DEA Reviews Fentanyl Bulk Manufacturer Application
Published Date: 2/13/2025
Notice
Summary
Benuvia Operations, LLC wants to become a big-time maker of certain controlled drugs like fentanyl-related substances and amphetamines for research and making medicine doses. If you’re already registered or interested, you can share your thoughts or ask for a hearing by April 14, 2025. This move affects drug makers and researchers and could speed up new medicine development without extra costs right now.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Benuvia applied to manufacture controlled drugs
On December 4, 2024, Benuvia Operations, LLC applied to be registered to bulk manufacture three controlled substances: Fentanyl-Related Substance (code 9850, Schedule I), Amphetamine (code 1100, Schedule II), and Lisdexamfetamine (code 1205, Schedule II). The company says the manufacturing would be for internal research and dosage formulation development, and the registration would not authorize any other activities for these codes.
Comments and hearing deadline for registrants
Registered bulk manufacturers of the affected basic classes and applicants may submit electronic comments or objections, or file a written request for a hearing, on or before April 14, 2025, via https://www.regulations.gov. Upon submission you will receive a Comment Tracking Number showing successful filing.
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