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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices Pharmacy 4 Less did not have readily retrievable records available during the June 6, 2017 on-site inspection. Id. at 87.20
Following the June 6, 2017 on-site inspection, DIs 21 returned to Pharmacy 4 Less again on June 21, 2017. Id. at 88.
Ms. Mincy was again at the pharmacy, and Mr. Richard Sprys joined them later that day. Id. at 88. DI1 stated that he discussed his findings from the initial on-site inspection and audit including the invoices and prescriptions with Mr.
Sprys and Ms. Mincy during this second visit. Id. at 88. During the discussion, DI1 asked Mr. Sprys and Ms. Mincy how they determined whether prescriptions were for a legitimate medical purpose, based on a review of the records the DIs had retrieved during the first on-site inspection. Id. at 8990.
The pharmacists both Mr. Sprys and Ms. Mincy responded that they checked EFORCSE, the Florida prescription monitoring program website, and that they would verify prescriptions by contacting the doctors office and/or requesting patient medical files. Id. at 9091. When asked how this information is documented, one of the pharmacists DI1 could not remember if it was Mr. Sprys or Ms. Mincy provided a red folder that they maintained. Id. at 9192. The red folder contained screenshots from the computer system, Rx30.22 Tr. 92. The red folder contained information related to multiple patients.
Tr. 93, 11931; GX 5, 7, 13, 17, 21, 23.
DI1 did not find any due diligence files for Patients A.V., B.F., K.Y.D., or R.R. in the files provided to him by Pharmacy 4 Less. Tr. 13136.
The following day on June 22, 2017, an administrative subpoena was served on Pharmacy 4 Less, requesting hard copy prescriptions for all Schedules 2
5 controlled substance prescriptions from October 2015 through June 22, 2017, all controlled substance prescription data from Rx30, and all due diligence patient files. Tr. 9394; GX 2.
Pharmacy 4 Less complied by delivering 20 DI1 explained that readily retrievable means that when DIs go into a pharmacy to perform an audit or to review a record, the pharmacy should be able to provide those records within a reasonable time. Tr. 87.
21 DI1 noted that on this second visit, he was present, along with DI Debbie George, Group Supervisor Linda Stocum, and Division Program Manager of the State of Florida, Susan Langston. Tr.
88.
22 Rx30 is a computer software that Pharmacy 4
Less used to maintain their inventory, the dispensing of controlled substances, and as DI1
testified, patient profile screens where the pharmacist can input notes about the patient, including information about the patient, treatment, injuries, and other diagnosis notes. Tr. 9293. The Respondent identified this as the patient record maintenance form PRM. Id. at 93.

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a gray tote container that contained California folders filled with Schedule 2 hard copy prescriptions, a thumb drive containing all Rx30 data, and the red folder seen during the June 21 on-site inspection. Id. at 96. The Schedules 35 prescriptions were delivered to the DIs by Pharmacy 4 Less at an unidentified later date. Id. at 97.
The red folder contained screenshots from the Rx30 program. Id. at 96. The red folder also contained the pharmacists notes on patients, referred to as due diligence files. Id. at 9697.
The California folders were organized by prescription number, which DI1
sorted through to locate prescriptions for the 10 charged patients at issue in this case. Tr. 97111; GX 6, 8, 10, 12, 14, 16, 18, 20, 22, 24.23 DI1 also discussed the Rx30 data retrieved from the thumb drive related to the 10
charged patients. Tr. 11116; GX 35, 36.24
Diversion Investigators the DIs were not identified by DI1 returned to Pharmacy 4 Less during approximately February 2018. Tr. 136. During this visit, DI1 acquired copies of invoices for controlled substances. Tr. 136. DI1
noted that a few of these invoices violated DEA regulations by failing to provide a date of receipt.25 thnsp;G
Tr. 13639.
Another administrative subpoena was served on Pharmacy 4 Less on July 9, 2018. Tr. 95; GX 3.
DI1 was recalled during the second portion of the hearing at the DEA
Hearing Facility in Arlington, Virginia.
DI1 credibly explained the purpose of the corrected GX 4, and how he arrived at his results during his audit of the pharmacys records and inventories. Tr.
91926. DI1 also testified to GX 38
Redacted Initial Response from Florida EFORCSE reflecting only the 10
charged patients and GX 40 A
23 These exhibits were admitted with the qualification that these exhibits only contained the Schedule 2 hard copy prescriptions for each of the 10 charged patients, not all of the prescriptions. Tr.
10211. The Government noted, that some of the prescriptions here are not Schedule 2s, but the Government did not litigate those prescriptions, and they are therefore not relevant to the Governments prima facie case. Tr. 103.
24 GX 35 is a narrowed version of Governments Proposed Exhibit 25, which was previously ruled inadmissible during prehearing proceedings. GX 35
only included information related to the 10 charged patients. Tr. 11618. See ALJ Ex. 32.
25 The Respondent conducted voir dire of DI1 on this point and argued that 21 CFR 1305 only applies to Schedule 2 controlled substances. Tr. 14045.
For further analysis, see infra section Date of Receipt on Invoices.
G DI clarified his testimony to say that only a few of them actually contained the . . . date of receipt; specifically, there were only four that contained the actual date of receipt, and eightyfive were not properly dated. Tr. 13738.

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declaration by DI3 as to an administrative subpoena sent to the Florida EFORCSE for user history, which was introduced at the second portion of the hearing. Tr. 92936.26 DI3
was asked by DI1 to send an administrative subpoena to the Florida EFORCSE program to request a user history report. Id. at 92930. Based on a follow-up request by DI1, the Florida EFORCSE personnel reviewed their system to see when Mr. Sprys and Ms.
Mincy had accessed the Florida PDMP
to look up patients. Tr. 93132; GX 40, Att. C.
DI1 also offered three arrest records for Patient K.Y.D. Tr. 937; GX 4143.
The arrest records were produced from arrest.org, a public website where members of the public can retrieve arrest information about individuals, which DI1 occasionally uses in the course of his employment. Id. at 93839.
DI1 indicated that this website is a tool that pharmacists or doctors can utilize to look up patients to see if they have ever been arrested for controlled substance violations. Id. at 940.
According to the records, Patient K.Y.D.
had previously been arrested on December 31, 2015, for possession of oxycodone with an intent to sell. Id. at 940; GX 43. Patient K.Y.D. had also previously been arrested on May 2, 2016, for operating with a suspended license, possession of Schedule 2
controlled substances, and possession of a Schedule 4 controlled substance. Tr.
941; GX 41. Finally, Patient K.Y.D. had also previously been arrested on February 25, 2017, for possession of a Schedule 2 controlled substance and resisting an officer without violence. Tr.
94142; GX 42.27
Dr. Thomas Hamilton, Pharm. D.
Dr. Hamilton received his Doctor of Pharmacy degree at Nova Southeastern University in Fort Lauderdale. Tr. 167.
He has worked as a pharmacist for 18
years. Id. at 169; GX 27. After being licensed in 1999, he worked for a short time at a small pharmacy before beginning full-time at Publix pharmacy as a pharmacist. Tr. 172. He served in 26 GX 38Redacted was admitted and substituted in place of the original GX 38. Tr. 934. GX 40, p.
1, Att. A, and Att. C. were also admitted into evidence. Tr. 93536.
27 The Respondent objected and argued that the arrest records were unreliable and irrelevant to this matter. This Tribunal found that these records were available to the public, and not being offered for the truth of the matter of the arrests, but as a resource that an individual such as a doctor or pharmacist would be confronted with if they accessed this website. They were admitted over objection. Tr.
94243. Reviewing such arrest websites is not required by the relevant standard of care, nor is it something that Dr. Hamilton or the other pharmacists did at Publix Pharmacies. Tr. 102223.

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