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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices Findings of Fact The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me.
1. The Respondent currently holds active COR FP5459082. ALJ Ex. 1.
2. DI1 conducted an on-site inspection of Pharmacy 4 Less on June 6, 2017. Tr. 37.
3. Pharmacy 4 Less was randomly picked for regulatory inspection by the DEA. Tr. 37.
4. Ms. Amy Mincy signed the Notice of Inspection presented to her by DI1.
Tr. 3839; GX 30.
5. Ms. Mincy could not locate an initial inventory, and Mr. Richard Sprys confirmed via speakerphone with DI1
that Pharmacy 4 Less did not have an initial inventory. Tr. 3940.
6. Ms. Mincy provided DI1 with a purported biennial inventory, but, according to DI1, it did not indicate whether it had been completed either at the opening or closing of business. Tr.
4142; GX 37.
7. When asked about the pharmacys CSOS system, Ms. Mincy demonstrated to DI1 how the pharmacy ordered controlled substances on the system. Tr.
4345.
8. DI1 contacted Mr. Chris Jewell, one of the personnel in charge of the CSOS
system at DEA Headquarters. Mr. Jewell ran a report which stated that Ms.
Mincy received her own CSOS
credentials in July 2018. Tr. 4749; GX
29.
9. DI1 conducted an audit of Pharmacy 4 Lesss records and inventories. Tr. 5393, 91926; GX 4, 31, 32. DI1 selected a starting date of January 1, 2017, due to discrepancies in the biennial inventory, the lack of an initial inventory, and Pharmacy 4 Less maintained handwritten Schedule 2
controlled substance logs. Tr. 56, 61.
10. DI1 and other personnel returned to Pharmacy 4 Less on June 21, 2017.
Both Ms. Mincy and Mr. Sprys were present. Tr. 8889.
11. DI1 asked Ms. Mincy and Mr.
Sprys how they determined whether prescriptions were for a legitimate medical purpose. Both pharmacists responded they would check EFORCSE
and that they would verify prescriptions by contacting the patients doctors. The DIs were provided with a red folder that contained screenshots from the pharmacys computer system, Rx30. Tr.
8992. The red folder contained screenshots from the Rx30 program. Id.
at 96. The red folder also contained the
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pharmacists notes on patients, referred to as due diligence files. Id. at 97.
12. On June 22, 2017, an administrative subpoena was issued to Pharmacy 4 Less, requesting hard copy prescriptions for all Schedules 25
controlled substance prescriptions from October 2015 through June 22, 2017, all controlled substance prescription data from Rx30, and all due diligence patient files. Id. at 9394; GX 2. Pharmacy 4
Less complied by delivering 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.
Treatment of Patient A.E.
13. Pharmacy 4 Less dispensed hydromorphone 8 mg to Patient A.E. on 21 occasions between November 19, 2015, and June 1, 2017. GX 6.
14. On November 19, 2015, Pharmacy 4 Less dispensed Patient A.E. 84 tablets of hydromorphone 8 mg without determining whether Patient A.E. was opioid nave. Tr. 18386; GX 28, p. 6;
GX 37, p. 11.
15. Between November 19, 2015, and June 1, 2017, Pharmacy 4 Less, on 21
separate occasions, dispensed hydromorphone 8 mg tablets to Patient A.E. at a price of approximately $5.95
per tablet, even though other retail pharmacies were selling hydromorphone 8 mg at approximately $1.50 per tablet. Tr. 19599; 20003; GX
28, pp. 67.
16. Between December 17, 2015, and June 1, 2017, Pharmacy 4 Less, on 20
separate occasions, dispensed hydromorphone to Patient A.E. without determining why hydromorphone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 19295; 20003;
GX 28, p. 6.
Treatment of Patient A.R.
17. Pharmacy 4 Less dispensed oxycodone 15 mg to Patient A.R. on 17
occasions between March 17, 2016, and June 7, 2017; GX 8.
18. On March 17, 2016, Pharmacy 4
Less dispensed Patient A.R. 112 tablets of oxycodone 15 mg without determining whether Patient A.R. was opioid nave. Tr. 20507; GX 28, p. 12.
19. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on 17
separate occasions, dispensed oxycodone 15 mg tablets to Patient A.R.
at a price of approximately $2.23 to $2.50 per tablet, even though other retail
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pharmacies were selling oxycodone 15
mg at approximately $0.90 per tablet at the time. Tr. 20507, 21214; GX 28, pp.
1213.
20. Between May 11, 2016, and June 7, 2017, Pharmacy 4 Less, on 15
separate occasions, dispensed oxycodone 15 mg to Patient A.R.
without determining why oxycodone was being prescribed on a long-term basis without the presence of a longacting pain medication. Tr. 21214, GX
28 p. 12.
21. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on 17
separate occasions, dispensed oxycodone 15 mg tablets to Patient A.R., even though Pharmacy 4 Lesss records do not show that Pharmacy 4 Less ever addressed why Patient A.R. traveled southwest approximately 37 miles from his house in Daytona Beach, Florida to his doctors office in Sanford, Florida;
traveled approximately 15 miles further southwest to buy his controlled substances from Pharmacy 4 Less, and then returned approximately 45 miles northeast to his home in Daytona Beach, Florida. Tr. 20714, 33435, GX 28, p.
13.
Treatment of Patient A.V.
22. Pharmacy 4 Less dispensed buprenorphine and/or oxycodone to Patient A.V. on 14 occasions between April 12, 2016, and April 10, 2017. GX
10.
23. On March 17, 2016, Pharmacy 4
Less dispensed Patient A.V. 112 tablets of oxycodone 20 mg without determining whether Patient A.V. was opioid nave. Tr. at 262, 26768; GX 28, p. 8.
24. Between April 12, 2016, and February 13, 2017, on 8 separate occasions, Pharmacy 4 Less filled prescriptions for Patient A.V. for 112
tablets of oxycodone 20 mg, an opioid, within nine days of filling a prescription for 2960 tablets of buprenorphine 8
mg, a controlled substance used to treat opioid addiction. Seven of the eight fills took place on the same day. Tr. at 261
76; GX 28, p. 8.
25. Between April 21, 2016, and April 10, 2017, Pharmacy 4 Less, on 12
separate occasions, dispensed oxycodone 20 mg tablets to Patient A.V.
at a price of approximately $2.59 per tablet, even though other retail pharmacies were selling oxycodone 20
mg at approximately $1.25 per tablet at the time. Tr. at 26276; GX 28, pp. 8
9.
26. Between July 5, 2016, and April 10, 2017, Pharmacy 4 Less, on 10
separate occasions, dispensed oxycodone to Patient A.V. without determining why oxycodone was being
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