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FY 2022 OTC drug Facility Fee

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 
1Finished OTC drug manufacturing  Facility  $ 24,178
2Contract Manufacturing  Facility for OTC Drugs$16,119

 

 

The due date for  OTC monograph drug facility fees for FY 2022  is June 1, 2022.