Company Applies to Import Psilocybin and Oxycodone Legally
Published Date: 6/30/2026
Notice
Summary
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.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Importation Limited; No Commercial Sale
The registration, if granted, would authorize only the import of the listed drugs as finished dosage form units for clinical trial purposes and explicitly states that no other activities for these drug codes are authorized. Authorization will not extend to importation of FDA-approved or non-approved finished dosage forms for commercial sale.
Application to Import Trial Drugs
Almac Clinical Services Incorp. applied on May 5, 2026 to be registered to import psilocybin (Schedule I) and five Schedule II drugs — oxycodone, hydromorphone, morphine, tapentadol, and fentanyl — as finished dosage form units for clinical trial purposes only. Registered bulk manufacturers and other applicants may submit comments or request a hearing on the application on or before July 30, 2026.
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: 2026-13144, Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Catalent Pharma Solutions wants to become an official importer of some powerful controlled substances like LSD and psilocybin. People who make or use these drugs can share their thoughts or ask for a hearing by July 30, 2026. This move could impact companies involved in these substances and the government’s control over them.
Next: 2026-13146, Privacy Act of 1974; System of Records
The Federal Housing Finance Agency is launching a new system to keep track of employees who want to be mentors or mentees in their mentorship program. This system starts on June 30, 2026, and anyone can send comments until July 30, 2026. It helps the agency connect people better without costing extra money or causing delays.