St. Michael's Pharmacy; 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 On September 10, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to St. Michael's Pharmacy of Rosenberg, Texas (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Registrant of the ( printed page 62755) immediate suspension of its DEA Certificate of Registration, No. FS0483951, pursuant to 21 U.S.C. 824(d) , alleging that Registrant'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 Registrant's DEA Certificate of Registration, alleging that Registrant's continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 823(g)(1) ; 824(a)(4)). [ 1 ] The OSC/ISO alleged that from at least March 2023 through February 2025, Registrant violated federal and Texas state law by continuously filling Schedule II controlled substance prescriptions despite obvious red flags of abuse and/or diversion and without addressing or resolving those red flags. RFAAX 1, at 1, 4-5. The OSC/ISO alleged that these unresolved red flags of abuse and/or diversion included pattern prescribing; prescriptions for controlled substances commonly known to be abused, prescriptions for controlled substances at their highest strength and/or in large quant…