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FDA Guidance on Unique Facility Identifier System for Drug Establishment Registration

Thursday, November 06, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has finalized a guidance for industry that specifies the unique facility identifier system for the registration of domestic and foreign drug establishments.

Facilities that manufacture, prepare, propagate, compound or process drugs are already required to register electronically with the FDA each year. The FDA Safety and Innovation Act directs the FDA to specify a UFI system in connection with that requirement. Once that system is specified , each initial and annual drug establishment registration must include a UFI.

The FDA states that in light of data standards, information technology and information management resources, its preferred UFI for drug establishments at this time is the Data Universal Numbering System (DUNS) number assigned and managed by Dun and Bradstreet. The DUNS number is available free of charge to all drug establishments and may be obtained by visiting the Web site for Dun and Bradstreet.

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