Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC
Published Date: 2/4/2026
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. People already registered or interested can share their thoughts or ask for a hearing by April 6, 2026. This move could speed up new medicine studies, but only for research—not for regular sales.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
New Bulk Supplier for Schedule I Research
On January 9, 2026, Sterling Pharma USA LLC applied to be registered as a bulk manufacturer of the Schedule I substances tetrahydrocannabinols (code 7370), 5‑methoxy‑N‑N‑dimethyltryptamine (code 7431), dimethyltryptamine (code 7435), psilocybin (code 7437), and psilocyn (code 7438). If registered, the company may manufacture these substances in bulk to support its internal research and to sell to customers for pre‑clinical trial studies; no other activities for these drug codes would be authorized under the registration.
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