Federal Register - October 1, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
587. William Sprys acts as the administrator for the pharmacy, but is not a registered pharmacist, so he primarily handles clerical administrative duties. Id. at 58788.
During the inspection, Ms. Mincy was handed a DEA Form 82, Notice of Inspection. Tr. 589; GX 30. She was uneasy about consenting to an inspection because she only works as an independent contractor at Pharmacy 4
Less, not as a regular employee. Tr. 590
91. She asked to contact Mr. Richard Sprys to ask about the form and whether she should consent and sign the form.
Id. at 59192. She had William Sprys contact Mr. Richard Sprys on the telephone because Richard was out of the country at the time of the inspection. Id. at 592. The DIs were also present during the telephone call. Id.
She spoke to Mr. Richard Sprys on speakerphone about the DEA inspection and the DIs request to inspect the pharmacy. Id. Mr. Sprys then gave permission and directed Ms. Mincy to sign the form. Id. at 59293. Ms. Mincy then signed the Form 82. Tr. 594.
After signing the form, Ms. Mincy was taken into a separate room in the pharmacy. Id. at 596. DI1 asked to see the pharmacys perpetual inventory. Id.
at 598. DI1 proceeded to count pills of controlled substances contained in the pharmacy. Id. DI1 asked for the perpetual inventory pages for January 1, 2017, through June 6, 2017. Tr. 60405.
The perpetual inventory was handwritten and was designed to keep track of the pharmacys prescription inventory. Tr. 63031; RX 31
Methadone, 32 Oxycodone.
He then requested the pharmacys biennial inventory. Tr. 60506, 77374;
GX 37; RX 38.36 The pharmacy keeps its inventories in a binder that is located inside the locked medication room. Tr.
607. The Respondents version of the biennial inventory indicated that it was completed on April 26, 2017, at 8:00
a.m. by Ms. Mincy and Mr. Sprys. Id. at 61718, 76773; RX. 38, pp. 1, 2, 3, 8
16. The inventory was completed by entering the drug room, verifying the number of pills, scanning the prescription bottles, and verifying their entry into the pharmacys computer system. Tr. 62627. Ms. Mincy testified she completed the biennial inventory in about three hours. Id. at 628. Ms. Mincy 36 Each version was admitted following the Governments voir dire and request to admit GX 37
if this Tribunal were to admit RX 38. The Government agreed to redact the pricing information contained at the Respondents request.
Tr. 77582. However, the Government later requested to withdraw the original GX 37 and offer an alternative version of GX 37, with only pages 1
7 considered for record. Tr. 91217.

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indicated her understanding that the biennial inventory must be completed either in the morning before the start of business or at the end of the day at the close of business, and that it was completed before the opening of business. Id. at 62021, 81719. The biennial inventory was kept inside a binder with the C2 perpetual inventory. Id. at 622. The biennial inventory was later sent by the pharmacy to DI1 after he left it at the pharmacy following the inspection. Id.
at 63842; 78288. She indicated she was not aware that a biennial inventory containing Schedule 2 prescriptions needed to be separate from an inventory containing Schedules 3 through 5
prescriptions. Id. at 818. To complete the biennial inventory, she would open the narcotic cabinet and would handcount the Schedule 2 pills inside. Id. at 82021.
For the inventories in the pharmacy, Ms. Mincy would keep a perpetual inventory of the prescriptions that had been filled. Id. at 62834; GX 31, 32.
The perpetual inventories were usually filled out by Ms. Mincy, but were sometimes updated by Mr. Sprys. Tr.
62829. Every time a prescription was filled, it would be noted by either Mr.
Sprys or Ms. Mincy so that they could keep up with their inventory that was on hand. Id. at 631. These were provided by Ms. Mincy to DI1 when he asked to see the pharmacys inventory to determine if it was correct. Id. at 634
35. Ms. Mincy explained from the perpetual inventories how it can be determined how many pills were currently in the inventory. Id. at 635.
DI1 also asked to see the pharmacys computer software, including print-outs and reports. Id. at 60911. DI1 then requested to inspect the pharmacys CSOS system. Id. at 61213. CSOS is the pharmacys electronic controlled substance ordering system. Id. at 611, 86566. The pharmacy uses the CSOS
system sourced through AmerisourceBergen. Id. at 612. Ms.
Mincy showed DI1 the steps to order, but could not order because she did not have CSOS credentials at the time of the inspection. Id. at 613, 83940, 867. Each authorized user receives an individual code that must be kept confidential to that user. Id. at 613. When showing the program to DI1, Ms. Mincy stated she did not put in any credentials because she did not have any at the time. Id. at 615, 86768. DI1 then accused her of ordering with Mr. Richard Sprys credentials, which she promptly denied.
Id. at 615. DI1 then proceeded to take all the original copies of the pharmacys Schedule 2 prescriptions and some of the Schedules 35 prescriptions from
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January 1, 2017, to June 6, 2017. Id. at 61517, 89193, 89496; RX 59, 60.37
Ms. Mincy could not explain how there were differences between the original copy of RX 59 she had maintained at the pharmacy and the version that the Government had introduced into evidence, as the version the Government had seized on June 6, 2017. Tr. 901903;
compare GX 26, pg. 50 with RX 59.
Ms. Mincy would use the Florida E
FORCSE system as part of her resolution of red flags. Tr. 64243. It is used to assist medical personnel in keeping track of medications individuals are taking. Id. at 642, 87071. It contains a log of a patients controlled substances that are disbursed from a prescription written by a doctor and filled by a pharmacist. Id. Pharmacies upload prescriptions daily into the EFORCSE
system. Id. at 643. EFORCSE contains prescriptions for Schedules 24
controlled substances. Id. Ms. Mincy would use it daily and prior to every fill of a new prescription for clients. Id. at 643. EFORCSE allows a pharmacist to immediately access a patients name, date of birth, address, and the aforementioned prescriptions. Id. at 645.
It also allows a pharmacist to see which pharmacies a patient goes to, or if the patient is doctor shopping or trying to fill prescriptions early. Tr. 645.
At the pharmacy each morning, either Mr. Sprys or Ms. Mincy would log on to the EFORCSE system and it would be left open on the computer to be accessed. Id. at 871. Ms. Mincy understood that when EFORCSE
started, it was permissible to use another persons login since the pharmacy manager or pharmacist would log in first thing in the morning and it could be used throughout the day under that persons login information. Id. at 903908.38 The login systems for CSOS
and EFORCSE are two separate systems. Id. at 872. CSOS is regulated directly by the DEA and individual authorization and access has to be 37 Testimony related to RX 59 and 60 were objected to by the Government for lack of notice and being beyond the scope of cross-examination that was conducted on November 7, 2018. This Tribunal permitted the Respondent to make a record of the testimony for the Administrators consideration, but sustained the Governments objection as to being beyond the scope of cross examination. Tr. 88591, 893, 896900.
38 Ms. Mincy explained that this is why sometimes another persons EFORCSE number would appear on the search records when she had actually done the search. Tr. 90809. There was further testimony about the pharmacys use of E
FORCSE and Ms. Mincys understanding of its use, along with discussion about proposed RX 57. Tr.
90309. However, proposed RX 57 was later withdrawn by the Respondent and GX 38 redacted was used instead after its introduction during DI1s rebuttal testimony. Tr. 92734; 102425.

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Federal Register - October 1, 2021

TitoloFederal Register

PaeseStati Uniti

Data01/10/2021

Conteggio pagine257

Numero di edizioni7798

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Ultima edizione18/06/2026

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