dispensing . . . controlled substances.
23, at 1 (Letter from E–FORCSE Program (3) The applicant’s conviction record under
would be ‘‘inconsistent with the public
Manager to DI dated April 2, 2015); see Federal or State laws relating to the . . . interest.’’ 21 U.S.C. 823(f). I further find
also Tr. 118. The Program Manager’s distribution[ ] or dispensing of controlled that Respondent failed to produce
letter, the DI explained, ‘‘shows . . . substances. sufficient evidence to rebut the
that . . . [the six prescriptions] were (4) Compliance with applicable State, Government’s prima facie case.
never uploaded’’ to E–FORCSE and that Federal, or local laws relating to controlled Specifically, I find that the record
there were no uploading attempts that substances. contains substantial evidence that
failed due to an error. Tr. 118. The DI (5) Such other conduct which may threaten Respondent’s pharmacists violated their
also testified that the second page of GX the public health and safety. corresponding responsibility when they
23 ‘‘shows the uploads that . . . 21 U.S.C. 823(f). [T]hese factors are . . . dispensed multiple prescriptions. I also
[Respondent] did in that timeframe, and considered in the disjunctive. Robert A. find there is substantial evidence in the
where those [six] prescriptions should Leslie, M.D., 68 FR 15,227, 15,230 record that Respondent was unable to
have fallen into if . . . [Respondent] (2003). readily retrieve prescriptions it had
had, in fact, uploaded them.’’ Id. The DI It is well settled that I ‘‘may rely on dispensed, shipped controlled
concluded from this evidence that any one or a combination of factors and substances out-of-state without
‘‘these [six] prescriptions were never may give each factor the weight [I] complying with States’ non-resident
entered’’ into E–FORCSE. Id. at 123. deem[ ] appropriate in determining pharmacy requirements, and filled
Respondent’s Owner and PIC did not whether’’ to revoke a registration. Id.; controlled substance prescriptions that
challenge the Government’s contention see also MacKay v. Drug Enforcement did not contain all the information
that the six prescriptions in GX 19 did Admin., 664 F.3d 808, 816 (10th Cir. required by 21 CFR 1306.05.
not appear in E–FORCSE. Her testimony 2011); Volkman v. U. S. Drug Accordingly, I agree with the CALJ that
included that ‘‘I fully believe it was Enforcement Admin., 567 F.3d 215, 222 Respondent’s registration should be
actually entered’’; ‘‘I do not know. I did (6th Cir. 2009); Hoxie v. Drug revoked. Further, I agree with the
the fair attempt to provide all Schedule Enforcement Admin., 419 F.3d 477, 482 CALJ’s conclusions concerning
prescriptions, and if other prescription (6th Cir. 2005). Moreover, while I am Respondent’s non-acceptance of
required to consider each of the factors, responsibility and the appropriate
was in E–FORCSE, this prescription
I ‘‘need not make explicit findings as to disposition of Respondent’s efforts to
should be in E–FORCSE’’; ‘‘I know that
I made a fair attempt to submit this each one.’’ MacKay, 664 F.3d at 816
registered location and elsewhere in Florida.
prescription along with other (quoting Volkman, 567 F.3d at 222); see According to Respondent’s cover letter, it provided
prescription that was accumulated for also Hoxie, 419 F.3d at 482. ‘‘In short, this material due to an Order during the Prehearing
that week. That was in a compiled file’’; . . . the Agency is not required to Conference on April 14, 2015. ALJX 12, at 1.
mechanically count up the factors and Material in Respondent’s submission indicated that
and ‘‘I can fairly testify that I did the the Florida Board of Pharmacy (1) found
best effort to submit the prescription to determine how many favor the Respondent had waived the right to request a
the E–FORCSE.’’ Id. at 898, 914–15, Government and how many favor the hearing by failing to respond in a timely manner to
922–23, 935, respectively. registrant. Rather, it is an inquiry which the Administrative Complaint against it, (2)
focuses on protecting the public approved, adopted, and incorporated the
I find that Respondent did not present Administrative Complaint’s factual allegations, and
evidence contesting the Government’s interest; what matters is the seriousness (3) disciplined Respondent, placing it on probation
allegation that six of the controlled of the registrant’s misconduct.’’ Jayam for two years and requiring quarterly inspections.
Krishna-Iyer, M.D., 74 FR 459, 462 Id. at 20–21. The materials do not establish that
substance prescriptions it filled did not Respondent lacks State authority or contain a
appear in E–FORCSE. I find that (2009). Accordingly, as the Tenth recommendation one way or another.
Respondent filled, but did not report to Circuit has recognized, findings under a While there is no evidence that Florida has
E–FORCSE, six controlled substance single factor can support the revocation revoked Respondent’s license, DEA has held
of a registration. MacKay, 664 F.3d at repeatedly that a registrant’s possession of a valid
prescriptions for Dilaudid 8 mg. written State license is not dispositive of the public interest
by the same doctor from July through 821. inquiry. Lon F. Alexander, M.D., 82 FR 49,704,
November of 2012. Under DEA’s regulation, ‘‘[a]t any 49,724 n.42 (2017) (citing Mortimer Levin, D.O., 57
hearing for the revocation or suspension FR 8680, 8681 (1992)). As DEA has long held, ‘‘[t]he
Discussion of a registration, the Administration Controlled Substances Act requires that the
Administrator . . . make an independent
Under Section 304 of the Controlled shall have the burden of proving that determination [from that made by state officials] as
Substances Act (hereinafter, CSA or the requirements for such revocation or to whether the granting of controlled substance
Act), ‘‘[a] registration . . . to . . . suspension pursuant to . . . 21 U.S.C. privileges would be in the public interest.’’
[§ ] 824(a) . . . are satisfied.’’ 21 CFR Alexander, 82 FR at 49,724 n.42 (citing Levin, 57
distribute[ ] or dispense a controlled FR at 8681).
substance . . . may be suspended or 1301.44(e). In this matter, while I have As to Factor Three, there is no evidence that
revoked by the Attorney General upon considered all of the factors, the Respondent has a ‘‘conviction record under Federal
a finding that the registrant . . . has Government’s evidence in support of its or State laws relating to the manufacture,
prima facie case was confined to Factors distribution, or dispensing of controlled
committed such acts as would render substances.’’ 21 U.S.C. 823(f)(3). However, as the
his registration under section 823 of this Two and Four.28 I find that the Agency has noted, there are any number of reasons
title inconsistent with the public 28 As to Factor One, there is no evidence that the
why a person who has engaged in criminal
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interest as determined by such section.’’ misconduct may never have been convicted of an
Florida Department of Health or the Florida Board offense under this factor, let alone prosecuted for
21 U.S.C. 824(a)(4). In the case of a retail of Pharmacy made a recommendation concerning one. Dewey C. MacKay, M.D., 75 FR 49,956, 49,973
pharmacy, which is a ‘‘practitioner’’ Respondent and the matter before me. Respondent (2010), pet. for rev. denied, MacKay v. Drug
under 21 U.S.C. 802 (21), Congress provided several filings, from administrative Enforcement Admin., 664 F.3d 808 (10th Cir. 2011).
proceedings and from Respondent’s lawsuit against The DEA has therefore held that ‘‘the absence of
directed the Attorney General to the Florida Department of Health, involving its such a conviction is of considerably less
consider the following factors in making permit to function as a community pharmacy and consequence in the public interest inquiry’’ and is
the public interest determination: the compounding side of its business at its therefore not dispositive. Id.
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show its remedial measures. R.D., at 58. prohibited uses.’’ Gonzales v. Oregon, substances despite the presence of red
For the reasons set out below, I will 546 U.S. 243, 274 (2006). flags of diversion that . . . [it] failed to
order that Respondent’s registration be The Government must show that the clear prior to dispensing the drugs.’’
revoked and that any pending pharmacist acted with the requisite ALJX 1, at 1–2 (citing Holiday CVS); see
application of Respondent be denied. degree of scienter to prove a violation of also Government’s Proposed Findings of
the corresponding responsibility Fact and Conclusions of Law dated
Factors Two and/or Four—The regulation.29 See Hills Pharmacy, LLC, August 28, 2015 (hereinafter, Govt. Br.),
Registrant’s Experience in Dispensing 81 FR 49,816, 49,835 (2016). According at 15–16.
Controlled Substances and Compliance to Agency precedent, the Government As discussed above, the testimony of
With Applicable Laws Related to may prove a violation by showing either Dr. Gordon, as well as testimony offered
Controlled Substances that: (1) The pharmacist filled a by Respondent’s own witness, Mr.
Allegations That Respondent Failed To prescription notwithstanding her actual Fisher, supported the Government’s
Exercise Its Corresponding knowledge that the prescription lacked allegations that the seven different
Responsibility When It Dispensed a legitimate medical purpose; or (2) the factual circumstances the Government
Controlled Substances Pursuant to pharmacist was willfully blind or alleged to be ‘‘red flags of diversion’’
Prescriptions Not Issued in the Usual deliberately ignorant to the fact that the existed as alleged, and that Respondent
Course of Professional Practice or for a prescription lacked a legitimate medical did not resolve them before dispensing
Legitimate Medical Purpose purpose. Id. To establish that a controlled substances.30 See also R.D., at
pharmacist acted with willful blindness, 9 (‘‘Dr. Gordon testified that she will not
Under the CSA, it is ‘‘unlawful for the Government must prove that the
any person knowingly or intentionally dispense a controlled medication in the
pharmacist had a subjective belief that face of an unresolved red flag . . ..’’)
. . . to . . . distribute[ ] or dispense, or there was a high probability that a fact
possess with intent to . . . distribute[ ] and at 13 (‘‘Mr. Fisher acknowledged
existed and she took deliberate actions that none of the Respondent’s pharmacy
or dispense, a controlled substance’’ to avoid learning of that fact. Id.
‘‘[e]xcept as authorized’’ by the Act. 21 paperwork reflected any documentation
(quoting Global-Tech Applications, Inc., that red flags were resolved prior to
U.S.C. 841(a)(1). A pharmacy’s v. SEB S.A., 563 U.S. 754, 769 (2011));
registration authorizes it to ‘‘dispense,’’ dispensing and that he did not know
see also United States v. Henry, 727 whether they were ever resolved.’’).
or ‘‘deliver a controlled substance to an F.2d 1373, 1378 (5th Cir. 1984) (citing
ultimate user . . . by, or pursuant to the Further, as discussed above, the CALJ
United States v. Hayes, 595 F.2d 258 recommended crediting that
lawful order of . . . a practitioner.’’ 21 (5th Cir.), cert. denied, 444 U.S. 866
U.S.C. 802(10). documentary and testimonial evidence.
(1979) (rejecting challenge that the I find credible the testimony of Dr.
According to the CSA’s implementing regulation was unconstitutionally
regulations, a lawful controlled Gordon and, to the extent he agreed
vague)) (‘‘What is required by him [the with Dr. Gordon, Mr. Fisher that
substance order or prescription is one pharmacist] is the responsibility not to
that is ‘‘issued for a legitimate medical Respondent filled controlled substance
fill an order that purports to be a prescriptions that raised ‘‘red flags’’
purpose by an individual practitioner prescription but is not a prescription
acting in the usual course of his without resolving, and documenting the
within the meaning of the statute resolution of, those red flags.
professional practice.’’ 21 CFR because he knows that the issuing
1306.04(a). While the ‘‘responsibility for Prior Agency decisions found that
practitioner issued it outside the scope prescriptions with the same ‘‘red flags’’
the proper prescribing and dispensing of of medical practice. . . . [A] pharmacist
controlled substances is upon the at issue here were so suspicious as to
can know that prescriptions are issued support a finding that the pharmacists
prescribing practitioner, . . . a for no legitimate medical purpose
corresponding responsibility rests with who filled them violated the Agency’s
without his needing to know anything corresponding responsibility rule due to
the pharmacist who fills the about medical science.’’).
prescription.’’ Id. The regulations actual knowledge of, or willful
The Government did not allege that blindness to, the prescriptions’
establish the parameters of the Respondent dispensed the prescriptions
pharmacy’s corresponding illegitimacy.31 21 CFR 1306.04(a). See,
having actual knowledge that the e.g., Hills Pharmacy, 81 FR at 49,836–
responsibility. prescriptions lacked a legitimate 39 (multiple customers filling
An order purporting to be a prescription medical purpose. Instead, the prescriptions written by the same
issued not in the usual course of professional Government alleged that Respondent prescriber for the same drugs in the
treatment . . . is not a prescription within violated the corresponding
the meaning and intent of section 309 of the
same quantities; customers with the
responsibility regulation as ‘‘evidenced’’
Act (21 U.S.C. [§ ] 829) and the person by its ‘‘dispensing of controlled 30 For example, Respondent’s Owner and PIC
knowingly filling such a purported
even testified that it was not a red flag ‘‘by itself’’
prescription, as well as the person issuing it, 29 The Show Cause Order alleged that for a customer to travel over 100 miles from their
shall be subject to the penalties provided for ‘‘Respondent’’ violated its corresponding Florida home to Respondent to fill a controlled
violations of the provisions of law relating to responsibility. Respondent and the Government substance prescription. Tr. 1028. Indeed, regarding
controlled substances. stipulated that: ‘‘The Respondent is owned and red flags, her testimony was that red flags were a
operated by Veronica Taran.’’ Further, Respondent’s stumbling block. Respondent’s Owner and PIC said
Id. As the Supreme Court has explained Owner and PIC admitted that she is Respondent’s that ‘‘just by strictly following these red flags, it will
in the context of the Act’s requirement pharmacist-in-charge and Respondent’s only prevent legitimate patient from obtaining the
that schedule II controlled substances pharmacist. Tr. 1012 (‘‘[I]n this particular practice, medication.’’ Id. at 1108.
may be dispensed only by written because there’s only me, there’s nobody else there, 31 Agency precedent has defined the term ‘‘red
like, there’s no other pharmacist there.’’). When flag’’ to mean ‘‘a circumstance that does or should
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prescription, ‘‘the prescription asked by her counsel whose responsibility it was to raise a reasonable suspicion as to the validity of a
requirement . . . ensures patients use resolve any red flags, she testified that ‘‘[u]ltimate prescription.’’ Hills Pharmacy, 81 FR at 49,839.
controlled substances under the responsibility lies up me as the pharmacist and This precedent, in conjunction with the terms of the
supervision of a doctor so as to prevent pharmacist-in-charge.’’ Id. at 1045. Thus, for corresponding responsibility regulation, means that
purposes of finding and attributing liability in this the suspicious circumstances presented by the red
addiction and recreational abuse . . . case, I find that the actions and inactions of flags must rise to the level necessary to support a
[and] also bars doctors from peddling to Respondent’s Owner and PIC were the actions and finding that the pharmacist acted with willful
patients who crave the drugs for those inactions of Respondent. blindness.
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same last name and street address testimony. The evidence in the record As for the ‘‘proper step’’ of having a
presenting similar prescriptions on the that Respondent charged exorbitantly customer sign the Relationship
same day; two short-acting opiates high prices for controlled substance Affidavit, Respondent’s Owner and PIC
prescribed together; long distances; drug prescriptions is further proof that did not explain why it was reasonable
cocktails; payment by cash); The Respondent knew or subjectively for her to expect customers who were
Medicine Shoppe, 79 FR 59,504, 59,507, believed that there was a high drug seekers to understand the content
59,512–13 (2014) (unusually large probability that its customers were of that document. Moreover, even if the
quantity of a controlled substance; either abusing or diverting those customers did understand the
pattern prescribing; irregular dosing controlled substances. See also id. at document, she offered no explanation as
instructions; drug cocktails); Holiday 362 (Dr. Gordon’s testimony that to why her customers would be honest
CVS, 77 FR 62,316, 62,317–22 (2012) ‘‘maybe the pharmacist knew what was and truthful in answering the questions
(long distances; multiple customers going on, and they were taking if they were seeking controlled
filling prescriptions written by the same advantage of these patrons that were substances to either personally abuse or
prescriber for the same drugs in the drug seeking.’’) and id. at 465 (Dr. divert to others.32
same quantities; customers with the Gordon’s testimony suggesting that Lastly, the ‘‘proper step’’ of ensuring
same last name and street address Respondent ‘‘knew . . . prescriptions that the prescription was not ‘‘signed’’
presenting virtually the same were [being] diverted’’ and ‘‘was taking by a rubber stamp might have showed
prescriptions within a short time span; advantage of that patron . . . [b]ecause that the prescription was not an outright
payment by cash); East Main Street they knew they would pay whatever fraud, but it did nothing to ensure that
Pharmacy, 75 FR 66,149, 66,163–65 they needed to pay’’ to fill the the prescription was issued for a
(2010) (long distances; lack of prescription.) legitimate medical purpose. 21 CFR
individualized therapy or dosing; drug The so-called ‘‘proper steps’’ for 1306.04(a).
cocktails; early fills/refills; other handling schedule II prescriptions that Respondent’s Owner and PIC also
pharmacies’ refusals to fill the Respondent’s Owner and PIC testified regarding the five CII/CIII Rx
prescriptions). constructed were actually abdications of Verification Forms which were part of
Agency precedent has made clear her corresponding responsibility. Respondent’s ‘‘patient files’’ (see RXs 6
that, when presented with a According to Respondent’s Owner and and 10) and ‘‘kept in the regular course
prescription clearly not issued for a PIC, her responsibility, when presented of business.’’ 33 Tr. 824–25. She also
legitimate medical purpose, a with a controlled substance stated that they ‘‘assisted . . . [her] to
pharmacist may not intentionally close prescription, was limited to (1) making resolve the red flags.’’ Id. at 824. Yet,
her eyes and thereby avoid positive sure the prescriber’s medical license neither she nor Respondent explained
knowledge of the real purpose of the was current; (2) checking the why Respondent submitted only five
prescription. JM Pharmacy Group, Inc., prescriber’s DEA registration against the such forms from its ‘‘patient files’’ when
d/b/a Farmacia Nueva and Best Pharma controlled substance in the prescription; the Government’s evidence included 60
Corp., 80 FR 28,667, 28,670 (2015). Yet, (3) obtaining the patient’s signature on prescriptions and 29 patients. Moreover,
that is exactly what Respondent’s the Relationship Affidavit as alleged while the forms indicated that the
Owner and PIC did. verification of a bona fide doctor-patient prescriptions were actually written by a
As I detailed above, the testimony of relationship; and (4) validating that the physician, that the physician saw and
Respondent’s Owner and PIC prescriber actually signed the physically examined the patient, and
acknowledged that schedule II prescription, as opposed to its having that there were diagnosis codes, the
controlled substances are highly risky been rubber stamped. These steps, forms contained no additional
and are subject to ‘‘a lot of diversion.’’ however, do not constitute an documentation as to what circumstance
Tr. 1129, 1116 (respectively). She also independent exercise of professional prompted Respondent to contact the
specifically testified that a prescription judgment by a pharmacist evaluating the physician and what information the
for a large quantity of a schedule II legitimacy of highly suspicious physician’s office provided which led
controlled substance raised red flags. Id. controlled substance prescriptions such the pharmacist to approve and fill the
at 881, 882, 887. Yet, she admitted as those at issue here. They were clearly prescription. Thus, at most, the forms
failing to address such schedule II insufficient to determine the legitimacy establish with respect to these five
prescriptions presented to her pharmacy of schedule II prescriptions that patients that Respondent verified each
in a fashion consistent with her Respondent’s Owner and PIC herself prescription with its issuer. However,
testimony. Id. at 1132–39. She did not characterized as ‘‘highly risky’’ and long-standing case law has explained
explain or justify her conscious and prone to diversion. Instead, they that ‘‘[v]erification by the issuing
deliberate choice to avoid learning constituted a pharmacist’s abdication of practitioner on request of the
legitimacy-related information about responsibility for a legitimacy pharmacist . . . is not an insurance
schedule II prescriptions that she knew assessment. policy against a fact finder’s concluding
were ‘‘highly risky,’’ prone to diversion, As for checking the currency of the that the pharmacist had the requisite
and raised red flags. These prescriber’s medical license and DEA knowledge despite a purported but false
acknowledgements and failures clearly registration, this is not enough as a verification.’’ United States v. Henry,
show her subjective belief of a high prescriber must generally hold both a 727 F.2d at 1378 (quoting United States
probability that the various schedule II license and registration to even issue a v. Hayes, 595 F.2d 258, 261 (5th Cir.
prescriptions presented to her were not prescription under the CSA. 21 CFR 1979)). In sum, Respondent’s CII/CIII Rx
legitimate and her deliberate actions to 1306.03(a). The fact that a practitioner Verification Forms are insufficient and
amozie on DSK30RV082PROD with NOTICES
avoid learning of their illegitimacy. possesses the requisite authority does do not alter my finding that Respondent
Further, although Respondent not, however, mean that he/she acted in
challenged Dr. Gordon’s expertise to the usual course of professional practice 32 Further, I find that the high prices Respondent
testify that it charged exorbitantly high in issuing any particular prescription charged for controlled substances, as discussed
above, suggest that Respondent knew its customers
prices for controlled substances, and that the prescription was issued for were either abusing or diverting them.
Respondent did not offer any price- a legitimate medical purpose. Cf. 33 Respondent submitted one other CII/CIII Rx
related evidence disputing Dr. Gordon’s Krishna-Iyer, 74 FR at 463. Verification Form. RX 5, at 9.
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violated the corresponding I considered Respondent’s claim that See, e.g., Tr. 400, 406, 410–11, 413, 415,
responsibility regulation. Dr. Gordon’s testimony should not be 417–18. Respondent’s Counsel objected,
The Government also submitted credited because ‘‘she never worked as stating that ‘‘the expert is testifying in
prescriptions, in support of the Show a pharmacist in an independent price difference against what a normal
Cause Order’s corresponding pharmacy’’ such as Respondent and, pharmacist, quote, unquote, would
responsibility allegation, that did not therefore, ‘‘her dispensing, managing charge versus what . . . [Respondent]
involve schedule II controlled and purchasing experience is not charged for certain drugs, drug being
substances. As discussed above, the comparable to those of [Respondent’s Dilaudid.’’ Id. at 419. He continued his
controlled substance was testosterone Owner and PIC].’’ Resp. Br., at 37–38. I objection by stating that, ‘‘I just
cypionate and the same doctor wrote all reject this claim. I have already set out reviewed the prehearing statement
of the prescriptions on the same day. GX my credibility determinations, which provided by the Government, and there
10. Respondent filled all of those are based on the credibility is no mention that their expert is going
prescriptions within the period of about recommendations of the CALJ. Those to get into the price . . . differentiation
an hour and a half. Id. Dr. Gordon, Mr. determinations afford Dr. Gordon’s . . . between a normal pharmacy and
Fisher, and Respondent’s Owner and testimony the appropriate weight in . . . [Respondent].’’ Id. at 419–20.
PIC agreed that these prescriptions these proceedings regarding the practice Respondent’s Counsel subsequently
raised red flags. Although Respondent’s of pharmacy in Florida. Further, elicited from Dr. Gordon that she was
Owner and PIC stated that she resolved Respondent’s claim is simply incorrect. ‘‘never in charge of purchasing
the red flags, she did not produce any The corresponding responsibility of a controlled substances for resale for a
documentary evidence to support her pharmacist is the same whether the small independent pharmacy.’’ Id. at
statement and, thus, I did not afford her pharmacist practices at an independent 482; see also Resp. Exceptions, at 2. The
statement any weight. As discussed pharmacy or in a chain pharmacy. In CALJ’s recommendation was that ‘‘the
above, I found that Respondent also other words, the size or corporate status Government did not adequately notice
filled these prescriptions in the face of of the pharmacy in which a pharmacist the relative price charged for the
their red flags. The fact that practices does not dictate the scope of medication . . . [because] [t]he Agency
Respondent’s Owner and PIC a pharmacist’s obligation under federal recently imposed an increasingly
acknowledged these prescriptions’ red law. rigorous standard of notice.’’ R.D., at 10
flags clearly evidenced her subjective I reject Respondent’s claim that the n.60.
belief of a high probability that these Government arbitrarily designated I reject the Exception. As to the issue
schedule III prescriptions were not customers as having travelled long of notice, for reasons previously
legitimate. The fact that she simply distances ‘‘since it is not relying on any explained, the Agency has rejected the
filled them showed that she took statutory enactment, federal or state to notion that the ‘‘Agency recently
deliberate actions to avoid learning of make such a designation.’’ Id. at 33. imposed an increasingly rigorous
their illegitimacy. Even Respondent’s witness, Mr. Fisher, standard of notice on its administrative
Accordingly, I find the Government agreed that customers traveling long prosecutors.’’ See, e.g., Wesley Pope,
has proved by substantial evidence that distances to fill prescriptions is a red M.D., 82 FR 14,944, 14,946 n.4 (2017).
controlled substance prescriptions flag. Tr. 754; see also R.D., at 47. Here, the Government in its Prehearing
Respondent, by Respondent’s Owner I considered Respondent’s claim that Statement gave notice that Dr. Gordon
and PIC, filled were not prescriptions Dr. Gordon’s testimony about pattern would testify about ‘‘patients willing to
issued in the usual course of prescribing created ‘‘an unrecognized pay exorbitant prices’’ as well as the
professional treatment, yet Respondent, standard under, both, case law and the relative price charged for the medication
by Respondent’s Owner and PIC, Florida statutory law.’’ Resp. Br., at 38. by Respondent. ALJX 5 (Govt.
knowingly filled, or filled with willful I find that Respondent’s claim is Prehearing Statement), at 11.
blindness, those prescriptions in without merit. Numerous agency and Accordingly, I find that the Government
violation of the corresponding court cases have recognized that pattern provided adequate notice that the prices
responsibility regulation. 21 CFR prescribing is a red flag. See, e.g., The charged by Respondent would be at
1306.04(a); see also Hills Pharmacy, 81 Medicine Shoppe, 79 FR at 59,512; see issue in the proceeding.
also United States v. Durante, No. 11– To the extent Respondent argues that
FR at 49,835; Superior Pharmacy I and
277, 2011 WL 6372775, at *3 (D.N.J. I should give no weight to Dr. Gordon’s
Superior Pharmacy II, 81 FR 31,310,
Dec. 20, 2011) (‘‘This is sufficient to testimony, I reject its argument that I
31,335 (2016); The Medicine Shoppe, 79
establish probable cause to believe that should reject her testimony because she
FR at 59,515–16; East Main Street has never purchased controlled
Pharmacy, 75 FR at 66,163–65.34 Defendant was engaged in an extensive
pattern of prescribing controlled substances for a small pharmacy.
34 This case is different from Superior Pharmacy substances without a legitimate medical Indeed, Dr. Gordon specifically testified
I and Superior Pharmacy II where the Government’s purpose to a broad group of patients in that she ‘‘actually looked up the
evidence was insufficient to establish a his medical practice.’’). Further, as national . . . price.’’ Id. at 503.
corresponding responsibility violation even though In its Exceptions, Respondent argues
Respondent dispensed controlled substance already discussed, even Respondent and
that the ‘‘absence of Respondent’s
prescriptions in the face of unresolved red flags Respondent’s own witness, Mr. Fisher,
corresponding exhibit should not be
such as long distances, multiple people presenting eventually admitted that pattern
identical or very similar prescriptions from the interpreted as an absence of records,’’
prescribing was a red flag of diversion.
same prescriber on the same day, drug cocktails, and that ‘‘it simply means that . . . the
two people in the same household or with the same During the hearing, Dr. Gordon
records in Respondent’s possession are
address needing the exact same drugs, and payment testified about the level of the cash price
amozie on DSK30RV082PROD with NOTICES
the same records as contained in a
by cash. 81 FR at 31,336. The Government’s Respondent charged for some
evidence in that case consisted only of the corresponding Government’s exhibit.’’
prescriptions, including in comparison
prescriptions allegedly dispensed without Resp. Exceptions, at 8 n.10. In this
documentation of the resolution of red flags. As to what another pharmacy might charge.
Exception, Respondent indicates its
explained in that decision, there was no applicable
law or rule requiring that documentation of the and testimonial evidence made abundantly clear
dispute with the Government’s
resolution of a red flag be placed on the that Respondent did not carry out its corresponding allegation that ‘‘Respondent failed to
prescription. Here, by contrast, the documentary responsibility. exercise its corresponding responsibility
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under the regulations by failing to For example, in its Exceptions, Exceptions, at 14–17. Respondent cites
acknowledge and resolve red flags Respondent argues that the no legal basis for its claim that the
related to a pattern of a doctor Government’s Expert ‘‘admitted that she provisions of this State Administrative
prescribing the exact same medication has no evidence that . . . any of the Code section, that were not even in
in a cookie-cutter fashion to multiple prescriptions . . . were diverted or effect during the entire period covered
patients on the same day.’’ Resp. somehow used for or with illicit by the Show Cause Order, are
Exceptions, at 8. As the CALJ noted, purposes.’’ Resp. Exceptions, at 11. determinative of liability under Federal
however, Respondent’s Owner and PIC Notwithstanding the Government’s law. I reject Respondent’s Exception.
‘‘conceded that the paperwork furnished Expert’s testimony, there is ample Finally, Respondent suggested that
to the DIs at the April 11th Inspection circumstantial evidence that the the Government’s case must fail because
did not memorialize any attempts to prescriptions at issue in this proceeding the DI did not meet with any prescriber
resolve this red flag and agreed that she were issued by a physician acting or speak with any customer. See, e.g.,
did not have any paperwork outside of the usual course of Resp. Br., at 35, 37. Respondent did not
documenting her identification or professional practice. The elaborate on its argument or cite any
resolution of the issue.’’ R.D., at 49 circumstantial evidence includes that legal precedent for it. Again, Agency
(citing Tr. 1094). While Respondent’s the prescriptions were for large precedent has made clear that
Exception purports to correlate its quantities of Dilaudid 8 mg., a highly Respondent’s argument is mistaken.36
‘‘corresponding exhibit’’ with the abused narcotic; that customers were Accordingly, I reject it.
Government’s evidence, Respondent traveling long distances; and that many Allegation That Respondent Filled
fails to explain the many instances in of the customers were paying cash and Controlled Substance Prescriptions Not
which Respondent simply did not offer exorbitantly high prices. In other Containing All of the Information
documentary evidence to support the instances, the evidence showed that Required by 21 CFR 1306.05(a) and (f)
bald assertions of Respondent’s Owner customers were obtaining early fills of
and PIC that Respondent complied with prescriptions. The Show Cause Order alleged that
the corresponding responsibility Second, Respondent suggests that the Respondent filled controlled substance
regulation. See, e.g., R.D., at 49–50 (‘‘[I]t Government’s failure to prove the prescriptions that did not contain all the
is difficult to reconcile the multiple prescribing doctors were not licensed or information required by 21 CFR
areas where the Respondent’s registered at the relevant time, or 1306.05(a) and (f). According to that
recordkeeping system . . . had the otherwise ‘‘unable to lawfully issue the regulation, a ‘‘corresponding liability
capacity to note details such as red flag prescription[s],’’ somehow exonerated rests upon the pharmacist . . . who fills
resolution with the absence of any Respondent. See, e.g., Resp. Exceptions, a prescription not prepared in the form
documented indication that this, or any at 13. Respondent cites no legal prescribed by DEA regulations.’’ 21 CFR
other red flags, were analyzed and authority for this Exception. Indeed, it 1306.05(f). Among other things, those
resolved.’’). is fatally flawed because it suggests that DEA regulations require that controlled
Further, this Agency has applied, and Respondent’s corresponding substance prescriptions be ‘‘dated as of,
I apply here, the ‘‘adverse inference responsibility is alleviated by the and signed on, the day when issued and
rule.’’ As the DC Circuit explained, prescriber’s medical license, controlled shall bear the full name and address of
‘‘Simply stated, the rule provides that substances registration, or other the patient, the drug name, strength,
when a party has relevant evidence credential. As the language of the dosage form, quantity prescribed,
within his control which he fails to regulation makes clear, while the directions for use, and the name,
produce, that failure gives rise to an prescribing practitioner is responsible address and registration number of the
inference that the evidence is for the proper prescribing and practitioner.’’ 21 CFR 1306.05(a). As
unfavorable to him.’’ Int’l Union, United dispensing of a controlled substance, a found above, Respondent filled
Auto., Aerospace & Agric. Implement corresponding responsibility rests with controlled substance prescriptions that
Workers of Am. (UAW) v. Nat’l Labor the pharmacist who fills a controlled did not contain all of the information
Relations Bd., 459 F.2d 1329, 1336 (DC substance prescription, and the required by 21 CFR 1306.05.
Cir. 1972). The Court reiterated this rule pharmacist who knowingly fills a As discussed above, the
in Huthnance v. District of Columbia, ‘‘purported prescription, as well as the uncontroverted evidence is not only that
722 F.3d 371, 378 (DC Cir. 2013). person issuing it, shall be subject to the Respondent violated this regulation, but
According to this legal principle, penalties provided for violations of the that Respondent admitted violating this
Respondent’s decision not to provide provisions of law relating to controlled regulation. I find, based on all of the
records gives rise to an inference that substances.’’ 21 CFR 1306.04(a). Thus, evidence in the record, that Respondent
any such evidence is unfavorable to contrary to Respondent’s suggestion, the violated 21 CFR 1306.05(a) by filling
Respondent. In any event, as explained good order of the prescribing multiple controlled substance
above, the records Respondent did practitioner’s license, registration, or prescriptions that were not prepared in
provide concerning the Government’s other credential does not alleviate the the form prescribed by DEA regulation.
allegations were insufficient to rebut pharmacist’s corresponding
those allegations. information to the identified health care
responsibility or exonerate the practitioners who have prescribed or dispensed
Respondent suggested throughout the pharmacist in any way. I reject controlled substances’’ to an individual ‘‘who
hearing and in its briefs that the Respondent’s Exception. within a 90-day time period . . . obtains a
Government’s case was deficient. See, Third, Respondent claims that the prescription for a controlled substance . . . from
e.g., Resp. Exceptions, at 9–10, 11, 13, more than one prescriber . . . and . . . is dispensed
Government failed to prove the a controlled substance . . . from five or more
amozie on DSK30RV082PROD with NOTICES
14, 15, and 16–17. Having reviewed and existence of any indicator of controlled pharmacies.’’
considered all of Respondent’s claims substance abuse specified in Fla. 36 ‘‘While it is true that a pharmacist cannot
and arguments, I find that none of them Admin. Code r. 64K–1.007 (adopted violate his corresponding responsibility if a
has merit. Adoption of any of them prescription was nonetheless issued for a legitimate
May 21, 2012).35 See, e.g., Resp. medical purpose, Respondent ignores that the
would undermine this Agency’s invalidity of a prescription can be proved by
regulatory mission, and I decline to rule 35 According to this provision, the E–FORCSE circumstantial evidence.’’ Hills Pharmacy, 81 FR at
against long-standing precedent. Program Manager ‘‘may provide relevant 49,836, n.33.
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Allegation That Respondent Filled Allegation That Respondent Filled against offending physicians.’’ Id. at 18
Prescriptions Written for ‘‘Office Use’’ Prescriptions Written by Physicians for (quoting Gonzales v. Raich, 545 U.S. 1,
in Violation of 21 CFR 1306.04(b) the Physicians’ Personal Use in 19 (2005)).
Violation of Florida Statute § 458.331(r) Respondent’s argument fails as does
The Show Cause Order alleged that its similar argument concerning its
Respondent violated 21 CFR 1306.04(b) According to the Show Cause Order,
admitted interstate shipment of
when it filled prescriptions issued for Respondent ‘‘filled prescriptions written
controlled substances in violation of
‘‘an individual practitioner to obtain by physicians for the physicians’
four States’ non-resident pharmacy
personal use, in violation of Fla. Stat.
controlled substances for supplying the requirements. The Florida statutes at
§ 458.331(r) which prohibits
individual practitioner for the purpose issue concerned exactly what
‘[p]rescribing, dispensing, or
of general dispensing to patients.’’ ALJX Respondent argued they did not. As the
administering any medicinal drug
1, at 10. As explained above, GX 17 CALJ stated, the Florida provision cited
appearing in any schedule set forth in
included two ‘‘RX Order Forms’’ that in the Show Cause Order ‘‘prohibits an
chapter 893 by the physician to himself
Respondent referred to as activity that ‘increases the opportunity
or herself.’’’ ALJX 1, at 10. The Show
‘‘prescriptions’’ and, pursuant to at least for those persons who are self-abusing
Cause Order also alleged that or engaged in diversion to obtain
one of them, admitted delivering
Respondent ‘‘violated Florida law by controlled substances.’’’ R.D., at 38
controlled substances to an entity
dispensing controlled substances n.159 (citing Fred Samimi, M.D., 79 FR
engaged in hormone replacement
pursuant to these invalid prescriptions.’’ 18,698, 18,710 (2014)). Further, Chapter
therapy for the purpose of allergy Id. Neither it nor the Government
testing. Based on Respondent’s 893, referenced in the Florida statute
Prehearing Statement, however, listed in the Show Cause Order, is
admissions, I find that Respondent specified the provision of the allegedly
filled prescriptions issued in violation entitled ‘‘Drug Abuse Prevention and
violated Florida law. The CALJ Control.’’ These provisions of Florida
of 21 CFR 1306.04(b).37 I note, however, referenced the corresponding
that 21 CFR 1306.04(b), the provision law concern much more than physician
responsibility provision of 21 CFR discipline; by their very title, they go to
the Government cited in the Show 1306.04(a) but that, of course, cannot be
Cause Order, prohibits the issuance, not the heart of the controlled substance
the provision of ‘‘Florida law’’ that the anti-diversion mission—drug abuse
the filling, of prescriptions. Show Cause Order referenced. prevention and control.
Neither the Show Cause Order nor the During the time period covered by the The dilemma posed by this Show
Government Prehearing Statement cited Show Cause Order, Florida law required Cause Order allegation is whether it, in
a statutory or regulatory provision that that a pharmacist, before dispensing a its and the hearing record’s brevity
prohibited the filling of a prescription controlled substance listed in schedules concerning this charge, sufficiently
issued in violation of 21 CFR II through IV, first determine ‘‘in the noticed Respondent of the charge being
1306.04(b). In addition, the Government exercise of her or his professional levied against it. The CALJ thought not.
did not discuss the ‘‘office use’’ judgment . . . that the order is valid.’’ See R.D., at 39. However, Respondent
allegation, let alone address the legal Fla. Stat. § 893.04(2)(a) (2009). The defended against this charge and, in
sufficiency of this allegation in the substances that Respondent admitted doing so, purported to understand the
Show Cause Order or in the Government dispensing to physicians for their charge being levied against it.
Prehearing Statement. I find that the personal use, testosterone and I find that neither the Show Cause
Government did not allege a legal basis phentermine, were listed in Florida law Order nor the Government Prehearing
for the revocation or suspension of as controlled substances under Statement specified a statutory
Registrant’s registration upon a finding schedules III and IV, respectively. Fla. provision that Respondent allegedly
that Registrant ‘‘filled’’ prescriptions Stat. § 893.03 (2011) (‘‘Standards and violated.38 21 CFR 1301.37(c). Thus,
issued in violation of 21 CFR schedules’’). See also Fla. Stat. even though there is evidence in the
1306.04(b). § 893.02(22) (2011) (defining a record that Respondent violated Florida
Thus, while I find that Respondent ‘‘prescription’’ as an order for drugs law when it filled prescriptions for the
admitted filling prescriptions issued in ‘‘issued in good faith and in the course personal use of the prescriptions’
violation of 21 CFR 1306.04(b), I also of professional practice . . . and prescribers, I did not consider this
find that the Government did not meeting the requirements of s. 893.04.’’). evidence when I conducted the public
The Respondent’s argument against interest analysis of 21 U.S.C. 823(f).39
comply with the requirement that the
liability was that the Florida statute
Show Cause Order ‘‘contain a statement Other Allegations
referenced in the Order to Show Cause
of the legal basis for . . . the denial,
was not sufficiently related to Allegation That Respondent Was Unable
revocation, or suspension of registration
preventing the diversion of controlled To Readily Retrieve Prescriptions It Had
and a summary of the matters of fact Dispensed
substances. Resp. Br., at 17–18.
and law asserted.’’ 21 CFR 1301.37(c).
According to Respondent, the ‘‘primary The Show Cause Order alleged that
Thus, I will not give any weight in the
purpose behind § 458.331 . . . is to Respondent was unable to ‘‘readily
public interest assessment to
regulate the practice of medicine and retrieve prescriptions it had dispensed’’
Respondent’s admission that it filled
discipline physicians that have engaged
prescriptions issued in violation of 21
in unethical and/or unprofessional 38 Neither did the Government Brief specify a
CFR 1306.04(b).
behavior.’’ Id. at 17. It argued that statutory provision that Respondent allegedly
‘‘[c]learly, the primary purpose behind violated.
37 After admitting that it filled ‘‘the prescriptions
amozie on DSK30RV082PROD with NOTICES
39 Fla. Stat. § 458.331(r) (which prohibited
alleged’’ in the Show Cause Order, Respondent
§ 458.331 . . . in general and
‘‘[p]rescribing, dispensing, or administering any
argued that its actions were ‘‘legal and proper’’ § 458.331(r) specifically is not medicinal drug appearing in any schedule set forth
under 21 CFR 1307.11(a), the so-called 5% Rule. ‘control[ling] the supply and demand of in chapter 893 by the physician to himself or
Resp. Br., at 15–16. Since I find that the controlled substances in both lawful herself’’) in conjunction with Fla. Stat.
Government did not allege a legal basis for the § 893.04(2)(a) (which prohibited a pharmacist from
‘‘office use’’ allegation, I need not address
and unlawful drug markets’ . . . or dispensing a controlled substance without first
Respondent’s argument concerning 21 CFR preventing drug diversion, but determining, in the exercise of her professional
1307.11(a). disciplinary actions and remedies judgment, that the order was valid).
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in violation of 21 CFR 1304.04(h)(3) and resident pharmacy requirements.40 As diversion to warrant consideration
(4). ALJX 1, at 7–8. The Show Cause found above, Respondent shipped under the Public Interest Factors.’’ R.D.,
Order cited 12 examples of controlled substances to customers in at 43. I agree with the result the CALJ
prescriptions that Respondent allegedly Alabama, Illinois, Kentucky, and recommended.
did not retrieve and provide to the DI Vermont without being licensed in, or The second public interest factor is
as required by law. permitted by, those States to do so. ‘‘experience in dispensing . . .
According to the regulation, which is Accordingly, I find that the Government controlled substances.’’ 21 U.S.C.
applicable to inventories and records of has proved by substantial evidence that 823(f)(2). ‘‘Dispense,’’ according to 21
controlled substances in schedules III Registrant failed to comply with the U.S.C. 802(10), means ‘‘deliver a
through V, ‘‘[p]aper prescriptions for non-resident pharmacy requirements of controlled substance to an ultimate user
Schedules III, IV, and V controlled four States. . . . pursuant to the lawful order of . . .
substances shall be maintained at the Respondent admitted that it was not a practitioner.’’ Despite the testimony of
registered location . . . in such form in compliance with any of these four Respondent’s Owner and PIC and her
that they are readily retrievable from the States’ non-resident pharmacy statements to the DI, Respondent
other prescription records of the requirements when it shipped admitted that it ‘‘dispensed’’ controlled
pharmacy.’’ 21 CFR 1304.04(h)(4). The controlled substances to customers at substances in violation of four States’
regulatory definition of ‘‘readily addresses in those States. Further, legal requirements. Thus, I find that
retrievable’’ calls for locating the Respondent did not challenge the Respondent’s experience in dispensing
records ‘‘in a reasonable time.’’ 21 CFR Government’s contention that it violated controlled substances includes the
1300.01(b). Agency precedent states that these four States’ non-resident dispensing of controlled substances to
‘‘what constitutes ‘a reasonable time’ pharmacy requirements when it argued customers living in four States in which
necessarily depends on the that ‘‘[i]t should be note [sic] that other Respondent was not licensed or legally
circumstances.’’ Edmund Chein, M.D., than the out-of-state dispensing authorized to dispense those controlled
72 FR 6580, 6593 (2007), pet. for rev. instances . . . [alleged], there was no substances. Id. This result is consistent
denied, Chein v. Drug Enforcement evidence that . . . [Respondent] is with Agency precedent. Sun & Lake
Admin., 533 F.3d 828, 832 n.6 (DC Cir engaged in shipping medications to Pharmacy, Inc.; d/b/a the Medicine
2008), cert. denied, 555 U.S. 1139 states where it does not hold a Non- Shoppe, 76 FR 24,523, 24,532 (2011)
(2009). According to that precedent, resident pharmacy license.’’ Resp. Br., at (finding that Respondent committed
‘‘under normal circumstances if a 9. Instead, Respondent argued that its actionable misconduct when it
practice is open for business, it should noncompliance with these four States’ dispensed prescriptions to residents of
be capable of producing a complete set non-resident pharmacy statutes was States in which it was not licensed.).
of records within several hours of the insufficiently related to preventing the See also 21 U.S.C. 802(21) (defining
request.’’ Id. The decision explained diversion of controlled substances to be ‘‘practitioner’’ as meaning, in relevant
that ‘‘[t]o allow a registrant an even considered under Factor Four of 21 part, a ‘‘pharmacy . . . licensed,
greater period of time to produce the U.S.C. 823(f). Id. at 4–9 (citing Fred registered or otherwise permitted . . .
records would create an incentive for Samimi, 79 FR at 18,710). The CALJ by the . . . jurisdiction in which . . .
those who are engaged in illegal activity disagreed and concluded that the out-of- [it] practices . . . to . . . dispense a
to obstruct investigations by stalling for state pharmacy provisions had a controlled substance’’).
time in the hopes that DEA personnel ‘‘sufficient nexus’’ to the Act’s ‘‘core Allegation That Respondent Violated
would eventually give up and leave.’’ purpose of preventing drug abuse and Florida State Law by Failing To Report
Id.
As found above, Respondent never Some Prescriptions to E–FORCSE in
40 Alabama (prescription shipped Jan. 14, 2013):
provided the 12 requested prescriptions Violation of Florida Statute § 893.055(4)
Ala. Admin. Code r. 680–X–2–.07(2) (2005) (‘‘No
to the DI. Respondent included ten of nonresident pharmacy shall ship, mail or deliver The Show Cause Order alleged that
the 12 prescriptions in an exhibit for the prescription drugs and/or devices to a patient in Respondent failed to comply with
this state unless registered by the Alabama State Florida State law by not reporting
hearing in this proceeding more than Board of Pharmacy.’’); Illinois (prescription shipped
two years after the unannounced Jan. 27, 2012): Ill. Admin. Code tit. 68 § 1330.550(a) specified prescriptions to E–FORCSE.
inspection, but this is insufficient to (2012) (‘‘The Division shall require and provide for As discussed above, I found that
comply with the ‘‘readily retrievable’’ an annual nonresident special pharmacy Respondent did not challenge the
registration for all pharmacies located outside of Government’s assertion that six
requirement. As of the final day of the this State that dispense medications for Illinois
hearing in this proceeding, or about 28 residents and mail, ship or deliver prescription controlled substance prescriptions it
months after the unannounced medications into this State. . . .’’); Kentucky dispensed did not appear in E–FORCSE.
inspection, Respondent still had not (prescription shipped March 19, 2012): Ky. Rev. The CALJ found ‘‘not persuasive’’
Stat. § 315.0351(1) (2007) (‘‘Every person or Respondent’s argument that the non-
provided the Government with two of pharmacy located outside this Commonwealth
the prescriptions. Accordingly, I find which does business, physically or by means of the reportings ‘‘had their genesis in a good-
that the Government has proved by internet, facsimile, phone, mail, or any other means, faith technical glitch.’’ R.D., at 46 n.184.
substantial evidence that Registrant inside this Commonwealth . . . shall hold a current He recommended finding the testimony
pharmacy permit . . . issued by the Kentucky of Respondent’s Owner and PIC on this
failed to comply with the requirements Board of Pharmacy.’’); and Vermont (prescription
of 21 CFR 1304.04(h)(3) and (4). shipped Jan. 10, 2013): Vt. Stat. Ann. tit. 26 allegation ‘‘wholly unpersuasive,’’
§ 2061(a) (2013) (‘‘All drug outlets shall biennially ‘‘even if assumed, arguendo, to be
Allegation That Respondent Shipped register with the board of pharmacy.’’); Vt. Stat. credible.’’ Id.
Controlled Substances Out-of-State Ann. tit. 26 § 2022(7) (2013) (‘‘ Drug outlet’ means The Florida statute that the
Without Complying With Those States’ all pharmacies, . . . and mail order vendors which
amozie on DSK30RV082PROD with NOTICES
are engaged in dispensing, delivery, or distribution
Respondent allegedly violated required
Non-Resident Pharmacy Requirements the reporting to E–FORCSE of each
of prescription drugs.’’); see also 20–4–1400 Vt.
The Order to Show Cause alleged that Code R. § 16.1 et seq. (2013) (‘‘ Non-resident controlled substance dispensed ‘‘as soon
Respondent shipped controlled pharmacy’ means a drug outlet . . . located outside thereafter as possible, but not more than
of Vermont which dispenses prescription drugs
substances to customers in Alabama, . . . for Vermont residents . . . and which mails,
7 days after the date the controlled
Illinois, Kentucky, and Vermont without ships, or delivers such prescription drugs . . . into substance is dispensed unless an
complying with those States’ non- this state. . . .’’). extension is approved.’’ Fla. Stat.
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§ 893.055(4) (2012). Respondent, a Respondent engaged in egregious Volkman, 73 FR 30,630, 30,644 (2008);
covered ‘‘dispenser’’ under the misconduct which supports the see also Paul Weir Battershell, 76 FR
provision, did not claim that it had been revocation of its registration. See Wesley 44,359, 44,369 (2011) (imposing six-
granted an extension under the statute. Pope, 82 FR 14,944, 14,985 (2017) month suspension, noting that the
Fla. Stat. § 893.055(1)(c) (‘‘ ‘Dispenser’ (collecting cases). evidence was not limited to security and
means a pharmacy . . . [or] dispensing I therefore hold that the Government recordkeeping violations found at first
pharmacist. . . .’’). has established a prima facie case that inspection and ‘‘manifested a disturbing
I disagree with Respondent’s claim Respondent’s continued registration pattern of indifference on the part of
that the Florida Statute did ‘‘not provide ‘‘would be inconsistent with the public [r]espondent to his obligations as a
for any penalties for non-compliance, interest.’’ 21 U.S.C. 823(f). registrant’’); Gregory D. Owens, 74 FR
partial compliance or reporting errors.’’ 36,751, 36,757 n.22 (2009).
Sanction
Resp. Br., at 25. To the contrary, the Finally, the Agency has also held that
Florida Statute contained a criminal Where, as here, the Government has ‘‘ ‘[n]either Jackson, nor any other
sanction for a willful and knowing met its prima facie burden of showing agency decision, holds . . . that the
failure to report the dispensing of that Respondent’s continued registration Agency cannot consider the deterrent
controlled substances. Fla. Stat. is inconsistent with the public interest value of a sanction in deciding whether
§ 893.055(9) (2011) (‘‘Any person who due to its numerous violations a registration should be [suspended or]
willfully and knowingly fails to report pertaining to its dispensing and revoked’ ’’ or an application should be
the dispensing of a controlled substance recordkeeping practices and its non- denied. Wesley Pope, 82 FR 14,944,
as required by this section commits a compliance with State laws, the burden 14,985 (2017) (quoting Joseph Gaudio,
misdemeanor of the first degree.’’); see shifts to the Respondent to show why its 74 FR 10,083, 10,094 (2009) (quoting
also Fla. Stat. § 893.13(7)(a)(2) and (c) continued registration would Southwood Pharmaceuticals, Inc., 72 FR
(2011) (A person who refuses or fails to nonetheless be consistent with the 36,487, 36,504 (2007))). See also Robert
keep any required record commits a public interest. Medicine Shoppe- Raymond Reppy, 76 FR 61,154, 61,158
misdemeanor of the first degree for a Jonesborough, 73 FR 364, 387, pet. for (2011); Michael S. Moore, 76 FR 45,867,
first violation and a felony of the third rev. denied sub nom. Medicine Shoppe- 45,868 (2011). This is so both with
degree for a second or subsequent Jonesborough v. Drug Enforcement respect to the respondent in a particular
violation). Admin., 300 F. App’x 409 (6th Cir. case and the community of registrants.
Based on all of the evidence in the 2008). Under Agency precedent, the See Pope, 82 FR at 14,985 (quoting
record, I find that Respondent did not Respondent must ‘‘present sufficient Gaudio, 74 FR at 10,095 (quoting
comply with the controlled substance mitigating evidence to assure the Southwood, 71 FR at 36,503)). Cf.
reporting requirements of Fla. Stat. Administrator that it can be entrusted McCarthy v. SEC, 406 F.3d 179, 188–89
893.055(4). Respondent’s non- with the responsibility carried by such (2d Cir. 2005) (upholding SEC’s express
compliance is appropriate for a registration.’’ Hills Pharmacy, 81 FR at adoptions of ‘‘deterrence, both specific
consideration under Factor Four. In this 49,845 (citing Medicine Shoppe- and general, as a component in
case, due to the overwhelming Jonesborough, 73 FR at 387 (quoting analyzing the remedial efficacy of
egregiousness of other violations that Samuel S. Jackson, D.D.S., 72 FR sanctions’’).
Respondent committed, my 23,848, 23,853 (2007)) (quoting Leo R. In this case, the CALJ found that
consideration of Respondent’s non- Miller, M.D., 53 FR 21,931, 21,932 Respondent’s acceptance of
compliance with the controlled (1988))). Moreover, because past responsibility was ‘‘limited in scope and
substance reporting requirements of Fla. performance is the best predictor of can be fairly characterized as minimal.’’
Stat. 893.055(4) did not have a future performance, DEA has repeatedly R.D., at 58. Specifically, the CALJ found
determinative impact on my public held that when a registrant has that Respondent’s Owner and PIC, on
interest assessment. committed acts inconsistent with the behalf of Respondent, accepted
public interest, the registrant must responsibility in ‘‘only three carefully
Summary of Factors Two and Four accept responsibility for those actions circumscribed’’ areas: (1) that she did
As discussed above, the Government and demonstrate that it will not engage not document every single conversation
presented a prima facie case that in future misconduct. East Main Street with every single prescriber; (2) that
Respondent, with a subjective belief of Pharmacy, 75 FR at 66,162 (quoting she, as the pharmacist-in-charge,
a high probability that controlled Medicine Shoppe-Jonesborough, 73 FR shouldered ultimate responsibility for
substance prescriptions were not at 387); see also MacKay, 664 F.3d at ensuring required documentation was
legitimate and while taking deliberate 820 (DEA may properly consider properly completed; and (3) that
actions to avoid learning of their whether a physician admits fault in Respondent filled controlled substance
illegitimacy, filled multiple determining if the physician’s prescriptions for patients who lived a
prescriptions for controlled substances registration should be revoked.). That significant distance from the pharmacy.
which lacked a legitimate medical acceptance of responsibility must be R.D., at 58.
purpose. The Government also unequivocal. Lon F. Alexander, M.D., 82 At the hearing, Respondent’s counsel
presented a prima facie case that FR 49,704, 49,728 (2017) (collecting asked Respondent’s Owner and PIC
Respondent was unable to readily cases). ‘‘[w]hat is it that you’re accepting
retrieve prescriptions it had dispensed, Moreover, the egregiousness and responsibility for in this case?’’ Tr.
filled controlled substance prescriptions extent of a registrant’s misconduct are 1025. Respondent’s Owner and PIC
and shipped them without meeting the significant factors in determining the testified: ‘‘That I don’t have any
amozie on DSK30RV082PROD with NOTICES
out-of-state pharmacy requirements of appropriate sanction. See Jacobo intention to violate DEA rules.’’ Tr.
four States, filled controlled substance Dreszer, 76 FR 19,386, 19,387–88 (2011) 1025. This is in no sense a meaningful
prescriptions that did not contain all of (explaining that a respondent can acknowledgement of Respondent’s
the required information, and failed to ‘‘argue that even though the misconduct.
report controlled substance Government has made out a prima facie In its Exceptions, Respondent
prescriptions to E–FORCSE in violation case, his conduct was not so egregious contends that it ‘‘accepted responsibility
of Florida law. Thus, I conclude that as to warrant revocation’’); Paul H. for filling long-distance prescriptions
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and, as remedial measures, stopped in any event, it does not constitute an appropriate result on the record in this
dispensing schedule II substances all acceptance of responsibility for case.
together.’’ Resp. Exceptions, at 8. violating the corresponding I agree with the CALJ’s assessment
Respondent also argues that, through responsibility rule. Further, the that, ‘‘[w]here no understanding is
Respondent’s Owner and PIC, it testimony was not offered in the context acquired about how the regulated
‘‘accepted the responsibility for not of addressing Respondent’s filling conduct fell short of professional and
documenting in every instance, its prescriptions from its Florida customers federal and state legal standards, it
efforts in resolving the red flags and as who travelled long distances to would be difficult (even illogical) to
[a] remedial measure stated that it patronize Respondent. Rather, the predict improvement.’’ Id. at 59. I also
‘document[s] everything that’s testimony was offered to address agree with the CALJ’s prediction that
possible.’ ’’ Id. It further contends that, Respondent’s filling of prescriptions for Respondent ‘‘is likely to proceed in the
‘‘[a]lthough . . . [Respondent’s Owner out-of-state customers, specifically future as it has in the past if not
and PIC] accepted responsibility for the customers from Kentucky about whom curtailed in its ability to do so.’’ Id. I
misfiling of the prescriptions, it is easily Respondent’s Owner and PIC testified further agree with the CALJ that the
deuced [sic] from the record and from she had been ‘‘clearly instructed’’ by ‘‘sheer number of established
the instituted corrective measures that DEA. Tr. 1023. transgressions of various types, coupled
the Respondent accepted the Notably, at no point in the hearing did with the refusal to admit that issues
responsibility for the missing Respondent’s Owner and PIC accept existed, would render a sanction less
information as well.’’ Id. at 18 n.19. responsibility, let alone accept than revocation as a message to the
I reject Respondent’s contentions. responsibility unequivocally, for regulated community that due diligence
Most significantly, Respondent’s Owner violating the corresponding is not a required condition precedent to
and PIC has entirely failed to responsibility regulation. Notably, the operating as a registrant.’’ Id.
acknowledge that Respondent violated testimony of Respondent’s Owner and Respondent has not rebutted the
the CSA when it knowingly dispensed PIC manifests that she still does not Government’s prima facie showing that
numerous controlled substance acknowledge the scope of a pharmacist’s its continued registration is
prescriptions which were clearly issued obligation under 21 CFR 1306.04(a). As ‘‘inconsistent with the public interest.’’
outside of the usual course of one example, she testified that ‘‘[t]he 21 U.S.C. 823(f). I will therefore order
professional practice and which lacked prescription is an order for the that Respondent’s registration be
a legitimate medical purpose. And even pharmacist to fill. For me not to fill that revoked and that any pending
as to the factual matters for which the applications be denied.
prescription, I have to have a very good
CALJ found she accepted responsibility,
reason not to fill it, because it’s an order Order
such as failing to adequately document
from the doctor to me to fill that
her conversations with prescribers, Pursuant to the authority vested in me
prescription for that patient.’’ Id. at
Respondent’s Owner and PIC by 21 U.S.C. 824(a) and 21 U.S.C. 823(f),
1168. As the Agency has previously
immediately equivocated by making as well as 28 CFR 0.100(b), I order that
recognized, a registrant cannot accept
excuses for not doing so in the future. DEA Certificate of Registration
responsibility for its misconduct when
She stated, ‘‘Now I document every FP1049546 issued to Pharmacy Doctors
it does not even understand what the
little thing that it’s concerned to the Enterprises d/b/a Zion Clinic Pharmacy
law requires of it. Alexander, 82 FR at
conversation and the dispensing of be, and it hereby is, revoked. I further
controlled substances. However, there’s 49,729. I agree with the CALJ’s
order that any pending application of
a lot of conversation going on on a daily conclusion that ‘‘there is no
Pharmacy Doctors Enterprises d/b/a
basis between doctors and offices.’’ Tr. unequivocal acceptance of
Zion Clinic Pharmacy for renewal or
1010–11. Similarly, after acknowledging responsibility on this record that would
modification of this registration be, and
that she filled controlled substance be particularly helpful to the
it hereby is, denied. This order is
prescriptions for patients who lived a Respondent’s efforts to avoid a
effective April 12, 2018.
significant distance from the pharmacy, sanction.’’ R.D., at 58.
Here, the CALJ concluded that ‘‘the Dated: February 28, 2018.
Respondent’s Owner and PIC justified
paltry nature of the Respondent’s Robert W. Patterson,
her filling of the prescriptions, asserting,
acceptance of responsibility would have Acting Administrator.
without any evidence to corroborate her
claim, that ‘‘some of them are working rendered remedial measure evidence [FR Doc. 2018–05020 Filed 3–12–18; 8:45 am]
locally and they all had a local doctor.’’ largely irrelevant.’’ Id. In addition, BILLING CODE 4410–09–P
Id. at 1026. Respondent’s misconduct included an
Respondent’s Owner and PIC also egregious abdication of the
testified that, ‘‘If the DEA provide me, corresponding responsibility DEPARTMENT OF LABOR
do not fill for 100 miles, like—that’s requirement involving the dispensing of
why I said, I accepted my responsibility, controlled substances such as Dilaudid Office of the Secretary
I took remedial measures. I do not fill 8 mg., a most potent and highly abused
schedule II prescriptions in my schedule II drug; the evidence also Agency Information Collection
pharmacy because of these conflicting shows that Respondent committed Activities; Submission for OMB
red flags. Because it’s a practice of extensive violations of other Federal Review; Comment Request; Voluntary
Florida to travel.’’ Id. at 1023–24. and State legal requirements. Thus, due Protection Program Information
Respondent characterized this to the Respondent’s ‘‘paltry’’ acceptance ACTION:Notice of availability; request
amozie on DSK30RV082PROD with NOTICES
testimony as meaning that Respondent’s of responsibility and its ‘‘intentional for comments.
Owner and PIC accepted responsibility decision to decline to notice evidence of
for filling long-distance prescriptions. remedial steps’’ leading to the SUMMARY: The Department of Labor
Resp. Br., at 36; see also Resp. preclusion of that evidence from (DOL) is submitting the Occupational
Exceptions, at 8. I specifically reject consideration, the CALJ recommended Safety and Health Administration
Respondent’s argument. Notably, this that ‘‘the record supports the imposition (OSHA) sponsored information
testimony began with the word ‘‘if’’ and of a sanction.’’ Id. I find that this is the collection request (ICR) titled,
VerDate Sep<11>2014 17:47 Mar 12, 2018 Jkt 244001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\13MRN1.SGM 13MRN1](https://thefederalregister.org/doc/83_FR_10925/page/28.svg)
Document Created: 2018-03-13 01:56:58
Document Modified: 2018-03-13 01:56:58
| 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 | 83 FR 10876 |
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