Federal Register #DEA-1750

DEA Solicits Public Input on Bulk Manufacturing Registration for Controlled Substances

This opportunity involves the Drug Enforcement Administration (DEA) seeking public input on applications for bulk manufacturing registration of controlled substances. - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEMs and Vendors: - Biopharmaceutical Research Company - Chattem Chemicals - Products/Services Requested: - Registration to manufacture Schedule I controlled substances: - Marihuana Extract (Drug Code 7350) - Marihuana (Drug Code 7360) - Tetrahydrocannabinols (Drug Code 7370) - Chattem Chemicals also seeks registration for additional controlled substances, including Gamma Hydroxybutyric Acid and various Schedule I and II drugs - Unique/Notable Requirements: - Applicants must comply with all local, state, and federal laws - Registration is strictly for bulk manufacturing and distribution for research purposes - DEA is soliciting public comments and objections regarding these applications - No other activities for these drug codes are authorized under this registration - Focus is on pharmaceutical-grade production to facilitate scientific research

Description

Biopharmaceutical Research Company has applied to be registered as a bulk manufacturer of basic classes of controlled substances including Marihuana Extract, Marihuana, and Tetrahydrocannabinols, all Schedule I substances. The company plans to bulk manufacture Pharmaceutical-grade marihuana to facilitate research in compliance with local, state, and federal regulations. Comments and objections to the application are due by October 26, 2026, which is also the deadline to request a hearing. The application is under the jurisdiction of the Drug Enforcement Administration within the Justice Department.

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