The US Food and Drug Administration (FDA) has issued Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites and Organizations.
This guidance aims to assist human generic drug facilities, sites, and organizations on how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III).
Specifically, this guidance outlines the following:
- 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 was released in September 2016.