Product Identifier  Requirements 
Under the Drug Supply Chain 
Security Act   
Compliance  Policy   
 
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) 
Office of Regulatory Affairs (ORA) 
 
 
 
 
 
 
 
 
 
 
 
 
 
September 2018 
Procedural 
 
   
Product Identifier  Requirements 
Under the Drug Supply Chain 
Security Act   
Compliance  Policy 
 
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  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/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) 
Office of Regulatory Affairs (ORA) 
 
 
 
 
September 2018 
Procedural 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ........................................................................................................ 2 
III.  COMPLIANCE POLICY FOR THE PRODUCT IDENTIFIER REQUIREMENT ..  
 .................................................................................................................................... 2 
IV.  RELATIONSHIP TO GRANDFATHERED PRODUCTS UNDER SECTION 
582(a)(5)(A) OF THE FD&C ACT............................................................................. 3 
  Contains Nonbinding Recommendations 
 
Product Identifier Requirements Under the Drug Supply  Chain 
Security Act  Compliance Policy 
Guidance for Industry1 
 
 
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 staff responsible for this guidance as listed on the 
title page.  
 
 
 
 
I.  INTRODUCTION  
 
This guidance describes FDAs compliance policy  with regard to a requirement related to 
product identifiers under the Drug Supply Chain Security Act.  Specifically,  this guidance 
addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers affix or imprint  a product 
identifier2  to each package3 and homogenous case4 of a product5 intended to be introduced in a 
transaction6 into commerce beginning  not later than November 27, 2017.7 
 
The compliance policy set forth in this guidance applies only to the requirement regarding 
product identifiers described above.  In brief, FDA does not intend to take action against 
manufacturers who do not affix or imprint  a product identifier  to each package and homogenous 
case of product before November 27, 2018.  This represents a one year delay in enforcement of 
the requirement for manufacturers to affix or imprint  product identifiers.   
 
In general, FDAs guidance documents 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 
                                              
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research 
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory 
Affairs (ORA) at the Food and Drug Administration. 
2 Product identifier is defined in section 581(14) of the FD&C Act (21 U.S.C. 360eee(14)) as a standardized graphic 
that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards 
developed by a widely recognized international standards development organization, the standardized numerical 
identifier, lot number, and expiration date of the product. 
3 Package is defined in section 581(11) of the FD&C Act. 
4 Homogeneous case is defined in section 581(7) of the FD&C Act.  The terms homogeneous and homogenous 
are used interchangeably throughout the DSCSA. FDA has chosen to use only the term homogenous throughout 
this guidance. 
5 Product is defined in section 581(13) of the FD&C Act. 
6 Transaction is defined in section 581(24) of the FD&C Act. 
7 See section 582(b)(2)(A) of the FD&C Act. 
  1  Contains Nonbinding Recommendations 
 
the word should in Agency guidances means that something  is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND 
 
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into 
law on November 27, 2013.  Section 202 of the DSCSA added section 582 to the FD&C Act.  
This section established product tracing, product identifier,  authorized trading partner, and 
verification  requirements for manufacturers, wholesale distributors,  repackagers, and dispensers 
to facilitate the tracing of a product through the pharmaceutical distribution  supply chain.  
Failure to comply with the requirements of section 582 is prohibited  under section 301(t) of the 
FD&C Act (21 U.S.C. 331(t)) and subject to enforcement action under the FD&C Act. 
 
An important requirement of the product tracing scheme outlined  in the DSCSA is the product 
identifier.  Section 582 requires that each package and homogenous case of product in the 
pharmaceutical distribution  supply chain bear a product identifier  in both a human-readable form 
and on a machine-readable data carrier.  The product identifier includes the products 
standardized numerical identifier,8  lot number, and expiration  date.  Manufacturers are required 
to begin affixing  or imprinting  a product identifier  to each package and homogenous case of a 
product intended to be introduced in a transaction into commerce no later than November 27, 
2017.  Repackagers are required to do the same no later than November 27, 2018.9 
 
Since product packaged by a manufacturer during the one year delay in enforcement of the 
product identifier requirement is also subject to the policy set forth in the final guidance 
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product 
Identifier (grandfathering policy),  trading partners should read that final guidance to understand 
how to treat such product for the purposes of the product identifier  and verification 
requirements.10  
 
 
III.  COMPLIANCE POLICY FOR THE PRODUCT IDENTIFIER REQUIREMENT 
 
                                              
8 Standardized numerical identifier is defined in section 581(20) of the FD&C Act as a set of numbers or characters 
used to uniquely identify each package or homogenous case that is composed of the National Drug Code that 
corresponds to the specific product (including the particular package configuration) combined with a unique 
alphanumeric serial number of up to 20 characters. 
9 See section 582(e)(2)(A)(i) of the FD&C Act. 
10 Final guidance for industry Grandfathering Policy for Packages and Homogenous Cases of Product Without a 
Product Identifier.  We update guidances periodically.  To make sure you have the most recent version of a 
guidance, check the FDA Drugs or Biologics guidance web pages at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . 
 
  2  Contains Nonbinding Recommendations 
 
In the years since passage of the DSCSA, FDA had received comments and feedback from 
manufacturers and other trading partners11 expressing concern with industry-wide  readiness for 
implementation  of the product identifier  requirements for manufacturers.  Specifically, 
stakeholders had described challenges with implementation  of manufacturer product identifier 
requirements due to:  (1) a limited  number of vendors have the expertise to provide solutions 
related to information  technology systems for data management or specific equipment for 
packaging or manufacturing lines, and (2) capabilities  and readiness of contract facilities that 
perform manufacturing operations on behalf of the manufacturer. 
 
Given the concerns expressed, FDA has recognized that some manufacturers may need 
additional  time beyond November 27, 2017, to ensure that products are properly affixed or 
imprinted  with a product identifier.   To minimize  possible disruptions  in the distribution  of 
prescription drugs in the United States, FDA does not intend to take action against manufacturers 
who do not affix or imprint a product identifier  to each package and homogenous  case of product 
as required by section 582(b)(2)(A) of the FD&C Act if the package and homogeneous case of 
product was packaged by the manufacturer on or after November 27, 2017, but before November 
27, 2018. 
 
This compliance policy  applies solely to packages and homogenous cases of product without 
product identifiers that are packaged by a manufacturer on or after November 27, 2017, but 
before November 27, 2018.  The compliance policy does not apply to any other provision  of 
section 582, including  the requirement for repackagers to affix or imprint  a product identifier  on 
each package or homogenous  case of product intended to be introduced in a transaction into 
commerce beginning  November 27, 2018.12  
 
 
IV.  RELATIONSHIP TO GRANDFATHERED PRODUCTS UNDER SECTION 
582(A)(5)(A) OF THE FD&C ACT 
 
FDA has issued the final guidance Grandfathering Policy for Packages and Homogenous Cases 
of Product Without a Product Identifier, which outlines the circumstances in which packages and 
homogenous cases of product not labeled with a product identifier  shall be subject to the 
grandfathering exemption set forth in section 582(a)(5)(A) of the FD&C Act (grandfathered).13  
Specifically,  a package or homogenous case of product without a product identifier  that was 
packaged by a manufacturer or repackaged by a repackager before November 27, 2018, is 
grandfathered as described in that guidance.  Trading partners should read the grandfathering 
policy for a more detailed description of their responsibilities  as they relate to products without a 
                                              
11 For this guidance, trading partner is defined as described in section 581(23)(A) of the FD&C Act (21 U.S.C. 
30eee(23)(A)).  Although third-party logistics providers are also considered trading partners under section 
581(23)(B) (21 U.S.C. 30eee(23)(B)) of the FD&C Act, the product tracing requirements of section 582 are not 
applicable to them. 
12 See section 582(e)(2)(A)(i) and (iii) of the FD&C Act. 
13 Section 582(a)(5)(A) of the FD&C Act gives FDA the authority to exempt packages and homogenous cases of 
product without a product identifier from certain requirements of section 582.  See the final guidance for industry 
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, for more 
information. 
  3  Contains Nonbinding Recommendations 
 
product identifier that were packaged by a manufacturer or repackaged by a repackager before 
November 27, 2018. 
  4