Specification of the Unique 
Facility Identifier (UFI) System 
for Drug Establishment 
Registration  
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Veterinary Medicine (CVM) 
Office of Regulatory Affairs (ORA) 
 
November 2014 
Procedural 
 
   Contains Nonbinding Recommendations 
 
Specification of the Unique Facility 
Identifier (UFI) System for Drug 
Establishment Registration  
 
Guidance for Industry 
 
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and/or 
 
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Food and Drug Administration 
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http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Veterinary Medicine (CVM) 
Office of Regulatory Affairs (ORA) 
 
November 2014 
Procedural 
  Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
A.    Food and Drug Administration Safety and Innovation Act ....................................................... 1 
B.    Scope of This Guidance ................................................................................................................. 2 
III.   SPECIFICATION OF THE UFI SYSTEM ................................................................... 2 
  Contains Nonbinding Recommendations 
 
Specification of the Unique Facility Identifier (UFI) System  
for Drug Establishment Registration 
1
Guidance for Industry  
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
 
 
I.  INTRODUCTION  
 
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.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
 
II.  BACKGROUND 
 
A.    Food and Drug Administration Safety and Innovation Act  
 
In July 2012, FDASIA was signed into law.  Sections 701 and 702 of FDASIA direct the 
Secretary of Health and Human Services (Secretary) to specify the UFI system for registration of 
domestic and foreign drug establishments.  Once the UFI system is specified, section 510 of the 
FD&C Act, as amended, requires that each initial and annual drug establishment registration 
include a UFI (21 U.S.C. 360(b), (c), and (i)).  
 
                                                 
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research, in 
cooperation with the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the 
Office of Regulatory Affairs at the Food and Drug Administration.  
  1  Contains Nonbinding Recommendations 
 
 
 
B.    Scope of This Guidance 
 
This guidance is intended solely to address sections 701 and 702 of FDASIA that direct the 
Secretary (and by delegation FDA) to specify the UFI system for registration of domestic and 
foreign drug establishments.  This guidance reflects current thinking in light of data standards, 
information technology, and information management resources.  As these variables change over 
time, FDA may revisit this guidance and the specification made in section III of this guidance.   
 
III.   SPECIFICATION OF THE UFI SYSTEM 
 
For drug establishment registration, FDA is specifying the following UFI system.  At this time, 
FDAs preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N-
S (DUNS) number, assigned and managed by Dun and Bradstreet.  FDA has been using the 
DUNS number as a registration number for drug establishments since the implementation of 
electronic drug registration and listing (for information on the electronic submission of 
registration and listing data, see 
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm).  
Currently, FDA finds the DUNS number appropriate to meet Agency needs for a data standard 
for drug establishment registration UFI.  The DUNS number is available free of charge to all 
drug establishments, and further information is available on the FDA Web site at 
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162544.htm.  If 
you want to use an alternative identifier for your drug establishment, contact FDA via email at 
eDRLS@fda.hhs.gov. 
  2