Federal Register #2026-06522

DEA Notice: Research Triangle Institute Application for Bulk Manufacturing of Controlled Substances

This notice concerns Research Triangle Institute's application to the DEA for registration as a bulk manufacturer of controlled substances. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - Applicant/Vendor: - Research Triangle Institute - Products/Services Requested: - Bulk manufacturing of Schedule I and II controlled substances, including: - Tetrahydrocannabinols, Lisdexamfetamine, Methylphenidate, Pentobarbital, Nabilone, ANPP, Cocaine, Codeine, Dihydrocodeine, Oxycodone, Hydromorphone, Ecgonine, Hydrocodone, Levorphanol, Meperidine, Meperidine intermediates (A, B, C), Methadone, Methadone intermediate, Morphine, Oripavine, Thebaine, Opium tincture, Opium (powdered and granulated), Oxymorphone, Noroxymorphone, Alfentanil, Remifentanil, Sufentanil, Carfentanil, Tapentadol, Fentanyl - Manufacturing for purposes of producing active pharmaceutical ingredients, analytical reference standards, clinical trial materials, and compounds for distribution - Unique/Notable Requirements: - Registration strictly authorizes only the listed manufacturing activities for the specified substances - No other activities for these drug codes are permitted under this registration - DEA is accepting public comments, objections, and hearing requests regarding this application - Place of Performance: - Research Triangle Institute, Durham, North Carolina - Contracting Office: - DEA, Department of Justice

Description

Research Triangle Institute has applied to be registered as a bulk manufacturer of controlled substances, including various Schedule I and II drugs such as Tetrahydrocannabinols and others. The registration would authorize the company to manufacture these substances synthetically for research, production of active pharmaceutical ingredients, and analytical reference standards for sale to customers. Comments or objections to the application are due by June 2, 2026, and a written request for a hearing can also be filed by that date. The application is managed by the Drug Enforcement Administration under the Justice Department.

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