Federal Register #DEA-1767

DEA Import Registration Application for Ibogaine by Benuvia Operations, LLC

This opportunity concerns Benuvia Operations, LLC's application to the Drug Enforcement Administration (DEA) for registration as an importer of the controlled substance Ibogaine (drug code 7260, Schedule I). - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEM/Vendor: - Benuvia Operations, LLC - Product Requested: - Ibogaine (Schedule I controlled substance) - Drug code: 7260 - Quantity: Not specified - Purpose: Internal research and development for bulk manufacture of active pharmaceutical ingredients (API) for future clinical trials - Unique Requirements: - Importation is strictly for internal R&D and API manufacturing for clinical trials - No authorization for commercial sale or importation of finished dosage forms (FDA-approved or non-approved) - DEA is accepting public comments and hearing requests regarding this application - No other OEMs, vendors, or products are mentioned

Description

Benuvia Operations, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). The application is for the import of controlled substances to support internal research and development toward the bulk manufacture of active pharmaceutical ingredients for future clinical trials. No other activity for the drug code is authorized for this registration. Comments and requests for hearings on the application must be submitted by October 28, 2026.

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