As per CARES Act, over-the counter (OTC) drugs otherwise known as OTC monograph drugs, can be marketed without an approved drug application if they meet the other applicable requirements. Under this OTC monograph reform legislation, FDA is entitled to assess and collect user fees dedicated to OTC monograph drug activities.
FDA states that OMUFA fee will fund a portion of their regulatory activities for OTC monograph drugs and its performance goals, which includes reviewing of new submissions within specific time frames and inspections.
On March 16th, 2022, FDA announced the OMUFA for FY 2022.
As per FD&C Act, a facility fee for FY 2022 will be calculated based on the facility that is identified as an OTC monograph drug facility during the fee-liable period from January 1, 2021, through December 31, 2021.
FDA will calculate and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. Facility fees will be calculated to each qualifying person that owns a facility identified as an MDF and a reduced facility fee (two- thirds) will be assessed to each qualifying person that owns a facility identified as a CMO facility. FY 2022 facility fees are due on June 1, 2022.
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 2022
| Type of Registration / Application | MDF Facility | CMO Facility |
| OTC Monograph Drug Facility Fee | $24,178 | $16,119 |
FDA also stated that manufacturers that entered the over-the-counter industry to Supply Hand Sanitizers during the COVID-19 Public Health Emergency are not subject to the Over-the-Counter Drug Monograph Facility Fee (OMUFA) fee.
Below are the facilities exempted from OMUFA.
- API Manufacturers.
- Clinical Research Supply manufacturers
- Testing establishment.
- Facilities placing outer packaging on already packaged products containing various products like creating multiple packaging.
- 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.Homeopathic drug manufacturers
Sudha S
Regulatory Consultant
Mail: Office@libertymanagment.us