DEA Finalizes Schedule III Rule for FDA-Approved and State-Legal Medical Marijuana Products
- The DEA has reclassified FDA-approved marijuana products and state-licensed medical marijuana from Schedule I to Schedule III of the Controlled Substances Act, effective April 28.
- The rule applies to FDA-approved delta-9 THC products and state medical marijuana but does not authorize adult-use or nonmedical marijuana activities.
- State-licensed medical marijuana businesses can now apply for expedited DEA registration, subject to approval unless it conflicts with public interest or treaty obligations.
- The new rule imposes federal requirements on handling marijuana products, including registration, recordkeeping, security, and labeling, marking a significant shift in federal marijuana policy while broader rescheduling is still under review.
The Drug Enforcement Administration (DEA) has published a final rule moving FDA-approved marijuana products, along with marijuana covered by state medical marijuana licenses, from Schedule I to Schedule III of the Controlled Substances Act. The rule took effect today, April 28.
The order applies to FDA-approved products containing delta-9 THC derived from the marijuana plant, as well as marijuana manufactured, distributed or dispensed under a state medical marijuana license. It does not authorize nonmedical marijuana activity, meaning adult-use marijuana remains outside the scope of the new rule.
Under the rule, state-licensed medical marijuana businesses may seek expedited DEA registration as manufacturers, distributors or dispensers. The DEA says applicants can submit proof of their state medical marijuana license, with approval required unless the agency determines registration would be inconsistent with the public interest or international treaty obligations.
The rule also creates federal requirements for handling covered marijuana products, including registration, recordkeeping, security, labeling, inventory and import/export controls. Dispensaries that transfer medical marijuana to patients must register with the DEA as practitioners, while manufacturers and distributors must register under the appropriate category.
In the filing, the DEA points to a 2023 recommendation from the Department of Health and Human Services that marijuana be moved to Schedule III, noting HHS found marijuana has a lower abuse potential than Schedule I and II substances and that its abuse may lead to moderate or low physical dependence or high psychological dependence.
The move marks a major shift in federal marijuana policy, giving state medical marijuana systems a pathway to operate under federal registration while leaving broader marijuana rescheduling unresolved. A separate DEA proceeding on the rescheduling of all marijuana is scheduled to move forward with a June 29 hearing.