Outsourcing facilities are compounding facilities defined under section 503B of the Federal Food Drug and Cosmetic Act (FD&C Act). There are yearly fees associated with establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. The FDA has Just published the fees for outsourcing facilities for FY 2021 (see FR Notice here).
Outsourcing Facility Fees for FY 2021
|Qualified Small Business Establishment Fee||$5,695|
|Non-Small Business Establishment Fee||$18,837|
Outsourcing fees for FY 2021 have increased marginally, from 1.7% for small business establishment fees and reinspection fees to 3% for non-small business establishment fees over FY 2020 rates.