Specification of the Unique Facility Identifier (UFI) System for Drug Establishment November 2014
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0984.