FDA Outsourcing Facility Fee Rate: Fiscal Year 2017

According to section 503B(d)(4) of the Federal Food, Drug, and Cosmetic (FD&C) an outsourcing facility is “a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.”  The FD&C Act authorizes the 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.  These rates are adjusted on an annual basis and are effective from October 1st to September 30th each year.  In addition, the Agency offers a significant discount for qualified small businesses.

Earlier this week, FDA announced its fiscal year 2017 rates, which are as follows:

Qualified Small Business Establishment Fee $5,279
Non-Small Business Establishment Fee $16,852
Re-Inspection Fee $15,837


We are extremely qualified and have helped many facilities with the FDA registration process in the past.  To learn more about how we can help your facility register and reduce the total cost to do so, contact us today.