FDA: OMUFA Fee Update for Over-The-Counter Products in 2025

FDA: Update on OMUFA Rates for 2025

The U.S. Food and Drug Administration (FDA) recently published new fees that must be paid by food production facilities. over-the-counter (OTC) drugs under the Monograph User Fee Program (OMUFA) for fiscal year 2025.

These amounts apply starting October 1, 2024, and will remain in effect until September 30, 2025. According to the official notice in the Federal Register, the fee for facilities classified as Monograph Drug Facilities (MDF) will be $37,556, while those registered as Contract Manufacturing Organizations (CMOs) will be required to pay $25,037. The payment deadline is June 2, 2025.

This adjustment reflects the methodology established by the FDA, which considers factors such as the number of manufacturers required to pay, the ratio of MDF to CMO, and inflation increases. For those seeking more details on the payment procedures and calculation methods, information is available in the official announcement and on the FDA website dedicated to the OMUFA program.

Keeping up with these fees is essential for businesses to continue operating in compliance with regulations. If your organization produces over-the-counter products, review how much you'll be required to pay and make sure you meet deadlines to avoid setbacks.

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