Prescript Pharmaceuticals; Decision and Order

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Justice Drug Enforcement Administration [Docket No. 24-21] On November 17, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Prescript Pharmaceuticals of Pleasonton, California (Respondent). OSC/ISO, at 1. The OSC/ISO informed Respondent of the immediate suspension of its DEA registration, No. RP0177798, pursuant to 21 U.S.C. 824(d) , alleging that Respondent's continued registration constitutes “ `an imminent danger to the public health or safety.' ” Id. (quoting 21 U.S.C. 824(d) ). The OSC/ISO also proposed the revocation of Respondent's registration, alleging that Respondent's continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4) , 823(a)(1) ). More specifically, the OSC/ISO alleges that between 2020 and 2023, Respondent, who is registered as a manufacturer engaged in repackaging and relabeling activities, ordered Schedule II opioids from a supplier without having requested or received any procurement quota from DEA, in violation of 21 CFR 1303.12(b) . 1 Id. at 2; Tr. 99. A hearing was held before DEA Chief Administrative Law Judge John J. Mulrooney, II (the Chief ALJ), [ 2 ] who, on October 31, 2024, issued his Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (Recommended Decision or RD), recommending that Respondent's registration be revoked. RD, at 37. The Government file…