According to CARES Act, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) is a program implemented by the U.S. Food and Drug Administration (FDA) to help fund the regulation of over the counter (OTC) drug products. The program aims to expedite the review and approval process for OTC drugs and improve the safety and availability of OTC products.
OMUFA’s goal is to provide the FDA with the necessary resources to evaluate, approve, and regulate new or modified OTC drug products more efficiently. It helps cover the costs of the FDA’s review activities, which are critical to ensuring the safety and effectiveness of OTC medications.
FDA has introduced two types of fees.
- Establishment/Facility fees
- OTC Monograph Order Request (OMOR) fees
Companies that wish to introduce a new OTC drug or update existing OTC monographs must pay user fees to the FDA.
OTC drugs are that products that fall under FDA’s OTC monograph which does not require FDA approval and can be marketed without a prescription. OMUFA was created to support the process of revising the monographs and reviewing drug products.
Manufacturers can submit new OTC drug products or requests for changes to the FDA’s existing monographs. These submissions are subject to review, and manufacturers must pay the applicable user fees.
OTC monograph drug facility (MDF) is a foreign or domestic establishment that is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.
A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliated partner or the establishment sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
FDA Fees for OTC Monograph
Drug Facility Registration for Fiscal Year 2025
| Type of Registration / Application | MDF Facility | CMO Facility |
| OTC Monograph Drug Facility Fee | $37,556 | $25,037 |
The following are the facilities that does not need to pay OMUFA for FY 2025.
- API manufacturer of OTC monograph drug
- OTC monograph drug facilities that had stopped all activities related to OTC monograph drugs prior to December 31, 2023, and had de-registered and de-listed their drugs.
- Drug establishment registered during pandemic period whose sole activity with respect to OTC monograph drugs consisted of manufacturing OTC hand sanitizer products and has stopped manufacturing hand sanitizer products and delisted and deregistered with the FDA on or before on December 31, 2024.
- Animal Drug manufacturers
- Homeopathic drug manufacturers.
Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.
Sudha S
Regulatory Consultatnt
Email : office@libertymanagement.us