This message is in reference to the March 21, 2025, Food and Drug Administration Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2025. ” The fiscal year (FY) 2025 Over-the-Counter (OTC) monograph drug facility user fees are due today, June 2, 2025. If you are a qualifying owner of an OTC monograph drug facility, as described in sections 744M and 744L of the Federal Food, Drug, and Cosmetic Act, please visit FDA’s payment portal to submit your payment. For more information on fee-qualifying OTC monograph drug facilities as well as fee payment options and procedures, please visit the aforementioned FRN. For more information on the OTC monograph drug user fee program (OMUFA), please visit our OMUFA user fee website.
FDA issued FY 2025 OMUFA facility user fee invoices on April 21, 2025.
If you have submitted your FY 2025 OMUFA facility user fee prior to this message, thank you for your attention to this matter and no further action is required at this time.
