Outsourcing Facility Fee Rates for Fiscal Year 2021

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

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.