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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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

1

Specification of the Unique Facility Identifier (UFI) System 

for Drug Establishment Registration

Guidance for Industry1

This guidance represents the Food and Drug Administration’s (FDA’s) 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. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency’s 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. 
Contains Nonbinding Recommendations

2

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, 

FDA’s preferred UFI for a drug establishment is the Data Universal Numbering System D-U-NS (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.