Importer of Controlled Substances Application: Quagen Pharmaceuticals LLC
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This notice informs that Quagen Pharmaceuticals LLC has applied to import controlled substances. Only registered bulk manufacturers and applicants can comment or object before May 18, 2026. The substance intended for import is Diphenoxylate, Schedule II, for distribution to customers. Import of finished commercial sale forms is not authorized.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Quagen Pharmaceuticals LLC has applied to import controlled substances
- Only specific substances and schedules are permitted
- Objections or comments must be submitted before May 18, 2026
Obligations
What this law requires
Registered bulk manufacturers and applicants may submit electronic comments on or objections to the issuance of the registration for Quagen Pharmaceuticals LLC by May 18, 2026.
Registered bulk manufacturers and applicants must request a hearing on the application of Quagen Pharmaceuticals LLC by submitting a written request by May 18, 2026.
Comments must be submitted electronically through the Federal eRulemaking Portal following the online instructions provided on the site.
Quagen Pharmaceuticals LLC is authorized to import only the listed controlled substance, Diphenoxylate, and is prohibited from importing any finished commercial sale forms of the substance.