FDA announced this week the availability of the draft guidance, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The draft guidance would implement sections 701 and 702 of the Food and Drug Administration Safety and Innovation Act (FDASIA) by specifying that domestic and foreign drug manufacturers should use the Data Universal Numbering Systems (DUNS) number for a drug establishment’s UFI.
Sections 701 and 702 of FDASIA require domestic and foreign drug establishments to register annually with FDA between October 1 and December 31 and requires the registration to include a UFI to be specified by FDA. The draft guidance explains that FDA has been using DUNS numbers as registration numbers for drug establishments since the implementation of electronic drug registration and listing. DUNS numbers are assigned and managed by Dun and Bradstreet and are available free of charge to all drug establishments. Under the draft guidance, establishments are instructed to contact FDA if they desire to use an alternate UFI.
While section 703 of FDASIA requires the use of the same UFI system to identify excipient manufacturers in product listings, FDA indicated that this draft guidance would be limited to UFI use under sections 701 and 702 and not address section 703.