OMUFA Fee Navigator
The CARES Act created an annual facility fee for OTC monograph drug manufacturers — but several categories of facilities are fully exempt. This tool walks through your facility’s role and product type to determine whether you owe the OMUFA fee or qualify for an exemption, citing the specific FD&C Act provision behind each outcome.
CARES Act 2020
Fee or Exemption?
Facility-Specific Guidance
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.
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.