Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Requirements for Transactions with
First Responders under Section 582
of the Federal Food, Drug, and
Cosmetic Act —
Compliance Policy
Guidance for Industry
This guidance is for immediate implementation.
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 Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. You should identify all comments with the docket number listed in the notice of
availability that publishes in the Federal Register.
For questions regarding this document contact CDER Office of Compliance at 301-796-3130 or
drugtrackandtrace@fda.hhs.gov.
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)
February 2017
Procedural
Revision 1

Requirements for Transactions with
First Responders under Section 582
of the Federal Food, Drug, and
Cosmetic Act —
Compliance Policy
Guidance for Industry
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Email: ocod@fda.hhs.gov
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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)
February 2017
Procedural
Revision 1

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	SCOPE OF THIS GUIDANCE ....................................................................................... 3
IV. 	SECTION 582 REQUIREMENTS FOR TRANSACTIONS WITH FIRST
RESPONDERS – COMPLIANCE POLICY ................................................................. 3
A. 	For trading partners transfering ownership of product to first responders ............................ 4
B. 	For first responders ....................................................................................................................... 5

Contains Nonbinding Recommendations
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Requirements for Transactions with First Responders under Section
582 of the Federal Food, Drug, and Cosmetic Act—
Compliance Policy
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 addresses the compliance of dispensers2 that engage in transactions3 with first
responders4 and the compliance of first responders with the provisions in section 582 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1) related to the
exchange of product tracing information (i.e., transaction information, transaction history, and
transaction statements) and verification. This guidance also addresses the compliance of trading
partners5 that engage in transactions with first responders with the requirement for conducting
business only with authorized trading partners. The requirements related to the exchange of
product tracing information took effect on July 1, 2015 for dispensers. Requirements for
verification and conducting business only with authorized trading partners went into effect for all
trading partners on January 1, 2015.
This guidance describes FDA’s compliance policy regarding certain requirements in section 582
of the FD&C Act for transactions with first responders. Specifically, FDA does not intend to
take action against a dispenser who transfers ownership of a product6 directly to a first responder
without providing product tracing information to the first responder, as required by sections
582(c)(1)(A)(ii)-(iv) and (d)(1)(A)(ii) of the FD&C Act, provided that the conditions enumerated
in Section IV. A of this guidance are met. FDA also does not intend to take action against
trading partners who conduct business with a first responder that is not “authorized” as a
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory
Affairs (ORA) at the Food and Drug Administration.
2 “Dispenser” is defined under FD&C Act § 581(3).
3 “Transaction” is defined under FD&C Act § 581(24).
4 For the purpose of this guidance, the term “first responder” is defined in Section III. of this guidance.
5 “Trading partner” is defined under FD&C Act § 581(23)(A). Although third-party logistics providers are also
considered trading partners under FD&C Act § 581(23)(B), the requirements of sections 582(a)-(e) are not
applicable to them.
6 “Product” is defined under FD&C Act § 581(13).

Contains Nonbinding Recommendations
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dispenser within the meaning of section 581(2)(D) of the FD&C Act. In addition, FDA does not
intend to take action against a first responder who: (1) accepts ownership of product without first
receiving the product tracing information as required by section 582(d)(1)(A)(i) of the FD&C
Act and does not capture and maintain product tracing information as required by section
582(d)(1)(A)(iii) of the FD&C Act; or (2) does not comply with the dispenser requirements for
verification of suspect or illegitimate product described in section 582(d)(4) of the FD&C Act.
This compliance policy is in effect until further notice by FDA.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. 	BACKGROUND
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into
law on November 27, 2013. The DSCSA outlines critical steps to build an electronic,
interoperable system to identify and trace products as they are distributed in the United States.
Section 202 of the DSCSA added sections 581 and 582 to the FD&C Act, which set forth various
definitions and requirements for trading partners.
To help build the product tracing system envisioned by the DSCSA, trading partners generally
are required under sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to provide
subsequent purchasers of product with specific product tracing information. Trading partners are
also generally required under sections 582(b)(4), (c)(4), (d)(4) and (e)(4) to have systems in
place to enable the verification of suspect and illegitimate product. Furthermore, sections
582(b)(3), (c)(3), (d)(3), and (e)(3) specify that the trading partners of manufacturers, wholesale
distributors, dispensers, and repackagers must be “authorized” within the meaning of section
581(2) of the FD&C Act.

Contains Nonbinding Recommendations
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III. 	SCOPE OF THIS GUIDANCE
This guidance applies to transactions between a trading partner and a first responder.7 For the
purpose of this guidance, a “first responder” is any person: (1) who is authorized by law to
administer a product in accordance with section 503(b)(1) of the FD&C Act, (2) is responsible
for the emergency treatment of ill or injured persons, and (3) provides such emergency treatment
outside of a health care facility. 8 First responders may include employees of Federal, State, and
local law enforcement, and governmental and nongovernmental fire/rescue and ambulance
services.
IV. 	SECTION 582 REQUIREMENTS FOR TRANSACTIONS WITH FIRST
RESPONDERS – COMPLIANCE POLICY
FDA understands that some dispensers, such as hospital pharmacies, provide prescription drugs
to first responders for use in the emergency treatment of ill or injured persons – often in small
quantities or on a periodic basis – and that such dispensers may lack the resources to provide
product tracing information for these transactions. FDA also understands that some first
responders may not meet the definition of “authorized” dispensers under section 581(2) of the
FD&C Act because they do not have a valid license under state law. Nevertheless, they may be
authorized, in accordance with applicable law, to administer certain products without a license,
such as pursuant to proscribed standards of practice and medical treatment protocols. FDA also
recognizes that first responders may lack the resources to comply with certain requirements
under section 582(d) of the FD&C Act, including receipt, capture and maintenance of product
tracing information and verification.
7 As a general matter, we note that some, but not all, activities covered by the compliance policy described in this
guidance might also be subject to certain statutory exemptions recognized in sections 581 and 582 of the FD&C Act.
For example, section 581(24)(B) specifies eighteen exemptions from the definition of “transaction,” which, in turn,
make the product tracing requirements specified in sections 582(c)(1)(A) and (d)(1)(A) inapplicable to activities
covered by those exemptions. This guidance does not interpret the scope of section 581(24)(B) or other statutory
exemptions described in sections 581 and 582.
8 Examples of health care facilities include physician offices, hospital emergency rooms, and urgent care centers.
Although health care practitioners are not included within the definition of “first responder” under this guidance
when providing treatment in a health care facility, we note that certain health care practitioners who meet the
definition of “dispenser” under section 581(3) are nevertheless exempt from certain requirements of section 582(d)
of the FD&C Act. Under section 582(d)(5) of the FD&C Act, the requirements of section 582(d)(1) and (d)(4) do
not apply to “licensed health care practitioners authorized to prescribe or administer medication under State law or
other licensed individuals under the supervision or direction of such practitioners who dispense or administer
product in the usual course of professional practice.”

Contains Nonbinding Recommendations
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To minimize possible disruptions to the activities of first responders, FDA does not intend to
take action against certain trading partners and first responders as described below. This
compliance policy is in effect until further notice by FDA.
A. For trading partners transferring ownership of products to first responders
FDA does not intend to take action against a dispenser who transfers ownership of product
directly to a first responder where the dispenser does not provide the first responder with product
tracing information (i.e., a transaction information, transaction history, and transaction
statement), as required by sections 582(c)(1)(A)(ii)-(iv) and (d)(1)(A)(ii) of the FD&C Act,9
provided that:
• 	the dispenser captures and maintains the product tracing information for such
transaction (including the creation of the product tracing information, prior to, at the
time of transaction, or, if necessary shortly thereafter) for not less than six years after
the transaction, as required under sections 582(c)(1)(A)(v) and (d)(1)(A)(iii) of the
FDC& Act; and
• 	the dispenser provides such product tracing information to the first responder or
Secretary, if requested, not later than two business days after receiving the request or
in such other reasonable time as determined by the Secretary, based on the
circumstances of the request.
FDA also does not intend to take action against a trading partner that transfers ownership of a
product to a first responder who is not “authorized” as a dispenser within the meaning of section
581(2)(D) of the FD&C Act.
This compliance policy does not extend to the other requirements of section 582, including the
requirement for manufacturers, wholesale distributors, dispensers, and repackagers to verify
suspect and illegitimate product (including quarantine, investigation, notification and
recordkeeping) under sections 582(b)(4), (c)(4), (d)(4) and (e)(4) of the FD&C Act, respectively.
In addition, this compliance policy does not extend to any other requirement of the FD&C Act
that may apply, including sections 503 and 583.
9 A trading partner may meet the definition of more than one entity depending on the activities in which it engages.
In the event that a trading partner meets the definition of more than one entity, pursuant to section 582(a)(1), it must
comply with all applicable requirements, but trading partners are not required to duplicate requirements. For
guidance on this provision, please refer to “DSCSA Standards for the Interoperable Exchange of Information for
Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.”

Contains Nonbinding Recommendations
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B. For first responders
FDA does not intend to take action against a first responder who:
• 	accepts ownership of product without first receiving the product tracing information, as
required by section 582(d)(1)(A)(i) of the FD&C Act and does not capture and maintain
product tracing information as required by section 582(d)(1)(A)(iii) of the FD&C Act; or
• 	does not have systems in place to enable the verification of suspect and illegitimate
product as required by section 582(d)(4) of the FD&C Act.
If a first responder believes it has received suspect or illegitimate product, FDA strongly
recommends that the first responder take steps to protect patients from receiving illegitimate
product, which includes quarantine and investigation of such product, contacting appropriate
authorities, and working with the previous owner to prevent further distribution of such product.
This compliance policy does not extend to the other requirements of section 582, including the
requirement that the first responder conduct business only with authorized trading partners under
section 582(d)(3) of the FD&C Act. In addition, this compliance policy does not extend to any
other requirement of the FD&C Act that may apply, including sections 503 and 583.