FDA Specifies DUNS for Drug Facility Registration

November 5, 2014
Pharmaceutical Technology Editors

FDA releases guidance specifying its preferred unique facility identifier system.

FDA Specifies DUNS for Drug Facility Registration

FDA has released guidance specifying the unique facility identifier (UFI) system for the registration of domestic and foreign drug establishments.  The guidance addresses sections 701 and 702 of the Food and Drug Administration Safety and Innovation Act (FDASIA) that direct FDA to specify the UFI system for registration of domestic and foreign drug establishments.

In the document, FDA states that it is specifying the Data Universal Numbering System (DUNS) number, assigned and managed by Dun and Bradstreet, which FDA has been using since the implementation of electronic drug registration and listing. The DUNS number is available free of charge to all drug establishments, and further information is available on FDA’s website.

Source: FDA