Tuesday, December 4, 2012

FDA announce Two-Week Grace Period for Generic Drug Facility Identification


FDA  announced a two-week grace period, until December 18, 2012, for Generic Drug Facilities that have not yet successfully completed the self-identification process.
The FY 2013 reporting period for facility self-identification closed on December 3, 2012.  Under the statute, generic drug products manufactured in facilities that have not self-identified, or including active ingredients manufactured in facilities that have not self-identified, are misbranded. 
source: fda