Federal Register #DEA-1680

DEA Bulk Manufacturer Registration for Controlled Substances: Purisys, LLC and Research Triangle Institute

The Drug Enforcement Administration (DEA) has announced applications from Purisys, LLC and Research Triangle Institute for registration as bulk manufacturers of controlled substances for pharmaceutical and research purposes. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors: - Purisys, LLC (Athens, GA) - Research Triangle Institute (Durham, NC) - Products/Services Requested: - Purisys, LLC seeks to manufacture a wide range of controlled substances, including: - Fentanyl and fentanyl-related substances - Morphine - Cathinone - Other basic classes of controlled substances (e.g., Heroin, Oxycodone, Hydromorphone, Methadone, Marihuana, Tetrahydrocannabinols, Mescaline, Lysergic acid diethylamide) - Research Triangle Institute seeks to manufacture tetrahydrocannabinols synthetically - Purpose: - Production of active pharmaceutical ingredients - Creation of analytical reference standards - Use in clinical trials and as starting materials for compounds distributed to customers - Unique or Notable Requirements: - Activities are strictly limited to manufacturing and distribution for research, clinical, and analytical purposes - No authorization for import or commercial sale of finished dosage forms - DEA is accepting public comments and hearing requests regarding these applications - Locations: - Purisys, LLC: 1550 Olympic Drive, Athens, GA - Research Triangle Institute: 3040 East Cornwallis Road, Durham, NC

Description

Purisys, LLC has applied to be registered as a bulk manufacturer of various basic classes of controlled substances. The company plans to bulk manufacture these substances for the production of active pharmaceutical ingredients and analytical reference standards for sale to its customers. Comments or objections to the issuance of the proposed registration, as well as requests for hearings, must be submitted by June 2, 2026. This notice is published by the Drug Enforcement Administration under the Department of Justice.

View original listing