Federal Register #DEA-1702

DEA Notice: Bulk Manufacturer Registration Application for Controlled Substances by Usona Institute, Inc.

This notice from the Drug Enforcement Administration (DEA) announces the application of Usona Institute, Inc. to become a registered bulk manufacturer of specific controlled substances for research and development purposes. - Government Buyer: - Department of Justice (DOJ) - Drug Enforcement Administration (DEA) - OEMs and Vendors: - Usona Institute, Inc. (applicant and manufacturer) - Products/Services Requested: - Bulk manufacture of the following controlled substances: - 5-Methoxy-NN-dimethyltryptamine - Psilocybin - Psilocyn - Intended use: chemical process development, pre-clinical, and clinical research - Unique or Notable Requirements: - Registration is strictly for bulk manufacturing of the listed substances - No authorization for other activities or drug codes - DEA is soliciting electronic comments, objections, or hearing requests from registered bulk manufacturers and applicants - Place of Performance: - Usona Institute, Inc. facility in Fitchburg, Wisconsin

Description

Usona Institute, Inc. has applied to be registered as a bulk manufacturer of certain controlled substances including 5-Methoxy-NN-dimethyltryptamine, Psilocybin, and Psilocyn. The registration would authorize the company to manufacture these substances for chemical process development and pre-clinical and clinical research. Interested parties may submit electronic comments or objections, or request a hearing regarding the application by June 16, 2026. This notice is issued by the Drug Enforcement Administration under the Department of Justice.

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