Federal Register #DEA-1688

DEA Notice: Importer Registration Applications for Schedule I Controlled Substances (Fisher Clinical Services, Inc. & Sterling Wisconsin, LLC)

This notice details applications to the Drug Enforcement Administration (DEA) for importer registration of Schedule I controlled substances for clinical trials and research: - Government Buyer: - Department of Justice, Drug Enforcement Administration (DEA), Importer Registration Division - OEMs and Vendors: - Fisher Clinical Services, Inc. (applicant for 3,4-Methylenedioxymethamphetamine) - Sterling Wisconsin, LLC (applicant for 5-Methoxy-N,N-dimethyltryptamine) - Products/Services Requested: - 3,4-Methylenedioxymethamphetamine (Drug Code 7405) — imported by Fisher Clinical Services, Inc. for clinical trials only - 5-Methoxy-N,N-dimethyltryptamine (Drug Code 7431) — imported by Sterling Wisconsin, LLC as a bulk active pharmaceutical ingredient for research and clinical investigational studies - Voice of Customer Survey — annual survey by FBI Office of Private Sector (900 responses estimated) - Unique or Notable Requirements: - Importation strictly limited to clinical trials or research; no commercial sale or import of finished dosage forms permitted - Compliance with 21 U.S.C. 952(a)(2) and DEA regulations - Public comments, objections, and hearing requests are solicited from registered bulk manufacturers and applicants - Locations: - DEA Headquarters, Springfield, VA (contracting office) - Fisher Clinical Services, Inc. locations in Allentown, PA and Breinigsville, PA - Sterling Wisconsin, LLC location in Germantown, WI

Description

Fisher Clinical Services, Inc. has applied to be registered as an importer of the basic class of controlled substance 3,4-Methylenedioxy-methamphetamine (Schedule I). The company plans to import this substance solely for use in clinical trials. Comments, objections, and requests for hearings regarding this application must be submitted by May 1, 2026.

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