DEA Notice on Patheon API Application to Manufacture Controlled Substances
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
Allows public review of Patheon API Inc.’s application to register as a bulk manufacturer of three Schedule I controlled substances: dimethyltryptamine, psilocybin, and psilocyn. The company says it would manufacture these substances only for research and clinical trials. Existing registered bulk manufacturers and applicants for the same substances may submit comments, objections, or hearing requests by July 6, 2026 through Regulations.gov. The notice does not approve the registration yet; it opens the comment period before the DEA decides.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Patheon API Inc. has applied to register as a bulk manufacturer of dimethyltryptamine, psilocybin, and psilocyn.
- The proposed manufacturing would be limited to research and clinical trials.
- Eligible competitors and applicants may submit comments, objections, or hearing requests by July 6, 2026.
Obligations
What this law requires
Registered bulk manufacturers of dimethyltryptamine, psilocybin, or psilocyn, and applicants for registration for those same substances, must submit any comments or objections to Patheon API Inc.’s proposed bulk manufacturer registration by the stated deadline if they wish DEA to consider them.
Any comments on or objections to the proposed registration must be submitted electronically through the Federal eRulemaking Portal at Regulations.gov, following the site’s online instructions.
Eligible registered bulk manufacturers or applicants that want a hearing on Patheon API Inc.’s application must file a written request for a hearing by the stated deadline.
If the DEA grants the registration described in the notice, Patheon API Inc. may bulk manufacture dimethyltryptamine, psilocybin, and psilocyn only for research and clinical trials; no other activities for those drug codes would be authorized under that registration.