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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
perfect, they keep their practice aboveaverage. Id. at 32. The Respondent maintains that before and after the DEA
on-site inspection, Pharmacy 4 Less has a clean record with the Florida Department of Health for their on-site inspections. Id. at 32.
Governments Case in Chief The Government presented its case in chief through the testimony of two witnesses. First, the Government presented the testimony of a Diversion Investigator hereinafter DI1. Secondly, the Government presented the testimony of its expert, Dr. Thomas D.
Hamilton.
Diversion Investigator DI1
DI1 has been a Diversion Investigator for approximately seven years. Id. at 33.
He is currently assigned to the Orlando District Office, in Orlando, Florida. Id.
at 33. DI1 described his training and experience at the DEA Academy and in the field at the Baltimore and Orlando offices, including experience in at least 5070 pharmacy investigations. Id. at 3435.
DI1 first met with the staff at Pharmacy 4 Less on June 6, 2017. Id. at 37. He explained that Diversion Investigators 8 were doing regulatory inspections and Pharmacy 4 Less was randomly picked for a regulatory inspection. Id. at 37. When they arrived, the DIs showed their credentials and presented Ms. Amy Mincy, a pharmacist at Pharmacy 4 Less, with a DEA Form 82 Notice of Inspection.9 Id. at 3738;
GX 30.10 The form was signed by Ms.
Mincy and the DIs began their on-site inspection. Tr. 3839.
The DIs began by asking questions about Pharmacy 4 Lesss customer base and prescriptions, and looked at the prescriptions records, log books, and other required records. Id. at 39. When DI1 asked Ms. Mincy about inventories, she could not locate the initial inventory; so Mr. Richard Sprys, the owner of Pharmacy 4 Less, was contacted via speakerphone by Ms.
Mincy to determine where the initial inventory could be located. Id. at 39
40.11 DI1 asked Mr. Sprys over the phone if Pharmacy 4 Less had an initial inventory, and Mr. Sprys replied that it did not. Id. at 40.
DI1 next inquired as to whether Pharmacy 4 Less had performed a 8 DI1 was accompanied by Group Supervisor DI2
during the on-site inspection. Tr. 41.
9 A Notice of Inspection is a DEA Form evidencing a voluntary consent to search.
10 GXGovernments Exhibit.
11 Richard Sprys was not present at Pharmacy 4
Less during the on-site inspection on June 6, 2017.
Tr. 40.

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biennial inventory. Id. at 4041. Ms.
Mincy provided DI1 with a document purported to be a biennial inventory. Id.
at 41. DI1 concluded that the document did not comply with DEA regulations as the purported biennial inventory did not include a statement that it had been completed either at the opening or closing of business.12 Id. at 4142.
Further, DI1 claimed that Ms. Mincy had indicated that she had completed it over several days. Id. at 41. DI1
indicated that biennial inventories need to be completed either at the opening or closing of business and it needs to be notated on the biennial inventory. Id. at 4142. DI1 claimed that during this exchange, Ms. Mincy said, what was I
supposed to do, shut down the pharmacy? Id. at 42. As part of his later audit of the pharmacys inventories, DI1 did not use the biennial inventory because he could not verify its accuracy due to the issues he had discovered during his review. Id. at 56, 61, 66, 15456.
DI1 then inquired of Ms. Mincy as to recordkeeping and CSOS records.13 Id. at 42. DI1 asked Ms. Mincy how Pharmacy 4 Less documents and records their ordering of controlled substances and validation of a prescriptions legitimacy.
Id. at 43.14 When DI1 asked Ms. Mincy to produce the CSOS records including records of receipt for Schedule 2s, he observed that Ms. Mincy proceeded to a laptop in the pharmacy to log into the CSOS system. Id. at 45. DI1 asked Ms.
Mincy if she had her own CSOS
credentials which DI1 asserted is required for anyone accessing the CSOS
system and cannot be shared with anyone else. Id. at 46. In response, Ms.
Mincy stated she did not have her own credentials and did not have a power of attorney for anyone elses credentials.
Id. at 46. Ms. Mincy stated to DI1 that she was using Mr. Richard Sprys credentials to log onto CSOS. Id. at 46.
DI1 later contacted Mr. Chris Jewell, one of the personnel in charge of the CSOS system at DEA Headquarters, to determine which personnel at Pharmacy 4 Less had access to the CSOS system.
Id. at 4748. Mr. Jewell ran a report and the report stated that Ms. Mincy received her own CSOS credentials in July 2018. Id. at 4849; GX 29.15
12 See
21 CFR 1304.11a.
Substance Ordering System.
14 DI1 asserted during his testimony that when a pharmacy orders and receives controlled substances on-site, they are required to notate that they received them with the date and the initials of the person that received them. Tr. 44.
15 The Respondent objected to admission of GX
29 on the basis of lack of authentication and not meeting the exception of a business record. Tr. 49.
DI1 made it clear that he did not personally 13 CSOSControlled
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DI1 described the audit 16 of Pharmacy 4 Lesss records and inventories.17 Tr. 5385, 91926; GX 4, 31, 32.18 DI1 conducted an audit of Pharmacy 4 Lesss records and inventories at a starting date of January 1, 2017. Tr. 5556. DI1 selected this date because Pharmacy 4 Less maintained handwritten Schedule 2 controlled substance logs, there was no initial inventory, and the investigating DIs were unsure of how accurate the biennial inventory was. Id. at 56, 61. For example, DI1 had used the pharmacys handwritten perpetual inventory forms for Methadone 10 mg tablets and Oxycodone 30 mg tablets during the audit, which had been provided to DI1
by Ms. Mincy during the on-site inspection on June 6, 2017. Id. at 5660;
GX 31, 32.19
DI1 explained that under DEA
regulations, records need to be readily retrievable and maintained at the pharmacy. Tr. 86. It does not satisfy the regulations that records may later be retrieved. Id. at 86. He discovered that produce this record, but requested it from Mr.
Jewell. Id. at 4950. This Tribunal noticed that it appears to be a government record and did not appear to have any indication of inaccuracy or unreliability. Id. at 50. The Respondent argued that portions of the document appeared to have inaccuracies as related to Mr. Sprys, but agreed that if the Government was only offering the document as related to Ms. Mincy, it would not object if the rest of the document was blackened out to only show Ms. Mincys records. Id. at 5052. The Government agreed that it was only offering the document for Ms. Mincys records on the top line and would not object to blackening out Mr. Sprys records. Id. at 5152. This Tribunal admitted GX 29
on that basis as altered and is only considering GX
29 for the top line as related to Ms. Mincys records.
Id. at 5152.
16 The audit occurred both at the pharmacy and later during a review of Pharmacy 4 Lesss records.
Tr. 100.
17 DI1 was later asked about his receipt and possession of records obtained from the pharmacy during the June 6, 2017 on-site inspection. Tr. 949
54; Proposed RX 10 not offered into evidence The Government also had a standing objection to this line of questioning as outside the scope of redirect examination. Tr. 951.. Proposed RX 10 was a DEA
12, a receipt of items taken by the DIs after their inspection. Tr. 951. The DEA12 forms indicated that the DEA had taken possession of six California folders containing C2 prescriptions, and 13 manila folders containing C2 invoices. Tr. 95153.
18 The Government initially offered GX 4 during the first portion of the hearing in Orlando, Florida.
Tr. 67. The Respondent conducted voir dire and objected that it was unreliable. Tr. 6881. This Tribunal initially admitted the exhibit. Tr. 8185.
However, this Tribunal reconsidered its ruling and found that GX 4 in its then present condition would not be helpful to the factfinder. Tr. 146. This Tribunal then afforded the Government the opportunity to resubmit GX 4 at a later time. Tr.
14648. During the portion of the hearing in Arlington, Virginia, the Government reintroduced a corrected version of GX 4. Tr. 925. The Respondent did not object and the corrected version of GX 4
was admitted. Tr. 92526.
19 For a full discussion of how DI1 conducted his audit, see Tr. 6167.

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