On September 23, 2016, the Food and Drug Administration (FDA) published the final guidance for industry “Self-Identification of Generic Drug Facilities, Sites and Organizations.” This final guidance is intended to assist generic manufacturing entities in complying with the annual identification requirements as required under the Generic Drug User Fee Amendments of 2012 (GDUFA). It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA and what the penalty is for failure to self-identify.
Self-identification is important for two purposes. First, it is necessary to determine the universe of facilities required to pay user fees. Second, self-identification is a central component of the GDUFA effort to promote global supply chain transparency. The information provided through self-identification enables quick, accurate and reliable surveillance of generic drugs and facilitates inspections and compliance.
The guidance is posted at: http://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM316672. pdf