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, 
drugtrackandtrace@fda.hhs.gov,  or (CBER) Office of Communication,  Outreach and 
Development at 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) 
 
 
October 2020 
Procedural 
 
 
 
  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) 
 
October 2020 
Procedural 
  Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ....................................................................................................... .2 
III.  COMPLIANCE POLICY FOR WHOLESALE DISTRIBUTOR VERIFICATION 
OF SALEABLE RETURNED PRODUCT ................................................. ............4 
IV.  COMPLIANCE POLICY FOR THE DISPENSER VERIFICATION 
REQUIREMENTS...................................................................................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 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)).  The 2019 
Compliance Policy explained that the Agency intended to delay enforcement of this requirement 
until November 27, 2020.  This guidance announces FDAs extension of such delay in 
enforcement.  It also sets 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 dispenser5 must 
verify the product identifier6  of suspect or illegitimate  product7 in the dispensers possession or 
control.   
 
This guidance addresses the readiness of wholesale distributors  to comply with the requirement 
to verify the product identifier upon receipt of a returned product that the wholesale distributor 
                                              
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 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 Dispenser is defined in section 581(3) of the FD&C Act. 
6 Product Identifier is defined in section 581(14) of the FD&C Act. 
7 Suspect product is defined in section 581(21) and illegitimate product is defined in section 581(8) of the FD&C 
Act. 
 
  1  Contains Nonbinding Recommendations 
 
intends to further distribute under section 582(c)(4)(D) of the FD&C Act.  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, 2019.8  FDA does not 
intend to take action against wholesale distributors  who do not, prior to November 27, 2023, 
verify the product identifier  prior to further distributing  returned product as required under 
section 582(c)(4)(D) of the FD&C Act.  This represents an additional  3-year delay from the 
delay set forth in the 2019 Compliance Policy in enforcement of the requirement for wholesale 
distributors  to verify the product identifier prior to further distributing  that returned product. 
 
This guidance also addresses the dispenser requirement in section 582(d)(4)(A)(ii)(II)  of the 
FD&C Act.  This provision,  which is effective as of November 27, 2020, requires a dispenser to 
verify whether the product identifier  of a suspect product, including  the standardized numerical 
identifier,9  of at least 3 packages10 or 10 percent of such suspect product, whichever is greater, or 
all packages, if there are fewer than 3, corresponds with the product identifier  assigned to such 
product by the manufacturer or repackager.11  Furthermore, this guidance addresses section 
582(d)(4)(B)(iii)  of the FD&C Act, which requires dispensers to verify product as described in 
section 582(d)(4)(A)(ii)  of the FD&C Act in response to a notification  of illegitimate  product 
from FDA or a trading partner.12  FDA does 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,  FDA does 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 partner as 
required by section 582(d)(4)(B)(iii)  of the FD&C Act.  This represents a 3-year delay in 
enforcement of the requirements for dispensers to verify the product identifier  when 
investigating  suspect or illegitimate  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.  
 
 
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 
                                              
8 See section 582(c)(4)(D) of the FD&C Act. 
9 Standardized numerical identifier is defined in section 581(20) of the FD&C Act.  
10 Package is defined in section 581(11) of the FD&C Act. 
11 See section 582(d)(4)(A) of the FD&C Act. 
12 For this guidance, 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 
 
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,  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.13  The product should be handled as suspect product if the product identifier 
is not successfully verified (i.e., it should be quarantined and investigated).14, 15  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. 
 
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 
prescription drugs.16,17  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.18  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. 
 
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 
                                              
13 See section 582(c)(4)(D) of the FD&C Act. 
14 See Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (October 
2018).  We update guidances periodically.  For the most recent version of the guidance, check the FDA guidance 
web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
15 Section 582(c)(4)(A)(i) of the FD&C Act details how wholesale distributors must handle suspect product. 
16 Transaction, transaction history, transaction information, and transaction statement are defined under sections 
581(24), (25), (26), and (27) of the FD&C Act.  
17 See section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act. 
18 See section 581(27)(E) of the FD&C Act.  
 
  3  Contains Nonbinding Recommendations 
 
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].19  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  of illegitimate  product 
from FDA or a trading partner.  
 
 
III.  COMPLIANCE POLICY FOR WHOLESALE DISTRIBUTOR VERIFICATION 
OF SALEABLE RETURNED PRODUCT 
 
After publishing  the 2019 Compliance  Policy, FDA has received 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 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.   
 
Given the concerns expressed, FDA recognizes that some wholesale distributors  may still need 
additional  time beyond November 27, 2020, when the delay in enforcement set forth in the 2019 
Compliance Policy 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, 
2023, 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 wholesale distributors  may still not have systems in place by 
November 27, 2020, 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, 2023, 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.20 
 
                                              
19 See section 582(d)(4)(A)(ii) of the FD&C Act. 
20 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). 
 
  4  Contains Nonbinding Recommendations 
 
This compliance policy  aligns with the statutory requirements that effective November 27, 2023, 
an enhanced system21 be used by manufacturers, repackagers, wholesale distributors,  and 
dispensers that allows for secure, interoperable,  electronic tracing of products at the package 
level.22  The enhanced system must allow for, 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.23  FDA believes that the extension of the delay in enforcement until November 
27, 2023, will allow wholesale distributors  to focus resources and efforts on implementing  the 
enhanced system.  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 2023 instead of 
developing  separate processes or infrastructures.  Extending the delay in enforcement also 
provides more time 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.24  This compliance policy does not 
affect the requirement that as of 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).25  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.  
Further, as of 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.26  FDA 
previously  issued the draft guidance, Verification Systems Under the Drug Supply Chain Security 
Act for Certain Prescription Drugs (October 2018) (Verification  Systems Draft Guidance) to 
describe FDAs interpretation  of the requirements of section 582 of the FD&C Act regarding 
verification  systems.27  Wholesale distributors  should refer to the Verification Systems Draft 
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 
                                              
21 For the purpose of this guidance, enhanced system refers to the interoperable, electronic, package-level product 
tracing systems and processes required by section 582(g) of the FD&C Act. 
22 See section 582(g)(1)(A) of the FD&C Act. 
23 See section 582(g)(1)(B) and (C) of the FD&C Act. 
24 See section 582(c)(4)(A) of the FD&C Act. 
25 See section 582(c)(2) of the FD&C Act. 
26 See section 582(c)(1)(B)(i)(II) of the FD&C Act. 
27 When final, this guidance will represent the FDAs current thinking on this topic. 
 
  5  Contains Nonbinding Recommendations 
 
Policy for Packages and Homogenous Cases of Product Without a Product Identifier (September 
2018), addresses such returns.28 
 
 
IV.  COMPLIANCE POLICY FOR THE DISPENSER VERIFICATION 
REQUIREMENTS 
 
In the years since the passage of the DSCSA, FDA has received 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.  Specifically,  dispensers have described challenges with implementation  of 
these provisions  in the DSCSA 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, 2020, before they can begin to verify the statutorily-designated  portion of 
product identifiers 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, 2023, against dispensers who do not verify the statutorily-designated 
portion of 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 enforcement action before November 27, 
2023, against dispensers who do not verify, as required by section 582(d)(4)(B)(iii)  of the FD&C 
Act, the statutorily-designated  portion of product identifiers of product that is the subject of an 
illegitimate  product notification  by FDA or a trading partner.  
 
Dispensers should refer to the Verification Systems Draft 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),29 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.   
 
This compliance policy  aligns with the statutory requirements for an enhanced drug distribution 
system discussed above in section III of this guidance.  When effective on November 27, 2023, 
                                              
28 For the most recent version of the guidance, check the FDA guidance web page. 
29 See section 582(d)(2) of the FD&C Act. 
 
  6  Contains Nonbinding Recommendations 
 
the enhanced system must include as part of the transaction information  the product identifier  for 
each package in the transaction.30  The enhanced system must also allow for the verification  of 
product at the package level.31  In addition,  the enhanced system must allow for 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.32  FDA believes that dispensers can use this 3-year 
period to ensure the systems and processes that are put into place to meet the enhanced system 
requirements by November 27, 2023, will also fulfill  all dispenser verification  requirements 
under section 582(d)(4) of the FD&C Act. 
 
                                              
30 See section 582(g)(1)(B) of the FD&C Act.  
31 See section 582(g)(1)(C) of the FD&C Act. 
32 See section 582(g)(1)(D) of the FD&C Act. 
  7