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.
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Department and Agencies
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