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# Generic Drug Facility Self-Identification Guidance
- URL: https://www.fdaweb.com/generic-drug-facility-self-identification-guidance/
- Published: 2016-09-22T12:00:00.000Z
- Updated: 2026-09-14T21:34:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136883

FDA has issued a guidance, *Self-Identification of Generic Drug Facilities, Sites, and Organizations*, to inform them about complying with the self-identification requirement in the Generic Drug User Fee Amendments of 2012 (GDUFA). Under that law, the [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316672.pdf?ref=fdaweb.com) says, human generic drug facilities, sites, and organizations are required to annually submit identification information to FDA electronically. Topics covered in the 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.

FDA says that self-identification is necessary for two purposes. First, it is needed to determine the universe of facilities required to pay user fees. And second, it is a central component of an 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 agency says.