FDA Sets New Fees for OTC Drug Facilities in 2025
Published Date: 3/21/2025
Notice
Summary
The FDA is setting new fees for facilities that make over-the-counter (OTC) drugs for fiscal year 2025. If you make or submit requests for these OTC drugs, you’ll need to pay updated fees starting October 1, 2024. These fees help the FDA keep OTC drugs safe and effective for everyone.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
OTC manufacturer facility fees start Oct 1
If you manufacture over-the-counter (OTC) monograph drugs, you must pay new OTC monograph drug facility (MDF) fees for fiscal year 2025 starting October 1, 2024. The FDA is publishing these FY2025 facility fee rates under the OTC Monograph Drug User Fee Program (OMUFA) and will assess them from qualifying manufacturers as authorized by the FD&C Act.
Submitters of OMORs must pay FY2025 fees
If you submit OTC monograph order requests (OMORs), you must pay user fees under the FY2025 OMUFA facility fee rates beginning October 1, 2024. The FDA will assess and collect these fees from OMOR submitters as authorized by the Federal Food, Drug, and Cosmetic Act.
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