Self-Identification of 
Generic Drug Facilities, 
Sites, and Organizations  
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) 
 
September 2016 
Generics  
Self-Identification of 
Generic Drug Facilities, 
Sites, and Organizations 
Guidance for Industry 
 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
7519 Standish Place, Rockville, MD  20855 
Phone: 240-276-9300 
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) 
September 2016 
Generics 
 
  Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  GDUFA SELF-IDENTIFICATION REQUIREMENTS .............................................. 2 
A.  Who Is Required to Self-Identify? ................................................................................................ 3 
B.  What Information Is Required for Submission? ........................................................................ 4 
1. D-U-N-S Numbers ............................................................................................................................ 4 
2. Facility Establishment Identifier ...................................................................................................... 5 
3. Additional Information..................................................................................................................... 5 
C.  What Is the Process for Submitting Self-Identification Information? ...................................... 5 
D.  What Is the Penalty for Failing to Self-Identify? ........................................................................ 6 
i 
 
  Contains Nonbinding Recommendations 
 
Self-Identification of Generic Drug Facilities, Sites, and 
Organizations 
1
Guidance for Industry  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
I.  INTRODUCTION  
 
This guidance is intended to assist human generic drug facilities, sites, and organizations by 
describing how to comply with the self-identification requirement contained in the Generic Drug 
User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as 
GDUFA.   
 
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit 
identification information electronically to FDA annually. FDA is issuing this guidance to help 
human generic drug facilities, sites, and organizations meet the self-identification requirement.  
Topics discussed in this guidance include: 
  
  which types of generic facilities, sites, and organizations are required to self-identify; 
  what information is requested;  
  what technical standards are to be used for electronically submitting the requested 
information; and 
  the penalty for failing to self-identify.   
 
This guidance also explains generally which types of generic facilities, sites, and organizations 
will be required to pay user fees.  
 
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.  
 
 
                                                 
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 
  1  Contains Nonbinding Recommendations 
 
II.  BACKGROUND 
 
On July 9, 2012, GDUFA was signed into law by the President.2  GDUFA is designed to speed 
the delivery of safe and effective generic drugs to the public and reduce costs to industry.  
GDUFA enables FDA to assess user fees to support critical and measurable enhancements to 
FDAs generic drugs program.  GDUFA will also significantly improve global supply chain 
transparency by requiring owners of facilities producing generic drug products, active 
pharmaceutical ingredients (API), and certain other sites and organizations that support the 
manufacture or approval of these products to electronically self-identify with FDA and update 
that information annually.   
 
Self-identification is required for two purposes.  First, it is necessary to determine the universe of 
facilities required to pay user fees.  Second, self-identification is a central component of an effort 
to promote global supply chain transparency.  The information provided through self-
identification enables quick, accurate, and reliable surveillance of generic drugs and facilitates 
inspections and compliance.    
 
Most facilities that self-identify are required to pay an annual facility user fee.  These include 
facilities manufacturing, or intending to manufacture, API of human generic drugs and/or 
finished dosage form (FDF) human generic drugs.  Other sites and organizations must self-
identify, but are not required to pay the annual facility user fee.  These include facilities that 
solely manufacture positron emission tomography (PET) drugs, or sites and organizations that 
only perform testing, repackaging, or relabeling operations.  Please note that while repackagers 
are not required to pay user fees, packagers are, in most cases, FDF manufacturers and subject to 
facility fees.   
 
A separate system for the electronic self-identification of generic industry facilities, sites, and 
organizations was established for GDUFA.  Entities required to register and list (under section 
510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service 
Act), and those required to self-identify under GDUFA submit information separately to the 
respective systems.  Each system populates its own database to meet unique requirements and 
deadlines.  The separate GDUFA system uses the same platform and technical standards already 
familiar to manufacturers required to register and list.   
 
 
III.  GDUFA SELF-IDENTIFICATION REQUIREMENTS     
 
The following discussion explains who is required to self-identify, what information is required 
for submission, and what the process is for submitting self-identification information.   
 
                                                 
2 On October 5, 2012 the President signed into law the FDA User Fee Correction Act of 2012.  This act amends 
GDUFA so that due dates for GDUFA user fees in fiscal year 2013 are not dependent on enactment of an 
appropriations act.  
  2  Contains Nonbinding Recommendations 
 
A.  Who Is Required to Self-Identify? 
 
The following types of generic industry facilities, sites, and organizations are required to self-
identify with FDA:    
 
1.   Facilities3 that manufacture, or intend to manufacture, human generic drug APIs or FDFs, 
or both.4 
 
2.   Facilities that package the FDF of a human generic drug into the primary 
container/closure system and label the primary container/closure system.5 
 
3.   Sites that are identified in a generic drug submission and pursuant to a contract with the 
applicant remove the drug from a primary container/closure system and subdivide the 
contents into a different primary container/closure system. 
 
                                                 
3  GDUFA has defined the term facility to identify those businesses required to pay fees and for self-identification.  
GDUFA defines a facility as a business or other entity under one management, either direct or indirect, at one 
geographic location or address, engaged in manufacturing or processing an API or an FDF.  It does not include a 
business or other entity whose only manufacturing or processing activities are one or more of the following: 
repackaging, relabeling, or testing.  Separate buildings within close proximity are considered to be at one 
geographic location or address if the activities in them are closely related to the same business enterprise; are 
under the supervision of the same local management; and are capable of being inspected by FDA during a single 
inspection. GDUFA further states that if a business entity would meet the definition of a facility but for being 
under multiple management, the business or entity is deemed to constitute multiple facilities, one per management 
entity.  
 
4 For purposes of self-identification and payment of fees, GDUFA defines API and FDF manufacturers differently 
from the way these categories of manufacturers have been defined historically.  For example, generic drug 
manufacturers who mix an API when the substance is unstable or cannot be transported on its own are considered 
API manufacturers and not FDF manufacturers for self-identification and the payment of GDUFA fees only.   
 
GDUFA defines an FDF as: 
(A) a drug product in the form in which it will be administered to a patient, such as a 
tablet, capsule, solution, or topical application; 
(B) a drug product in a form in which reconstitution is necessary prior to administration  to a patient, such as oral 
suspensions or lyophilized powders; or 
(C) any combination of an active pharmaceutical ingredient (as defined in the statute) with another component of 
a drug product for purposes of production of a drug product described in subparagraph (A) or (B). 
 
GDUFA defines an API as: 
(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended 
(i)  to be used as a component of a drug; and 
(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or 
prevention of disease, or to affect the structure or any function of the human body; or 
(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those 
activities, to become a substance or mixture described in subparagraph (A). 
 
5 Facilities that package the FDF of a human generic drug into the primary container/closure system and label the 
primary container/closure system are considered to be manufacturers, whether or not that packaging is done 
pursuant to a contract or by the applicant itself. 
  3  Contains Nonbinding Recommendations 
 
4.   Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug 
submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected 
from clinical BE/BA testing, and/or in vitro BE testing.   
 
5.  Sites that are identified in a generic drug submission and perform testing of one or more 
attributes or characteristics of the FDF or the API pursuant to a contract with the 
applicant to satisfy a current good manufacturing practice (CGMP) testing requirement 
(excludes sites that are testing for research purposes only). 
 
 
B.  What Information Is Required for Submission? 
 
The following information is required to meet the self-identification requirement in GDUFA:  
 
1.  D-U-N-S Numbers 
 
FDA requires Data Universal Numbering System (D-U-N-S) numbers for both the facility or site 
and the registrant owner of the facility or site if the facility or site is in a different location than 
the registrant owner location.  A D-U-N-S number is required to uniquely identify the registrant 
(the owner or operator) and each physical location of the businesss facility or site (e.g., 
branches, divisions, and headquarters). 
 
A D-U-N-S number is a unique nine-digit sequence provided by Dun & Bradstreet. The  
D-U-N-S number is specific for each site.  Each distinct physical location of an entity (e.g., 
branch, division, and headquarter) would be assigned a different D-U-N-S number.   
 
The site-specific D-U-N-S number is a widely recognized business identification tool and serves 
as a useful resource for FDA in identifying and verifying certain business information submitted 
by a user.   
 
If no D-U-N-S number has been assigned, a business entity may obtain one at no cost directly 
from Dun & Bradstreet.  A new number may be obtained, or an existing number verified, by 
phone or online.  Existing facilities D-U-N-S numbers may also be verified on FDAs current 
registration site for drug establishments.6 
 
Note:  It takes Dun & Bradstreet approximately 30 business days to process a new 
D-U-N-S number and communicate it via email. A business entity may receive a  
D-U-N-S number in approximately 10 business days for an expedited service fee.  Please 
note that a business entity may not request or apply for a new D-U-N-S number on behalf 
of another business entity due to the verification procedures used by Dun & Bradstreet.    
 
More information is available at the Dun & Bradstreet web page.  See also the step-by-step 
instructions for obtaining a D-U-N-S number for businesses based either in the United States or 
abroad. 
                                                 
6 http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm 
  4  Contains Nonbinding Recommendations 
 
2. Facility Establishment Identifier 
 
Facilities must also submit a Facility Establishment Identifier (FEI), a unique identifier 
designated by FDA to assign, monitor, and track inspections of regulated firms. 7  
A business entity that has previously obtained an FEI number may verify its FEI number by 
sending an email request to FDAGDUFAFEIRequest@fda.hhs.gov.  
 
Alternatively, business entities that have not previously registered with FDA can obtain an FEI 
number by sending an email request to FDAGDUFAFEIRequest@fda.hhs.gov.  Please type 
GDUFA FEI Request in the subject line and include the following information in the body of 
the email:   
 
Firm Name  
Facility Address including City, Province, Country, and Mail Code 
Size of Firm 
Type of Operation (Manufacturer, Lab, etc.) 
Type of Industry:  Drugs 
 
Requests for issuance of FEI numbers associated with GDUFA self-identification are typically 
processed within 10 to 15 business days.  
 
3.  Additional Information   
 
FDA requests the name and contact information for the registrant owner and facility information, 
including name, type of business operation, and contact information.  Submitters are also asked 
to indicate whether they manufacture drugs that are not generic drugs. 
 
C.  What Is the Process for Submitting Self-Identification Information? 
 
The self-identification process is similar to other FDA electronic submission standards.  Self-
identification files should be formatted in the same electronic messaging standard used for drug 
registration and listing information and for the content of labeling for abbreviated new drug 
applications (ANDAs). This standard, known as Health Level Seven Structured Product Labeling 
(SPL), allows information to be exchanged, searched, and combined with other data sources in a 
manner that supports health information technology initiatives to improve patient care. 
 
Providing Regulatory Submissions in Electronic Format  Drug Establishment Registration and 
Drug Listing8 provides detailed instructions on how to submit information using SPL.  FDA also 
offers tools and information for creating and submitting SPL files.  Additional information can 
be found at www.fda.gov/edrls.   
 
 
                                                 
7 For the Agencys policy on the assignment of FEIs, please refer to Field Management Directive (FMD) #130, 
Official Establishment Inventory (OEI) Development and Maintenance, which provides standardized definitions and 
associated procedures to facilitate consistency of data in the OEI.  
8 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm072339.pdf 
  5  Contains Nonbinding Recommendations 
 
D.  What Is the Penalty for Failing to Self-Identify? 
 
Although GDUFA provides no explicit penalty for sites and organizations that fail to comply 
with the self-identification requirement, the failure of a site or organization to comply with the 
law and self-identify may raise significant concerns about that site.  Such failure is a factor that 
may increase the likelihood of a site inspection prior to approval.  FDA does not expect to give 
priority to completion of inspections that are required simply because sites fail to comply with 
self-identification requirements. 
 
More importantly, under GDUFA, if a facility fails to self-identify, all FDF or API products 
manufactured at the facility and all FDFs containing APIs manufactured at the facility will be 
deemed misbranded.9 It is a violation of federal law to ship misbranded products in interstate 
commerce or to import them into the United States.  Such violations can result in prosecution of 
those responsible, injunctions, or seizures of the misbranded products. Products that are deemed 
misbranded because of failure of the facility to self-identify are subject to being denied entry into 
the United States.   
 
 
 
                                                 
9 21 U.S.C. 352(aa) 
  6