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Draft FDA Guidance on Unique Facility Identifiers for Drug Establishment Registration

Friday, September 06, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has made available a draft guidance for industry that specifies the unique facility identifier system for the registration of domestic and foreign drug establishments. To be considered in the development of the final version of this guidance, comments should be submitted no later than Nov. 5.

Facilities that manufacture, prepare, propagate, compound or process drugs are already required to register electronically with the FDA each year. The Food and Drug Administration 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. Because drug firms generally possess, and those already registered have previously provided, a DUNS number for each facility, the FDA expects that they will submit DUNS numbers as the UFIs for drug establishments. However, if a company wants to use an alternative UFI for its drug establishment it may contact the FDA.

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