U.S. FDA Self-Identification Requirements for Generic Drug Facilities
Generic Drug User Fee Amendments of 2012 (GDUFA): P.L. 112-144, Title III; 77 F.R. 191, at pp. 60125-26.
Operators of facilities that produce generic drugs and generic drug APIs must submit “self-identification” information to FDA between May 1 and June 1 of each year. This information is required by the Generic Drug User Fee Amendments of 2012 (GDUFA). FDA uses self-identification data to calculate generic drug user fees. Under GDUFA, if a facility fails to self-identify, the generic drugs it manufactures will be deemed misbranded.
For assistance with determining whether your firm is subject to FDA’s self-identification requirements or submitting self-identification information to FDA, simply complete the fields below.