Outsourcing Facility Fee Rates for Fiscal Year 2022

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2022 rates for the establishment and reinspection fees related to entities 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. This document establishes the FY 2022 rates for the small business establishment fee ($5,824), the non-small business establishment fee ($18,999), and the reinspection fee ($17,472) for outsourcing facilities; provides information on how the fees for FY 2022 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2021, and will remain in effect through September 30, 2022.