Under the Generic Drug User Fee Amendments (GDUFA) of 2012, all generic facilities, sites and organizations are required to comply with the self-identification requirements of the GDUFA. This Guidance document is intended to facilitate firms’ understanding of the requirements, and thus, make self-identification easier to accomplish. The document also discusses which of the facilities, sites, and or organizations will have to pay a GDUFA user fee.
The Guidance discusses:
- 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.
The self-identification process was established to accomplish two goals:
- determine the number of fee paying establishments and
- develop a list of all sites and establishments to promote supply chain transparency and provide an accurate listing of sites and facilities that may need inspection.
The Guidance document, which can be found here, provides concise descriptions, identifies processes, and outlines requirements that must be followed in the self-identification scheme. It also reminds us that if a firm fails to self-identify, any product that is associated with that establishment is considered to be misbranded, and thus, subject to immediate enforcement action. Talk about the carrot and the stick! Also remember, this is not a one-time process, and must be completed annually.