Wholesale Distributor Verification 
Requirement for Saleable Returned Drug 
Product and Dispenser Verification 
Requirements When Investigating a 
Suspect or Illegitimate Product
Compliance Policies 
Guidance for Industry 
 
 
 
 
 
 
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.  You should identify all comments 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 at 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) 
 
August 2023 
Administrative/Procedural 
Revision 1
   
Wholesale Distributor Verification 
Requirement for Saleable Returned Drug 
Product and Dispenser Verification 
Requirements When Investigating a 
Suspect or Illegitimate Product
Compliance Policies 
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/guidance-compliance-regulatory-information/guidances-drugs 
 
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/biologics-guidances 
 
 
 
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) 
 
August 2023 
Administrative/Procedural 
Revision 1 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 3 
III.  COMPLIANCE POLICY FOR WHOLESALE DISTRIBUTOR VERIFICATION 
OF SALEABLE RETURNED PRODUCT .................................................................... 4 
IV.  COMPLIANCE POLICY FOR DISPENSER VERIFICATION REQUIREMENTS 
REGARDING SUSPECT OR ILLEGITIMATE PRODUCT ..................................... 6 
  Contains Nonbinding Recommendations 
Wholesale Distributor Verification Requirement  
for Saleable Returned Drug Product and Dispenser Verification 
Requirements When Investigating a Suspect  
or Illegitimate ProductCompliance Policies 
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  
 
On October 23, 2020, FDA published the Wholesale Distributor Verification Requirement for 
Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a 
Suspect or Illegitimate ProductCompliance Policies guidance (the 2020 Compliance Policies). 
This guidance revises and extends the 2020 Compliance Policies for an additional year, from 
November 27, 2023, to November 27, 2024. 
 
Previously, on September 24, 2019, FDA published the Wholesale Distributor Verification 
Requirement for Saleable Returned Drug ProductCompliance Policy guidance (the 2019 
Compliance Policy), where FDA announced a 1-year delay in enforcement of the requirement for 
wholesale distributors2 to verify3 saleable returned product4 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)) 5.  The 2019 Compliance Policy explained that the Agency intended to delay 
enforcement of this requirement until November 27, 2020.  Subsequently, the 2020 Compliance 
Policies announced FDAs extension of the enforcement policy embodied in the 2019 
 
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 Wholesale distributor is defined in section 581(29) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 360eee(29)). 
3 Verification or verify is defined in section 581(28) of the FD&C Act. 
4 Product is defined in section 581(13) of the FD&C Act.  Return is defined in section 581(17) of the FD&C Act. 
5 Under section 582(c)(4)(D) of the FD&C Act, upon receipt of a returned product that the wholesale distributor 
intends to further distribute, before further distributing such product, the wholesale distributor shall verify the 
product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such 
product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the 
standardized numerical identifier, on each package. 
1  Contains Nonbinding Recommendations 
 
Compliance Policy with respect to this requirement for an additional three years, until November 
27, 2023.   
 
This guidance, like the 2019 and 2020 Compliance Policies, addresses the readiness of wholesale 
distributors to comply with the requirement under section 582(c)(4)(D) of the FD&C Act to 
verify the product identifier6 upon receipt of a returned product that the wholesale distributor 
intends to further distribute. The requirement under section 582(c)(4)(D) of the FD&C Act for 
wholesale distributors to verify saleable returned products prior to redistribution went into effect 
on November 27, 2019.7  For reasons discussed below, FDA does not intend to take action 
against wholesale distributors who do not, prior to November 27, 2024, verify the product 
identifier prior to further distributing saleable returned product as required under section 
582(c)(4)(D) of the FD&C Act.  This represents a 1-year extension of the 2020 Compliance 
Policies, from November 27, 2023, until November 27, 2024, with respect to enforcement of this 
requirement for wholesale distributors. 
 
The 2020 Compliance Polices also set forth the Agencys enforcement policy with respect to 
section 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the FD&C Act (21 U.S.C. 360eee-
1(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)), which generally provide that, beginning November 27, 
2020, a dispenser8 must verify the product identifier of suspect or illegitimate product9 in the 
dispensers possession or control.   
 
The 2020 Compliance Policies announced that FDA did not intend to take action before 
November 27, 2023, against dispensers who do not verify the product identifiers of suspect 
product as required by section 582(d)(4)(A)(ii)(II) of the FD&C Act.  In addition, the 2020 
Compliance Policies stated that FDA did not intend to take action before November 27, 2023, 
against dispensers who do not verify the product identifiers of illegitimate product that are the 
subject of a notification from FDA or a trading partner10 as required by section 582(d)(4)(B)(iii) 
of the FD&C Act.  This represented a 3-year enforcement policy with respect to the requirements 
for dispensers to verify the product identifier when investigating suspect or illegitimate product. 
 
For the reasons discussed below, FDA does not intend to take action before November 27, 2024, 
against dispensers who do not verify the product identifiers of suspect product as required by 
section 582(d)(4)(A)(ii)(II) of the FD&C Act.  In addition, FDA does not intend to take action 
before November 27, 2024, against dispensers who do not verify the product identifiers of 
illegitimate product that are the subject of a notification from FDA or a trading partner as 
required by section 582(d)(4)(B)(iii) of the FD&C Act.  This represents a 1-year extension of the 
2020 Compliance Policies, from November 27, 2023, until November 27, 2024, with respect to 
enforcement of these requirements for dispensers to verify the product identifier when 
investigating suspect or illegitimate product. 
 
6 Product Identifier is defined in section 581(14) of the FD&C Act. 
7 See section 582(c)(4)(D) of the FD&C Act. 
8 Dispenser is defined in section 581(3) of the FD&C Act. 
9 Suspect product is defined in section 581(21) and illegitimate product is defined in section 581(8) of the FD&C 
Act. 
10 Trading partner is defined as described in section 581(23)(A) of the FD&C Act.  Although third-party logistics 
providers are also considered trading partners under section 581(23)(B) of the FD&C Act, they are not subject to the 
same product tracing requirements of section 582 of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
 
 
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.  
 
 
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 of the FD&C Act 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. 
 
One 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,11 for each sealed homogeneous case12 of saleable returned 
product, or, if such product is not in a sealed homogeneous case, on each package13 of saleable 
returned product.  A saleable returned product may not be further distributed until the product 
identifier is verified.14  The product should be handled as suspect product if the product identifier 
is not successfully verified (i.e., it should be quarantined and investigated).15, 16  FDA published 
the 2019 Compliance Policy on September 24, 2019, announcing a 1-year delay in enforcement 
against wholesale distributors who do not verify the product identifier of saleable returned 
product prior to further distributing such product as required by section 582(c)(4)(D) of the 
FD&C Act.  FDA subsequently published the 2020 Compliance Policies announcing a 3-year 
extension of the enforcement policy described in the 2019 Compliance Policy with respect to this 
requirement. 
 
In addition, 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 
 
11 Standardized numerical identifier is defined in section 581(20) of the FD&C Act.  
12 Homogeneous case is defined in section 581(7) of the FD&C Act. 
13 Package is defined in section 581(11) of the FD&C Act. 
14 See section 582(c)(4)(D) of the FD&C Act. 
15 See the draft guidance for industry Verification Systems Under the Drug Supply Chain Security Act for Certain 
Prescription Drugs (March 2022).  When final, this guidance will represent the FDAs current thinking on this 
topic.  For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.  
16 Section 582(c)(4)(A)(i) of the FD&C Act details how wholesale distributors must handle suspect product. 
  3  Contains Nonbinding Recommendations 
 
prescription drugs.17,18  A transaction statement must 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 of the FD&C Act.19  In the 2019 Compliance Policy, 
FDA acknowledged 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, the 
2019 Compliance Policy indicated FDAs intent to take no enforcement action prior to 
November 27, 2020, against a wholesale distributor that provided a transaction statement to a 
subsequent purchaser of product on the basis that such wholesale distributor did not yet have 
systems and processes in place to comply with the saleable return verification requirements 
under section 582(c)(4)(D) of the FD&C Act.  The 2020 Compliance Policies extended this 
enforcement policy for an additional 3 years, until November 27, 2023. 
 
Section 582 also includes requirements for dispensers to verify product identifiers when 
investigating suspect or illegitimate product.  Specifically, section 582(d)(4)(A)(ii)(II) of the 
FD&C Act provides that, effective November 27, 2020, dispensers must verify the product 
identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of 
such suspect product, whichever is greater, or all packages, if there are fewer than 3, corresponds 
with the product identifier for such product [in the dispensers possession or control].20  Section 
582(d)(4)(B)(iii) of the FD&C Act requires dispensers to verify product as described in 
582(d)(4)(A)(ii) of the FD&C Act when they have received a notification from FDA or a trading 
partner that the product is an illegitimate product. The 2020 Compliance Policies also provided a 
3-year enforcement discretion policy with respect to these dispenser requirements, until 
November 27, 2023. 
 
 
III.  COMPLIANCE POLICY FOR WHOLESALE DISTRIBUTOR VERIFICATION 
OF SALEABLE RETURNED PRODUCT 
 
After publishing the 2020 Compliance Policies, FDA has continued to receive comments and 
feedback from wholesale distributors, as well as other trading partners and stakeholders, 
expressing additional concern with industry-wide readiness for implementation of the 
verification of saleable returned product requirement for wholesale distributors.  Stakeholders 
have explained that the primary factors FDA considered when issuing the 2019 Compliance 
Policy still exist: (1) the very large volume of saleable returned products requiring verification; 
(2) the need to refine and test verification systems during actual production using real-time 
 
17 Transaction, transaction history, transaction information, and transaction statement are defined under sections 
581(24), (25), (26), and (27) of the FD&C Act.  
18 See section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act. Beginning November 27, 2023, section 
582(k)(1) of the FD&C Act effectively ends the requirements for trading partners to provide and receive transaction 
history.  However, under section 582(g)(1)(E) of the FD&C Act, trading partners must by that date have systems and 
processes necessary to promptly facilitate the gathering of information necessary to produce the transaction 
information for each transaction going back to the manufacturer, as applicable, in the event of a recall or for certain 
investigations. 
19 See section 581(27)(E) of the FD&C Act.  
20 See section 582(d)(4)(A)(ii) of the FD&C Act. 
  4  Contains Nonbinding Recommendations 
 
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.21   
 
Given the continuing concerns expressed, FDA recognizes that some wholesale distributors may 
still need additional time beyond November 27, 2023, when the enforcement policy set forth in 
the 2020 Compliance Policies expires, before they can begin verifying returned products prior to 
resale or other further distribution as required by 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 
certain prescription drugs in the United States, FDA does not intend to take action before 
November 27, 2024, 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, FDA recognizes that some wholesale distributors may still not have systems in 
place by November 27, 2023, 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, 2024, 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) of the 
FD&C Act.22 
 
This compliance policy aligns with FDAs intention to generally not enforce the DSCSAs 
enhanced drug distribution security requirements, i.e., for interoperable, electronic, package-
level product tracing, including specified systems and processes,23 before November 27, 2024.24 
Enhanced drug distribution security includes, among other things, incorporation of the product 
identifier into product tracing and utilization of the product identifier to verify a product at the 
package level.25 FDA believes that the extension of the enforcement policy embodied in the 2020 
Compliance Policies for another year, until November 27, 2024, will allow wholesale 
distributors to focus resources and efforts on implementing the enhanced drug distribution 
security requirements. We envision that, along with other enhanced drug distribution security 
requirements, wholesale distributors can increase their efficiency by incorporating the saleable 
return verification requirements into the enhanced verification required by enhanced drug 
distribution security instead of developing separate processes or infrastructures.  Extending the 
2020 Compliance Policies in this respect also accommodates the additional time that may be 
 
21 Public Meeting (Virtual): The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts 
for 2023. December 7-8, 2022.  
22 See section 581(27)(E) of the FD&C Act which defines transaction statement to include systems and processes 
to comply with the verification requirements of section 582, including the saleable returns requirements of section 
582(c)(4)(D). 
23 See section 582(g) of the FD&C Act, as added by the DSCSA. 
24 See Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and 
Cosmetic Act  Compliance Policies (88 FR 58498).  
25 See section 582(g)(1)(B) and (C) of the FD&C Act. 
  5  Contains Nonbinding Recommendations 
 
needed for wholesale distributors to test their ability to verify saleable returns using real-time 
volume, involving all trading partners. 
 
The compliance policy described in this section 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.26  This compliance policy does not 
affect the requirement that 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).27  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 an authorized wholesale distributor.  FDA previously issued a draft 
guidance for industry Verification Systems Under the Drug Supply Chain Security Act for 
Certain Prescription Drugs (March 2022) (Verification Systems Guidance) to describe FDAs 
interpretation of the requirements of section 582 of the FD&C Act regarding verification 
systems.28  Wholesale distributors should refer to the Verification Systems Guidance for a 
detailed description of responsibilities that are applicable to them. 
 
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 
Policy for Packages and Homogenous Cases of Product Without a Product Identifier (September 
2018), addresses such returns.29 
 
 
IV.  COMPLIANCE POLICY FOR DISPENSER VERIFICATION REQUIREMENTS 
REGARDING SUSPECT OR ILLEGITIMATE PRODUCT 
 
In the years since publication of the 2020 Compliance Policies, FDA has continued to receive 
comments and feedback from dispensers expressing concern with readiness for implementation 
of certain requirements under section 582(d) of the FD&C Act, including the verification 
requirements addressed in this compliance policy.30  Specifically, dispensers have described 
challenges with implementation of these verification requirements due to the time necessary to 
develop technologies and processes that would support a robust verification system.  
 
Given the concerns expressed, FDA recognizes that some dispensers may need additional time 
beyond November 27, 2023, before they can begin to verify the product identifier of the 
 
26 See section 582(c)(4)(A) of the FD&C Act. 
27 See section 582(c)(2) of the FD&C Act. 
28 When final, this guidance will represent the FDAs current thinking on this topic.   
29 We update guidances periodically.  To make sure you have the most recent version of a guidance, check the FDA 
guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.   
30 Public Meeting (Virtual): The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts 
for 2023. December 7-8, 2022.  
  6  Contains Nonbinding Recommendations 
 
statutorily designated proportion of suspect and illegitimate products as described in sections 
582(d)(4)(A)(ii)(II) and (B)(iii) of the FD&C Act.  To minimize possible disruptions in the 
distribution of certain prescription drugs in the United States, FDA does not intend to take action 
before November 27, 2024, against dispensers who do not verify the product identifier of the 
statutorily designated proportion of suspect product as required by section 582(d)(4)(A)(ii)(II) of 
the FD&C Act.  In addition, FDA does not intend to take enforcement action before November 
27, 2024, against dispensers who do not verify, as required by section 582(d)(4)(B)(iii) of the 
FD&C Act, the product identifier of the statutorily designated proportion of product that is the 
subject of an illegitimate product notification by FDA or a trading partner.  
 
Dispensers should refer to the Verification Systems Guidance for a detailed description of 
responsibilities that are applicable to them, as the compliance policy described in this section 
applies only to the dispenser requirements regarding verification of product identifiers described 
in sections 582(d)(4)(A)(ii)(II) and (B)(iii) of the FD&C Act and does not apply to any other 
provision in section 582 of the FD&C Act.  This compliance policy does not address any of the 
other verification requirements set forth in section 582(d)(4) of the FD&C Act.  For example, 
this compliance policy does not affect the requirement that as of November 27, 2020, a dispenser 
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),31 and this 
compliance policy does not affect the other activities required by section 582(d)(4)(A) and 
section 582(d)(4)(B) by incorporation (e.g., dispensers must still quarantine product, conduct 
investigations, and disposition illegitimate product).  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 an authorized dispenser.   
 
The duration of this compliance policy aligns with that of FDAs enforcement policy with 
respect to the enhanced drug distribution security requirements, as discussed above in section III 
of this guidance and addressed in the guidance for industry Enhanced Drug Distribution Security 
Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act  
Compliance Policies (August 2023).  As more specifically detailed in section 582(g)(1), 
enhanced drug distribution security includes as part of the transaction information the product 
identifier for each package in the transaction.32  Enhanced drug distribution security also 
includes verification of product at the package level.33  Generally speaking, enhanced drug 
distribution security also incorporates the ability to promptly generate and provide specific 
product and transaction documentation upon request by FDA, another Federal or State official, 
or an authorized trading partner for purposes of investigating suspect or illegitimate product.34  
FDA believes that aligning the duration of the compliance policy under this revised guidance 
with the compliance policy applicable to enhanced drug distribution security under section 
582(g)(1) will facilitate the ability of dispensers  to ensure the systems and processes that are put 
into place to meet the enhanced drug distribution security requirements will also fulfill the 
dispenser verification requirements under section 582(d)(4) of the FD&C Act. 
 
 
31 See section 582(d)(2) of the FD&C Act. 
32 See section 582(g)(1)(B) of the FD&C Act.  
33 See section 582(g)(1)(C) of the FD&C Act. 
34 See section 582(g)(1)(D) of the FD&C Act. 
  7