Pharma Firm Seeks DEA OK to Bulk-Manufacture Magic Mushroom Psilocybin
Published Date: 3/17/2025
Notice
Summary
Sterling Pharma USA LLC wants to become a big-time maker of some powerful controlled substances like psilocybin and DMT for research and early drug testing. If you’re a current manufacturer or interested party, you can share your thoughts or ask for a hearing by May 16, 2025. This move could speed up new medicine research, but it’s all tightly watched and regulated.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Sterling Pharma applied to bulk-manufacture Schedule I drugs
On February 11, 2025, Sterling Pharma USA LLC applied to register as a bulk manufacturer of Schedule I substances including tetrahydrocannabinols (code 7370), 5-methoxy-N,N-dimethyltryptamine (code 7431), dimethyltryptamine (code 7435), psilocybin (code 7437), and psilocyn (code 7438). The company says it plans to bulk manufacture these substances to support internal research and to sell them to customers for pre-clinical trial studies.
Stakeholders can object or request a hearing by May 16, 2025
Registered bulk manufacturers of the affected drug classes and other applicants may submit electronic comments or objections, or file a written request for a hearing, on or before May 16, 2025 using regulations.gov.
Registration limited to bulk manufacture for research
The application states that no other activities for the listed drug codes are authorized for this registration; the planned authorization would be limited to bulk manufacture to support internal research and sale for pre-clinical studies.
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