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
