DEA Approves Health Firm's Bid to Import Controlled Drugs
Published Date: 12/19/2025
Notice
Summary
Groff Health Inc. wants to become an official importer of some powerful controlled substances like psilocybin and psilocyn. People and companies involved with these drugs can share their thoughts or ask for a hearing by January 20, 2026. This move could shake up the market and rules around importing these substances, so keep an eye on the deadline!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Import Limited to Bulk, Not Finished Drugs
The application states imports would be for bulk substances to support internal research, clinical trials, analytical purposes, and distribution to customers. The registration would not authorize import of FDA-approved or non-approved finished dosage forms for commercial sale.
Application to Import Psilocybin and Psilocyn
Groff Health Inc. applied on November 7, 2025 to be registered as an importer for psilocybin (drug code 7437) and psilocyn (drug code 7438), both listed in Schedule I. If approved, the company could import those bulk controlled substances under that registration.
Comment and Hearing Deadline Jan 20, 2026
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 January 20, 2026. Comments must be submitted through https://www.regulations.gov and hearing requests have specified mailing addresses to the DEA.
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