2025-21790Notice

DEA Considers Bulk Manufacturing of Psilocybin for Science

Published Date: 12/3/2025

Notice

Summary

Kinetochem LLC wants to become a big-time maker of some powerful controlled substances like marijuana and psilocybin for research and medicine. People and companies involved with these drugs can share their thoughts or ask for a hearing by February 2, 2026. This move could speed up scientific studies and drug development, with no direct cost changes announced yet.

Analyzed Economic Effects

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

New Schedule I API supplier seeks registration

On October 15, 2025 Kinetochem LLC applied to be registered as a bulk manufacturer of Schedule I controlled substances including Marihuana (code 7360), Tetrahydrocannabinols (7370), Psilocybin (7437), and Psilocyn (7438). The company says it plans to bulk manufacture these drugs as Active Pharmaceutical Ingredients (APIs) for its customers and for research and clinical trials.

Synthetic-only manufacture for marijuana and THC

For drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), Kinetochem plans to bulk manufacture these drugs as synthetic only, and the notice states that no other activities for these drug codes are authorized for this registration.

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Key Dates

Published Date
Comments Due
12/3/2025
2/2/2026

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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