FDA Finalizes Requirement for DUNS Number in Drug Facility Registrations

The Food and Drug Administration finalized its guidance that outlines the Unique Facility Identifier (UFI) system for use in registration foreign and domestic drug facilities (here). The guidance specifies that drug establishments should include a Data Universal Numbering System (DUNS) from Dun and Broadstreet as the UFI in their initial registrations and annual registration renewals, although other forms of identifiers are allowed with FDA approval. The final guidance makes few changes from a draft guidance issued in September 2013 (see 13090518). DUNS numbers are already required for drug establishments to register in the electronic Structured Product Labeling format, said an FDA spokesman.