Opportunity
Federal Register #2026-08176
DEA Final Rule: Rescheduling FDA-Approved Marijuana Products to Schedule III
Buyer
Justice Department / Drug Enforcement Administration
Posted
April 28, 2026
Identifier
2026-08176
This final rule from the Drug Enforcement Administration (DEA) changes the regulatory status of certain marijuana products: - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or commercial vendors are named - FDA is referenced as the approving authority for drug products - Products/Services Requested: - No procurement of products or services; this is a regulatory change - Rescheduling of the following substances from Schedule I to Schedule III: - Marijuana in FDA-approved drug products or subject to a state medical marijuana license (21 U.S.C. 802(16)) - Marijuana extract in FDA-approved drug products or subject to a state medical marijuana license (21 CFR 1308.11(d)(58)) - Naturally derived delta-9-tetrahydrocannabinols in FDA-approved drug products or subject to a state medical marijuana license - Unique or Notable Requirements: - Establishes an expedited DEA registration process for state-licensed medical marijuana entities - Requires import/export permits for these products - Maintains strict controls on unlicensed bulk marijuana - Supports compliance with international treaty obligations and state regulatory systems - Registration fees and prescription requirements apply for manufacturers, distributors, and dispensers - Entities must comply with all federal, state, local, and tribal laws
Description
This final rule places drug products containing marijuana that have been approved by the Food and Drug Administration (FDA) into Schedule III of the Controlled Substances Act (CSA). It establishes an expedited registration process for entities holding state medical marijuana licenses, allowing them to manufacture, distribute, and dispense marijuana for medical purposes under federal law. The rule also adds these drugs to the list of substances that require import or export permits. The rule is effective from April 28, 2026.