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Many Drug Companies have yet to Self-Identify with the FDA

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 http://www.registrarcorp.com/livehelp or phone Registrar Corp: +1-757-224-0177.