Regulatory Focus™ > News Articles > FDA Sets Deadline for Submission of GDUFA Information

FDA Sets Deadline for Submission of GDUFA Information

Posted 01 October 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling on owners of generic drug facilities to submit identification information to FDA under authority recently granted to regulators under the terms of the FDA Safety and Innovation Act's (FDASIA) Generic Drug User Fee Act (GDUFA) titles.

Under the Federal Register notice, facilities that manufacture or otherwise produce or finish generic pharmaceutical products or their active pharmaceutical ingredients will be required to register with FDA through its online registration process.

Other facilities, including ones that package a finished generic pharmaceutical product into its primary container or closure system or label the finished packaging, are also required to register with FDA, as are contract repackagers, clinical research organizations conducting bioequivalence and bioavailability testing for products and other testing sites.

All required entities should provide FDA with information in Structured Product Labeling (SPL) format, including:

  • name of the registrant owner
  • name of the facility owner
  • name of the Company
  • type of business operation
  • DUNS number
  • Facility Establishment Identifier
  • facility address

(Additional information may be found in Regulatory Focus' 23 August story, "FDA Releases Guidance on Facility Registrations, Payments Under GDUFA.")

"This self-identification information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs," FDA wrote in its Federal Register posting. Any facilities not providing FDA with the required information are subject to prosecution, injunctions and product seizures, as well as products being denied entry into the US.

All identification information is due to FDA by 1 December 2012.

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