💰FDA Announces FY 2026 Outsourcing Facility Fee Rates
Outsourcing Facility Fee Rates for Fiscal Year 2026
Summary
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2026 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 2026 rates for the small business establishment fee ($6,829), the non-small business establishment fee ($20,726), and the reinspection fee ($20,486) for outsourcing facilities; provides information on how the fees for FY 2026 were determined; and describes the payment procedures outsourcing facilities should follow.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulatory notice specifies FY 2026 outsourcing facility fee rates, including establishment and reinspection fees, which directly affect financial planning for businesses registering as outsourcing facilities. Compliance with these fees is mandatory for operation under FDA regulations, impacting cash flow and operational costs.