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GUIDANCE DOCUMENT

Specification of the Unique Facility Identifier (UFI) System for Drug Establishment November 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0984
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance specifies the unique facility identifier (UFI) system for registration of domestic and foreign drug establishments. This guidance is intended to address provisions set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144), regarding the specification of the UFI system.

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All written comments should be identified with this document's docket number: FDA-2013-D-0984.

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