U.S. Joins Much of the World in Acknowledging Medical Marijuana
On April 28 2026 the Acting Attorney General issued a final order that places certain marijuana‑related products into Schedule III of the Controlled Substances Act (CSA). The move signals that the United States now recognizes a functional medical‑marijuana program and opens the door for international trade in federally registered medical‑marijuana products.
How the Order Was Issued
The order relies on 21 U.S.C. § 811(d)(1), which permits the Attorney General to reschedule a substance when doing so better aligns the United States with its international treaty obligations—in this case, the Single Convention on Narcotic Drugs. Although a recommendation from the Department of Health and Human Services (HHS) was received in 2023, the Attorney General noted that the statutory authority does not require HHS input; he exercised discretion to select the schedule that most closely matches HHS’s findings while satisfying treaty commitments.
The final order is 23 pages long and explicitly states that it is not a proposed rule but a binding determination under § 811(d)(1).
Registration Requirements
State‑Licensed Medical Marijuana Operators
The order creates an expedited registration pathway under 21 CFR § 1301 for entities that hold a valid state medical‑marijuana license. State‑licensed manufacturers, distributors, and dispensaries may now submit their existing state credentials as conclusive proof of authorization to obtain a DEA registration for manufacturing, distributing, or dispensing marijuana for medical purposes.
Key points of the expedited process:
- Applications filed within 60 days of the order’s publication must be processed within six months.
- Applicants may continue to operate under their state license while the DEA review is pending.
- DEA must grant registration unless doing so would conflict with the public‑interest factors listed in 21 U.S.C. § 823 or violate the Single Convention.
- State‑level labeling, packaging, disposal, and physical‑security rules may be used in lieu of federal requirements, provided the statutory warning label mandated by 21 U.S.C. § 825(c) is included.
DEA registration fees for Schedule III activities remain:
- Manufacturer: $3,999 per year
- Distributor: $1,850 per year
- Dispensary (including pharmacies): $888 for a three‑year registration
FDA‑Approved Marijuana Operators
For those handling only FDA‑approved drug products that contain marijuana, the order imposes the standard Schedule III regulatory framework:
- Any person or entity handling such products must be DEA‑registered.
- Entities that transfer the product to patients (e.g., dispensaries) must register as “practitioners” under 21 U.S.C. § 823(g).
- Disposal must follow 21 CFR § 1317 in addition to applicable state and federal rules.
- Annual DEA fees apply as noted above.
- Prescriptions are required before dispensing and must contain specific information.
- Registrants must maintain records and submit reports as required by federal law.
- All registrants must comply with DEA security, labeling, packaging, and inventory requirements.
International Trade and Import/Export
The order acknowledges that moving marijuana into Schedule III triggers import‑and‑export permit obligations under the Single Convention. Accordingly, the DEA has amended 21 CFR § 1312.30 to include FDA‑approved marijuana products and state‑licensed medical‑marijuana products on the list of Schedule III‑V substances that require an import or export permit.
DEA registrants may now apply for import and export licenses, potentially allowing U.S. state‑licensed medical‑marijuana operators to participate in global markets. The DEA also revised its regulatory definition of “medicinal cannabis” to exempt state‑legal medical marijuana from the requirement that such cannabis be FDA‑approved and legally marketable under the Food, Drug, and Cosmetic Act.
DEA’s Role in the State Medical Marijuana Supply Chain
Under the order, DEA will purchase marijuana grown by registered state manufacturers and resell it to satisfy the Single Convention’s purchase‑and‑sale requirement. Registered manufacturers must store their crops in DEA‑maintained facilities until the transaction is complete and must provide the exact cultivation location to the agency. The DEA retains authority to deny or revoke registrations where public‑interest concerns arise.
Research
Researchers who obtain marijuana or marijuana‑derived products from state‑licensed sources are shielded from civil and criminal liability under the CSA, provided they hold a DEA registration. This change facilitates scientific investigations using state‑regulated medical‑marijuana material.
I.R.C. § 280E
The order notes that state medical‑marijuana licensees will no longer be subject to the restrictive tax code provision I.R.C. § 280E, which disallows ordinary business deductions for traffickers of Schedule I substances. However, the order does not determine the final tax status of these businesses; it advises licensees to consult tax professionals and encourages the Treasury Secretary to consider retrospective relief for prior tax years.
Operators that hold both adult‑use and medical licenses (dual‑license states) may still face § 280E exposure if they cannot separate medical and adult‑use activities in their books and records.
What the Order Does Not Cover
The Schedule III placement applies only to:
- FDA‑approved drug products containing marijuana.
- Marijuana and marijuana extracts that are authorized by a state medical‑marijuana license.
- Naturally occurring delta‑9‑THC derived from the marijuana plant (excluding mature stalks and seeds).
All other marijuana—including unlicensed bulk marijuana, adult‑use (recreational) marijuana, synthetically derived THC analogues such as delta‑10‑THC, and hemp products exceeding the 0.4 mg THC threshold after November 12, 2025—remains in Schedule I and is subject to a separate administrative hearing scheduled for June 29 2026.
Outstanding Issues
Several questions remain unresolved:
- How will dual‑license operators that commingle medical and adult‑use inventory be treated for Schedule III registration and § 280E purposes?
- Will the DEA’s price‑based purchase‑and‑sale mechanism be practical given the volume of flower produced in state systems?
- How will states that do not separate medical and adult‑use sales at the point of sale (e.g., Arizona) track compliance?
These issues may influence whether early applicants qualify for the expedited DEA registration process.
Upcoming DEA Administrative Law Hearing
Because the order does not reschedule all marijuana, any substance not covered will be reviewed in a forthcoming administrative law hearing. The hearing is set to begin on June 29 2026 at 9:00 a.m. ET and will determine whether the remaining marijuana should also be moved to Schedule III.
Certain Legal Challenges
The DEA anticipates litigation, noting in a footnote that if any portion of the order is invalidated, the remaining provisions will stay in effect. Critics, including groups such as Smart Approaches to Marijuana, are expected to challenge the Attorney General’s authority to amend operational and registration regulations under § 811(d)(1). The outcome of these challenges will shape the durability of the current framework.
For state‑licensed medical‑marijuana operators seeking DEA registration, or for foreign operators interested in entering the U.S. market, the window of opportunity is now open—at least until further judicial or administrative decisions alter the landscape.
Source: Here
