The Generic Drug User Fee Amendments of 2012 (GDUFA) require that all facilities involved in the manufacture of human generic drugs and associated active pharmaceutical ingredients self-identify with the U.S. Food and Drug Administration (FDA). Under GDUFA, FDA can deem all generic drug products manufactured in facilities that have not self-identified, including active ingredients manufactured in facilities that have not self-identified, as misbranded.
The original deadline set under GDUFA for self-identification with the FDA was December 3, 2012. Last week, FDA announced a two-week grace period, giving facilities until December 18, 2012 to self-identify without penalty.
FDA estimates that 1 out of 8 facilities has failed to self-identify. FDA has provided a list of companies that have successfully completed the GDUFA self-identification process.
All other GDUFA-required drug facilities have only 8 more days to complete the self-identification process.
For more information about the GDUFA Self-identification process, or any U.S. FDA Regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or phone Registrar Corp: +1-757-224-0177.