Federal Register #2026-14280

DEA Notice: Catalent CTS, LLC Application to Import Schedule I Controlled Substances for Clinical Trials

This opportunity involves the Drug Enforcement Administration (DEA) announcing an application from Catalent CTS, LLC to import controlled substances for clinical trial support. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEM/Vendor: - Catalent CTS, LLC - Products/Controlled Substances Requested: - Gamma Hydroxybutyric Acid (GHB), drug code 2010, Schedule I - Marihuana Extract, drug code 7350, Schedule I - Marihuana, drug code 7360, Schedule I - Tetrahydrocannabinols (synthetic THC), drug code 7370, Schedule I - All substances to be imported as bulk and dosage unit products - Purpose: - Substances will be used to support customers' clinical trials - Specific plan to import synthetic tetrahydrocannabinol - Notable Requirements: - Only the listed activities (importation for clinical trials) are authorized under this registration - No other activities for these drug codes are permitted - Public comments and hearing requests are invited regarding the application

Description

Catalent CTS, LLC has applied to be registered as an importer of basic classes of controlled substances including Gamma Hydroxybutyric Acid, Marihuana Extract, Marihuana, and Tetrahydrocannabinols. The company plans to import these substances as bulk and dosage unit products to support customers' clinical trials. Specifically, for Tetrahydrocannabinols, the company plans to import a synthetic form. No other activities for these drug codes are authorized under this registration. Comments and hearing requests on the application must be submitted by August 17, 2026.

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