FDA has published the OTC monograph facility fees for FY 2022. There is about a 19 % increase in the fee structure compared to FY 2021.
Facility Type | FY 2022 OMUFA Fee | |
1 | Finished OTC drug manufacturing Facility | $ 24,178 |
2 | Contract Manufacturing Facility for OTC Drugs | $16,119 |
The due date for OTC monograph drug facility fees for FY 2022 is June 1, 2022.