Federal Register #Docket No. DEA-372

DEA Exempt Chemical Preparations Order – Certified Reference Materials

The Drug Enforcement Administration (DEA), part of the Department of Justice, has issued an order regarding exempt chemical preparations under the Controlled Substances Act. - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors: - Cayman Chemical Company (highlighted as the primary manufacturer) - Products/Services Requested: - Certified reference materials (CRMs) for controlled substances, including: - Alprazolam (CRM) 1 mg/mL in methanol - Alprazolam-d5 (CRM) 1 mg/mL in methanol - Clonazepam (CRM) 1 mg/mL in acetonitrile - Custom 13-Phytocannabinoid Mixture (CRM)AIT (500 g/mL each in acetonitrile) - Custom Phytocannabinoid Mixture 3, 1 mg/mL each in acetonitrile - Flunitrazepam (CRM) 1 mg/mL in acetonitrile and methanol - Lorazepam (CRM) 1 mg/mL in acetonitrile - Lorazepam-13C2-d4 (CRM) 0.1 mg/mL in acetonitrile - Unique or Notable Requirements: - Exemptions are strictly limited to the specific chemical preparations described in the applications - Preparations are for in-house use only by the manufacturer; distribution or transport to other facilities is prohibited - Any change in composition or designation requires a new application - DEA may impose additional requirements for bulk quantities to prevent diversion - The order corrects previous listings and invites public comment

Description

The Drug Enforcement Administration (DEA) has published an order regarding applications for exempt chemical preparations received between July 1, 2025, and March 31, 2026. The order lists preparations that were accepted for filing and have been approved or denied, correcting previous listings published on March 20, 2026. These exemptions apply only to the specific preparations described and limit distribution to in-house use by manufacturers. Comments on this order must be submitted by July 20, 2026.

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