Determine whether your drug establishment is required to pay Over-the-Counter Monograph User Fees (OMUFA) under the CARES Act 2020 and 21 CFR OMUFA regulations. Not all drug registrants owe these fees.
CARES Act 2020 Instant Result FY2025 Rates
What is OMUFA? The Over-the-Counter Monograph User Fee Act (OMUFA), enacted as part of the CARES Act (2020), authorizes FDA to collect fees from OTC drug monograph facilities and OTC monograph order requesters. These fees are separate from PDUFA (prescription drug) and MDUFA (device) fees. Not every drug establishment owes OMUFA fees.
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Drug Type
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Monograph
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Activity
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Result
Question 1
What type of drug products does your establishment manufacture?
CARES Act 2020 — FD&C Act §744L
Select the category that best describes your drug products:
OMUFA fees apply specifically to OTC (Over-the-Counter) drug products that are marketed under an FDA OTC monograph. Prescription drugs, biologics, and certain other drug types are not subject to OMUFA fees.
Question 2
Are your OTC products covered by a currently applicable OTC monograph?
21 CFR — OTC Monograph System
Are the OTC drug products your facility manufactures covered by a currently applicable OTC drug monograph (a final monograph or an interim final monograph)?
Examples of OTC monograph categories: antacids (21 CFR 331), analgesics (aspirin, ibuprofen, acetaminophen), antihistamines, sunscreens (21 CFR 352), anti-dandruff (zinc pyrithione), antiperspirants, cough/cold, fluoride toothpaste. A drug sold without an Rx and not NDA/ANDA-approved is very likely monograph-covered.
Question 3
What does your facility do with the OTC monograph drug?
FD&C Act §744L(b) — OTC Monograph Drug Facility
Which of the following activities does your facility perform on OTC monograph drug products?
OMUFA fees apply to OTC Monograph Drug Facilities — defined as any facility that engages in manufacturing or processing of a finished OTC monograph drug. Facilities that only store or distribute (without manufacturing) may not be subject.
Assessment Complete
Your OMUFA Fee Obligation
For informational purposes only. OMUFA fee obligations depend on specific product formulations, regulatory status, and FDA determinations. Fee amounts change each fiscal year. Always confirm your fee status with a qualified FDA regulatory specialist and the FDA’s official OMUFA invoices.