Company Applies to Legally Mass-Produce Controlled Drugs
Published Date: 11/26/2025
Notice
Summary
Irvine Labs Inc. wants to make large amounts of some powerful, tightly controlled drugs like psilocybin and LSD for research. People and companies involved with these drugs can share their thoughts or ask for a hearing by January 26, 2026. This move could boost scientific studies but also means careful government oversight and no quick cash changes for now.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Application to Manufacture Schedule I Drugs
On October 29, 2025, Irvine Labs Inc. applied to be registered as a bulk manufacturer for several Schedule I substances, including ibogaine, lysergic acid diethylamide (LSD), mescaline, peyote, diethyltryptamine (DET), dimethyltryptamine (DMT), psilocybin, and psilocyn. The company says it plans to manufacture these drugs in bulk for research and development and to distribute them to its research customers.
Comment and Hearing Deadline
Registered bulk manufacturers of the affected drug classes, and applicants, may submit electronic comments or objections and may file written requests for a hearing on this application on or before January 26, 2026. Comments must be submitted through https://www.regulations.gov.
Registration Limited to Research Use
The notice states that, if registered, Irvine Labs' authorization would be limited to bulk manufacture of the listed drug codes for research and development internally and for distribution to its research customers. The registration would not authorize any other activities for those drug codes.
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