Health

Bulk Manufacturer Application for Controlled Substances: Usona Institute

🇺🇸United States··Notice·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This notice informs that Usona Institute has applied to become a bulk manufacturer of certain controlled substances like psilocybin. This registration affects industries involved in chemical process development and research, as they might need to adapt to new supply sources for these substances. Companies already registered as bulk manufacturers can submit comments or objections by June 16, 2026.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Usona Institute seeks registration as a bulk manufacturer of controlled substances.
  • The hearing or comment submission deadline is June 16, 2026.
  • Potential new supply sources for controlled substances in research sectors.

Obligations

What this law requires

high

Registered manufacturers and applicants must submit electronic comments or objections regarding Usona Institute, Inc.'s application for bulk manufacturing registration on or before June 16, 2026.

registered manufacturersapplicants
June 16, 2026
reporting
high

Registered bulk manufacturers of the affected basic class(es) of controlled substances must submit electronic comments or objections to the issuance of Usona Institute, Inc.'s proposed registration by June 16, 2026.

registered bulk manufacturers
June 16, 2026
disclosure
high

Registered manufacturers and applicants may request a hearing regarding Usona Institute, Inc.'s application on or before June 16, 2026.

registered manufacturersapplicants
June 16, 2026
licensing
high

Registered bulk manufacturers may file a written request for a hearing regarding Usona Institute, Inc.'s application by June 16, 2026.

registered bulk manufacturers
June 16, 2026
reporting
medium

Comments must be submitted electronically through the Federal eRulemaking Portal as per DEA requirements.

registered bulk manufacturers
operational

Affected Parties

Chemical process development industriesPre-clinical and clinical research sectors

Tags

controlled substances,pharmaceutical manufacturing,research