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.
- Facilities identified in generic drug submission where the applicant remove the drug from a primary container and subdivide into different primary containers.
- Lab performing Bioequivalence (BE) / bioavailability (BA) testing for generic drugs.
- Facilities identified in a generic drug submission where the testing is performed to check the characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a cGMP testing requirement
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.
When to submit the Self Identification?
- Self-identification must be submitted between May 1 and June 1 of each year.
Liberty Management Group LTD provides assistance with SPL preparation and submission of Self-Identification to FDA.