US FDA Self Identification for Generic Drug Facilities

The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that human generic drug facilities identified in a generic drug submission, provide identification information to FDA every year.

Who Needs Self Identification?

  • Facilities that manufacture human generic drug APIs or finished generic drugs or both.
  • Generic drug packager and labeler.
  • Lab performing Bioequivalence (BE) / bioavailability (BA) testing for generic drugs.

Who Is Required To Pay the FDA Fees?

  • Facilities that manufacture generic drug APIs or Finished Drugs are required to pay facility fees.
  • Generic drug packaging and labeling (which are considered as manufacturing) facilities are required to pay the fees.

Who Is Not Required To Pay the FDA Fees?

  • Facilities that only perform testing, repackaging, or relabeling are not required to pay a user fee

What If Self Identification is not submitted?

  • All products manufactured in the facility may considered as misbranded.
  • Products from foreign facilities entry to the US may denied.

If you need assistance with self identification for your establishment or sites, please contact us we can help you with SPL preparation and submission to FDA.