Federal Register #DEA-1741

DEA Importer Registration Application for Schedule I Controlled Substances by Catalent Greenville, Inc.

This opportunity concerns Catalent Greenville, Inc.'s application to the Drug Enforcement Administration (DEA) for importer registration of Schedule I controlled substances. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEM/Vendor: - Catalent Greenville, Inc. - Products/Controlled Substances Requested: - Lysergic acid diethylamide (LSD), drug code 7315 - 3,4-Methylenedioxymethamphetamine (MDMA), drug code 7405 - Psilocybin, drug code 7437 - Purpose and Requirements: - Importation is strictly for dosage formulation development, research, clinical trial studies, and analytical purposes - No authorization for importation of finished dosage forms for commercial sale (FDA-approved or non-approved) - No other activities for these drug codes are permitted under this registration - Notable Details: - Only Catalent Greenville, Inc. is named as the applicant and OEM - Public comments, objections, or hearing requests are invited regarding this application

Description

Catalent Greenville, Inc. has applied to be registered as an importer of basic classes of controlled substances including Lysergic acid diethylamide, 3,4-Methylenedioxymethamphetamine, and Psilocybin. The company plans to import these substances for dosage formulation development, research, clinical trial studies, and analytical purposes. No other activities for these drug codes are authorized under this registration. Interested parties may submit comments or objections and request a hearing by August 17, 2026.

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