Patheon application to bulk manufacture gamma hydroxybutyric acid
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Opens a comment period on Patheon Pharmaceuticals Inc.’s application to register as a bulk manufacturer of gamma hydroxybutyric acid, a Schedule I controlled substance. The company says it would make the substance as an active pharmaceutical ingredient for later use in FDA-approved dosage forms. Registered bulk manufacturers and applicants for the same drug class can submit comments, objections, or request a hearing by July 6, 2026. The registration, if granted, would cover only this manufacturing activity for this drug code.
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Key Changes
- Opens public comment on Patheon’s application to bulk manufacture gamma hydroxybutyric acid
- Sets July 6, 2026 as the deadline for comments, objections, and hearing requests
- Limits the requested registration to making the substance as an active pharmaceutical ingredient for FDA-approved dosage forms
Obligations
What this law requires
Registered bulk manufacturers of gamma hydroxybutyric acid and applicants for that affected basic class who submit comments or objections on Patheon Pharmaceuticals Inc.’s proposed registration must submit them electronically through the Federal eRulemaking Portal at https://www.regulations.gov.
Registered bulk manufacturers of gamma hydroxybutyric acid and applicants for that affected basic class who want a hearing on Patheon Pharmaceuticals Inc.’s application must file a written request for a hearing by the stated deadline.
If DEA grants Patheon Pharmaceuticals Inc. the requested registration, the registration authorizes only bulk manufacture of gamma hydroxybutyric acid, drug code 2010, as an active pharmaceutical ingredient for further synthesis into FDA-approved dosage forms; no other activity for this drug code is authorized under this registration.