Federal Register #2026-08585

DEA Registration Application: Bulk Manufacture of Gamma Hydroxybutyric Acid by Patheon Pharmaceuticals Inc.

This notice concerns Patheon Pharmaceuticals Inc.'s application to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of a controlled substance. - Government Buyer: - Drug Enforcement Administration (DEA), Justice Department - OEM/Vendor: - Patheon Pharmaceuticals Inc. (highlighted as the sole OEM and applicant) - Product Requested: - Gamma Hydroxybutyric Acid (GHB), Drug code 2010, Schedule I - To be manufactured in bulk as an Active Pharmaceutical Ingredient (API) - Intended for further synthesis into FDA-approved dosage forms - No other activities for this drug code are authorized under this registration - Unique/Notable Requirements: - Registration is specifically for manufacturing a Schedule I controlled substance - The manufactured API is for pharmaceutical use only - Public comments, objections, or hearing requests are invited regarding this registration - Place of Performance: - Patheon Pharmaceuticals Inc. facility in Cincinnati, Ohio

Description

Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The application involves the bulk manufacture of Gamma Hydroxybutyric Acid (Drug code 2010, Schedule I) as an Active Pharmaceutical Ingredient for further synthesis into FDA-approved dosage forms. Interested parties may submit electronic comments or objections by July 6, 2026, and may also request a hearing by the same date. The notice is published by the Drug Enforcement Administration under the Justice Department.

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