Enhanced Drug Distribution 
Security Requirements Under 
Section 582(g)(1) of the Federal 
Food, Drug, and Cosmetic Act 
 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) 
 
August 2023 
Administrative/Procedural 
 
 
    
Enhanced Drug Distribution 
Security Requirements Under 
Section 582(g)(1) of the Federal 
Food, Drug, and Cosmetic Act 
 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 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  DSCSA ............................................................................................................................................ 2 
B.  Enhanced Drug Distribution Security ......................................................................................... 2 
III.  COMPLIANCE POLICIES REGARDING SECTION 582(G)(1)(B) OF THE 
FD&C ACT ........................................................................................................................ 5 
IV.  COMPLIANCE POLICIES FOR OTHER ENHANCED DRUG DISTRIBUTION 
SECURITY REQUIREMENTS UNDER SECTION 582(G)(1) OF THE FD&C 
ACT .................................................................................................................................... 6 
 
  Contains Nonbinding Recommendations 
 
Enhanced Drug Distribution Security Requirements Under Section 
582(g)(1) of the Federal Food, Drug, and Cosmetic Act  
 Compliance 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 
 
This guidance is for trading partners2  namely manufacturers, wholesale distributors, 
dispensers, and repackagers3  who are subject to requirements for enhanced drug distribution 
security under section 582(g)(1) 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).  These requirements go into effect on November 27, 2023.4  FDA is issuing this 
guidance to address industry readiness to comply with these requirements. 
 
This guidance announces the Food and Drug Administrations (FDA or Agency) compliance 
policies regarding enforcement of the enhanced drug distribution security requirements5 under 
section 582(g)(1) of the FD&C Act that will go into effect on November 27, 2023.  FDA 
believes the compliance policies provided in this guidance will help supply chain stakeholders, 
particularly trading partners, by accommodating the additional time that may be needed to 
continue to develop and refine appropriate systems and processes to conduct interoperable, 
electronic tracing at the package level, to achieve robust supply chain security under the DSCSA 
while helping ensure continued patient access to prescription drugs. 
 
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 Federal Food, Drug, and Cosmetic Act (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. 
3 Manufacturer, wholesale distributor, dispenser, and repackager are defined in section 581(10), (29), (3), and (16) 
of the FD&C Act, respectively. 
4 See section 582(g)(1) of the FD&C Act. (On the date that is 10 years after the date of enactment of the Drug 
Supply Chain Security Act, the following interoperable, electronic tracing of product at the package level 
requirements shall go into effect:) 
5 For the purpose of this guidance, enhanced drug distribution security requirements refers to the requirements for 
interoperable, electronic, package-level product tracing, including specified systems and processes, in section 
582(g)(1) of the FD&C Act. 
  1  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 
 
A.  DSCSA 
 
The DSCSA was signed into law on November 27, 2013. The DSCSA outlines critical steps for 
building an electronic, interoperable system by November 27, 2023, that will identify and trace 
certain prescription drugs as they are distributed within the United States. Section 202 of the 
DSCSA added section 582 to the FD&C Act, which established product tracing, product 
identifier, authorized trading partner, and verification requirements for manufacturers, 
repackagers, wholesale distributors, and dispensers to facilitate the tracing of product6 through 
the pharmaceutical distribution supply chain. Section 582 of the FD&C Act also imposed 
requirements for enhanced drug distribution security that go into effect on November 27, 2023.7  
 
B.  Enhanced Drug Distribution Security 
 
The compliance policies described in this guidance address the requirement that beginning 
November 27, 2023, the use of electronic-based approaches generally will be required among all 
trading partners to meet the enhanced drug distribution security requirements outlined in section 
582(g)(1) of the FD&C Act.  As described in this provision (and generally summarized below), 
on that date, trading partners are required to: 
 
(1) Use secure, interoperable, electronic approaches to exchange transaction information,8 
which must include package level product identifiers9 for each package included in the 
transaction, and to exchange transaction statements;10,11  
 
(2) Have systems and processes in place to verify products at the package level;12  
 
6 Product is defined in section 581(13) of the FD&C Act as a prescription drug for human use in a finished dosage 
form for administration to a patient without substantial further manufacturing.  See section 581(13) of the FD&C 
Act for specific exclusions. 
7 See section 582(g)(1) of the FD&C Act. 
8 Transaction information is defined in section 581(26) of the FD&C Act. 
9 Product identifier is defined in section 581(14) of the FD&C Act.  
10 Transaction statement is defined in section 581(27) of the FD&C Act.  
11 See section 582(g)(1)(A) and (B) of the FD&C Act.   
12 See section 582(g)(1)(C) of the FD&C Act.  
  2  Contains Nonbinding Recommendations 
 
(3) Have systems and processes in place to promptly respond with the transaction 
information and transaction statement for a product upon a request by the Secretary,13 or 
other appropriate Federal or State official, in the event of a recall or for investigations of 
suspect or illegitimate product;14  
 
(4) Have systems and processes in place to facilitate the gathering of information needed to 
produce the transaction information for a product going back to the manufacturer, as 
applicable, in the event of a request by the Secretary, or other appropriate Federal or State 
official, on account of a recall or for suspect or illegitimate product investigations, or in 
the event of a request by an authorized trading partner (in a secure manner that protects 
confidential commercial information and trade secrets) for purposes of investigating a 
suspect product or assisting with such a governmental request;15 and  
 
(5) Have systems and processes in place to accept saleable returns under appropriate 
conditions, i.e., being able to associate the saleable return product with the transaction 
information and transaction statement associated with that product.16 
 
Until November 27, 2023, wholesale distributors, dispensers, and repackagers can use either 
paper-based or electronic-based methods17 to provide transaction history,18 transaction 
information, and transaction statements to subsequent purchasing trading partners as long as the 
selected method allows the information to be exchanged in a manner that complies with the 
requirements of section 582(c)(1), (d)(1), and (e)(1) of the FD&C Act, respectively.  However, 
under section 582(b)(1)(C) of the FD&C Act, manufacturers have been required since November 
2017 to use electronic-based methods to provide transaction history, transaction information, and 
transaction statements to subsequent purchasing trading partners, except that the manufacturer 
may provide transaction history, transaction information, and transaction statements in a paper 
format if the subsequent purchaser is either a: (1) State licensed health care practitioner 
authorized to prescribe medication; or (2) licensed individual who dispenses product in the usual 
course of professional practice and is under the supervision or direction of a licensed prescribing 
health care practitioner.19 
 
Since the enactment of DSCSA, FDA and trading partners have been preparing for the 
implementation of the enhanced drug distribution security requirements imposed by section 
 
13 In practice, references in the FD&C Act to the Secretary generally mean FDA. The Secretary of Health and 
Human Services (the Secretary) has redelegated to the Commissioner of Food and Drugs (Commissioner), with 
authority to redelegate (except when specifically prohibited), authority including functions vested in the Secretary 
under the FD&C Act  see FDA Staff Manual Guide 1410.10 at https://www.fda.gov/media/81983/download.  
14 See section 582(g)(1)(D) of the FD&C Act. 
15 See section 582(g)(1)(E) of the FD&C Act. 
16 See section 582(g)(1)(F) of the FD&C Act. 
17 See section 582(a)(2)(A) of the FD&C Act; see also sections 581(25) and 581(27) of the FD&C Act. 
18 Beginning Nov 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  as 
described in section II.B  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 582(b)(1)(C)(i)(ii) of the FD&C Act. 
  3  Contains Nonbinding Recommendations 
 
582(g)(1) of the FD&C Act.20  Trading partners are continuing to put in place the necessary 
systems and processes in order to electronically exchange product tracing information21 with 
each transaction22 of product in anticipation of the November 27, 2023, effective date for these 
requirements.  While trading partners have the obligation to comply with the requirements in 
section 582 of the FD&C Act, there are other stakeholders involved and affected, including but 
not limited to: solution providers, standards organizations, trade and professional organizations, 
state authorities, and federal authorities.   
 
FDA understands that collaboration and alignment among trading partners and other 
stakeholders throughout the supply chain are critical for achieving interoperability under the 
DSCSA.  FDA has heard from stakeholders, including a broad representation of trading partners, 
about concerns regarding trading partner readiness and the need for clarity and flexibility to 
ensure trading partners can continue to move product through the supply chain when the 
enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act take 
effect.23  While FDA generally expects trading partners to have the systems and processes in 
place to meet these requirements as of November 27, 2023, we recognize that some technical and 
operational issues, including issues involving trading partners and other affected stakeholders, 
may not be fully resolved by that time.24  The Agency also understands that additional time 
beyond November 27, 2023 may be needed for systems to stabilize and be fully interoperable for 
accurate, secure, and timely electronic data exchange.  This guidance is intended to provide 
clarity and flexibility to trading partners to help ensure continued patient access to prescription 
drugs as the supply chain transitions to the interoperable, electronic product tracing at the 
package level under the DSCSA.  The compliance policies in this guidance can help trading 
partners throughout the supply chain implement the requirements under section 582(g)(1) of the 
FD&C Act by accommodating the additional time that may be needed to implement, 
troubleshoot, and mature their systems and processes while supporting the continued availability 
of products to patients.  
 
 
20 For example, FDA has issued a number of guidances and has held several public meetings to support the efficient 
and effective implementation of DSCSA requirements.  Additionally, FDAs DSCSA Pilot Project Program offered 
stakeholders the opportunity to explore and evaluate methods for the enhanced drug distribution security 
requirements to go into effect on Nov 27, 2023.  See FDAs DSCSA web page, available at 
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.  
21 Product tracing information to be exchanged under the enhanced drug distribution requirements of section 
582(g)(1) of the FD&C Act refers to the transaction information, including product identifiers at the package level 
pursuant to section 582(g)(1)(B), and the transaction statement.  
22 Transaction is defined in section 581(24) of the FD&C Act as the transfer of product between persons in which a 
change of ownership occurs.  For specific exemptions, see section 581(24)(B) of the FD& Act. 
23 On Dec 78, 2022, FDA held a virtual public meeting on DSCSA Implementation and Readiness Efforts for 2023, 
available at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-
2023-12072022.  The purpose of this public meeting was to provide members of the pharmaceutical distribution 
supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation. 
24 For example, FDA has issued a proposed rule to amend FDA regulations governing the format of the NDC.  The 
regulation, if finalized, would establish a uniform, 12-digit format for the NDC.  See FDAs proposed rule, 
Revising the National Drug Code Format and Drug Label Barcode Requirements (87 FR 44038), available at 
https://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-
drug-label-barcode-requirements.  Trading partners may need to consider how to best plan for potential NDC format 
changes and incorporate them into their systems and processes if or when such changes become effective.   
  4  Contains Nonbinding Recommendations 
 
FDA will continue to monitor trading partner readiness to meet the requirements under section 
582(g)(1) during and after the period of the compliance policy in this guidance and is committed 
to supporting the efforts of trading partners to achieve enhanced drug distribution security.   We 
note FDA has the authority under section 582(a)(3) of the FD&C Act to grant exemptions from 
certain requirements in section 582 of the FD&C Act  including after the compliance policy 
period in this guidance  when the Agency determines that an exemption is appropriate to 
maintain public health or is otherwise appropriate.25   
 
This guidance is not intended to provide, and should not be viewed as providing, a justification 
for delaying efforts by trading partners to implement the enhanced drug distribution security 
requirements under section 582(g)(1) of the FD&C Act.  FDA strongly urges trading partners to 
continue their efforts to implement necessary measures to satisfy these enhanced drug 
distribution security requirements.   
 
 
III.  COMPLIANCE POLICIES REGARDING SECTION 582(G)(1)(B) OF THE 
FD&C ACT 
 
Section 582(g)(1)(B) of the FD&C Act requires that, as of November 27, 2023, the transaction 
information required to be exchanged under section 582 include the product identifier (i.e., the 
standardized numerical identifier consisting of the NDC and serial number, lot number, and 
expiration date) at the package level for each package included in the transaction.  FDA does not 
intend to take action to enforce this requirement until November 27, 2024.  FDA is issuing this 
compliance policy to accommodate the additional time (beyond November 27, 2023) that may be 
needed by trading partners to achieve compliance and to help ensure continued access to 
prescription drugs as trading partners continue to refine processes for the inclusion of the product 
identifier at the package level for each package in a transaction into the transaction information 
in accordance with section 582(g)(1)(B). 
 
In addition, FDA does not intend to take action to enforce the requirement under section 
582(g)(1)(B) of the FD&C Act with respect to product that is introduced in a transaction into 
commerce by the products manufacturer or repackager before November 27, 2024, and for 
subsequent transactions of such product through the products expiry. This means that FDA does 
not intend to take action if the transaction information for product introduced in a transaction 
into commerce by the products manufacturer or repackager before November 27, 2024, does not 
incorporateat the package level for each package in the transactionthe product identifier.  
This policy will facilitate the use and exhaustion of product supply already in the supply chain 
prior to November 27, 2024.  
 
 
25 See https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-
waivers-exceptions-and-exemptions and the guidance for industry Waivers, Exceptions, and Exemptions from the 
Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act (August 2023) referenced therein.  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  Contains Nonbinding Recommendations 
 
This section 582(g)(1)(B) compliance policy will not apply to product that is introduced in a 
transaction into commerce by the products manufacturer or repackager on or after November 
27, 2024.    
 
 
IV.  COMPLIANCE POLICIES FOR OTHER ENHANCED DRUG DISTRIBUTION 
SECURITY REQUIREMENTS UNDER SECTION 582(G)(1) OF THE FD&C 
ACT 
 
FDA is issuing the following compliance policies with respect to the other requirements under 
section 582(g)(1) of the FD&C Act for the interoperable, electronic product tracing at the 
package level that go into effect on November 27, 2023.   
 
Until November 27, 2024, FDA does not intend to take action to enforce: 
 
  The requirement under section 582(g)(1)(A) of the FD&C Act that the transaction 
information and the transaction statements be exchanged in a secure, interoperable, 
electronic manner in accordance with the standards established under the guidance issued 
pursuant to paragraphs (3) and (4) of section 582(h); and  
 
  The requirement under section 582(g)(1)(C) of the FD&C Act that systems and processes 
for verification of product at the package level, including the standardized numerical 
identifier, be in accordance with the standards established under the guidance issued 
pursuant to section 582(a)(2) and the guidances issued pursuant to paragraphs (2), (3), 
and (4) of section 582(h). 
 
FDA believes these compliance policies will facilitate the continued use of methods currently 
used for providing, capturing, and maintaining data for the data exchange between trading 
partners for product tracing and verification while accommodating the additional time that may 
be needed for trading partners to continue to develop and refine systems and processes for 
electronic data exchange (e.g., modify IT capabilities, make business operations more routine, 
and modify business relationships as needed). 
 
In addition, until November 27, 2024, FDA does not intend to take action to enforce: 
 
  The requirement under section 582(g)(1)(D) of the FD&C Act for systems and 
processes necessary to promptly respond with the transaction information and 
transaction statement for a product upon a request by the Secretary, or other 
appropriate Federal or State official, in the event of a recall or for the purposes of 
investigating a suspect product or an illegitimate product; and 
 
  The requirement under section 582(g)(1)(E) of the FD&C Act for systems and 
processes necessary to promptly facilitate gathering the information necessary to 
produce the transaction information for each transaction going back to the 
manufacturer, as applicable (i) in the event of a request by the Secretary, or other 
appropriate Federal or State official, on account of a recall or for the purposes of 
  6  Contains Nonbinding Recommendations 
 
investigating a suspect product or an illegitimate product; or (ii) in the event of a 
request by an authorized trading partner, in a secure manner that ensures the 
protection of confidential commercial information and trade secrets, for purposes of 
investigating a suspect product or assisting the Secretary, or other appropriate Federal 
or State official, with a request described in clause (i).  Under this compliance policy, 
we recommend that trading partners respond to such requests with its relevant 
transaction information if it directly transacted the product(s) that are subject to the 
request. 
 
FDA believes these compliance policies will facilitate the continued use of methods currently 
being used by trading partners to respond to the type of requests for information described above 
while accommodating the additional time that may be needed for trading partners to mature the 
new systems and processes required for such activities under section 582(g)(1)(D) and (E) of the 
FD&C Act.  
 
Lastly, until November 27, 2024, FDA does not intend to take action to enforce the requirement 
under section 582(g)(1)(F) of the FD&C Act that each person accepting a saleable return 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 for the product.  FDA believes that this compliance policy 
will facilitate the continued use of methods currently being used by wholesale distributors26 for 
associating a saleable return product with its applicable transaction information and transaction 
statement while accommodating the additional time that may be needed for all trading partners to 
mature the new systems and processes required for acceptance of saleable returns under section 
582(g)(1)(F).  
 
The compliance policies described above balance the development of robust interoperable, 
electronic tracing of product at the package level through the pharmaceutical distribution supply 
chain with the technical and operational complexities associated with the implementation of the 
enhanced drug distribution security requirements established by the DSCSA.  FDA believes 
these compliance policies will support the development and utilization of accurate, efficient, and 
secure systems and processes to help protect patients from exposure to drugs that may be 
counterfeit, stolen, contaminated, or otherwise harmful and to ensure adequate distribution of 
finished prescription drugs throughout the supply chain.   
 
The compliance policies described in this guidance do not apply to other requirements in section 
582 of the FD&C Act. 
 
26 Section 582(c)(1)(B)(i)(II) of the FD&C Act provides that, as of Nov 27, 2019, wholesale distributors may accept 
returned product from a dispenser or repackager only if the wholesale distributor can associate returned product with 
the transaction information and transaction statement associated with that product. Under section 582(k)(2) of the 
FD&C Act, section 582(c)(1)(B)(i) sunsets on Nov 27, 2023.  
  7