DEA Reviews Halo's Request to Import Controlled Drugs
Published Date: 11/26/2025
Notice
Summary
Halo Pharmaceutical Inc. wants to become an official importer of certain controlled substances, including psilocybin. People and companies involved with these drugs can share their thoughts or ask for a hearing by December 26, 2025. This move could impact how these substances enter the U.S., so keep an eye on the deadline to have your say!
Analyzed Economic Effects
2 provisions identified: 0 benefits, 0 costs, 2 mixed.
Import Authorization Limited to Trials, Not Commercial Sale
The company plans to import psilocybin to support formulation development and use in clinical trials, and any registration would not authorize importation of FDA-approved or non-approved finished dosage forms for commercial sale.
Application to Import Psilocybin Filed
Halo Pharmaceutical Inc. applied on September 29, 2025 to be registered as an importer of psilocybin (controlled substance code 7437, Schedule I). Registered bulk manufacturers and applicants may submit electronic comments or file requests for a hearing on the application on or before December 26, 2025.
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