The FD&C Act lets the FDA assess and collect user fees from qualifying OTC monograph drug manufacturers and OTC monograph order requests (OMOR) submitters. These OMUFA fees help fund timely FDA reviews and oversight so your OTC products can reach the market safely and effectively.
Before figuring out your obligations under OMUFA, you need to know:
- An OTC monograph drug is a non-prescription drug without an NDA, governed by section 505G of the FD&C Act.
- An OTC Monograph Drug Facility (MDF) is any facility that manufactures or processes the finished dosage form of an OTC monograph drug.
- A Contract Manufacturing Organization (CMO) is a facility that makes OTC monograph drugs but doesn’t sell them directly to wholesalers, retailers, or consumers.
What Fees Apply?
OMUFA has two main fee types:
- Annual facility fees for manufacturers, MDFs, and CMOs
- Fees for OMORs, except those involving certain safety-related changes
To pay your facility fees, you’ll complete and submit an OTC Monograph User Fee Cover Sheet through the FDA’s User Fee System Portal. Fees are due by December 31 of each fiscal year in which your facility is identified.
How Intertek Can Help
Intertek can help you determine which fees apply to your operations, prepare and submit your cover sheets, and ensure your annual fees are paid accurately and on time. With our support, you’ll stay compliant and keep your OTC products moving to market without unnecessary delays.
Be proactive about your compliance, reach out to Intertek and let us help you meet your OMUFA user fee obligations with ease.
