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.