This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.

Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. FDA is issuing this guidance to help human generic drug facilities, sites, and organizations meet the self-identification requirement. Topics discussed in this guidance include:

  • which types of generic facilities, sites, and organizations are required to self-identify;
  • what information is requested;
  • what technical standards are to be used for electronically submitting the requested information; and
  • the penalty for failing to self-identify.

This guidance also explains generally which types of generic facilities, sites, and organizations will be required to pay user fees.

Posted on the FDA website on 22 September 2016