Federal marijuana rescheduling arrives

Scope of the rescheduling

The Acting Attorney General issued the order under CSA authority allowing him to reschedule a controlled substance by order to satisfy U.S. treaty obligations under the Single Convention on Narcotic Drugs, bypassing notice-and-comment rulemaking procedures and the need to request a scheduling recommendation from HHS. The order places into Schedule III (1) FDA-approved drug products containing CSA-defined marijuana and (2) marijuana subject to a state-issued license to manufacture, distribute, or dispense for medical purposes. All other marijuana, including recreational marijuana, unlicensed bulk marijuana, and marijuana extract and naturally derived delta-9 THC outside the two rescheduled categories, remains in Schedule I, as does synthetically derived THC.

The order does not legalize marijuana at the federal level, does not authorize interstate commerce in marijuana outside DEA-registered channels, and does not alter the applicability of the Federal Food, Drug, and Cosmetic Act (FDCA). The order also does not affect scheduled FDA-approved synthetic cannabinoids such as Marinol and Syndros.

Implications for drug development and research

The order is limited. As a Schedule I controlled substance, the CSA subjects prospective marijuana research investigators to a special review process. Research involving a Schedule I substance may only proceed pursuant to an FDA-approved protocol and stringent security, storage, and record-keeping requirements, and by access to only a very limited number of federally authorized cannabis suppliers. The order does not impact the application of Schedule I requirements to research involving bulk marijuana, marijuana extracts, or delta-9 THC material. Notably, these substances remain subject to the quota controls in place for Schedule I substances. Although the order permits researchers to obtain marijuana from a state licensee for use in scientific research, rather than a DEA-registered bulk manufacturer, it is not clear how advantageous this path will be for sponsors conducting large scale marijuana research. The NDA pathway remains unchanged. Any drug containing marijuana would still require FDA approval before it could be introduced into interstate commerce unless an IND is in effect. Medical marijuana sold through state dispensaries still cannot be distributed through traditional pharmacies or prescribed under federal law.

However, by anchoring FDA‑approved products containing marijuana in Schedule III, sponsors can have meaningful assurance that an FDA-approved marijuana product will not face a Schedule II determination—a classification that would impose significantly more burdensome prescribing, dispensing, and supply-chain requirements. Engagement with both FDA and DEA during the clinical development process for marijuana-containing drug products has historically been fraught with uncertainty regarding the ultimate scheduling determination upon approval. A clear federal classification at Schedule III would help mitigate that uncertainty and could also promote more streamlined alignment at the state level, where many jurisdictions rely on federal scheduling as the basis for administrative or automatic rescheduling.

New DEA registration pathway for state-licensed operators

The order creates an expedited review process under which state-licensed medical marijuana entities can obtain DEA registration as manufacturers, distributors, or dispensers based on their existing state credentials. DEA must grant the registration unless doing so would be inconsistent with the public interest and the entity's federal registration is tethered to the state license, meaning that if the state medical marijuana license is suspended, revoked, or expires, the DEA registration is automatically suspended. The order directs DEA to process applications submitted within 60 days of publication within six months, and early applicants can operate under their state-issued licenses during the pendency of their review.

Looking ahead

The initiation of the administrative hearing process on June 29, 2026, will determine whether Schedule III status extends to all marijuana. Although DEA is aiming to “accelerate the administrative process,” this order or any broader rescheduling rule resulting from the hearing process will likely be challenged in court. Companies should assess now whether DEA registration applications, adjustments to research protocols, or IND planning are warranted in light of the order.

Authored by Dave Fox and Stephanie Agu.

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