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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile 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.
2026-16665, Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration between March 1, 2026, and June 30, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through June 30, 2026, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published.
2026-16413, Schedules of Controlled Substances: Temporary Placement of O-Desmethyltramadol in Schedule I
The Drug Enforcement Administration issues this temporary order to schedule O-desmethyltramadol (other names: O-DSMT; desmetramadol; 3-[(1R,2R)-2-[(dimethylamino)methyl]-1- hydroxycyclohexyl]phenol), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing O-DSMT in schedule I is necessary to avoid an imminent hazard to public safety. This order imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle O-DSMT.
2026-16375, Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V
The Drug Enforcement Administration proposes to transfer suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4- diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone), lemborexant ((1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)- N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide), and daridorexant ([(2S)-2-(5-chloro-4-methyl-1H-benzimidazol-2-yl)-2-methylpyrrolidin-1- yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone) from schedule IV to schedule V of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule V controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle suvorexant, lemborexant, and daridorexant.
2026-15624, Amendment to 3,4-MDP-2-P Methyl Glycidic Acid, a List I Chemical
The Drug Enforcement Administration is proposing to modify the listing of the list I chemical 3,4-MDP-2-P methyl glycidic acid (also known as PMK glycidic acid) to include esters of 3,4-MDP-2-P methyl glycidic acid, not listed elsewhere in the Controlled Substances Act (CSA), as list I chemicals under the CSA. The current listing of 3,4- MDP-2-P methyl glycidic acid includes its salts, optical and geometric isomers, and salts of isomers. DEA proposes the new listing to read as follows: 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its esters, not listed elsewhere in the CSA, its optical and geometric isomers, its salts, salts of its optical and geometric isomers, salts of its esters, not listed elsewhere in the CSA, and any combination thereof, whenever the existence of such is possible.
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.