Zdrowie i gospodarka · 2.08.2017
Outsourcing Facility Fee Rates for Fiscal Year 2018
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2018 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2018 rates for the small business establishment fee ($5,364), the non-small business establishment fee ($17,364), and the re-inspection fee ($16,093) for outsourcing facilities; provides information on how the fees for FY 2018 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2017, and will remain in effect through September 30, 2018.