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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices not have one. This evidence went essentially uncontested.
The Agency has previously found that testimony alone provides substantial evidence to support a finding that a registrant failed to properly prepare records. Jones Total Health Care Pharmacy, L.L.C., & SND Health Care, L.L.C., 81 FR 79,188, 79,191 2016, pet.
for rev. denied, 881 F.3d 823 11th Cir.
2018. The Agency rejected the respondents argument that because the DEA bears the burden of proof, it must provide independent evidence towards such allegations. Id.
As previously discussed, I find that DI1s testimony in these proceedings was credible and indicated trustworthiness. The Government has submitted testimonial proof sufficient to satisfy its burden, that the Respondent did not have an initial inventory.
Further, while the Respondent has no burden to disprove the Governments allegation, it would not benefit the Respondent to withhold such a document if such document existed.
Based on DI1s testimony and the lack of physical evidence presented by either party, I find that the Government has met its burden to show that the Respondent has failed to keep an initial inventory as required under 1304.11b.
Biennial Inventory The Government has charged that Pharmacy 4 Less failed to indicate whether the biennial inventory was taken at the opening or closing of business as required by 21 CFR
1304.11a. Section 1304.11a provides, in part, that the inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.
The Government presented testimony from DI1 that the biennial inventory was provided to him by Ms. Mincy during the June 6, 2017 on-site inspection. DI1
testified that the biennial inventory given to him did not meet the requirements as set in the DEA
regulations. Tr. 41. One failing that DI1
noted was that, by Ms. Mincys statements, the biennial inventory was not completed during a single day, but over the course of several days. Tr. 41.
Another defect was that there was no notation on the biennial inventory as to whether it was completed at the opening or closing of business. Id. at 4142. DI1 was unsure about the accuracy of the biennial inventory due to these issues, which caused him not to use it as part of his audit of the pharmacys inventory. Id. at 56, 61, 66, 15456.

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The Respondent presented testimony from Ms. Mincy that DI1 had asked to see the biennial inventory, which she produced and gave him a copy. Id. at 605. She indicated that the biennial inventory was located in a binder in the locked medication room along with the perpetual inventory. Id. at 607, 62223.
Ms. Mincy testified that on June 6, 2017, she gave DI1 the biennial inventory at the pharmacy. Id. at 77374. She indicated that he had left it at the pharmacy after the inspection, and that he called back looking for it because he had forgotten to take it with him. Id. at 774.
The Respondent then introduced a copy of the biennial inventory. RX 38.
The exhibit included a cover sheet that noted that the biennial inventory was completed on April 26, 2017, at 8:00
a.m., and was completed by Ms. Mincy and Mr. Sprys. Tr. 61718, 76768; RX
38, p. 1. The following page was the actual first page of the printed out biennial inventory. Tr. 619, 767; RX 38, p. 2. The remaining pages are all part of the biennial inventory, and the printout indicates a date of April 26, 2017. Tr.
62022; RX 38, pp. 216. The exhibit contains handwriting that indicates that the biennial inventory was completed on April 26, 2017, at 8:00 a.m. and was signed by Mr. Sprys and Ms. Mincy. Tr.
76769; RX 38, pp. 1, 2, 8.
Ms. Mincy testified that the biennial inventory had been completed at 8:00
a.m. because it must be completed in the morning before business or at the end of the day at the close of business to avoid discrepancies in the pharmacys counts. Tr. 620. She further testified that she and Mr. Sprys had signed and dated the biennial inventory to validate that the information was true and correct, and that she had completed it during that date and time. Id. at 624
25. She indicated that it took her approximately three hours to complete the biennial inventory, so she would have arrived at the pharmacy at approximately 5:00 a.m. Id. at 628. She testified that she personally prepared both reports contained within the biennial inventory, and personally entered all of the information herself on the date listed on the form. Id. at 772.
As for the date indicated at the top of each page, Ms. Mincy stated that it reflects the date on which the report was run. Id. at 77273; RX 38, pp. 27, 916.
The Government conducted a voir dire of Ms. Mincy as to RX 38. Tr. 774.
She testified that RX 38 was a true and correct copy of what she had given DI1
on June 6, 2017, and that there had not been any alterations made to the document after she gave it to him. Id. at
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77475. She claimed that no one had written on the document to include the handwriting at the top of RX 38, p. 2
after she had given it to DI1 or after it had been faxed to him. Id. at 775. She testified that the biennial inventory had later been faxed to DI1 by Bill Sprys. Id.
at 77677. The Government showed Ms.
Mincy another version of a copy of the biennial inventory that did not contain the handwriting written on RX 38. Id. at 77881. The Governments copy was admitted as GX 37. Ms. Mincy indicated that there must be two versions of the inventory, one labeled complete and one that was not labeled. Id. at 780.
The Government later conducted cross-examination of Ms. Mincy about the biennial inventory. Id. at 817. She admitted that while the biennial inventory did not indicate that it was conducted at the close of business, she asserted that it was completed before the opening of business at 8:00 a.m. Id.
at 817. When asked on crossexamination, she changed her earlier testimony to say that she completed the biennial inventory from 6:00 a.m. to 8:00 a.m. on April 26, 2017, an hour later than she had previously indicated.
Id. at 822.
Ms. Mincy was also confronted with statements DI1 testified she had said during the inspection. When asked if she had said during the on-site inspection that she had completed the inventory over the course of several days, she claimed that DI1 was confused. Id. at 82324. When asked if she had said that she would have to shut down the pharmacy to do the biennial inventory, she said that DI1
misunderstood. Id. at 825.
Based on both parties assertions, DI1
left the biennial inventory at the pharmacy after the on-site inspection.
At that point, DI1 did not have a copy of the biennial inventory. I noted during the course of the hearing that DI1 had testified Ms. Mincy had provided a document that was represented as a biennial inventory, but that it didnt qualify because there was no indication that the document was prepared on a single occasion, so he left it at the pharmacy because he would not use it as part of his audit. Tr. 155.XX
At the outset, I note the immediate differences between GX 37 and RX 38 as highlighted by the Government. Both GX 37, p. 7, and RX 38, p. 2, present similarly printed material, but RX 38
contains handwritten material at the top of the page that purports to show that the biennial inventory was completed on 4/26/17 at 8AM and is contains signatures purported to be Ms. Mincy XX Paragraph
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