Last Updated on May 10, 2022 by Ithos Global Regulatory Team
The Food and Drug Administration (FDA) has announced the fiscal year 2021 fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program, or “OMUFA”.
Last year’s Coronavirus Aid, Relief, and Economic Security (CARES) Act authorized the FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests.
The fees are for the period from October 1, 2020, through September 30, 2021 are as follows:
- Monograph Drug Facility (MDF): $20,322
- Contract Manufacturing Organization (CMO): $13,548
An OTC MDF is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.
A CMO facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
There is a fee for requesting a modification to the monograph. Monographs are a set of rules, such as what active ingredients are allowed and what warnings are required that apply to an OTC drug category, including cosmetic-like drugs such as sunscreens, anti-acne products, anti-perspirants, anti-dandruff shampoos, skin protectants, and toothpaste with fluoride, etc.
Facility fees are due 45 days after the notice was published, or May 10, 2021.