Federal Register #DEA-1695

DEA Registration Applications for Controlled Substance Manufacturing and Import

This notice from the Drug Enforcement Administration (DEA) details multiple applications for registration to manufacture or import controlled substances for research and clinical use: - Government Buyer: - Department of Justice, Drug Enforcement Administration (DEA) - OEMs and Vendors Mentioned: - Pharmaron Manufacturing Services (US) LLC - Royal Emerald Pharmaceuticals - Fisher Clinical Services, Inc. - Sterling Wisconsin, LLC - Products/Services Requested: - Pharmaron Manufacturing Services (US) LLC seeks registration to bulk manufacture Schedule II opioids: - Oxycodone (part number 9143) - Thebaine (9333) - Oxymorphone (9652) - Noroxymorphone (9668) - Royal Emerald Pharmaceuticals seeks registration to bulk manufacture Schedule I cannabis derivatives: - Marihuana Extract (7350) - Marihuana (7360) - Tetrahydrocannabinols (7370) - Fisher Clinical Services, Inc. seeks registration to import Schedule I 3,4-Methylenedioxy-methamphetamine (MDMA, 7405) for clinical trials - Sterling Wisconsin, LLC seeks registration to import Schedule I 5-Methoxy-N,N-dimethyltryptamine (7431) - Unique or Notable Requirements: - Registrations are strictly for research, clinical trials, or bulk manufacturing—not for commercial sale - Public comments and hearing requests are invited regarding these applications - Each registration is substance- and activity-specific (e.g., import or manufacture only, not both) - Key Locations: - DEA Headquarters, Springfield, VA (contracting/government office) - Pharmaron Manufacturing Services (US) LLC, Coventry, RI (place of performance) - Royal Emerald Pharmaceuticals, Desert Hot Springs, CA (place of performance) - Fisher Clinical Services, Inc., Allentown, PA (place of performance) - Sterling Wisconsin, LLC, Germantown, WI (place of performance)

Description

Fisher Clinical Services, Inc. has applied to be registered as an importer of controlled substances, specifically 3,4-Methylenedioxy-methamphetamine (Schedule I). The company plans to import this substance solely for clinical trials. Comments and objections to this application are accepted until May 1, 2026, and a written request for a hearing can also be filed by this date.

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