The notice sets the annual establishment fee for small and non-small businesses, and the fee charged for each reinspection of an outsourcing facility, for the coming fiscal year.
Washington, 30 July 2026 — The Food and Drug Administration announced the fiscal year 2027 rates for the establishment and reinspection fees that apply to entities which compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act.
The notice sets the small business establishment fee at 7,142 dollars, the non-small business establishment fee at 22,074 dollars and the reinspection fee at 21,427 dollars. The Act authorises the agency to assess and collect an annual establishment fee from outsourcing facilities, and a reinspection fee for each reinspection of one.
Source documents
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Outsourcing Facility Fee Rates for Fiscal Year 2027
- Identifier
- Federal Register document 2026-15342
- As the record states
- The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 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 2027 rates for the small business establishment fee ($7,142), the non-small business establishment fee ($22,074), and the reinspection fee ($21,427) for outsourcing facilities; provides information on how the fees for FY 2027 were determined; and describes the payment procedures outsourcing facilities should follow.
- Document number
- 2026-15342