Federal Register #DEA-1726

DEA Notice: CalCog Inc. Application to Import Controlled Substances for Clinical Trials

This notice concerns CalCog Inc.'s application to import controlled substances for clinical trials, as published by the Drug Enforcement Administration (DEA) under the Department of Justice. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEM/Vendor: - CalCog Inc. - Products Requested: - Lysergic acid diethylamide (LSD), Drug Code 7315 - 5-Methoxy-N,N-dimethyltryptamine, Drug Code 7431 - Dimethyltryptamine, Drug Code 7435 - Psilocyn, Drug Code 7438 - All substances are to be imported as dosage units for clinical trials only - Unique/Notable Requirements: - Importation is strictly limited to use in clinical trials - No commercial sales or other activities are authorized under this registration - The notice invites comments or objections from registered bulk manufacturers and applicants, and allows for hearing requests - Authorization does not extend to FDA-approved or non-approved finished dosage forms for commercial sale

Description

CalCog Inc. has applied to be registered as an importer of basic classes of controlled substances including Lysergic acid diethylamide, 5-Methoxy-N,N-dimethyltryptamine, Dimethyltryptamine, and Psilocyn. The company plans to import these substances as dosage units for clinical trials only, with no other activities authorized under this registration. Comments or objections to the issuance of the proposed registration may be submitted electronically by registered bulk manufacturers and applicants by July 8, 2026. Requests for a hearing on the application must also be filed by this date.

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