Pine 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 I. Introduction On April 9, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Shreeji 16 Inc. d/b/a Pine Pharmacy, of Ocala, Florida (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Registrant of the immediate suspension of its DEA Certificate of Registration, No. FS1451222, 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 registration, alleging that Registrant's continued registration is inconsistent with the public interest. Id. at 1-2 (citing 21 U.S.C. 823(g)(1) , 824(a)(4) ). More specifically, the OSC/ISO alleged that as recently as December 5, 2024, Registrant repeatedly filled prescriptions for Schedule II through V controlled substances without addressing, resolving, and/or documenting resolution of red flags of abuse and diversion prior to dispensing. Id. The OSC/ISO alleges that filling these prescriptions violated federal and Florida state law. Id. (citing 21 CFR 1306.04(a) , 1306.06 ; Fla. Admin. Code Ann. r. 64B16-27.810, 64B16-27.831). [ 1 ] The OSC/ISO also alleges that Registrant allowed a non-certificate holder to use Registrant's digital certificat…