Federal Register #DEA-1756

DEA Review of Application for Bulk Manufacturing of Ibogaine and MDMA APIs by Scottsdale Research Institute SRI Montana Satellite Laboratory

The Drug Enforcement Administration (DEA), part of the Department of Justice, is reviewing an application from Scottsdale Research Institute SRI Montana Satellite Laboratory to become a registered bulk manufacturer of controlled substances. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEM/Vendor: - Scottsdale Research Institute SRI Montana Satellite Laboratory - Products Requested: - Ibogaine (drug code 7260) as Active Pharmaceutical Ingredient (API) - 3,4-Methylenedioxymethamphetamine (drug code 7405) as API - Quantities not specified - Purpose: - Manufacture APIs for internal research and clinical trials - Supply other schedule I researchers collaborating on clinical trials - Unique Requirements: - Registration is limited to manufacturing for research and clinical trials only - No other activities for these drug codes are authorized - Comments or objections are invited from registered bulk manufacturers and applicants regarding the proposed registration.

Description

Scottsdale Research Institute SRI Montana Satellite Laboratory has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients (API) to support internal research and clinical trials, and to supply other schedule I researchers collaborating on clinical trials. No other activities for these drug codes are authorized for this registration. Comments or objections to the issuance of the proposed registration may be submitted electronically by October 26, 2026, and written requests for a hearing must also be filed by this date.

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