2025-05283NoticeWallet

Promega Seeks to Manufacture Psychedelic Psilocybin and Psilocyn

Published Date: 3/27/2025

Notice

Summary

Promega Corporation wants to become a big-time maker of special drugs called psilocybin and psilocyn, which are tightly controlled by the government. They plan to produce these substances as ingredients for medicines and are open to public comments or objections until May 27, 2025. This move affects drug makers and buyers, with no immediate cost changes announced but a clear deadline for feedback.

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

New API supplier for psilocybin and psilocyn

Promega Corporation applied on February 26, 2025 to be registered as a bulk manufacturer of psilocybin (code 7437) and psilocyn (code 7438), both Schedule I. The company plans to bulk manufacture these substances as Active Pharmaceutical Ingredients (APIs) for sale to its customers, and no other activities for these codes are authorized under this registration. Interested parties may submit comments or request a hearing on the application by May 27, 2025.

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Key Dates

Published Date
3/27/2025

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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