💰FDA Announces FY 2026 Outsourcing Facility Fee Rates
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.
Learn More💊FDA Notice on Challenges for Compounding Outsourcing Facilities
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More🏥FDA Issues Interim Guidance on Compounding Bulk Drug Substances
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
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