DSCSA Implementation: 
Product Tracing Requirements 
 Compliance Policy 
 
Guidance for Industry 
 
 
 
 
 
This guidance is for immediate implementation.
 
   
 
This guidance is for immediate implementation.  FDA is issuing this guidance for immediate 
implementation in accordance with 21 CFR 10.115(g)(2). Submit one set of either electronic or 
written comments on this guidance at any time. Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. You should identify all comments with Docket Number FDA-2014-D-2254. 
 
For questions regarding this document contact CDER Office of Compliance at 301-796-3100 or 
drugtrackandtrace@fda.hhs.gov.  
 
 
 
 
 
 
 
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) 
 
December 2014 
Procedural 
   
DSCSA Implementation: 
Product Tracing Requirements 
 Compliance Policy 
 
Guidance for Industry 
 
 
 
 
Additional copies are available from: 
 
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Office of Communications 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Avenue 
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Silver Spring, MD 20993 
(Tel) 301-796-3400 or 855-543-3784; (Fax) 301-431-6353 
druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
and/or 
Office of Communication, Outreach and 
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 Food and Drug Administration 
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Phone: 800-835-4709 or 240-402-7800 
ocod@fda.hhs.gov  
http://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  
Center for Biologics Evaluation and Research 
Office of Regulatory Affairs 
 
December 2014 
Procedural 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  SCOPE OF THIS GUIDANCE ....................................................................................... 2 
IV.  PRODUCT TRACING REQUIREMENTS  COMPLIANCE POLICY ................... 2 
  Contains Nonbinding Recommendations 
DSCSA Implementation: Product Tracing Requirements 
Compliance Policy 
1
Guidance for Industry  
 
 
This guidance represents the Food and Drug Administrations (FDAs or Agencys) 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 is intended for trading partners (manufacturers, wholesale distributors, and 
repackagers) who must provide and capture certain product tracing information, as required 
under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-
1).  This guidance addresses the readiness of the pharmaceutical distribution supply chain to 
comply with the provisions in section 582 of the FD&C Act related to the exchange of product 
tracing information.  Requirements for the tracing of products through the pharmaceutical 
distribution supply chain go into effect on January 1, 2015, for manufacturers, wholesale 
distributors, and repackagers, and on July 1, 2015, for dispensers.   
 
This guidance announces the Food and Drug Administrations (FDAs) intention with regard to 
enforcement of the product tracing information requirements under section 582 of the FD&C 
Act.  FDA does not intend to take action against trading partners (manufacturers, wholesale 
distributors, and repackagers) who do not, prior to May 1, 2015, provide or capture the 
transaction information, transaction history, and transaction statement required by section 582 of 
the FD&C Act (product tracing information) associated with each transaction of certain human, 
finished prescription drugs, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). 
 
FDAs guidance documents do not typically establish legally enforceable responsibilities.  
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 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. 
  1  Contains Nonbinding Recommendations 
 
II.  BACKGROUND 
 
On November 27, 2013, the DSCSA was signed into law.  Section 202 of the DSCSA, which 
adds new sections 581 and 582 to the FD&C Act, sets forth new definitions and requirements 
related to product tracing.  The DSCSA outlines critical steps to build an electronic, 
interoperable system by November 27, 2023, which will identify and trace certain prescription 
drugs as they are distributed within the United States.  This system will enhance FDAs ability to 
help protect U.S. consumers by improving detection and removal of potentially dangerous 
products from the pharmaceutical distribution supply chain. 
 
Starting in 2015, trading partners are required under section 582(b)(1), (c)(1), (d)(1), and (e)(1) 
of the FD&C Act to provide the subsequent purchaser with product tracing information when 
engaging in transactions involving certain prescription drugs.  Trading partners are also required 
to capture the product tracing information and maintain the applicable information for not less 
than 6 years after the date of the transaction. 
   
FDA, in consultation with other appropriate Federal officials and pharmaceutical distribution 
supply chain stakeholders, published a draft guidance as required under section 582(a)(2)(A) of 
the FD&C Act, entitled DSCSA Standards for the Interoperable Exchange of Information for 
Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing 
Information (November 2014).2  This draft guidance established initial standards for the 
interoperable exchange of the product tracing information related to each transaction of certain 
human, finished, prescription drugs covered by the statute, in paper or electronic format, through 
the extension and/or use of current systems and processes. 
 
 
III.  SCOPE OF THIS GUIDANCE 
 
This guidance applies to certain trading partners (manufacturers, wholesale distributors, and 
repackagers) engaged in transactions3 involving products, as defined in section 581(13) of the 
FD&C Act.   
 
 
IV.  PRODUCT TRACING REQUIREMENTS  COMPLIANCE POLICY 
 
The product tracing requirements in sections 582(b), (c), and (e) of the FD&C Act take effect for 
manufacturers, wholesale distributors, and repackagers on January 1, 2015.  However, some 
trading partners have expressed concern that unforeseen complications with the exchange of the 
required information may result in disruptions in the supply chain, and ultimately could impact 
                                                           
2 This draft guidance, when finalized, will represent FDAs current thinking on this topic.  We update guidances 
periodically.  To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web 
page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
 
3 Transaction is defined in section 581(24) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
patients access to needed prescription drugs.  FDA recognizes that some manufacturers, 
wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to 
work with trading partners to ensure that all of the product tracing information required under 
section 582 of the FD&C Act is provided to and captured by the recipient trading partner.  To 
minimize possible disruptions in the distribution of prescription drugs in the United States, FDA 
does not intend to take action against trading partners who do not, prior to May 1, 2015, provide 
or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the 
FD&C Act.  This compliance policy is limited to the requirements that trading partners provide 
and capture product tracing information; it does not extend to other requirements in section 582 
of the FD&C Act, such as verification related to suspect and illegitimate product (including 
quarantine, investigation, notification and recordkeeping) and requirements related to engaging 
in transactions only with authorized trading partners. 
 
  3