In November, the Food and Drug Administration published a Guidance for Industry entitled: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.
This guidance is a direct result of the Food and Drug Administration Safety and Innovation Act of July 2012. Sections 701 and 702 of FDASIA require FDA to specify the UFI system for registration of domestic and foreign drug establishments. Once the UFI system is specified, section 510 of the FD&C Act requires that each initial and annual drug establishment registration include a UFI. From the guidance document:
“For drug establishment registration, FDA is specifying the following UFI system. 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. FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing…. Currently, FDA finds the DUNS number appropriate to meet Agency needs for a data standard for drug establishment registration UFI.
The DUNS number is available free of charge to all drug establishments, and further information is available on the FDA Web site at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm. If you want to use an alternative identifier for your drug establishment, contact FDA via email at eDRLS@fda.hhs.gov.”