The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility.” 

The Federal Register notice on its prepublication page (here) that announces the fees and discussed how the FDA reached its decision on establishing the new fees for FY 2024. 

Outsourcing Facility Fees  

Type of 503B Ffacility  FY 2023 Fees  FY 2024 Fees  Change 
Qualified Small Business Establishment Fee  $5,941  $6,196  +$255 
Non-Small Business Establishment Fee  $18,661  $20,036  +$1375 
Reinspection Fee  $17,823  $18,588  +$765 


Not much to say here as most of the fees are in line with other FDA establishment inspection fees and remember these are all domestic operations.