Bulk Manufacturer of Controlled Substances Application: Promega Corporation
Published Date: 2/2/2026
Notice
Summary
Promega Corporation wants to make large amounts of psilocybin and psilocyn, two controlled substances, to sell as ingredients for medicines. People and companies involved with these drugs can share their thoughts or ask for a hearing by April 3, 2026. This move could boost medicine development but also means Promega will handle some powerful substances under strict rules.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Promega Seeks to Make Schedule I APIs
On January 7, 2026, Promega Corporation (3075 Sub Zero Parkway, Fitchburg, Wisconsin) applied to be registered to bulk manufacture psilocybin (code 7437) and psilocyn (code 7438), both listed as Schedule I. The company says it plans to make these substances as Active Pharmaceutical Ingredients (APIs) for sale to its customers, and the registration would not authorize any other activities for those drug codes. Comments or requests for a hearing are due by April 3, 2026.
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