Under the Generic Drug User Fee Amendments of 2012 (GDUFA), human generic drug manufacturers and certain other generic drug industry facilities, sites, and organizations are required to self-identify with the U.S. Food and Drug Administration (FDA) each year. The self-identification reporting period for fiscal year (FY) 2016 is May 1 to June 1, 2015. If a facility does not self-identify by the deadline, FDA will consider FDF and API products manufactured at the facility to be misbranded.
Self-identification information should be submitted in Health Level Seven (HL7) Structured Product Labeling (SPL) format, the standard format used for drug registration and listing information. FDA uses the self-identification information to calculate the generic drug user fees for the next fiscal year. FDA is expected to publish the FY 2016 fees about 60 days before the start of the fiscal year. User fees are due on October 1 of each year. Not all facilities that are required to self-identify are required to pay user fees. Only facilities that manufacture (or intend to manufacture) generic drug APIs or FDFs are subject to the fees.
Registrar Corp can help generic drug industry professionals determine whether or not they are required to self-identify and help them submit their information to FDA in the correct SPL format. For more information about FDA GDUFA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at https://www.registrarcorp.com/livehlep.