The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OMUFA fee rates for fiscal year (FY) 2027.
US Federal Register - FDA Notices · July 30, 2026
Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
FDA publishes user fee rates for OTC monograph drug manufacturers and submitters for fiscal year 2027 under OMUFA II.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.