Wholesale Distributor 
Verification Requirement for 
Saleable Returned Drug 
ProductCompliance 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 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number listed in the notice of 
availability that publishes in the Federal Register. 
 
For questions regarding this document, contact (CDER) Office of Compliance, 301-796-3130, or 
(CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010.  
 
 
 
 
 
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 2019 
Procedural 
    
Wholesale Distributor 
Verification Requirement for 
Saleable Returned Drug 
ProductCompliance 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics 
 
    
 
 
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 2019 
Procedural 
  Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.   COMPLIANCE POLICY FOR VERIFICATION OF SALEABLE RETURNED 
PRODUCT ......................................................................................................................... 2 
  Contains Nonbinding Recommendations 
 
Wholesale Distributor Verification Requirement for Saleable 
Returned Drug ProductCompliance 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 office responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
This guidance is intended for wholesale distributors who must verify the product identifier upon 
receipt of a returned product2 that the wholesale distributor intends to further distribute as 
required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360eee-1(c)(4)(D)).  This guidance addresses the readiness of wholesale distributors 
to comply with the provisions in section 582 of the FD&C Act related to the verification of 
saleable returned drug products.  The requirement under section 582(c)(4)(D) for wholesale 
distributors to verify saleable returned drug products prior to redistribution goes into effect on 
November 27, 2019.3 
 
This guidance announces the Food and Drug Administrations (FDA or the Agency) compliance 
policy regarding enforcement of the verification of saleable returned product requirement under 
section 582(c)(4)(D) of the FD&C Act.  FDA does not intend to take action against wholesale 
distributors who do not, prior to November 27, 2020, verify a product identifier prior to further 
distributing returned product as required under section 582(c)(4)(D) of the FD&C Act.  This 
represents a one-year delay in enforcement of the requirement for wholesale distributors to verify 
a product identifier prior to further distributing that returned product. 
 
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 
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 Regulatory Policy in the Center for Drug Evaluation and Research 
(CDER) in cooperation with the Office of Compliance in CDER, the Center for Biologics Evaluation and Research 
(CBER) and the Office of Regulatory Affairs (ORA) at the Food and Drug Administration.  
2 Product is defined in section 581(13) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360eee(13)). Return is defined in section 581(17) of the FD&C Act. 
3 See section 582(c)(4)(D) of the FD&C Act. 
  1  Contains Nonbinding Recommendations 
 
 
 
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 verification scheme outlined in the DSCSA is the verification of 
saleable returned product.  Under section 582(c)(4)(D) of the FD&C Act, wholesale distributors 
must have systems in place that will enable them to verify the product identifier, including the 
standardized numerical identifier, on each sealed homogeneous case of saleable returned 
product, or, if such product is not in a sealed homogeneous case, on each package of saleable 
returned product.  A saleable returned product may not be further distributed until the product 
identifier is verified.4  The product should be handled as suspect product if the product identifier 
is not successfully verified (i.e., it should be quarantined and investigated).5 
 
 
III.   COMPLIANCE POLICY FOR VERIFICATION OF SALEABLE RETURNED 
PRODUCT 
 
In the years since passage of the DSCSA, including most recently within the past year, FDA has 
received comments and feedback from wholesale distributors as well as other trading partners 
and stakeholders expressing concern with industry-wide readiness for implementation of the 
verification of saleable returned product requirement for wholesale distributors.  Specifically, 
stakeholders have described challenges with implementation of verification of the product 
identifier on saleable returned drug product packages or sealed homogenous cases due to a 
number of factors, including: (1) the very large volume of saleable returned product requiring 
verification; (2) the need to refine and test verification systems during actual production using 
real-time volumes of saleable returned product rather than simply in pilots; and (3) the 
complexities of building an interoperable, electronic system with the capabilities to timely and 
efficiently verify the large volume of saleable returned products amid immature technologies.  
Through FDAs DSCSA pilot project program, FDA is aware that several pilot participants are 
in the early stages of developing and testing interoperable, electronic systems to enable 
verification and achieve interoperability between networks.  
 
Given the concerns expressed, FDA recognizes that some wholesale distributors (in collaboration 
with other trading partners) may need additional time beyond November 27, 2019, before they 
can begin verifying returned products prior to resale or other further distribution as required by 
                                                 
4 See section 582(c)(4)(D) of the FD&C Act. 
5 Section 582(c)(4)(A)(i) of the FD&C Act details how wholesale distributors must handle suspect product. 
  2  Contains Nonbinding Recommendations 
 
section 582(c)(4)(D) of the FD&C Act in an efficient, secure, and timely manner.  To minimize 
possible disruptions in the distribution of prescription drugs in the United States, FDA does not 
intend to take action before November 27, 2020, against wholesale distributors who do not verify 
a product identifier prior to resale or other further distribution of a package or sealed 
homogenous case of product as required by section 582(c)(4)(D) of the FD&C Act. 
 
Additionally, section 582 of the FD&C Act requires certain trading partners (manufacturers, 
repackagers, wholesale distributors, and dispensers) to exchange transaction information, 
transaction history, and a transaction statement when engaging in transactions involving certain 
prescription drugs.6,7  Section 581(27)(E) of the FD&C Act requires that the transaction 
statement include a statement that the entity transferring ownership in a transaction had systems 
and processes in place to comply with verification requirements under section 582.  FDA 
recognizes that wholesale distributors may not have systems in place by November 27, 2019, to 
enable the wholesale distributor to timely and efficiently comply with the verification of saleable 
returned product requirements under section 582(c)(4)(D) of the FD&C Act without potentially 
causing a disruption to the pharmaceutical distribution supply chain.  Therefore, prior to 
November 27, 2020, FDA does not intend to take action against a wholesale distributor for 
providing a transaction statement to a subsequent purchaser of product on the basis that such 
wholesale distributor does not yet have systems and processes in place to comply with the 
saleable return verification requirements under section 582(c)(4)(D). 
 
This compliance policy is limited to the requirements that wholesale distributors verify saleable 
returned products prior to further distribution and have verification systems in place to comply 
with the requirements of section 582(c)(4)(D) of the FD&C Act; it does not extend to the other 
requirements in section 582 of the FD&C Act.  For example, it does not affect the requirement 
that a wholesale distributor must have verification systems in place to determine whether a 
returned product is a suspect product.8  This compliance policy does not affect the requirement 
that beginning November 27, 2019, a wholesale distributor may engage in transactions involving 
a product only if such product is encoded with a product identifier (except as provided pursuant 
to section 582(a)(5) of the FD&C Act).9  This compliance policy does not relieve a manufacturer 
of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a 
request for verification from a wholesale distributor.  Further, beginning November 27, 2019, 
wholesale distributors must only accept returned product from a dispenser or repackager if the 
wholesale distributor can associate returned product with the transaction information and 
transaction statement associated with that product.10   
 
This compliance policy is not applicable with respect to returns of saleable packages and sealed 
homogeneous cases of product without product identifiers that were in the pharmaceutical 
distribution supply chain before November 27, 2018.  The guidance for industry Grandfathering 
                                                 
6 Transaction, transaction history, transaction information, and transaction statement are defined under sections 
581(24), (25), (26), and (27) of the FD&C Act.  
7 See section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act. 
8 See section 582(c)(4)(A) of the FD&C Act. 
9 See section 582(c)(2) of the FD&C Act. 
10 See section 582(c)(1)(B)(i)(II) of the FD&C Act. 
  3  Contains Nonbinding Recommendations 
 
Policy for Packages and Homogenous Cases of Product Without a Product Identifier (September 
2018), addresses such returns.11 
                                                 
11 We update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page 
at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.  
  4