DOJ Announces Controlled Substances Act Scheduling Changes for FDA-Approved Marijuana and State-Licensed Medical Marijuana Products

On April 23, 2026, the U.S. Department of Justice (DOJ), in conjunction with the Drug Enforcement Administration (DEA), announced that pursuant to President Trump’s December 18, 2025, Executive Order “Increasing Medical Marijuana and Cannabidiol Research,” issuance of a final rule by way of Attorney General order (Order) that immediately placed both U.S. Food and Drug Administration (FDA)-approved products containing marijuana and marijuana products regulated by a state medical marijuana license in Schedule III of the Controlled Substances Act (CSA). Previously, marijuana products were placed on Schedule I of the CSA, which generally limited its use to tightly controlled research. DOJ did not institute this change through notice and comment rulemaking but instead under 21 U.S.C. 811(d)(1) which allows the attorney general to reschedule substances to carry out the United State’s obligations under the Single Convention on Narcotic Drugs.

Scope of the Order

The Order applies to marijuana (as defined in 21 CFR 1308.11(d)(23)), marijuana extracts (as defined in 21 CFR 1308.11(d)(58)), and naturally derived delta‑9‑THC only to the extent those substances are (a) in an FDA‑approved product or (b) subject to a qualifying “state medical marijuana license” (i.e., a state or territorial license to manufacture, distribute, and/or dispense marijuana or marijuana-containing products for medical purposes).

The Order repeatedly notes that unlicensed bulk marijuana and other non‑covered marijuana remain in Schedule I, emphasizing that maintaining “unlicensed bulk marijuana” (and related materials used to make FDA‑approved products) in Schedule I supports U.S. treaty compliance and quota requirements. Likewise, the Order does not affect hemp’s status¹ (because hemp is excluded from “marijuana”), and it does not reschedule marijuana/THC products that were already rescheduled out of Schedule I in prior actions. The Order also does not apply to synthetically derived THC products, which remain in Schedule I.

DEA Registration Requirements

For entities handling marijuana exclusively in the form of an FDA‑approved drug product, the Order summarizes typical Schedule III requirements, including DEA registration, recordkeeping/reporting, security, inventories, prescription controls (and notes that activity not authorized by the CSA/regulations may trigger administrative/civil/criminal sanctions).

The Order amends 21 C.F.R. § 1301.13 to require DEA to establish an expedited review process for entities holding state medical marijuana licenses seeking registration as marijuana manufacturers, distributors, and/or dispensers. Applicants must submit proof of the state medical license, and DEA “shall” register unless registration would be inconsistent with the public interest factors in 21 U.S.C. § 823 and treaty obligations (including quota requirements). Critically, registrations will not be approved for marijuana activities that are used for recreational/non-medical purposes. This, in effect, leaves all recreational marijuana as remaining on Schedule I for now. The Order calls for DEA to process all applications submitted within 60 days of publication of the Order within six months.

Scientific Research Clarification

The Order clarifies that researchers may obtain marijuana or marijuana-derived products from a state licensee for use in scientific research, provided that the researcher is registered with the administration to conduct research with marijuana under 21 CFR. 1301.13 and the state licensee from whom the researcher obtained the marijuana held a valid federal registration at the time of the transfer. Previously, DEA-registered researchers were limited to obtaining marijuana for research from a DEA-registered bulk manufacturer. The Order further provides that DEA “shall not treat the use of state-licensed marijuana products in federally registered research as a basis for adverse action against a researcher's registration.”

Tax and Import/Export Implications

Under 26 U.S.C. § 280E, a cannabis business that made unapproved Schedule 1 cannabis products could not deduct certain business expenses from federal taxes. The Order notes that 26 U.S.C. § 280E applies to businesses “trafficking” in Schedule I or II controlled substances and states that, as a consequence of the Order, holders of state medical marijuana licenses would no longer be subject to § 280E’s deduction disallowance (while also stressing that nothing in the rule constitutes a determination of federal tax liability and advising consultation with tax counsel). The Order also “encourages” the Secretary of the Treasury to consider retrospective relief for prior taxable years for qualifying state licensees (again, not presented as a binding tax determination).

The Order also states that 21 C.F.R. § 1312.30 has been amended to allow for import/export permits for covered Schedule III marijuana categories (FDA‑approved products and state‑licensed medical marijuana) by adding them to the list of non‑narcotic Schedule III–V substances requiring permits. This will allow, for the first time, marijuana to be imported and exported internationally.

Next Steps and Implications for Industry

DOJ also separately announced that it was going to expedite ongoing rulemaking to fully remove marijuana from Schedule I and place it into Schedule III. The Biden administration previously undertook a notice of proposed rulemaking to reschedule marijuana, but the DEA is terminating those proceedings and moving forward with its current expedited rulemaking process. DOJ will hold administrative hearings beginning on June 29, 2026, regarding the proposed rescheduling of marijuana.

The changes brought by the Order are some of the most significant changes in the regulation of marijuana so far this century, though, as noted above, DOJ and DEA are seeking to make further changes as well. Arnold & Porter will continue to monitor any new legislation or regulatory rulemaking related to hemp products. If you have any questions about this Advisory or would like more information, please reach out to one of the authors or your existing Arnold & Porter contacts.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.