Federal Register #2026-21353

DEA notice concerning Halo Pharmaceutical Inc.’s application to import psilocybin

This is a Drug Enforcement Administration notice about Halo Pharmaceutical Inc.’s application to import psilocybin, not a government purchase or contract award. - Government agency: U.S. Department of Justice, Drug Enforcement Administration (DEA). - Applicant: Halo Pharmaceutical Inc. seeks registration to import psilocybin, a Schedule I controlled substance (drug code 7437), for formulation development and clinical trials. - The notice does not specify a purchase quantity, part number beyond the drug code, or government procurement requirement. - Any authorization would not cover importing finished dosage forms, whether FDA-approved or not, for commercial sale. - No procurement period of performance, contract value, or award is specified.

Description

Halo Pharmaceutical Inc. applied to the Drug Enforcement Administration to be registered as an importer of psilocybin (drug code 7437, Schedule I). The company plans to import the controlled substance for formulation development and use in clinical trials. Registered bulk manufacturers of the affected basic class and applicants may submit comments or objections, or request a hearing, on or before November 18, 2026. The notice states that authorization will not extend to importing FDA-approved or nonapproved finished dosage forms for commercial sale.

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