Self-Identification with FDA
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.