The user fees for outsourcing facilities (also known as compounding or 503B facilities) have been announced! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, MDUFA, and ADUFA.
The establishment fee for a qualified small business and the re-inspection fee increased by 5.2%. However, the establishment fee for a non-small business decreased by 3.8%.
1To be paid when invoiced
For outsourcing facilities, the establishment fee at the initial registration will be incurred at the time of registration, after the FDA has confirmed that the information is complete. After the initial registration, in order to maintain their status, outsourcing facilities must register annually during the period from October 1st to December 31st (though the FDA advises that this be completed by December 10th) of each year. Registration and payment must be made by December 31st each year in order to continue status as an outsourcing facility.
Reinspection fees will be invoiced by the FDA after the conclusion of the reinspection. Payments must be made within thirty days of the invoice date.
