Je veux savoir à propos de…

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices qanda.html.BBB Further had Ms. Mincy actually purchased controlled substances using the CSOS account during the inspection, I find it confusing that the Government did not include evidence related to such purchase.
Despite the credibility issues present in this case,CCC the Governments evidence lacked basic information regarding the CSOS system and what the DI actually observed as opposed to what he heard Ms. Mincy say that led to his conclusion that Ms. Mincy had used Mr. Sprys credentials to log into the CSOS system. Without that information it is difficult to determine the weight of the evidence, and as the Government has the burden of proof, I
simply cannot find substantial evidence to support violations of 1311.30 a &
c.
Electronically Linked Record of Quantity and Date Received The Government has charged that Pharmacy 4 Lesss receiving records showed that Pharmacy 4 Less failed to create an electronically linked record of a quantity and date received for its controlled substances in violation of 21
CFR 1305.22g. Section 1305.22g provides that when a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record must be electronically linked to the original order and archived.
After a thorough review of the evidence and testimony presented by the parties, I have found a lack of any evidence presented towards this charge by the Government. While the DI1
extensively testified about the Governments charge of a lack of a date of receipt on the pharmacys invoices, the Government did not probe into the allegation that Pharmacy 4 Less failed to create electronically linked records under 1305.22g. While DI1 indicated that Pharmacy 4 Less did not have PDF
BBB What is a CSOS Certificate? A CSOS
Certificate is a digital identity issued by the DEAs CSOS Certification Authority CSOS CA that allows for electronic ordering for Schedule I and II
as well as IIIV controlled substances. A CSOS
Certificate is the digital equivalent of the identification information contained on a DEA
Form-222. CSOS Certificates are issued to individuals and are required for electronic ordering of Schedule I and II controlled substances.
CCC The Recommended Decision stated that it is more believable than not, from this record, that Ms.
Mincy was given access to Mr. Sprys digital certificate and private key. Despite her contractor status, she ran the pharmacy Monday through Thursday. She used Mr. Sprys credentials to log onto the CSOS system in the presence of DI1, before she had her own credentials. Although I agree with the ALJs credibility findings generally, I
believe that the Government could have easily produced evidence to support this claim, and I
decline to find a violation.

VerDate Sep<11>2014

20:19 Sep 30, 2021

Jkt 256001

copies of the CSOS records, he did testify that the CSOS is online and can be a totally electronic record. Tr. 4445.
However, there was no evidence that Pharmacy 4 Less had failed to create an electronically linked record of any shipments of controlled substances.
However, the Respondent, while brief, presented some evidence of their compliance with 1305.22g. The Respondent presented testimony by Ms.
Mincy towards two inspections at Pharmacy 4 Less by the Florida Department of Health Investigative Services. Tr. 65881; RX 14, 15. One inspection report, dated February 28, 2017, before the DEAs on-site inspection, indicated that the investigator from the Florida Department of Health had found that Pharmacy 4 Less was compliant with the requirement that DEA 222 forms properly completed or records of receipt of CSOS orders electronically completed, archived and retrievable.
Tr. 661; RX 15, p. 2. This requirement then directly cites to 21 CFR 1305.22g.
RX 15, p. 2. The second inspection report, dated September 5, 2017, after the DEAs on-site inspection, indicated that the investigator from the Florida Department of Health again found that Pharmacy 4 Less was compliant with the requirement under 1305.22g. RX
14, p. 2.
While the Respondents evidence will ultimately go towards the analysis of Factor Two under the public interest factors, it is also relevant to rebut the Governments charge under 1305.22g. While the DIs may have had some indication that Pharmacy 4
Less was not in compliance with the requirements under 1305.22g, the record is void of any testimony or evidence to support such a charge.
Further, the Respondent has offered evidence, at least from the viewpoint of an inspector with the Florida Department of Health, that Pharmacy 4
Less was in compliance with the requirements under 1305.22g before and after the DEAs on-site inspection.
Therefore, I find that the Government has not met their burden of proof as to this allegation.
Date of Receipt on Invoices The Government has charged that Pharmacy 4 Less possessed 85 invoices without the date of receipt recorded in violation of 21 CFR 1304.22c. Section 1304.22c provides, in part, that each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph a2i, ii, iv, vii, and
PO 00000

Frm 00031

Fmt 4701

Sfmt 4703

54579

ix of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.
I note at the outset that a review of the Governments charge in the OSC and in their Prehearing Statements presents a problem. Upon a careful review of the language of 1304.22c, it becomes apparent to me that this section has no requirement that the pharmacy must indicate a date of receipt of controlled substances. Section 1304.22c relates to Records for dispensers and researchers and requires certain records be maintained, both those provided in 1304.22c and those required under 1304.22a2i, ii, iv, vii, and ix. None of these subsections indicate any requirement to maintain a date of receipt.
I find that the Governments subject allegation does not cite to a regulation which proscribes the conduct alleged.
Substituting a different regulation posthearing would create daunting notice and due process issues. To allow the Government to do so would create an improper burden-shifting beyond those recognized by the APA and the fundamental tenets of notice and due process. See Farmacia Yani, 80 FR
29,053, 29,05960 2015. One of the fundamental tenets of Due Process is that an Agency must provide a Respondent with notice of those acts which the Agency intends to rely on in seeking the revocation of its registration so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agencys action. See NLRB v. I.W.G., Inc., 144 F.3d 685, 688
89 10th Cir. 1998; Pergament United Sales, Inc. v. NLRB, 920 F.2d 130, 134
2d Cir. 1990. Because the Government apparently did not allege in the Order to Show Cause or in its Prehearing Statements the applicable citation to the law on which it bases its allegation, before proceeding to address whether the evidence supports the Governments factual contention, it is necessary determine whether the Government otherwise provided adequate notice of its intent to litigate the issue. See 5
U.S.C. 554b Persons entitled to notice of an agency hearing shall be timely informed of . . . the matters of fact and law asserted.. The primary function of notice is to afford a respondent an opportunity to prepare a defense by investigating the basis of the
E:FRFM01OCN2.SGM

01OCN2