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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
and Mr. Sprys. The Government represents that GX 37 is the biennial inventory that was faxed to DI1 from Bill Sprys at Pharmacy 4 Less on the day following the June 6, 2017 on-site inspection. While it cannot be ascertained when exactly the handwritten material was included on RX 38, p.2, I find it inescapable that the handwritten notes were added after the inventory was faxed to the government.
This is further supported by the assertion from Ms. Mincy that she did not appear to know where the handwritten notes came from.YY Tr.
78688. In sum, the handwriting on RX
38 demonstrates that it is more likely that DI1 was provided a clean copy by the Respondent through the fax on June 7, 2017, and the handwriting on RX 38
was written at a later time.59 ZZ I credit DI1s testimony as to the statements made during the June 6, 2017 on-site inspection, as well as the lack of indication on the biennial inventory when the inventory had taken place.
I agree with the ALJs credibility finding regarding the handwriting on GX 37, p. 7 and RX 38, p.2. However, I also note that both the copy of the biennial inventory faxed to the Government, GX 37, p. 2, and the copy maintained by Respondent, RX 38, p. 1, contained what Ms. Mincy described as a cover page which stated Biennial Inventory, completed 4/26/17, 8am and was signed by both Ms. Mincy and Mr. Spry. Tr. 61718. While the cover sheet contained the same information written in GX 37, p. 7 and RX 38, p. 2, there is simply insufficient information in the record for me to determine whether or not this cover page was attached to the Biennial Inventory at the time of inspection. Accordingly, I
cannot say that there is enough evidence to support a violation of 1304.11a. As my finding differs from the ALJs in this regard, the remainder of the ALJs discussion on this topic is omitted. Even without this violation, there is more than enough evidence on the record to indicate that Respondent pharmacys registration is inconsistent with the public interest.
YY Furthermore, I do not find credible Ms.
Mincys assertion that there were two or three versions of the inventory, one labeled complete and others that were not labeled. Content was moved for clarity.
59 In their Posthearing Brief, the Government asserts that Ms. Mincy has intentionally backdated documents, including RX 38. Govt Posthearing Brief, at 36. As discussed, I cannot determine exactly who added the additional handwriting included on RX 38 or when it was added, and cannot accept the Governments assertion that it was, in fact, Ms. Mincy who backdated it after it had been delivered to the Government.
ZZ The preceding sentence and the following sentence were relocated for clarity.

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Therefore, I find that the Government has not established by sufficient evidence that Respondents biennial inventory failed to comply with the requirements of 21 CFR 1304.11a as alleged.
Ms. Mincys Access to CSOS
The Government has charged that during DEAs review of Pharmacy 4
Lesss CSOS, Ms. Mincy admitted to using Mr. Sprys CSOS credentials to order controlled substances in violation of 21 CFR 1311.30a, c. Section 1311.30a provides that only the certificate holder may access or use his or her digital certificate and private key. Section 1311.30c provides that a certificate holder must ensure that no one else uses the private key. While the private key is activated, the certificate holder must prevent unauthorized use of that private key.
The Government presented credible testimony from DI1 that he asked Ms.
Mincy how Pharmacy 4 Less documents and records their ordering of controlled substances and validation of a prescriptions legitimacy. Tr. 43.60 DI1
testified that he observed 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. DI1 testified that Ms. Mincy stated she did not have her own credentials and did not have a power of attorney for anyone elses credentials. Id. Ms. Mincy stated to DI1
that she was using Mr. Richard Sprys credentials to log onto CSOS. Id. The Government put on further evidence that 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 only received her own CSOS
credentials in July 2018, after the on-site inspection. Id. at 4849; GX 29.61
The Respondent presented testimony from Ms. Mincy that she was asked by DI1 to look at the pharmacys CSOS
system. Id. at 61213. The pharmacy uses the CSOS system sourced through AmerisourceBergen. Id. at 612. Ms.
Mincy testified that she showed DI1 the steps to order, but could not order because she did not have CSOS
60 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.
61 See supra n.15.

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credentials at the time of the inspection.
Id. at 613, 83940, 867. During her testimony, Ms. Mincy went into some detail explaining how the system worked; AAA she testified that she logged into AmerisourceBergen and demonstrated how controlled substances could be added to an order without the CSOS credentials. Id. at 840, 867. She explained that upon completion of the order, Schedule IIIV
medications are submitted to AmerisourceBergen, but that Schedule II
controlled substances are not submitted without taking extra steps to verify the CSOC certificate. Id. at 867. When showing the program to DI1, Ms. Mincy stated she did not put in any credentials to complete the process of ordering Schedule II controlled substances, because she did not have any at the time. Id. at 615, 86768. Ms. Mincy stated she then heard DI1 say that she had been ordering with Mr. Sprys credentials, which she followed up by telling him that was not correct. Tr. 615.
It is extremely difficult to reconcile the testimony and evidence presented by the parties regarding this allegation.
On one hand, the Government presented testimony of DI1 indicating that he observed Ms. Mincy log onto the CSOS
system, and that Ms. Mincy stated during the on-site inspection that she had ordered controlled substances using Mr. Sprys credentials. On the other hand, the Respondent presented testimony of Ms. Mincy that she logged in to the AmerisourceBergen system, not CSOS, that she never said she was using Mr. Sprys credentials, and that she told DI1 that his assertion was not correct. Both versions cannot be correct.
Based on the previous analysis of the witnesses credibility, DI1s version is generally more credible, considering Ms. Mincys memory issues and motivation to color her testimony.
However, Ms. Mincy testified in much greater detail than DI regarding the system and the steps she took to demonstrate it to DI, and this testimony was not addressed by DI when he later took the stand as a rebuttal witness. The Agency is clear that CSOS is the only method for ordering Schedule I and II
controlled substances electronically, and can be used for other Schedules, but there is no information on the record about at what point during the purchasing process the credentials are necessary. https www.deaecom.gov/
AAA Respondent, in its exceptions, made additional factual assertions regarding Mr. Sprys ability to access CSOS and order controlled substances, which are not only missing from the evidentiary record but are entirely irrelevant to the issue at hand and have no impact on my decision in this case. Resp Exceptions, at 10.

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