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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
complaint and fashioning an explanation that refutes the charge of unlawful behavior. Pergament United Sales, 920 F.2d at 135 citation omitted.
While the issue of whether an allegation has been fully and fairly litigated by consent is so peculiarly fact-bound as to make every case unique, id. at 136, the simple presentation of evidence important to an alternative allegation does not satisfy the requirement that a respondent be afforded with a full and fair opportunity to litigate the alternative allegation. I.W.G., 144 F.3d at 688 quoting NLRB v. Quality C.A.T.V., Inc., 824 F.2d 542, 547 7th Cir. 1987 citation omitted.
From the outset, the Government has consistently cited to 1304.22c as the basis of this charge for Pharmacy 4 Less failing to record the date of receipt on 85 invoices. However, as discussed, 1304.22c does not contain any such requirement. In this proceeding, it is not the responsibility of the Respondent, this Tribunal, or the Administrator to substitute a different regulation than charged to fit the evidence the Government has presented.62 The Government has been given multiple opportunities to amend its pleadings, but it has not done so.
Moreover, the record does not support a finding that the issue was litigated by consent. To further confuse the matter, the Respondent conducted voir dire of DI1 as to GX 26. The Respondent questioned whether the federal regulations require that invoices had to be signed and dated by the person receiving the controlled substances shipment. Tr. 141. DI1 stated that while he could not accurately quote the regulations off the top of his head, he had a general understanding that the regulations required these things. Id. at 14041. The Respondent then argued that if the Government were offering GX
26 to prove a violation of 1305, the exhibit should not be admitted because 1305 only requires a signature and date by the receiver for Schedule 2
controlled substances.63 Id. at 142. The Government responded that it offered the entire exhibit into evidence for all controlled substances, but stated that it 62 It is the Governments obligation as part of its burden of proof and not the ALJs responsibility to sift through the records and highlight that information which is probative of the issues in the proceeding. Top RX Pharmacy, 78 FR 26,069, 26070 n.7 2013 quoting Gregg & Son Distribs., 74
FR 17,51718 n.1 2009; James William Eisenberg, M.D., 77 FR 45,663, 45,674 n.47 2012.
63 Upon review of the OSC and the Governments Prehearing Statements, I believe that the Respondent misstated 1305 as the basis for this charge and questioned DI1 on the basis of a regulation not charged. The Government charged a failure to indicate a date of receipt under 1304.22.

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may have cited an improper section and would limit their ability to prove that charge. Id. at 14243. The Respondent argued that the Government cited to 1305.22 throughout the Order to Show Cause, the Governments Prehearing Statement, and the Governments Supplemental Prehearing Statement, and that they had been given notice of their citation mistake by the Tribunal during the prehearing conference. Id. at 143. The Government said that it may have intended to limit itself to strictly Schedule 1 and 2 controlled substances, but that it could not cite that at that moment. Tr. 144. Here, although Respondent pharmacy clearly believed that the 1304.22 citation in the OSC
was incorrect, they proceeded with the litigation believing that the Government had intended to cite 1305.22g.DDD 64
21 CFR 1305.22 deals strictly with electronic as opposed to paper orders for Schedules I and II controlled substances as opposed to Scheduled IIIV, so it also does not provide a legal basis for the allegation that Respondent violated the law by failing to record a receipt date on its paper invoices. I
suspect the Government intended to charge Respondent with a violation of 1304.21,EEE but I will not consider it based on lack of notice.
While the Government has presented a sufficient amount of evidence towards DDD This text was relocated for clarity. When I
later asked about 1305.22, DI1 was provided a copy of the Code of Federal Regulations to determine if it was the section that requires a person receiving a shipment of controlled substances must initial and date. Tr. 163. While looking at the regulations, DI1 indicated that it was not 1305.22. Tr. 16364. He stated that 1305.22
refers to the procedure for filling electronic orders, which refers to CSOS. Tr. 16465. After looking through the regulations, he indicated that he didnt know the actual regulation, but that 1305.22 was not what he was talking about. Tr. 165.
64 The following morning on the second day of the hearing, before the start of testimony, I inquired with the Government as to whether they still intended to include all scheduled controlled substances or limit the evidence to only those invoices including Schedules 1 and 2 controlled substances. The Government indicated that they wanted to proceed with all scheduled controlled substances. The Respondent objected and again raised his argument that 1305 only provides requirements for Schedules 1 and 2 controlled substances. However, upon a review of the hearing transcripts, I have found that these conversations were not recorded and transcribed. This recitation of the discussion is from my memory, but should be provided in the context of the analysis as to any ultimate due process concerns.
EEE At one point, DI identified and read 21 CFR
1304.21d into the record, but agreed that section did not require the recording of the date of receipt and he did not identify 1304.21a which does require pharmacies to keep records regarding the date of receipt of controlled substances. Tr. 164.
Ultimately DIs testimony was that he did not know which regulation required pharmacies to document the date controlled substances were received. Tr.
165.

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their allegation that Pharmacy 4 Less possessed invoices without the date of receipt as the Government claims the cited regulation requires, the Respondent has consistently objected to the Governments legal basis for its allegation and there has been no notice of a proper legal basis. Therefore, I find that the Government cannot sustain their burden in their allegation under 1304.22c as charged. Therefore, it is not necessary to review the evidence and testimony in support of this allegation, and I have omitted it accordingly.
Inaccurate Inventory The Government has charged that Pharmacy 4 Less maintained an inaccurate inventory FFF in violation of 21 CFR 1304.22c. Section 1304.22c again 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 ix of this section.GGG 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.
The Government included this new charge, after the issuance of the Order to Show Cause, in its Prehearing Statement. The Governments Supplemental Prehearing Statement states that DI1 will testify that he conducted an audit of Pharmacy 4
Lesss inventory, and found that it was inaccurate, a violation of 21 CFR
1304.22c. The way that the audit was performed depended on the controlled substance involved. For Schedule II
Controlled Substances, Pharmacy 4 Less maintained a handwritten perpetual inventory which was used to audit the controlled substances with a start date FFF The Governments reference to an inaccurate inventory in this section does not seem to refer to any specific inventory document such as the initial inventory, biennial inventory, or even the perpetual inventory. Rather, the Government seems to be using the phrase generally to state that the Pharmacys records and the quantity of controlled substances on hand at the pharmacy did not align.
GGG These required records include, amongst other things, the name, quantity, and strength of controlled substances and the number of units that are acquired to inventory or distributed or disposed.
Id.

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