FDA Hikes Outsourcing Drug Facility Fees—Small Biz Pays $7,142
Published Date: 7/30/2026
Notice
Summary
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.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
FY2027 Outsourcing Facility Fees
If you operate an outsourcing facility that compounds human drugs and register with FDA, the FY 2027 annual establishment fee is $7,142 for qualified small businesses and $22,074 for non-small businesses. The FY 2027 reinspection fee is $21,427. These rates are effective October 1, 2026 through September 30, 2027.
Small Business Fee Exception Deadline
To qualify for the FY 2027 small business reduced establishment fee, entities had to submit their small business exception requests by April 30, 2026; that time has passed for FY 2027. Entities that wish to request a small business exception for FY 2028 should consult section 744K(c)(4) of the FD&C Act and FDA guidance.
Registration And Payment Deadlines
Outsourcing facilities must register between October 1, 2026 and December 31, 2026 to maintain status for FY2027 and should submit registration information by December 10, 2026 to allow time for invoicing and payment. Once FDA issues an invoice, you must pay the full invoiced amount within 15 calendar days or FDA will treat the registration submission as withdrawn; failure to register and complete payment by December 31, 2026 will result in loss of outsourcing facility status on January 1, 2027.
Payment Methods, Limits, And Collections
Payments to FDA must be in U.S. currency drawn on a U.S. bank and can be made online via Pay.gov using ACH (eCheck) or credit card; credit card payment is available only for balances under $25,000, and balances over $25,000 must use ACH. Reinspection fee invoices must be paid within 30 days, and unpaid reinspection fees will be treated as a government claim and referred to collections.
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