Over-The-Counter Monograph Drug User Fee Program (OMUFA)

https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa?utm_campaign=42504259-FnB%2C%20Cosmetics%2C%20Med%20Dev%2C%20Drugs%20%7C%20Newsfeed%20%7C%20Global%20%7C%202026&utm_medium=email&_hsenc=p2ANqtz-9Pwe3L1NjcGXyBgiUYISktq2r10ZeLRTX6zWiPmssr0uCDJr11j52-B1bun2pEAGz-liZ4jdhC5LkCQ39qHSl0EUs_jQ&_hsmi=416156928&utm_content=416156883&utm_source=hs_email FDA OMUFA Updates Highlight 2026 Fee Obligations for OTC Manufacturers FDA’s OMUFA page now reflects key FY2026 updates for companies manufacturing OTC monograph drugs, including new facility fee rates, OMOR fee rates, and updated arrears and paid facilities lists. The page states that FY2026 facility fees are $19,188 for monograph drug facilities and $12,792 for contract manufacturing organization facilities, and that FY2026 facility fees are due on June 1, 2026. FDA also notes that paper-based payments are no longer accepted and payments must be made electronically, by credit card, or by wire transfer. For OTC drug companies, these updates reinforce that OMUFA is not just a background fee program but an active compliance obligation tied to facility status, registration information, and payment timing. Companies should confirm whether their facilities fall within the statutory definition of an OTC monograph drug facility, verify payment readiness, and make sure internal teams are aligned well ahead of the June deadline.