Federal Register #DEA1766

DEA Importer Registration for Controlled Substances for Clinical and Analytical Research

This opportunity involves the Drug Enforcement Administration (DEA) processing applications for importer registration of controlled substances for clinical and analytical research. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors: - Fisher Clinical Services, Inc. - AndersonBrecon, Inc. DBA PCI Pharma Services - Irvine Labs, Inc. (mentioned, but no product details provided) - Products/Services Requested: - Schedule I and II controlled substances for import, including: - Marihuana Extract (7350) - Marihuana (7360) - Tetrahydrocannabinols (7370) - 3,4-Methylenedioxymethamphetamine (7405) - 5-Methoxy-N-N-dimethyltryptamine (7431) - Dimethyltryptamine (7435) - Psilocybin (7437) - Methylphenidate (1724) - Levorphanol (9220) - Noroxymorphone (9668) - Tapentadol (9780) - AndersonBrecon, Inc. specifically requests Marihuana (7360) for analytical and clinical research - Unique/Notable Requirements: - Substances are strictly for clinical trial or analytical research use; no commercial sale or other activities permitted - Registration and import authorization are subject to compliance with federal regulations (21 U.S.C. 952(a)(2)) - No authorization for FDA-approved or non-approved finished dosage forms for commercial sale - Applications from multiple vendors highlight a competitive environment for clinical research supply - OEMs are central to the opportunity, with Fisher Clinical Services and AndersonBrecon, Inc. named as primary applicants.

Description

Fisher Clinical Services, Inc. has applied to be registered as an importer of basic classes of controlled substances. The substances include Marihuana Extract, Marihuana, Tetrahydrocannabinols, 3,4-Methylenedioxymethamphetamine, 5-Methoxy-N-N-dimethyltryptamine, Dimethyltryptamine, Psilocybin, Methylphenidate, Levorphanol, Noroxymorphone, Tapentadol, among others. The company plans to import these controlled substances for use in clinical trials only, with no authorization for other activities or commercial sale of finished dosage forms. Comments and objections to the application are due by October 8, 2026, and hearing requests must also be submitted by this date.

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