💊FY 2025 Facility Fee Rates for OTC Monograph Drugs Announced
Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2025
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2025.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The text outlines the FDA's facility fee rates for over-the-counter (OTC) monograph drug facilities for FY 2025. Businesses involved in the manufacture of OTC drugs will incur new costs, with fees set at $37,556 for MDF and $25,037 for CMO facilities. Compliance is required to avoid penalties, indicating significant financial implications for affected businesses.