DEA Considers New Importer for Psilocybin and Cannabis
Published Date: 7/7/2026
Notice
Summary
Benuvia Operations, LLC wants to become an official importer of certain controlled substances like marijuana extract and psilocybin. People and companies involved with these drugs can share their thoughts or ask for a hearing by August 6, 2026. This move could shake up who gets to bring these substances into the U.S., so keep an eye on the deadline if you’re interested!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Comment and Hearing Deadline: Aug 6, 2026
Registered bulk manufacturers of the affected drug classes and applicants may submit electronic comments or objections, or file a written request for a hearing, on or before August 6, 2026. Comments must be submitted through https://www.regulations.gov and hearing requests must be sent to the DEA addresses listed in the notice.
Application to Import Specific Controlled Substances
On May 7, 2026, Benuvia Operations, LLC (Round Rock, Texas) applied to be registered as an importer of these basic classes: Marihuana Extract (7350, Schedule I); Psilocybin (7437, Schedule I); Psilocyn (7438, Schedule I); Amphetamine (1100, Schedule II); Lisdexamfetamine (1205, Schedule II); Ecgonine (9180, Schedule II); and Remifentanil (9739, Schedule II). The company plans to import the listed substances as active pharmaceutical ingredients to support its customers.
Import Authorization Limited to APIs — No Finished Dosage Forms
The registration, if approved, will authorize import of the listed substances as active pharmaceutical ingredients (APIs) only; authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. The notice also states that no other activities for these drug codes are authorized for this registration.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11526 — Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Starting July 9, 2026, new rules make it easier for doctors and pharmacies to provide medicine that helps people recover from opioid addiction. These changes affect healthcare providers by expanding who can give medication-assisted treatment and how pharmacies can deliver these medicines. The goal? Faster, safer access to treatment with clear rules that save time and support recovery.
2026-10128 — Revision of Applications for Manufacturing and Procurement Quotas
The DEA wants to update how companies apply for permission to make and buy certain controlled drugs and chemicals. These changes will make the rules clearer, help prevent drug shortages, and ensure enough supply for medical and scientific needs. If you’re a manufacturer or involved in this process, get ready to follow new steps and share your thoughts by July 20, 2026.
2026-13581 — Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I
Starting July 6, 2026, the DEA plans to temporarily put three substances related to 7-hydroxymitragynine—Mitragynine Pseudoindoxyl, MGM-15, and MGM-16—into Schedule I, the strictest drug category. This means anyone making, selling, or using these chemicals will face tough legal rules and penalties. The move aims to control these substances quickly while the DEA studies them further, affecting businesses and researchers handling these compounds.
2026-13580 — Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I
Starting July 6, 2026, the DEA plans to temporarily put 7-hydroxymitragynine above a certain amount into Schedule I, meaning it’s treated like the most tightly controlled drugs. This affects anyone who makes, sells, studies, or even just has this substance, bringing strict rules and penalties. The move aims to keep people safe while the government figures out the long-term plan.
2026-13364 — Schedules of Controlled Substances: Temporary Placement of 5,6- Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule I of the Controlled Substances Act
Starting July 1, 2026, the DEA is temporarily putting four new substances—5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N-propionitrile chlorphine, and spirochlorphine—into Schedule I, the strictest drug category. This means anyone making, selling, or using these chemicals will face tough legal rules and penalties. The move helps keep these potentially dangerous drugs off the streets while the DEA studies them further.
2026-13145 — Importer of Controlled Substances Application: Almac Clinical Services Incorp. (ACSI)
Almac Clinical Services Incorp. (ACSI) wants to become an official importer of certain controlled substances, including psilocybin and oxycodone. This affects drug manufacturers and others in the industry who can comment or request a hearing by July 30, 2026. No direct costs are mentioned, but the decision could impact how these substances enter the U.S. market.
Previous / Next Documents
Previous: 2026-13704 — Certain Flash-Spun Nonwoven Materials and Products Containing Same; Notice of Request for Submissions on the Public Interest
The U.S. International Trade Commission is asking the public and government agencies to share their thoughts on whether certain flash-spun nonwoven materials and products containing them should be blocked from entering the U.S. This comes after a judge suggested these products might be violating trade rules. If blocked, it could affect companies importing or selling these materials, so your input matters before any final decision is made.
Next: 2026-13706 — Endangered Species Act; Taking of Endangered and Threatened Species; Permit Modification; Permit No. 23861
The Midwest Biodiversity Institute wants to change its permit to keep studying certain endangered fish like shortnose sturgeon, Atlantic sturgeon, and Atlantic salmon in Maine rivers. This change lets them continue their work while protecting these special fish. People have until August 6, 2026, to share their thoughts, and no new costs or delays are expected.