Federal Register #DEA-1742

DEA Notice: Bulk Manufacturing Registration for Controlled Substances by American Radiolabeled Chem

The Drug Enforcement Administration (DEA), part of the Department of Justice, has published a notice regarding an application from American Radiolabeled Chem to become a bulk manufacturer of controlled substances for research purposes. - Government Buyer: - Department of Justice (DOJ) - Drug Enforcement Administration (DEA) - OEM/Vendor: - American Radiolabeled Chem (applicant and prospective manufacturer) - Products/Services Requested: - Bulk manufacturing registration for a comprehensive list of controlled substances, including: - Synthetic Tetrahydrocannabinols - Opioids (e.g., Heroin, Morphine, Oxycodone, Fentanyl, Hydrocodone, Hydromorphone, Methadone, Codeine, Dihydrocodeine, Dihydromorphone, Oxymorphone, Thebaine, Oripavine, Carfentanil, Phenazocine, Metazocine, Dextropropoxyphene) - Stimulants (e.g., Amphetamine, Methamphetamine, Phenylacetone, Cocaine) - Hallucinogens (e.g., Lysergic acid diethylamide, Ibogaine, Dimethyltryptamine, Phencyclidine) - Other substances (e.g., Gamma Hydroxybutyric Acid, Amobarbital, Meperidine, Ecgonine) - No specific quantities or part numbers provided - Unique/Notable Requirements: - Registration authorizes manufacture of controlled substances in bulk for internal use as intermediates or for sale as radiolabeled compounds for biochemical research - Activities are restricted to those listed in the application - Compliance with DEA regulations for handling and manufacturing controlled substances is mandatory

Description

American Radiolabeled Chem has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The application includes a list of controlled substances the company plans to manufacture in bulk for internal use as intermediates or for sale to customers, primarily as radiolabeled compounds for biochemical research. The registration authorizes the manufacture of synthetic Tetrahydrocannabinols and other specified substances. Interested parties may submit comments or objections and request a hearing by September 21, 2026.

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