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13 Sep 2013

FDA Draft Guidance - Specification of Unique Facility Identifier System for Drug Establishment Registration

FDA has issued for comment a draft guidance on specification of the Unique Facility Identifier (UFI) System for registration of domestic and foreign drug Establishments. This guidance is intended solely to address the provisions in section 701 and 702 of Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in July 2012.

The guidance indicate that at this time, FDA’s preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet. 

Upon application, each business entity is assigned a distinct site-specific 9-digit DUNS number. The DUNS number is available free of charge to all drug establishments.

FDA has been using the DUNS number as a registration number for drug establishments since implementation of electronic drug registration and listing.

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