Pharmaceutical Company Seeks Federal Approval to Import Psilocybin
Published Date: 10/19/2026
Notice
Summary
Halo Pharmaceutical Inc. wants to become an official importer of psilocybin, a controlled substance. People and companies involved with these drugs can share their thoughts or ask for a hearing by November 18, 2026. This move could impact how psilocybin is brought into the U.S., but no costs or changes for the public are mentioned yet.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Application to Import Psilocybin for Trials
On September 4, 2026, Halo Pharmaceutical Inc. applied to be registered to import psilocybin (controlled substance, Schedule I). The company says it plans to import the drug to support formulation development and use in clinical trials.
No Commercial Finished-Form Imports Allowed
The notice states that authorization for this registration will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. That means this importer registration cannot be used to bring finished psilocybin products into the U.S. for sale.
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Key Dates
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