Exemption and Exclusion From 
Certain Requirements of the 
Drug Supply Chain Security 
Act for the Distribution of 
FDA-Approved Naloxone 
Products During the Opioid 
Public Health Emergency
 
Guidance for Industry 
 
This guidance is for immediate implementation. 
 
 
FDA is issuing 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, 301-796-3130. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2022 
Procedural 
 
    
Exemption and Exclusion From 
Certain Requirements of the 
Drug Supply Chain Security 
Act for the Distribution of 
FDA-Approved Naloxone 
Products During the Opioid 
Public Health Emergency 
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 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
 
September 2022 
Procedural 
 
    Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  BACKGROUND ........................................................................................................ 3 
A.  Naloxone ...................................................................................................................... 3 
B.  DSCSA......................................................................................................................... 3 
III.  SCOPE OF THE EXEMPTION AND EXCLUSION DURING THE OPIOID 
PUBLIC HEALTH EMERGENCY ...................................................................................... 5 
A.  DSCSA Statutory Exemption and Exclusion for Public Health Emergency........................ 5 
1. Exemption From Certain Product Tracing and Product Identification Requirements Under 
Section 582 of the FD&C Act ............................................................................................... 5 
2. Exclusion From Wholesale Distribution Under Section 503(e) of the FD&C Act ...................... 6 
B.  Authorized Trading Partner RequirementsCompliance Policy During the Opioid Public 
Health Emergency ................................................................................................................ 7 
C.  Time Frame.................................................................................................................. 7 
IV.  BUSINESS WITH TRUSTED SOURCES ................................................................. 7 
  Contains Nonbinding Recommendations 
Exemption and Exclusion From Certain Requirements of the Drug 
Supply Chain Security Act for the Distribution of FDA-Approved 
Naloxone Products During the Opioid Public Health Emergency 
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  
 
Combating the opioid overdose epidemic is an urgent public health priority for FDA.  The 
Agency is committed to advancing solutions to reduce opioid overdose deaths in the United 
States, including by supporting efforts to increase public availability of and access to naloxone.  
 
The opioid crisis was initially declared a public health emergency under section 319 of the 
Public Health Service Act on October 26, 2017, and the determination that a public health 
emergency exists has been subsequently renewed at 90-day intervals.2  Naloxone hydrochloride 
(naloxone) is medication that rapidly reverses the effects of opioid overdose and is the 
standard treatment for opioid overdose.3  FDA believes that this lifesaving drug can help address 
the devastating consequences of the opioid overdose epidemic and supports efforts to make this 
emergency treatment more readily available and more accessible. 
 
FDA understands that naloxone is being made available to underserved communities through 
entities such as harm reduction programs.  FDA is issuing this guidance to support efforts by 
these entities to facilitate public availability of and access to FDA-approved naloxone products 
for emergency treatment of opioid overdoses, particularly in underserved communities.  FDA is 
aware of concerns that harm reduction programs are having difficulty acquiring naloxone.4  The 
 
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research at 
the Food and Drug Administration.  
2 See the October 26, 2017, U.S. Department of Health and Human Services web page Determination That a Public 
Health Emergency Exists, available at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/opioids.aspx) and subsequent renewals of the 
determination, available at the Public Health Emergency Declarations web page at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.   
3 See FDAs web page Information About Naloxone, available at https://www.fda.gov/drugs/postmarket-drug-
safety-information-patients-and-providers/information-about-naloxone.  
4 A web link to the March 29, 2022, public meeting Naloxone Access: Answering Questions, hosted in collaboration 
with the Reagan-Udall Foundation for the FDA, is available on FDAs web page at 
 
  1  Contains Nonbinding Recommendations 
Agency is also aware that some stakeholders consider contributing factors to be the current 
availability of approved naloxone products only as prescription drugs and certain requirements 
under the Drug Supply Chain Security Act (DSCSA)5 for distribution of FDA-approved 
prescription drug products, e.g., being an authorized trading partner.6 
 
To help facilitate the availability of naloxone to harm reduction programs, FDA is issuing this 
guidance to clarify the scope of the public health emergency exclusion and exemption under the 
DSCSA as they apply to the distribution of FDA-approved naloxone products indicated for the 
emergency treatment of opioid overdose to harm reduction programs during the opioid public 
health emergency.  This guidance is limited to clarifying the applicability of this public health 
emergency exclusion and exemption only with respect to the distribution of such naloxone 
products to:  
 
(1)  Organizations, referred to in this guidance as harm reduction programs, that provide 
harm reduction7 services to individuals at risk of experiencing an opioid overdose or 
those who might respond to an overdose, including providing FDA-approved naloxone 
products to such individuals  
 
(2)  Entities/organizations, referred to in this guidance as harm reduction suppliers, that 
distribute FDA-approved naloxone products to harm reduction programs   
 
The guidance does not address the applicability or FDAs interpretation of the public health 
emergency exclusion or exemption under the DSCSA as they relate to the distribution of other 
products during the opioid public health emergency or the distribution of FDA-approved 
naloxone products among entities other than harm reduction programs or harm reduction 
suppliers during the opioid public health emergency.  Further, the prescription status of drug 
products and prescription requirements under federal and state law are beyond the scope of this 
guidance.8  Therefore, this guidance does not address the prescription-only status of FDA-
approved naloxone products.  
 
 
https://www.fda.gov/drugs/news-events-human-drugs/naloxone-access-answering-questions-03292022#event-
information.  
5 Title II of Public Law 113-54 (November 23, 2013).  The Agency has recently become aware of concerns related 
to naloxone distribution in light of certain DSCSA requirements. 
6 Under sections 582(b)(3), 582(c)(3), 582(d)(3), and 582(e)(3) of the FD&C Act, respectively, the trading partners 
of a manufacturer, a wholesale distributor, a repackager, or a dispenser must be authorized trading partners.  The 
term trading partner is defined in section 581(23) of the FD&C Act and includes manufacturers, repackagers, 
wholesale distributors, dispensers, and third-party logistics providers (which are respectively defined in sections 
581(10), (16), (29), (3), and (22) of the FD&C Act).  The term authorized, with respect to a trading partner, is 
defined in section 581(2) of the FD&C Act.   
7 See https://www.samhsa.gov/find-help/harm-reduction.  Harm reduction services can include distribution of opioid 
overdose reversal medications (e.g., naloxone) to individuals at risk of overdose, or to those who might respond to 
an overdose; lessening harms associated with drug use and related behaviors that increase the risk of infectious 
diseases, including HIV, viral hepatitis, and bacterial and fungal infections; and reducing overdose deaths, 
promoting linkages to care, and facilitating co-location of services as part of a comprehensive, integrated approach. 
8 The public health emergency exclusion and exemption addressed in this guidance have no impact on the status of a 
drug product as a prescription drug.  
  2  Contains Nonbinding Recommendations 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
This guidance is being implemented without prior public comment because FDA has determined 
that prior public participation for this guidance is not feasible or appropriate (see section 
701(h)(1)(C) of the Federal Food, Drug and Cosmetic (FD&C) Act (21 U.S.C. 371(h)(1)(C)) and 
21 CFR 10.115(g)(2)).  There is an urgent public health need to facilitate and expedite access to 
naloxone for emergency medical reasons under the opioid public health emergency.  FDA has 
determined that the clarifications set forth in this guidance will help to address this need.  This 
guidance document is being implemented immediately, but it remains subject to comment in 
accordance with the Agencys good guidance practices. 
 
 
II.  BACKGROUND 
 
A.  Naloxone  
 
On October 26, 2017, the Acting Secretary of Health and Human Services (HHS) issued a 
determination,9 in accordance with section 319(a)(2) of the Public Health Service (PHS) Act (42 
U.S.C. 247d(a)(2)), that a public health emergency exists as a result of the continued 
consequences of the opioid crisis.  The declaration has been subsequently renewed at 90-day 
intervals and remains in place as of the publication date of this guidance.  Addressing opioid 
overdose continues to be one of the most urgent public health priorities for FDA.  
 
Naloxone is a critical drug to help reduce opioid overdose deaths.  There are three FDA-
approved forms of naloxone (injectable, auto-injector, and nasal spray) and all three currently 
require a prescription.  FDA understands that naloxone is being made available to underserved 
communities through harm reduction programs, but that access to naloxone continues to be 
limited in some communities.  
 
FDA is issuing this guidance to clarify the applicability of an exemption and exclusion from 
certain DSCSA requirements, with respect to the distribution of FDA-approved naloxone 
products to harm reduction programs and to harm reduction suppliers during the opioid public 
health emergency.  We believe clarifying the applicability of this exemption and exclusion will 
help facilitate and expedite the distribution of naloxone to harm reduction programs on the front 
lines of the opioid overdose crisis, and thus directly aid in addressing this public health 
emergency.  
 
B.  DSCSA 
 
The DSCSA (Title II of Pub. L. 113-54) was signed into law on November 27, 2013.  Section 
202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), establishing the 
 
9 See footnote 2. 
  3  Contains Nonbinding Recommendations 
product tracing, product identifier, authorized trading partner, and verification requirements for 
manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of 
products through the pharmaceutical distribution supply chain. 
 
The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 
2023, that will enable the identification and tracing of certain prescription drugs as they are 
distributed within the United States.  For example, since 2015, for each transaction10 of 
product,11 trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) 
are required under section 582 of the FD&C Act to capture, maintain, and provide subsequent 
purchasing trading partners with transaction information, transaction history, and a transaction 
statement (product tracing information) and to notify FDA and certain immediate trading 
partners when they have determined that a product in their possession or control is an illegitimate 
product.  By 2018, manufacturers and repackagers were required to begin affixing or imprinting 
a product identifier to each package and homogenous case of a product intended to be introduced 
in a transaction into commerce.12  Once products have product identifiers affixed or imprinted on 
them, manufacturers and repackagers are required to verify products using the product identifiers 
in circumstances specified in section 582.  In addition, sections 583 and 584 of the FD&C Act 
(21 U.S.C. 360eee-2 and 360eee-3), as added by the DSCSA, direct FDA to establish national 
licensure standards for wholesale distributors and third-party logistics providers and require that 
these entities report licensure and other information to FDA annually. 
 
Under the DSCSA, specific activities are automatically excluded from certain DSCSA 
requirements upon the declaration of a public health emergency under section 319 of the PHS 
Act.  The distribution13 of a product for emergency medical reasons, including a public health 
emergency declaration pursuant to section 319 of the PHS Act, is exempted from the definition 
of a transaction14 and excluded from the definition of wholesale distribution15 under the DSCSA.  
 
 
 
10 Transaction is defined as the transfer of product between persons in which a change of ownership occurs (section 
581(24)(A) of the FD&C Act (21 U.S.C. 360eee(24)(A)).  For specific exemptions, see section 581(24)(B) of the 
FD&C Act. 
11 Product is defined as a prescription drug for human use in a finished dosage form for administration to a patient 
without further manufacturing (section 581(13) of the FD&C Act).  See section 581(13) of the FD&C Act for 
specific exclusions. 
12 Sections 582(b)(2)(A) and (e)(2)(A) of the FD&C Act. 
13 In section 581(5) of the FD&C Act, distribute or distribution is defined as the sale, purchase, trade, delivery, 
handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription 
executed in accordance with section 503(b)(1) [of the FD&C Act (21 U.S.C. 353(b)(1))] or dispensing of a product 
approved under section 512(b) of the FD&C Act (21 U.S.C. 360b(b)).  
14 Section 581(24)(B)(iii) of the FD&C Act exempts from the definition of transaction the distribution of a product 
for emergency medical reasons[,] including a public health emergency declaration pursuant to section 319 of the 
Public Health Service Act, except that a drug shortage not caused by a public health emergency shall not constitute 
an emergency medical reason.   
15 Wholesale distribution is defined as distribution of a drug . . . to a person other than a consumer or patient, or 
receipt of a drug . . . by a person other than [a] consumer or patient (section 503(e)(4) of the FD&C Act).  Section 
503(e)(4)(C) excludes from the definition of wholesale distribution, the distribution of a drug or an offer to 
distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to 
section 319 of the Public Health Service Act, except that . . . a drug shortage not caused by a public health 
emergency shall not constitute an emergency medical reason. 
  4  Contains Nonbinding Recommendations 
III.  SCOPE OF THE EXEMPTION AND EXCLUSION DURING THE OPIOID 
PUBLIC HEALTH EMERGENCY 
 
A.  DSCSA Statutory Exemption and Exclusion for Public Health Emergency 
 
The declaration of the opioid public health emergency pursuant to section 319 of the PHS Act 
automatically triggered two statutory provisions in the FD&C Act under which, for the duration 
of the declaration, certain DSCSA requirements do not apply to a range of product distribution 
activities to address the public health emergency.16  These automatically-triggered statutory 
provisions are as follows: 
 
  The exemption of certain product distribution activities from the definition of transaction 
under FD&C Act section 581(24) 
 
  The exclusion of certain product distribution activities from the definition of wholesale 
distribution under FD&C Act section 503(e)(4) 
 
FDA interprets the above exemption and exclusion to apply to the distribution of FDA-approved 
naloxone products to harm reduction programs and to harm reduction suppliers to address the 
opioid public health emergency during the public health emergency.   
 
This exemption and exclusion provided under the DSCSA during the opioid public health 
emergency strike a balance between the need to facilitate the effective distribution of lifesaving 
FDA-approved naloxone products to harm reduction programs and harm reduction suppliers 
under emergency conditions while helping to protect consumers from exposure to products that 
may be counterfeit, stolen, or otherwise harmful. 
 
The scope of this guidance is limited to FDAs interpretation of the DSCSA exemption from 
transaction and the exclusion from wholesale distribution, for emergency medical reasons 
including a public health emergency, only as they apply to the distribution of FDA-approved 
naloxone products to harm reduction programs and to harm reduction suppliers during the opioid 
public health emergency.  This guidance does not address the distribution of other products 
during the opioid public health emergency.  It also does not address the distribution of FDA-
approved naloxone products among entities other than harm reduction programs or harm 
reduction suppliers during the opioid public health emergency.   
 
1.  Exemption From Certain Product Tracing and Product Identification 
Requirements Under Section 582 of the FD&C Act 
 
Because the statutory definition of transaction explicitly exempts the distribution of a product 
for emergency medical reasons including a public health emergency declaration pursuant to 
section 319 of the [PHS] Act,17 the product tracing and product identification requirements in 
 
16 See sections 581(24)(B)(iii) and 503(e)(4)(C) of the FD&C Act.  
17 See section 581(24)(B)(iii) of the FD&C Act. 
  5  Contains Nonbinding Recommendations 
section 582 of the FD&C Act that are triggered18 by a transaction do not apply to the 
distribution of FDA-approved naloxone products to harm reduction programs or harm reduction 
suppliers during the opioid public health emergency.  This means that trading partners engaged 
in the distribution of FDA-approved naloxone products to harm reduction programs and harm 
reduction suppliers, and the harm reduction programs and harm reduction suppliers obtaining 
naloxone through such distribution, are not required to comply with the product tracing and 
product identification requirements in section 582 of the FD&C Act that are triggered by a 
transaction during the opioid public health emergency.19   
 
However, if a trading partner is also distributing product during the opioid public health 
emergency for purposes unrelated to addressing the public health emergency, then that trading 
partner must comply with all applicable DSCSA requirements with respect to distribution of 
such product.  
 
2.  Exclusion From Wholesale Distribution Under Section 503(e) of the FD&C Act 
 
The statutory definition of wholesale distribution under section 503(e)(4) of the FD&C Act 
explicitly excludes the distribution of a drug . . . for emergency medical reasons, including a 
public health emergency declaration pursuant to section 319 of the [PHS] Act.20  As a result, 
DSCSA requirements related to wholesale distribution do not apply to the distribution of FDA-
approved naloxone products to address the opioid public health emergency.  This means that 
harm reduction suppliers that are distributing FDA-approved naloxone products are not required 
to comply with the DSCSAs licensure provisions and reporting requirements under section 
503(e) of the FD&C Act or the wholesale distributor requirements under section 582 of the 
FD&C Act during the opioid public health emergency, for such distribution activity.  For 
example, an organization that obtains FDA-approved naloxone products from a manufacturer 
and distributes them to harm reduction programs during the opioid public health emergency 
would not be required to be licensed as a wholesale distributor and would not be subject to 
DSCSA requirements related to wholesale distribution, with respect to such distribution activity.  
However, if a harm reduction supplier is also distributing product unrelated to addressing the 
public health emergency, then that trading partner must comply with all applicable DSCSA 
requirements with respect to wholesale distribution of that product. 
   
 
18 Id.  As noted above, this section specifies that a drug shortage not caused by a public health emergency does not 
constitute an emergency medical reason.  The exemption provided under section 581(24)(B)(iii) of the FD&C Act 
does not apply to DSCSA requirements under section 582 of the FD&C Act that are not triggered by a transaction.  
For example, the requirements that trading partners conduct verification as required by section 582(b)(4), (c)(4), 
(d)(4), and (e)(4) of the FD&C Act and investigate suspect or illegitimate product are not triggered by a 
transaction.  Suspect product and illegitimate product are defined in section 581(21) and (8) of the FD&C Act, 
respectively.  
19 To the extent that compliance with DSCSA requirements covered by an exemption or exclusion is not a barrier to 
timely distribution of FDA-approved naloxone products, entities should continue to comply with those requirements 
during the opioid public health emergency. 
20 See section 503(e)(4)(C) of the FD&C Act. 
  6  Contains Nonbinding Recommendations 
B.  Authorized Trading Partner RequirementsCompliance Policy During the 
Opioid Public Health Emergency 
 
Although the authorized trading partner requirements still apply in most circumstances during 
the opioid public health emergency, FDA generally does not intend to take enforcement action 
against trading partners during the opioid public health emergency for engaging in either of the 
following activities:  
 
(1)  Distribution of FDA-approved naloxone products to harm reduction suppliers that 
would otherwise meet the definition of wholesale distributor under the DSCSA, except 
thatas a result of the exclusion from the definition of wholesale distribution for 
emergency medical reasonsthese entities would not be considered wholesale 
distributors because they are currently engaged in distributing FDA-approved naloxone 
products for emergency medical reasons resulting from the opioid public health 
emergency.  
 
(2)  Distribution of FDA-approved naloxone products directly to harm reduction programs 
that are not authorized trading partners, including through product donations. 
 
C.  Time Frame 
 
The policies described in this guidance, including the compliance policy and interpretation of the 
exemption and exclusion from certain DSCSA requirements, apply only during the opioid public 
health emergency.  The opioid public health emergency will last until the HHS Secretary 
declares that the public health emergency no longer exists or until it expires 90 days after the 
date of an opioid public health emergency determination, whichever occurs first.21  The HHS 
Secretary may extend the opioid public health emergency determination for subsequent 90-day 
periods for as long as the public health emergency related to the opioid epidemic continues to 
exist.22 
 
 
IV.  BUSINESS WITH TRUSTED SOURCES 
 
Some people and companies may try to profit from the opioid epidemic by selling unproven and 
illegally marketed products with false claims, such as claims that the products are effective in the 
diagnosis, treatment, or prevention of opioid overdoses.  Some of these products may result in 
serious adverse health consequences.  FDA cautions harm reduction programs against obtaining 
naloxone from untrusted sources.23  Buying drugs from untrusted sources could put patients at 
risk of receiving drugs that may be ineffective or harmful such as counterfeit, stolen, diverted, or 
intentionally adulterated products.   
 
21 See section 319(a)(2) of the PHS Act. 
22 Id.  
23 FDA provides information to help educate health care providers about buying medicines from licensed sources, 
which may be a helpful resource for harm reduction programs.  See FDAs Know Your Source web page, 
available at https://www.fda.gov/drugs/information-health-care-professionals-drugs/know-your-source-protecting-
patients-unsafe-drugs.  
  7