DSCSA Implementation: 
Product Tracing Requirements 
for Dispensers  
 Compliance Policy 
(Revised) 
 
 
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-2015-D-2270. 
 
For questions regarding this document, contact CDER Office of Compliance at 301-796-3130 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) 
 
October 2015 
Procedural 
   
DSCSA Implementation: 
 
Product Tracing Requirements 
for Dispensers  
 Compliance Policy 
(Revised) 
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 
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 240-402-7800 
Email: 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 
 
October 2015 
Procedural 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  SCOPE OF THIS GUIDANCE ....................................................................................... 2 
IV.  PRODUCT TRACING REQUIREMENTS FOR DISPENSERS  COMPLIANCE 
POLICY ............................................................................................................................. 2 
  Contains Nonbinding Recommendations 
DSCSA Implementation: Product Tracing Requirements for 
Dispensers  Compliance Policy 
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 staff responsible for this guidance as listed on the 
title page. 
   
 
 
 
I.  INTRODUCTION  
 
This guidance addresses the readiness of dispensers in the pharmaceutical distribution supply 
chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360eee-1(d)(1)) related to the exchange of transaction information, 
transaction history, and transaction statements (product tracing information).  For dispensers, 
requirements for the tracing of products through the pharmaceutical distribution supply chain 
under section 582(d)(1) of the FD&C Act took effect on July 1, 2015.2   
 
On July 6, 2015, FDA published a Notice of Availability in the Federal Register (80 FR 38449) 
announcing a guidance document entitled DSCSA Implementation:  Product Tracing 
Requirements for Dispensers  Compliance Policy.  The guidance described FDAs intention 
with regard to enforcement of the product tracing information requirements under section 
582(d)(1) of the FD&C Act.  The guidance stated that FDA does not intend to take action against 
dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving 
product tracing information, prior to or at the time of a transaction, as required by section 
582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing 
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.  As described below, 
FDA is extending this compliance policy to transactions that occur before March 1, 2016.  
Section IV of this guidance provides further detail about the scope of this compliance policy and 
FDAs expectations for dispensers and trading partners involved in transactions with dispensers.   
 
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 Dispenser is defined in section 581(3) of the FD&C Act (21 U.S.C. 360eee(3)). 
  1  Contains Nonbinding Recommendations 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
 
II.  BACKGROUND 
 
On November 27, 2013, the Drug Supply Chain Security Act (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 (manufacturers, wholesale distributors, dispensers and 
repackagers) were 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 were 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.  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 dispensers engaged in transactions3 involving products as defined 
under section 581(13) of the FD&C Act. 
 
 
IV.  PRODUCT TRACING REQUIREMENTS FOR DISPENSERS  COMPLIANCE 
POLICY 
 
The product tracing requirements in sections 582(d)(1) of the FD&C Act took effect for 
dispensers on July 1, 2015, and FDA published a guidance document on July 6, 2015, stating that 
it does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept 
ownership of product without receiving the product tracing information, as required by section 
                                                           
3 Transaction is defined in section 581(24) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing 
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.  However, some 
dispensers  primarily smaller, independent pharmacies and health systems  have expressed 
concern that they will be unable to comply with these requirements by November 1, 2015.  Thus, 
FDA recognizes that these dispensers continue to need additional time to work with trading 
partners to ensure that the product tracing information required by section 582 is captured and 
maintained by dispensers.   
 
FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept 
ownership of product without receiving the product tracing information, as required by section 
582(d)(1)(A)(i) of the FD&C Act.  This compliance policy does not extend to the requirements 
under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale 
distributors, and repackagers) provide product tracing information to dispensers.  In addition, this 
compliance policy does not extend to transactions in which dispensers must provide the 
subsequent owner with product tracing information, including transaction history, as required by 
section 582(d)(1)(A)(ii).  If a dispenser has not received product tracing information prior to or at 
the time it takes ownership of a product, FDA recommends that the dispenser work with the 
previous owner to receive this information.  FDA believes that product tracing information 
serves as an important tool for dispensers to meet their obligation under section 582(d)(4) to 
identify suspect product, quarantine the product, and investigate whether that product is 
illegitimate.4 
 
Prior to March 1, 2016, FDA also does not intend to take action against dispensers who do not 
capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of 
the FD&C Act.   
 
This compliance policy does not extend to other requirements of the FD&C Act, including those 
in section 582, 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.   
                                                           
4 See the draft guidance for industry Drug Supply Chain Security Act Implementation:   Identification of Suspect 
Product and Notification.  This draft guidance, when finalized, will represent FDAs current thinking on this topic. 
 
  3