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 |