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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices b. V.W. filled his prescriptions for immediate release oxycodone since at least November 30, 2015, even though oxycodone is not prescribed for longterm use or chronic conditions.
c. V.W. paid cash for his prescriptions at inflated prices, paying up to $400.00
for 112 tablets of oxycodone, approximately $3.57 per tablet, at a time when legitimate pharmacies were charging approximately $0.90 per tablet.
Recordkeeping Violations 1. The Respondent did not have an initial inventory, when requested by DEA during an on-site inspection of June 6, 2017, in violation of 21 CFR
1304.11b.
2. The Respondents biennial inventory failed to indicate whether it was taken at the opening or closing of business as required by 21 CFR
1304.11a.
3. The Respondents pharmacist on duty, Amy Mincy, stated that the biennial inventory was performed over several days, in violation of 21 CFR
1304.11a.
4. The Respondents pharmacist on duty during the June 6, 2017 on-site inspection admitted to using the pharmacy owners, Mr. Richard Sprys, CSOS credentials to order controlled substances in violation of 21 CFR
1311.30a & c.
5. The Respondents receiving records showed that the Respondent failed to create an electronically linked record of a quantity and date received for its controlled substances in violation of 21
CFR 1305.22g. The Respondent also possessed 89 invoices without the date of receipt recorded in violation of 21
CFR 1304.22c.
The Hearing Preliminary Matters At the outset of the hearing, the Government confirmed that it was not going forward with pursuing any independent violation against the Respondent for a delay by the Respondent in complying with the July 2018 administrative subpoena. Tr. 14
15.6 This Tribunal also noticed the Government that if it intended to assert a new allegation or expand the charges, it must inform this Tribunal at the time the new matter is broached at the hearing. Id. at 1516. This would also give the Respondent the opportunity to either litigate the issue by consent or to object to the new allegation. Id. at 15
6 Tr.Refers to the hearing transcript. The numbers immediately following refer to the transcript page numbers.

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16. No supplemental allegations were broached by the Government.
The Respondent noted that they would be withdrawing their motion to suppress evidence, a motion that this tribunal had only preliminarily ruled upon. Id. at 17; ALJ Ex. 35. This Tribunal noted that the preliminary evidentiary rulings were for guidance and that the parties would still need to make their objections at the time of the hearing to preserve those objections. Tr.
17. The Respondent further requested that this Tribunal take official notice of 21 CFR 1304.21a and 21 U.S.C.
827a3, to which this Tribunal acceded. Id. at 1718. Next, the Respondent made preliminary objections as to authentication, failure to meet the business records exception, and improper burden shifting as to Governments Proposed Exhibits 9, 11, and 13. Id. at 1819. This Tribunal carried those objections over to the hearing. Id. at 19. Then, the Respondent clarified that Governments Proposed Exhibit 25 had been ruled inadmissible and excluded.7 Id. at 20. The Respondent then discussed a number of other matters related to proposed exhibits, which will be later discussed.
Id. at 2022. Finally, the Respondent objected to Governments Proposed Exhibit 26, which objection was also carried to the hearing. Id. at 23.
Governments Opening Statement In the Governments Opening Statement, it previewed that the DEA
conducted an audit of Pharmacy 4 Less on June 6, 2017. Id. at 25. The Government intended to explain the onsite audit through the testimony of DI1, including the findings from the audit, and explain the record keeping and regulatory violations that were discovered. Id. at 25. The Government also intended to offer the testimony of Dr. Hamilton regarding his review of the prescriptions and due diligence files that Pharmacy 4 Less maintained and how the Respondent filled prescriptions for controlled substances without resolving red flags. Id. at 25. Finally, the Government argued that the Respondent had not accepted responsibility for any of the alleged violations. Id. at 2526.
Respondents Opening Statement In the Respondents Opening Statement, it described Pharmacy 4 Less 7 GX 25 consisted of over 1000 pages of an Excel spreadsheet involving records of patients additional to the ten patients who are the subject of the allegations. GX 25 was ruled inadmissible as generally irrelevant. The Government was permitted to reconstitute the exhibit reflecting only the ten subject patients. The Governments substitute exhibit was introduced as GX 35.

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as a small, independent pharmacy. Id. at 27. Pharmacy 4 Less has two pharmacists and a low volume of patients. Id. at 27. The Respondent contrasted it from Publix, the pharmacy where Dr. Hamilton is employed. Id. at 2728. The Respondent stated that Pharmacy 4 Less cannot purchase in volume like other retail pharmacies, and cannot sell at the same prices as other larger pharmacies. Id. at 28.
The Respondent described Mr.
Richard Sprys, the owner and operator of Pharmacy 4 Less. Id. at 28. The Respondent detailed Mr. Sprys community involvement in his capacity as a pharmacist, and how he has previously testified as a witness in several cases for the Government in whistleblower cases against pharmacies.
Id. at 28. The Respondent further asserted that Mr. Sprys has always attempted to cooperate with the Government, including the process involving the July 9, 2018
administrative subpoena. Id. at 2829.
The Respondent also described Ms.
Amy Mincy, another pharmacist that works at Pharmacy 4 Less, including her extensive background and experience as a pharmacist. Id. at 30.
The Respondent described the June 6, 2017 on-site inspection of Pharmacy 4
Less. Id. at 29. The Respondent asserted that the DEA diversion investigators related to Ms. Mincy, the pharmacist onsite at the time of the inspection, that the inspection would only last ten to fifteen minutes when the inspection actually lasted over six hours. Id. at 29.
The Respondent asserted that the Governments portrayal that the Respondent has not accepted responsibility is misplaced. Id. at 30.
The Respondent stated that they submitted a corrective action plan which the DEA rejected, they have modified their behavior, they have reduced the number of patients they see and fill prescriptions for, and they have implemented a number of other remedial changes. Id. at 30.
The Respondent further described the treatment of patients when they visit Pharmacy 4 Less. Id. at 3032. The Respondent asserted that each patient receives specialized attention by the pharmacists because of Pharmacy 4
Lesss small size. Id. at 31. The Respondent also stated that not only does Pharmacy 4 Less contact patients doctors to resolve red flags, but Pharmacy 4 Less goes beyond that of other pharmacies because they will request and keep medical records of their patients to assist in the resolution of red flags. Id. at 3132.
Finally, the Respondent stressed that while Pharmacy 4 Less may not be
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