Federal Register #DEA-1707

DEA Notice: Applications to Manufacture and Import Controlled Substances for Research

This notice from the Drug Enforcement Administration (DEA), Department of Justice, details applications for registration to manufacture or import controlled substances for research and clinical purposes: - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors Mentioned: - AJNA Biosciences (applicant for bulk manufacturing) - VA Cooperative Studies Program (applicant for import) - Leading Pharma LLC (applicant for import) - Products/Controlled Substances Requested: - AJNA Biosciences: Bulk manufacture of Psilocybin (part number 7437) and Psilocyn (part number 7438) for research and clinical trials - VA Cooperative Studies Program: Import of Marihuana Extract (part number 7350) and Tetrahydrocannabinols (part number 7370) for research and clinical trials - Leading Pharma LLC: Import of Diphenoxylate (part number 9170) as an active pharmaceutical ingredient for research and development - Unique or Notable Requirements: - All activities are strictly limited to research, clinical trials, or research and development purposes - No commercial distribution or other uses are authorized under these registrations - The DEA invites comments, objections, or hearing requests from interested parties - Locations: - DEA Headquarters, Springfield, VA (federal facility) - AJNA Biosciences, Littleton, CO - VA Cooperative Studies Program, Albuquerque, NM - Leading Pharma LLC, Fairfield, NJ

Description

AJNA Biosciences has applied to be registered as a bulk manufacturer of basic classes of controlled substances, specifically Psilocybin and Psilocyn, both Schedule I substances. The company plans to bulk manufacture mushrooms containing these substances to support internal research, clinical trials, and analytical purposes, as well as to distribute to customers conducting Schedule I clinical research. Comments or objections to the issuance of the proposed registration are due by June 22, 2026, and requests for hearings must also be submitted by that date.

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