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29 Dec 2014

Rx-360 Summary of FDA's Published Final Guidance for Industry: Specification of the Unique Facility Identifier System for Drug Establishment Registration

FDA published its final Guidance for Industry: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. This final guidance specifies the unique facility identifier system for registration of domestic and foreign drug establishments. This guidance is intended to address the 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 FDASIA Sections 701 and 702, regarding the specification of the UFI system.

 

To view or download the FDA Guidance, click here

 

To view or download the Rx-360 Summary of the Guidance, click here

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