DEA Greenlights Bulk Psychedelic Production for Medical Trials
Published Date: 5/4/2026
Notice
Summary
Patheon API Inc. wants to make large amounts of special research drugs like dimethyltryptamine and psilocybin. This affects researchers and companies involved in clinical trials, with a chance to comment or ask for a hearing by July 6, 2026. No money changes are mentioned, but this move could speed up important medical studies.
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Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Application to Bulk-Manufacture Schedule I Psychedelics
Patheon API Inc. applied on February 9, 2026 to be registered to bulk manufacture three Schedule I controlled substances: dimethyltryptamine (drug code 7435), psilocybin (drug code 7437), and psilocyn (drug code 7438). The company says the planned manufacturing is for research and clinical trials only, and no other activities for these drug codes are authorized under this application.
Comment and Hearing Deadline for Stakeholders
Registered bulk manufacturers of the affected substances and applicants may submit electronic comments or objections, or file a written request for a hearing, on or before July 6, 2026 via the Federal eRulemaking Portal (https://www.regulations.gov). The notice provides a Comment Tracking Number upon successful submission.
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