Verification Systems 
Under the Drug Supply 
Chain Security Act for 
Certain Prescription Drugs 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 2023 
Procedural  
 
   
Verification Systems 
Under the Drug Supply 
Chain Security Act for 
Certain Prescription Drugs 
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) 
 
December 2023 
Procedural  
 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 3 
A.  DSCSA Verification Requirements .............................................................................................. 3 
B.  Scope of This Guidance ................................................................................................................. 5 
III.  VERIFICATION SYSTEMS UNDER SECTION 582 OF THE FD&C ACT ............ 6 
A.  System to Determine That a Product Is Suspect ......................................................................... 6 
B.  Systems for Suspect Product Quarantine and Investigation...................................................... 7 
1. Quarantine ....................................................................................................................................... 7 
2. Components of a Robust Investigation............................................................................................. 8 
C.  Systems for Cleared Product Notification Regarding Suspect Product.................................. 11 
1. Cleared Product Notifications to be Submitted to FDA ................................................................ 11 
2. Components of Cleared Product Notifications .............................................................................. 11 
3. Recordkeeping of Suspect Product Investigations Resulting in Cleared Product ......................... 12 
D.  Systems for Illegitimate Product Quarantine and Disposition ................................................ 13 
1. Quarantine ..................................................................................................................................... 13 
2. Disposition ..................................................................................................................................... 14 
3. Records .......................................................................................................................................... 14 
4. Retention of Samples ...................................................................................................................... 14 
E.  Systems for Illegitimate/High Risk of Illegitimacy Product Notifications .............................. 15 
F.  Systems for Responding to Requests for Verification of the Product Identifier From 
Authorized Trading Partners ..................................................................................................... 15 
G.  Systems for Processing Saleable Returns ................................................................................... 17 
 
  Contains Nonbinding Recommendations 
Verification Systems Under the Drug Supply Chain Security Act for 
Certain Prescription Drugs  
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 
 
Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as 
added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), 
established requirements to facilitate the tracing and verification of certain prescription drug 
products through the U.S. pharmaceutical distribution supply chain. Paragraphs (b)(4), (c)(4), 
(d)(4), and (e)(4) of section 582 of the FD&C Act use the heading verification and describe the 
required systems for various trading partners2 (manufacturers, wholesale distributors, dispensers, 
and repackagers).  Certain requirements in these paragraphs involve activities described in the 
definition of verification under section 581(28) of the FD&C Act.3  However, the paragraphs in 
section 582 impose several requirements that are distinct from the activities described in the 
section 581(28) definition of verification.  Consistent with this, in this guidance we use the term 
verification in referring to both the 581(28) definition as well as the broad set of requirements set 
forth in paragraphs (b)(4), (c)(4), (d)(4), and (e)(4) of section 582 of the FD&C Act, where 
appropriate to the context. 
 
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 in 
cooperation with the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs at the Food 
and Drug Administration. 
2 Trading partner is defined in section 581(23) of the FD&C Act. Although third-party logistics providers (3PLs) 
are also considered trading partners under section 581(23)(B), the verification provisions of section 582(b) through 
(e) do not impose direct requirements on 3PLs. However, 3PLs must have a valid license under State law or section 
584(a)(1), in accordance with section 582(a)(7), and must comply with the licensure reporting requirements under 
section 584(b). 
3 Verification or verify is defined in section 581(28) of the FD&C Act (21 U.S.C. 360eee(28)): The term 
verification or verify means determining whether the product identifier affixed to, or imprinted upon, a package 
or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned 
to the product by the manufacturer or the repackager, as applicable in accordance with section 582. 
1  Contains Nonbinding Recommendations 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
Certain trading partners are required to have verification systems in place to comply with the 
requirements under section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act.  For the 
purposes of this guidance, FDA interprets system or systems to mean a coordinated body of 
processes and procedures that forms a trading partners individual organizational scheme.4  
 
Verification systems requirements include the quarantine and investigation of suspect products and the 
quarantine and disposition5 of illegitimate products.6  In addition, verification systems requirements 
include notification to FDA and certain immediate trading partners of illegitimate product. 7  If a 
suspect product is determined after investigation not to be an illegitimate product, a trading partner is 
required to notify FDA that the product has been cleared, if applicable,8 and the product may then be 
further distributed.9  Trading partners must keep records of the investigation of a suspect product for 
not less than 6 years after the conclusion of the investigation.10  Records of the disposition of an 
illegitimate product must also be kept by a trading partner for not less than 6 years after the conclusion 
of the disposition.11 
 
The DSCSA also requires manufacturers and repackagers to respond to requests for verification of the 
product identifier from other trading partners,12 and requires manufacturers, wholesale distributors, 
and repackagers to verify the product identifier before further distribution of the returned product.13, 14 
 
FDA is issuing this guidance to describe FDAs interpretation of the requirements of section 582 of 
the FD&C Act regarding verification systems.  This guidance provides recommendations for robust 
 
4 While many of the verification systems requirements will necessitate communication with trading partners and 
FDA, the verification systems requirements discussed in this guidance refer to a trading partners individual 
processes and procedures.  Trading partners should consult the guidances for industry Enhanced Drug Distribution 
Security at the Package Level Under the Drug Supply Chain Security Act (August 2023) (Enhanced Drug 
Distribution Security Guidance) and DSCSA Standards for the Interoperable Exchange of Information for Tracing 
of Certain Human, Finished, Prescription Drugs (September 2023) to ensure that individual policies and procedures 
for verification of the product identifier are sufficient to satisfy the 2023 requirements for the interoperable, 
electronic tracing of product at the package level under section 582(g)(1) of the FD&C Act. 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.  
5 Disposition is defined in section 581(4) of the FD&C Act: The term disposition, with respect to a product within 
the possession or control of an entity, means the removal of such product from the pharmaceutical distribution 
supply chain, which may include disposal or return of the product for disposal or other appropriate handling and 
other actions, such as retaining a sample of the product for further additional physical examination or laboratory 
analysis of the product by a manufacturer or regulatory or law enforcement agency. 
6 Suspect product is defined in section 581(21) and illegitimate product is defined in section 581(8) of the FD&C 
Act. 
7 Section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) of the FD&C Act. 
8 See section III.C  Systems for Cleared Product Notifications Regarding Suspect Products. 
9 Section 582(b)(4)(A)(ii), (c)(4)(A)(ii), (d)(4)(A)(iii), and (e)(4)(A)(ii) of the FD&C Act. 
10 Section 582(b)(4)(A)(iii), (c)(4)(A)(iii), (d)(4)(A)(iv), and (e)(4)(A)(iii) of the FD&C Act. 
11 Section 582(b)(4)(B)(v), (c)(4)(B)(v), (d)(4)(B)(v), and (e)(4)(B)(v) of the FD&C Act. 
12 Section 582(b)(4)(C) and (e)(4)(C) of the FD&C Act. 
13 Section 582(b)(4)(E), (c)(4)(D), and (e)(4)(E) of the FD&C Act. 
14 These requirements will be phased in over a period of years as outlined in section 582(b)(4)(C) and (E), (c)(4)(D), 
and (e)(4)(C) and (E) of the FD&C Act. 
2  Contains Nonbinding Recommendations 
verification systems for the determination, quarantine, and investigation of suspect products, as well as 
the quarantine, notification, and disposition of illegitimate products.  The guidance also addresses the 
manner in which FDA recommends that trading partners submit cleared product notifications.  
Finally, this guidance addresses the statutory requirements for verification, including verification of 
saleable returns, at the package level for product identifiers on packages and homogenous cases 
intended to be introduced in a transaction into commerce. 
 
 
II.  BACKGROUND 
 
A.  DSCSA Verification Requirements  
 
On November 27, 2013, the DSCSA was signed into law.  Section 202 of the DSCSA added 
section 582 to the FD&C Act, which set forth verification systems requirements that took effect 
on January 1, 2015, for manufacturers, wholesale distributors, dispensers, and repackagers of 
prescription drug products covered by the DSCSA. 
 
Under section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act, trading partners must have 
systems in place: 
 
  To identify and determine whether a product is a suspect product. 
 
  To quarantine and investigate a product that has been determined to be a suspect product 
and to coordinate with trading partners, as applicable, in making the determination as to 
whether that product is illegitimate. 
 
  To clear a product for distribution, as appropriate, if, after investigation, it is determined 
that the suspect product is not an illegitimate product.  The trading partner is required to 
notify FDA of cleared products, if applicable. 
 
  For products determined to be illegitimate, to complete the following: 
 
 Further quarantine the illegitimate product. 
 
 Disposition of the illegitimate product within the trading partners possession or 
control. 
 
 Take reasonable and appropriate steps to assist another trading partner to 
disposition the illegitimate product. 
 
 Retain a sample of the illegitimate product if asked to do so by the manufacturer, 
FDA, or other Federal or State official.  These should be retained in an amount 
sufficient for further physical examination and laboratory analysis by the 
manufacturer and/or FDA or other appropriate Federal or State official. 
 
3  Contains Nonbinding Recommendations 
 Provide notification of the illegitimate product to FDA and other trading partners, 
and upon making a determination, in consultation with FDA, that a notification is 
no longer necessary, terminate that notification.  In addition, a manufacturer must 
have systems in place for notifying its immediate trading partners and FDA of a 
product that has a high risk of illegitimacy, as required under section 
582(b)(4)(B)(ii)(II) of the FD&C Act. 
 
  That include procedures for taking appropriate action when the trading partner has 
received an illegitimate product notification or a manufacturers notification of a high 
risk of illegitimacy. 
 
  To create and maintain records related to suspect product investigations and the 
disposition of illegitimate products for a minimum of 6 years as required by section 582 
of the FD&C Act. 
 
In addition, manufacturers, wholesale distributors, and repackagers have additional requirements 
outlined in section 582(b)(4)(C) and (E), (c)(4)(D), and (e)(4)(C) and (E) of the FD&C Act: 
 
  Manufacturers must have systems in place that will allow them to respond to requests 
from trading partners to confirm that a particular product identifier affixed to, or 
imprinted upon, a package or homogeneous case of product that is the subject of the 
request corresponds to the standardized numerical identifier (SNI)15 or lot number and 
expiration date assigned to the product by the manufacturer. 
 
  Repackagers must have systems in place that will allow them to respond to requests from 
trading partners to confirm that a particular product identifier affixed to, or imprinted 
upon, a package or homogeneous case of product that is the subject of the request 
corresponds to the standardized numerical identifier or lot number and expiration date 
assigned to the product by the repackager. 
 
  Manufacturers, wholesale distributors, and repackagers must have systems in place that 
will allow them, upon receipt of a saleable returned product, to verify the product 
identifier, including the SNI, for each sealed homogenous case or package before further 
distribution of such product. 
 
With this guidance, FDA is highlighting that paragraphs (b)(4), (c)(4), (d)(4), and (e)(4) of 
section 582 of the FD&C Actwhich describe the required systems for various trading 
partnersuse the heading verification. Certain requirements in these paragraphs involve 
activities described in the definition of verification under section 581(28), which is defined to 
mean the determination of whether the product identifier affixed to or imprinted upon a package 
or homogenous case corresponds to the SNI or lot number and expiration date assigned to the 
 
15 Standardized numerical identifier or SNI is defined in section 581(20) of the FD&C Act to mean a set of numbers 
or characters used to uniquely identify each package or homogenous case that is composed of the National Drug 
Code that corresponds to the specific product (including the particular package configuration) combined with a 
unique alphanumeric serial number of up to 20 characters. 
4  Contains Nonbinding Recommendations 
product by the manufacturer or repackager.16 However, the paragraphs in section 582 impose 
several requirements that are distinct from the activities described in the section 581(28) 
definition of verification. For example, subparagraphs (b)(4)(A)(i)(I), (c)(4)(A)(i)(I), 
(d)(4)(A)(i)(I), and (e)(4)(A)(i)(I) of section 582 of the FD&C Act require that trading partners 
quarantine product that has been determined to be suspect.  As explained above in the 
Introduction, we use the term verification in referring to the broad set of requirements set forth in 
paragraphs (b)(4), (c)(4), (d)(4), and (e)(4) of section 582 of the FD&C Act in addition to using 
the term with the meaning defined in section 581(28) of the FD&C Act, where appropriate to the 
context. In general, the focus of this guidance is on the former (i.e., the broad set of 
requirements). 
 
B.  Scope of This Guidance  
 
This guidance applies to the verification systems that manufacturers, wholesale distributors, 
dispensers, and repackagers must have in place, as described in section 582(b)(4), (c)(4), (d)(4), 
and (e)(4) of the FD&C Act.  
 
This guidance is intended to provide assistance to industry in understanding the verification 
systems requirements under section 582 of the FD&C Act and to provide guidance on what 
should be included in these systems.  This guidance serves to inform trading partners of the 
information that should be reviewed and communicated with other trading partners when 
investigating whether a suspect product is illegitimate.  This guidance also serves to inform 
trading partners of the information that should be included in responding to requests for 
verification of the product identifier from FDA and other trading partners, where applicable, and 
in verifying the product identifier of saleable returned product.  This guidance does not address 
all of the provisions in section 582 of the FD&C Act related to verification.  For example, the 
Agency previously issued a guidance on the identification of suspect products and notification of 
illegitimate products that includes processes by which notifications to FDA and other trading 
partners of illegitimate product are made, as well as the termination of those notifications, as 
described in section 582(h)(2)(A)(iii) of the FD&C Act.17  
 
When designing and implementing the verification systems required under the DSCSA, trading 
partners are cautioned that although section 582 of the FD&C Act may not require that a product 
be withheld or removed from the U.S. pharmaceutical distribution supply chain because it does 
not fit within the definition of suspect product or illegitimate product, trading partners have other 
obligations under the FD&C Act and the Public Health Service Act regarding the introduction of 
products into interstate commerce.  Violation of those requirements may result in enforcement 
actions, regardless of a trading partners compliance with section 582 of the FD&C Act.  For 
example, an adulterated product may not be a suspect product because it is not within the 
definition in section 581(21) of the FD&C Act, but it is a prohibited act to introduce or deliver 
for introduction into interstate commerce an adulterated drug under section 301(a) of the FD&C 
Act (21 U.S.C 331(a)). 
 
16 Section 582(b)(4)(A)(i)(II), (C), and (E); (c)(4)(A)(i)(II) and (D); (d)(4)(A)(ii); and (e)(4)(A)(i)(II), (C), and (E) of 
the FD&C Act obligates trading partners to verify products at the package level, including the SNI. 
17 See the guidance for industry Drug Supply Chain Security Act Implementation: Identification of Suspect Product 
and Notification (June 2021) (hereafter referred to as the Suspect Product and Notification Guidance). 
5  Contains Nonbinding Recommendations 
 
 
III.  VERIFICATION SYSTEMS UNDER SECTION 582 OF THE FD&C ACT 
 
Section 582 of the FD&C Act requires manufacturers, wholesale distributors, dispensers, and 
repackagers to have systems in place to enable [them] to comply with certain verification 
requirements relating to the identification and handling of suspect and illegitimate products. 
Specific requirements include the quarantine and investigation of a product determined to be a 
suspect product and the quarantine, disposition, and notification of a product determined to be an 
illegitimate product.18  
 
To satisfy the requirements under section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act, 
these verification systems may be based on existing standard operating procedures (SOPs) or 
processes, new SOPs or processes, or a combination of both.  These systems may include the 
use of a secure electronic database, as provided under section 582(b)(4)(D), (c)(4)(C), (d)(4)(C), 
and (e)(4)(D) of the FD&C Act. 
 
A.  System to Determine That a Product Is Suspect  
 
Trading partners must have systems in place to determine whether a product is a suspect 
product.19  These systems should ensure that, when appropriate, a trading partner makes a 
consistent, effective, and timely determination that a product is suspect.  The determination that 
a product is suspect triggers obligations to quarantine and investigate the suspect product under 
sections 582(b)(4)(A)(i), (c)(4)(A)(i), (d)(4)(A)(i), and (e)(4)(A)(i) of the FD&C Act.  In order to 
help ensure patient safety, it is essential that these systems be well-designed to detect and assess 
suspect product.  Trading partners should focus on drugs that potentially fall into one of the 
categories of drugs listed in the definition of suspect product in section 581(21) of the FD&C 
Act: product that the trading partner has reason to believe is counterfeit, diverted, stolen, 
intentionally adulterated, the subject of a fraudulent transaction, or unfit for distribution.  In the 
guidance for industry Definitions of Suspect Product and Illegitimate Product for Verification 
Obligations Under the Drug Supply Chain Security Act (March 2023), FDA clarified its 
interpretation of the following terms listed in the definition of suspect product in section 581(21) 
of the FD&C Act: counterfeit, fraudulent transaction, unfit for distribution, stolen and diverted.20  
 
In particular, trading partners should consider the risk of such product entering the U.S. 
pharmaceutical distribution supply chain and the scenarios that could significantly increase such 
risk.  The guidance for industry Drug Supply Chain Security Act Implementation: Identification 
of Suspect Product and Notification (June 2021) (Suspect Product and Notification Guidance) 
provides recommendations on how trading partners can identify a suspect product and determine 
whether the product is a suspect product as soon as practicable.  The list of scenarios and 
recommendations in that guidance are not all- inclusive, and trading partners should always 
exercise due diligence to ensure that a suspect product is identified. 
 
18 See section 582(b)(4)(A) and (B), (c)(4)(A) and (B), (d)(4)(A) and (B), and (e)(4)(A) and (B) of the FD&C Act. 
19 See section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act. 
20 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. 
6  Contains Nonbinding Recommendations 
 
FDA may make a request for verification of the product identifier to a trading partner when FDA 
has determined that the trading partner has a suspect product within its possession or control.21 
For purposes of determining compliance with the DSCSAs verification systems requirements, 
FDA interprets the phrase possession or control to include physical custody of the product, or 
ownership of the product.22, 23 Upon receipt of a request for verification of the product identifier 
from FDA, trading partners must proceed as directed by section 582(b)(4)(A)(i), (c)(4)(A)(i), 
(d)(4)(A)(i), and (e)(4)(A)(i) of the FD&C Act (see section III.B below).   
 
B.  Systems for Suspect Product Quarantine and Investigation 
 
Upon determining that a product is suspect, or upon receiving a request for verification of the 
product identifier from FDA (following a determination by the Agency that a product within the 
possession or control of the trading partner is a suspect product), a trading partner is required to 
quarantine the product, and to conduct an investigation in coordination with other trading 
partners, as applicable, to determine whether it is an illegitimate product.24  Trading partners 
must have systems in place to enable such quarantines and investigations of suspect product.25 
 
1.  Quarantine 
 
Quarantine of a suspect product may be accomplished using physical separation and/or other 
procedures.26  FDA interprets other procedures to include electronic means when a trading 
partner lacks physical possession of the product.  FDA encourages trading partners to use both 
physical and electronic quarantine when possible to ensure accurate record keeping.  FDA 
understands quarantine by electronic means (or electronic quarantine) to be an electronic system 
or process, or multiple systems or processes, that designates specific products as being 
quarantined to prevent the sale and further distribution of the product.  For example, if a trading 
partner places a product in quarantine using electronic means, the trading partners system(s) 
should designate the product as quarantined so that information retrieved from the system(s) 
 
21 See section 582(b)(4)(A)(i), (c)(4)(A)(i), (d)(4)(A)(i), and (e)(4)(A)(i) of the FD&C Act. 
22 FDA recognizes that this understanding of possession or control could result in confusion among trading 
partners about who is responsible for specific requirements under section 582 of the FD&C Act.  FDA emphasizes 
that the verification requirements in section 582(b)(4)(A)(II) and (B), (c)(4)(A)(II) and (B), (d)(4)(A)(II) and (B), 
and (e)(4)(A)(II) and (B) require trading partners to coordinate with each other as appropriate.  As such, we believe 
that trading partners will communicate with each other as needed to ensure full compliance with the FD&C Act.   
23 Possession or control includes physical custody by a trading partner of product that was received from a patient 
or consumer who identified a potential issue with the product after it was dispensed.  A trading partner who receives 
such product should use their systems and processes for suspect product identification discussed in section III.A 
above as well as other current company policies and procedures, as appropriate, to look into the circumstances 
surrounding the product to determine whether it is suspect product.  If the product is determined to be suspect 
product, the trading partner should proceed to investigate the product in accordance with appropriate provisions 
described in section 582(b)(4)(A), (c)(4)(A), (d)(4)(A), and (e)(4)(A) of the FD&C Act. It is important for future 
monitoring and overall oversight of supply chain security for trading partners to understand whether such product in 
their possession or control is illegitimate even after dispensing.  However, if this suspect product is determined not 
to be illegitimate product, it should not be further distributed or dispensed.   
24 See section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act. 
25 See section 582(b)(4)(A), (c)(4)(A), (d)(4)(A), and (e)(4)(A) of the FD&C Act. 
26 See section 581(15). 
7  Contains Nonbinding Recommendations 
about that product would indicate that the product is currently quarantined and should not be sold 
or further distributed. 
 
The systems for quarantine should be robust enough to ensure that the suspect product is not 
inadvertently distributed.  The authority to terminate a quarantine of suspect product and to 
release the product for further distribution should be assigned to an appropriate person(s) in the 
trading partners organization.  For example, a member of the quality control unit for a 
manufacturer or repackager, a facility manager or responsible person identified by a wholesale 
distributor, or a pharmacist-in-charge for a dispenser may be an appropriate person to exercise 
such authority. 
 
2.  Components of a Robust Investigation 
 
Trading partners are required to promptly conduct an investigation, in coordination with other 
trading partners, as applicable, into whether a suspect product is an illegitimate product.27  Such 
investigations must include validation of any applicable transaction history28 and transaction 
information29 in the trading partners possession.30  In addition, such investigations should 
include: 
 
  Active communication and coordination of the investigation with the manufacturer, 
repackager, and/or other trading partners, as appropriate, to ensure that the investigation 
is thorough, and the conclusions are accurate. 
 
  Use of appropriate laboratory standards, controls, and techniques in situations where 
laboratory testing of suspect product is necessary to determine whether the product is an 
illegitimate product.31 
 
  An analysis by the trading partner of how the product came to be in its possession or 
control when the trading partner determines that a suspect product is an illegitimate 
product, and of how to help prevent a similar situation in the future. 
 
As noted above, all trading partners are required to conduct suspect product investigations in 
coordination with other trading partners, as appropriate.  FDA therefore considers it appropriate 
for trading partners participating in a coordinated investigation with the products manufacturer 
or repackager to rely on the results of the investigation conducted by that manufacturer or 
repackager.  FDA expects manufacturers and repackagers to share the results of their 
investigations with their trading partners with whom they are conducting the investigation 
 
27 See section 582(b)(4)(A)(i)(II), (c)(4)(A)(i)(II), (d)(4)(A)(i)(II), and (e)(4)(A)(i)(II) of the FD&C Act. 
28 Section 582 requires manufacturers, wholesale distributors, dispensers and repackagers to provide product tracing 
information prior to or at the time of each transaction where ownership of a product is transferred.  The requirement 
to provide transaction history (defined in section 581(25) of the FD&C Act) as part of the product tracing 
information sunsets on November 27, 2023 (see section 582(k)(1)) and will no longer be required as part of the 
product tracing information at that time. 
29 Transaction information is defined in section 581(26) of the FD&C Act. 
30 See section 582(b)(4)(A)(i)(II), (c)(4)(A)(i)(II), (d)(4)(A)(ii)(III), and (e)(4)(A)(i)(II) of the FD&C Act. 
31 FDA expects that the products manufacturer will conduct most laboratory analyses carried out as part of a 
coordinated investigation. 
8  Contains Nonbinding Recommendations 
because doing so would be consistent with their obligation under section 582 of the FD&C Act 
to conduct investigations in coordination with their trading partners.32 
 
In addition, investigations into whether a suspect product is an illegitimate product must include 
verifying the product identifier of the product at the package level.33  The verification steps 
required under applicable provisions of the statute vary, depending on the trading partner making 
the verification. 
 
For manufacturers, verification systems for suspect product must enable manufacturers to 
validate any applicable transaction history and transaction information in their possession.34  
FDA interprets this provision to include the requirement that the manufacturer confirm that the 
National Drug Code (NDC) and lot number reported in the manufacturers internal records for 
the transaction information made at the time of the transaction corresponds to the information 
assigned to the suspect product.35  The manufacturer must then verify the product identifier by 
confirming that the NDC, serial number, lot number and expiration date of the product identifier 
imprinted upon or affixed to the package or homogenous case of the suspect product corresponds 
to the information originally assigned to the product by the manufacturer.36, 37  Similarly, the 
suspect product verification systems of repackagers must enable repackagers to validate any 
applicable transaction history and transaction information in its possession.38  FDA interprets 
this provision to include the requirement that the repackager confirm that the NDC and lot 
number reported in the repackagers internal records for the transaction information made at the 
time of the transaction corresponds to the information assigned to the suspect product. The 
repackager must then verify the product identifier by confirming that the NDC, serial number, lot 
number and expiration date of the product identifier imprinted upon or affixed to the package or 
homogenous case of the suspect product corresponds to the information originally assigned to 
the product by the repackager.39  
 
As of November 27, 2019, wholesale distributors, and, as of November 27, 2020, dispensers, 
must have systems in place to enable them to comply with a number of verification requirements 
for determining whether a suspect product is an illegitimate product.40  A wholesale distributor 
 
32 See section 582(b)(4)(A)(i)(II) and (e)(4)(A)(i)(II) of the FD&C Act. 
33 Section 582(b)(4)(A)(i)(II), (c)(4)(A)(i)(II), (d)(4)(A)(ii)(II), and (e)(4)(A)(i)(II) of the FD&C Act. 
34 See section 582(b)(4)(A)(i)(II) of the FD&C Act. 
35 See section 581(26) of the FD&C Act.  The transaction information includes the NDC and lot number of a 
product.  Under the 2023 enhanced drug distribution security requirements described in section 582(g) of the FD&C 
Act, the transaction information will include the product identifier at the package level for each package included in 
the transaction (section 582(g)(1)(B)). 
36 See section 582(b)(4)(A)(i)(II) of the FD&C Act. 
37 Trading partners must verify suspect product (sections 582(b)(4)(A)(i)(II), (c)(4)(A)(i)(II), (d)(4)(A)(i)(II), and 
(e)(4)(A)(i)(II)). This includes determining whether the product identifier affixed to, or imprinted upon, the package 
or homogeneous case of product corresponds to the information assigned by the manufacturer or repackager. The 
product identifier includes the standardized numerical identifier (SNI), lot number and expiration date of the 
product. The SNI includes the products National Drug Code (NDC) and serial number.  See sections 581(14), (20), 
and (28) of the FD&C Act for the definitions of product identifier, standardized numerical identifier, and verify. 
38 See section 582(e)(4)(A)(i)(II) of the FD&C Act. 
39 Id. 
40 In October 2020, FDA published the guidance for industry Wholesale Distributor Verification Requirement for 
Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or 
9  Contains Nonbinding Recommendations 
must validate any applicable transaction history and transaction information in its possession.41  
FDA interprets this provision to include the requirement that the wholesale distributor confirm 
that the NDC and lot number in the wholesale distributors internal records for the transaction 
information corresponds to the information assigned to the product that the wholesale distributor 
received from the manufacturer, repackager, or other wholesale distributor of such product.  In 
addition, the wholesale distributor must also verify the product identifier with the respective 
manufacturer or repackager by confirming that the product identifier imprinted upon or affixed 
to the package or homogenous case corresponds to the information assigned to the product by the 
respective manufacturer or repackager (i.e., the standardized numerical identifier or lot number 
and expiration date).42 
 
Like the other trading partners, during an investigation of suspect product, dispensers must 
validate any applicable transaction history and transaction information in its possession.43  FDA 
interprets this provision to include the requirement that the dispenser confirm that the NDC and 
lot number in the dispensers internal records for the transaction information corresponds to the 
information assigned to the product that the dispenser received from the manufacturer, 
repackager, or wholesale distributor of such product.  Dispensers must also verify the product 
identifier with the respective manufacturer or repackager  by confirming that the product 
identifier imprinted upon or affixed to the package or homogeneous case corresponds with the 
information (i.e., the standardized numerical identifier or lot number and expiration date) 
assigned to the product by the respective manufacturer or repackager.44  The product identifier 
must be verified for at least 3 packages or 10 percent of such suspect product, whichever is 
greater, or all packages if there are fewer than 3.45  Therefore, the verification requirement for 
dispensers differs from that of other trading partners when there are more than three packages of 
suspect product.  In addition, dispensers have the additional requirement to verify the product 
identifier by confirming that the lot number corresponds with the lot number assigned to the 
product by the respective manufacturer or repackager.46  To do this, a dispenser may consult the 
transaction information and transaction history to verify the product lot number and if the 
dispenser is not able to verify the product lot number (e.g., neither the transaction information or 
 
Illegitimate Product - Compliance Policies (2020 Compliance Policies). This guidance explained FDAs intent to 
extend the delay in enforcement of the DSCSA provisions requiring wholesale distributors to verify the product 
identifier prior to further distributing returned product beginning on November 27, 2019. (FDAs intent to delay 
enforcement of this provision was originally described in the guidance entitled Wholesale Distributor Verification 
Requirement for Saleable Returned Drug Product - Compliance Policy (September 2019).) In addition, the 2020 
Compliance Policies announced FDA's intended enforcement policy with respect to the DSCSA provisions requiring 
dispensers to verify the product identifier for suspect or illegitimate product in the dispenser's possession or control 
beginning on November 27, 2020.  On September 1, 2023, FDA announced in the Federal Register the availability 
of the guidance for industry Wholesale Distributor Verification Requirement for Saleable Returned Drug Product 
and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product - Compliance 
Policies Revision 1, extending the 2020 Compliance Policies for 1 year. For these wholesale distributor and 
dispenser provisions, FDA will delay enforcement until November 27, 2024. 
41 See section 582(c)(4)(A)(i)(II) of the FD&C Act. 
42 Id. 
43 See section 582(d)(4)(A)(ii)(III) of the FD&C Act. 
44 See section 582(d)(4)(A)(ii)(II) of the FD&C Act. 
45 Id. 
46 See section 582(d)(4)(A)(ii)(I) of the FD&C Act. 
10  Contains Nonbinding Recommendations 
transaction history contains the required information) the dispenser should contact the 
manufacturer or repackager of the product. 
 
FDA encourages trading partners to periodically evaluate their systems for conducting 
investigations to identify opportunities for improvement and to ensure that the systems are 
compliant with the applicable verification requirements. 
 
C.  Systems for Cleared Product Notification Regarding Suspect Product 
 
Trading partners must have systems in place to enable them to promptly notify FDA, if 
applicable, when suspect product is determined not to be illegitimate product.47  Under section 
582 of the FD&C Act, trading partners must promptly notify FDA, if applicable, if they 
determine after investigation that a suspect product is not an illegitimate product and is therefore 
a cleared product.48  This notification is considered a cleared product notification.  FDA expects 
trading partners to inform the Agency about cleared product only if the suspect product is the 
subject of an FDA request for verification of the product identifier; where FDA has made no 
request for verification of the product identifier, a trading partner is not expected to submit a 
cleared product notification to the Agency.  Cleared product notifications should be made before 
the product is further distributed or dispensed.  Trading partners should be advised that once a 
product has been cleared, they must still ensure compliance with the other applicable provisions 
of the FD&C Act before the product may be further distributed. 
 
1.  Cleared Product Notifications to be Submitted to FDA 
 
If, after investigating a suspect product that is the subject of an FDA request for verification of 
the product identifier, a trading partner determines that the product is not an illegitimate product, 
the trading partner must promptly submit a cleared product notification to FDA documenting its 
determination.49  Only the trading partner to whom FDA made its request for verification need 
submit a cleared product notification.  The cleared product notification should be submitted to 
drugnotifications@fda.hhs.gov until FDAs electronic DSCSA Portal is active.  Once active, 
cleared product notifications should be submitted to the Agency through FDAs electronic 
DSCSA Portal.50  
 
2.  Components of Cleared Product Notifications 
 
Cleared product notifications should include: 
 
  A subject line that states, Cleared Product Notification. 
 
 
47 See section 582(b)(4), (c)(4), (d)(4), and (e)(4) of the FD&C Act. 
48 See section 582(b)(4)(A)(ii), (c)(4)(A)(ii), (d)(4)(A)(iii), and (e)(4)(A)(ii) of the FD&C Act. 
49 Id.  
50 Cleared product notifications should not be submitted using the FDA Form 3911 because that form is for 
notifying FDA of illegitimate product and products with a high risk of illegitimacy. 
11  Contains Nonbinding Recommendations 
  The identity of the product that was determined to be a suspect product but has now been 
determined, after investigation, not to be an illegitimate product.  The product should be 
identified by the: 
 
 Proprietary or established name of the product51 
 Strength and dosage form of the product  
 NDC of the product52 
 Lot number 
 Expiration date 
 Serial number(s) of the product(s) (if available)53 
 Container size  
 Number of containers 
 
  The date of the FDA request for verification of the product identifier to which the cleared 
product notification applies and the name of the FDA office and/or employee who made 
the request for verification of the product identifier. 
 
  The reason why the product was determined to be suspect and a summary of the 
investigation that led to the trading partners determination that the product was not an 
illegitimate product. 
 
  The date the product was cleared. 
 
  The name and official position of the employee or officer representing the trading partner 
who cleared the suspect product. 
 
3.  Recordkeeping of Suspect Product Investigations Resulting in Cleared Product  
 
Records of suspect product investigations, including all cleared product notifications, must be 
maintained for a period of at least 6 years after the conclusion of the investigation.54  This 
recordkeeping requirement also includes maintaining records about cleared product when no 
notification is made to FDA because the suspect product was not the subject of an FDA request 
for verification.  The investigative record should also clearly explain how the trading partner 
reached the decision that a suspect product was not illegitimate. 
 
 
51 The proper name should be used for biological products. See 21 CFR 600.3(k). 
52 If an alternatively formatted NDC is approved for use in accordance with 21 CFR 207.33(b)(4), the alternatively 
formatted NDC should be used to identify the product. 
53 When a product identifier must be affixed to or imprinted upon a product per section 582(b)(2) and (e)(2) of the 
FD&C Act, trading partners should include the serial number along with the NDC, lot number, and expiration date 
as the product identifier of the product package(s) or sealed homogenous case of product (see section 581(14) and 
(20) of the FD&C Act).  Also, a product might not have a serial number if it was packaged or repackaged before 
November 27, 2018 (considered as grandfathered), or if it received a waiver, exception, or exemption from the 
product identifier requirement under section 582(a)(3) of the FD&C Act. 
54 Section 582(b)(4)(A)(iii), (c)(4)(A)(iii), (d)(4)(A)(iv), and (e)(4)(A)(iii) of the FD&C Act. 
12  Contains Nonbinding Recommendations 
D.  Systems for Illegitimate Product Quarantine and Disposition 
 
Trading partners must meet certain requirements for the quarantine and disposition of 
illegitimate product, including coordination with other trading partners, as applicable.55  In 
making the determination that a product is illegitimate, trading partners are required to 
coordinate with the manufacturer.56  In addition, FDA recognizes that a situation may arise 
where a trading partner is not able to physically quarantine, disposition, or collect a sample of 
illegitimate product that the trading partner owns because that product has been stolen and is no 
longer in the trading partners physical custody. 
 
1.  Quarantine 
 
Upon determining that a product in the possession or control of a manufacturer, repackager, or 
wholesale distributor is an illegitimate product, such trading partner must quarantine such 
illegitimate product within its possession or control from product intended for distribution until 
such product is dispositioned.57  Upon receipt of a notification from FDA or a trading partner 
that a determination has been made that a product is an illegitimate product, a manufacturer, 
repackager, wholesale distributor, or dispenser must identify all illegitimate product subject to 
such notification that is in its possession or control, including any illegitimate product that is 
subsequently received by that trading partner, and quarantine and investigate such product, 
pursuant to section 582(b)(4)(A), (c)(4)(A), (d)(4)(A), and (e)(4)(A) of the FD&C Act, 
respectively.58  Quarantine of an illegitimate product may be accomplished using physical 
separation and/or other procedures.59  As explained above in section III.B.I, other procedures 
may include electronic means, when a trading partner lacks physical possession of the product. 
FDA encourages trading partner to use both physical and electronic quarantine when possible to 
ensure accurate record keeping. 
 
The systems for quarantine should be robust enough to ensure that an illegitimate product is not 
inadvertently distributed.  As a best practice, systems should identify product received by a 
trading partner that has the same product information (e.g., the same transaction information or 
the same data elements in its product identifier, particularly the serial number) as product that the 
trading partner has already identified as illegitimate in its system(s).  Authority to release the 
illegitimate product from quarantine should only be exercised by appropriate people in the 
organization who are expressly authorized to terminate quarantine for the illegitimate product.  
For example, a member of the quality control unit for a manufacturer or repackager, a facility 
manager or responsible person for a wholesale distributor, or a pharmacist-in-charge for a 
dispenser may be an appropriate person to exercise such authority. 
  
 
55 Section 582(b)(4)(B), (c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act. 
56 Id.  
57 Section 582(b)(4)(B)(i)(I), (c)(4)(B)(i)(I), and (e)(4)(B)(i)(I) of the FD&C Act. Section 582(d)(4)(B)(iii) of the 
FD&C Act requires dispensers to quarantine product for which they receive a notice of illegitimacy. Dispensers 
should also quarantine product they determine to be illegitimate. 
58 Section 582(b)(4)(B)(iii), (c)(4)(B)(iii), (d)(4)(B)(iii), and (e)(4)(B)(iii) of the FD&C Act. 
59 See section 582(15) of the FD&C Act. 
13  Contains Nonbinding Recommendations 
2.  Disposition 
 
Disposition involves the removal of product from the pharmaceutical distribution supply chain.60  
The method of disposition of an illegitimate product should ensure that the public health hazards 
associated with that product are appropriately controlled.  A trading partner should have SOPs 
detailing its systems and processes for the disposition of illegitimate product that is within its 
possession or control.61  Each trading partner is also required to maintain systems to assist in the 
disposition of illegitimate product not in its own possession or control, but, instead, in the 
possession or control of one of its trading partners.62 
   
3.  Records 
 
Records of the disposition of an illegitimate product must be maintained by trading partners for 
not less than 6 years after the conclusion of the disposition.63  This should include records about 
contractors hired to disposition the illegitimate product and sample retention. 
 
4.  Retention of Samples 
 
Trading partners must retain a sample of the illegitimate product for further physical examination 
or laboratory analysis by the manufacturer or FDA (or other appropriate Federal or State official) 
upon request by the manufacturer or FDA (or other appropriate Federal or State official).64  Such 
samples are illegitimate product and should be appropriately quarantined.  Consistent with the 
manufacturers responsibility to assist trading partners in the disposition of illegitimate 
product,65 FDA expects manufacturers to inform trading partners in a timely manner about 
whether a sample is needed for further physical examination or laboratory analysis before the 
investigation can be completed.  FDA also intends to inform trading partners in a timely manner 
if the collection of samples is necessary for further physical examination or laboratory analysis 
by the Agency. 
 
Samples should be: 
 
  Representative of the illegitimate product. 
 
  Of an amount/quantity sufficient for analysis if available, to permit proper laboratory 
examination by the entity or entities requesting that a sample be retained. 
 
  Maintained and appropriately stored so that the condition of the product will be preserved 
until it is collected. 
 
 
60 Section 581(4) of the FD&C Act. 
61 Section 582(b)(4)(B)(i)(II), (c)(4)(B)(i)(II), (d)(4)(B)(i)(I), and (e)(4)(B)(i)(II) of the FD&C Act. 
62 Section 582(b)(4)(B)(i)(III), (c)(4)(B)(i)(III), (d)(4)(B)(i)(II), and (e)(4)(B)(i)(III) of the FD&C Act. 
63 Section 582(b)(4)(B)(v), (c)(4)(B)(v), (d)(4)(B)(v), and (e)(4)(B)(v) of the FD&C Act. 
64 Section 582(b)(4)(B)(i)(IV), (c)(4)(B)(i)(IV), (d)(4)(B)(i)(III), and (e)(4)(B)(i)(IV) of the FD&C Act. 
65 Section 582(b)(4)(B)(i)(III). 
14  Contains Nonbinding Recommendations 
  Appropriately labeled and stored to preserve the identity of the sample. For example, a 
product should be identified and labeled as a retained sample of illegitimate product for a 
specific investigation, and a log identifying each person who handled the product, 
identifying the date they handled it and describing the manner in which they handled it, 
should be maintained, and should accompany the sample when it is submitted for testing. 
 
E.  Systems for Illegitimate/High Risk of Illegitimacy Product Notifications 
 
Trading partners must have systems in place for notifying FDA and immediate trading partners 
of an illegitimate product and, for manufacturers, products with a high risk of illegitimacy.66  In 
accordance with section 582(b)(4)(B)(ii)(II), high risk may include a specific high risk that could 
increase the likelihood that illegitimate product will enter the pharmaceutical distribution supply 
chain and other high risks, as determined by FDA in guidance.67, 68  Upon receipt of an 
illegitimate product notification from a trading partner or a notification from FDA that a product 
has been determined to be an illegitimate product, a trading partner must identify all illegitimate 
products subject to such notification in its possession or control, including any product that is 
subsequently received, and conduct the activities required for suspect product, as applicable, 
described in section 582(b)(4)(A), (c)(4)(A), (d)(4)(A), and (e)(4)(A) of the FD&C Act.69  
Trading partners should follow these same procedures upon receipt of a notification from a 
manufacturer that a product has a high risk of illegitimacy.70  The Suspect Product and 
Notification Guidance referenced above sets forth in more detail the process by which trading 
partners should notify FDA of the illegitimate product or products with a high risk of 
illegitimacy and the process they must use to terminate notifications, in consultation with FDA.71  
Refer to that guidance for specific information related to these notifications. 
 
F.  Systems for Responding to Requests for Verification of the Product Identifier 
From Authorized Trading Partners 
 
Manufacturers and repackagers must have systems in place to respond to requests for verification 
of the product identifier from an authorized trading partner72 that is in possession or control of a 
product that they believe to be manufactured or repackaged by the respective manufacturer or 
repackager not later than 24 hours after receiving such request or in other such reasonable time 
 
66 Section 582(b)(4)(B)(ii)(I) and (II), (c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) of the FD&C Act. 
67 Section 582(b)(4)(B)(ii)(II) of the FD&C Act. 
68 See Suspect Product and Notification Guidance. 
69 Section 582(b)(4)(B)(iii), (c)(4)(B)(iii), (d)(4)(B)(iii), and (e)(4)(B)(iii) of the FD&C Act. 
70 Again, FDA emphasizes that the verification requirements in section 582 of the FD&C Act require trading 
partners to coordinate with each other as appropriate.  As such, we believe that when trading partners receive a 
notification of illegitimate product or a product with a high risk of illegitimacy, they will communicate with each 
other as needed to ensure full compliance with the FD&C Act.  
71 For terminating notification requirements, see section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and 
(e)(4)(B)(iv) of the FD&C Act. 
72 A manufacturer or repackager must respond to a request for verification from an authorized trading partner, even 
if that trading partner was not an immediate trading partner of the manufacturer or repackager.  The transaction 
information and transaction history of the product, or an explanation of how the trading partner obtained the product 
if not through a transaction, as defined by section 581(24) of the FD&C Act, , could be used to facilitate the 
manufacturers or repackagers determination that the trading partner making the request for verification is an 
authorized trading partner.   
15  Contains Nonbinding Recommendations 
as determined by FDA, based on the circumstances of the request.73  We interpret the 24-hour 
requirement as meaning that a manufacturer or repackager should provide a rapid response to 
such a request for verification of a product identifier, a best practice being no later than 1 
business day from receipt of the request.  The systems must allow the manufacturer or 
repackager to respond to the trading partner inquiring whether a particular product identifier 
affixed to, or imprinted upon, a package or homogeneous case of product corresponds to the 
standardized numerical identifier or lot number and expiration date assigned to the product by 
the manufacturer or repackager.74  The systems should allow the manufacturer or repackager to 
respond to the request with a clear statement as to whether the product identifier has been 
verified.  In addition, these systems should be integrated with SOPs and business practices used 
to identify suspect product and illegitimate product. 
 
If the manufacturer or repackager responding to the request for verification identifies a product 
identifier that does not correspond to the standardized numerical identifier or lot number and 
expiration date assigned to the product by the manufacturer or repackager, the manufacturer or 
repackager must treat the product as suspect product.75  In addition, in their response to a request 
to verify the product identifier, a manufacturer or repackager must notify the trading partner 
making the request if they have reason to believe that a product is illegitimate.76  This 
requirement does not prohibit a manufacturer or repackager from providing additional 
information that may be helpful to a trading partner when responding to a request to verify the 
product identifier.  For example, a manufacturer or repackager may indicate why they believe the 
product is illegitimate or, if a manufacturer or repackager knows product has been the subject of 
a recall, they could provide this relevant information as a way of further ensuring that 
nonsaleable product is identified and not inadvertently distributed into the market.  To avoid a 
public health risk, a trading partner should not further distribute or dispense product until they 
receive a response to their request for verification of the product identifier from a manufacturer 
or repackager.   
 
In addition, on a case-by-case basis, FDA may consider other such reasonable time for 
responding to requests for verification of the product identifier under limited circumstances (e.g., 
power outages, transportation infrastructure disruptions, local regional disruptions, scope of the 
request).  In such situations, FDA expects manufacturers and repackagers to make a good faith 
effort to provide a rapid response, but FDA understands that they may need to follow-up with 
their trading partner with additional information.  Again, a trading partner making the request for 
verification of the product identifier should wait until the manufacturer or repackager is able to 
verify the product identifier before the product is further distributed or dispensed, if 
appropriate.77  
 
 
73 See section 582(b)(4)(C) and (e)(4)(C) of the FD&C Act. 
74 Id. 
75 Id. 
76 Id. 
77 When a manufacturer or repackager is able to verify the product identifier, product may still be suspect or 
illegitimate.  Please consult the Suspect Product and Notification guidance to learn how to identify suspect and 
illegitimate product 
16  Contains Nonbinding Recommendations 
G.  Systems for Processing Saleable Returns 
 
Manufacturers, wholesale distributors, and repackagers must have systems in place that will 
allow them to process saleable return products that they intend to further distribute.78, 79, 80   
These systems must allow the trading partners to verify the product identifier, including the SNI, 
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.81  A saleable returned 
product may not be further distributed until the product identifier has been verified.82  If the 
product identifier is not successfully verified, the product should not be distributed until the issue 
has been resolved, as appropriate.  It may be necessary to classify the product as suspect product 
and initiate an investigation to determine whether it is illegitimate product.83  Because the 
systems and processes for verification of saleable returns are similar to those used for verifying 
the product identifier of suspect product at the package level as required by sections 
582(b)(4)(A)(i)(II), (c)(4)(A)(i)(II), and (e)(4)(A)(i)(II), FDA anticipates that some trading 
partners may use the same system(s) for both requirements. 
 
 
78 See section 582(b)(4)(E), (c)(4)(D), and (e)(4)(E) of the FD&C Act. Section 582(b)(4)(E) and 582(e)(4)(E) 
provide that manufacturers and repackagers, respectively, verify the product identifier of saleable return product 
before it is further distributed.  Section 582(k)(2) provides for the sunset of these provisions.  Accordingly, after the 
implementation of enhanced drug distribution security requirements, manufacturers and repackagers need not verify 
the product identifier of saleable return product. Instead, under section 582(g)(1)(F), [e]ach person accepting a 
saleable return shall have systems and processes in place to allow acceptance of such product and may accept 
saleable returns only if such person can associate the saleable return product with the transaction information and 
transaction statement associated with that product. See FDAs Enhanced Drug Distribution Security Guidance for 
information regarding the enhanced drug distribution security requirements for processing saleable returns.  
79 Under the statute, these systems must be in place by November 27, 2017, for manufacturers; by November 27, 
2018, for repackagers; and by November 27, 2019, for wholesale distributors. However, in Wholesale Distributor 
Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When 
Investigating a Suspect or Illegitimate Product - Compliance Policies Revision 1 (August 2023), FDA explained that 
we do not intend to take action against wholesale distributors who do not, before November 27, 2024, verify a 
product identifier before further distribution of returned product, as required under section 582(c)(4)(D) of the 
FD&C Act. 
80 Return is defined in section 581(17) of the FD&C Act. 
81 Section 582(b)(4)(E), (c)(4)(D), and (e)(4)(E) of the FD&C Act. 
82 Id. 
83 For how these trading partners must handle suspect product, see section 582(b)(4)(A)(i), (c)(4)(A)(i), and 
(e)(4)(A)(i) of the FD&C Act. 
17  Contains Nonbinding Recommendations 
When a manufacturer or repackager receives returned product that it intends to further distribute, 
before further distributing such product, the manufacturer or repackager must verify the product 
identifier for each sealed homogeneous case of such product or, if such product is not in a sealed 
homogeneous case, verify the product identifier on each package, as explained above in sections 
III.B.2 and III.F.84  Before a wholesale distributor may further distribute returned product, it 
must first verify that the product identifier imprinted upon or affixed to the package or 
homogenous case corresponds to the information assigned to the product by the manufacturer or 
repackager of such product, as explained above in section III.B.2.85  A dispenser may return 
product, saleable and non-saleable, to the trading partner it purchased the product from without 
providing the related transaction history, transaction information, and transaction statement.86 
 
84 See section 582(b)(4)(E) and (e)(4)(E) of the FD&C Act. 
85 See section 582(c)(4)(D) of the FD&C Act.  FDA does not intend to take action against wholesale distributors 
who do not, before November 27, 2024, verify a product identifier before further distribution of returned product, 
as required under section 582(c)(4)(D) of the FD&C Act. See the guidance for industry Wholesale Distributor 
Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When 
Investigating a Suspect or Illegitimate Product - Compliance Policies Revision 1 (August 2023). 
86 See section 582(d)(1)(C) of the FD&C Act. Additional information regarding processing of saleable returns under 
enhanced drug distribution security requirements can be found in FDAs Enhanced Drug Distribution Security 
Guidance. 
18