FDA Announces Generic Drug Facility Self-Identification Reporting Period for FY 2014

  • April 16, 2013

By Nick Fleischer, R.Ph., Ph.D.

Today, FDA announced that the FY 2014 generic drug facility self-identification reporting period will begin May 1, 2013 and end June 1, 2013. As required by the Generic Drug User Fee Amendments of 2012, all generic drug facilities, certain sites and organizations are required to submit, update or reconfirm this information to FDA annually.

According to FDA, this annual self-identification is required for two purposes:

  1. To help determine the group of facilities required to pay user fees, and
  2. To promote global supply chain transparency.

The information FDA receives through the self-identification process enables the Agency to quickly, accurately and reliably survey generic drugs and facilities inspections and compliance. If you fall under this requirement, the Agency offers two electronic tools for submitting the required information: eSubmitter and Structured Product Labeling Xforms.

Additional information, including exactly who is expected to self-identify, may be found here. If your company is in need of help with the self-identification process, The Weinberg Group may assist.

Nick Fleischer, R.Ph., Ph.D. is Vice President and Claire Robertson is a Marketing Associate at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.