Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry: Guidance for Industry

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

Wholesale Distributor
Verification Requirement for
Saleable Returned Drug
Product—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 Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified 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, or
(CBER) Office of Communication, Outreach and Development, 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)
September 2019
Procedural

Wholesale Distributor
Verification Requirement for
Saleable Returned Drug
Product—Compliance Policy
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., 4 th 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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
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)
September 2019
Procedural

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	COMPLIANCE POLICY FOR VERIFICATION OF SALEABLE RETURNED
PRODUCT ......................................................................................................................... 2

Contains Nonbinding Recommendations
1
Wholesale Distributor Verification Requirement for Saleable
Returned Drug Product—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 is intended for wholesale distributors who must verify the product identifier upon
receipt of a returned product2 that the wholesale distributor intends to further distribute as
required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360eee-1(c)(4)(D)). This guidance addresses the readiness of wholesale distributors
to comply with the provisions in section 582 of the FD&C Act related to the verification of
saleable returned drug products. The requirement under section 582(c)(4)(D) for wholesale
distributors to verify saleable returned drug products prior to redistribution goes into effect on
November 27, 2019.3
This guidance announces the Food and Drug Administration’s (FDA or the Agency) compliance
policy regarding enforcement of the verification of saleable returned product requirement under
section 582(c)(4)(D) of the FD&C Act. FDA does not intend to take action against wholesale
distributors who do not, prior to November 27, 2020, verify a product identifier prior to further
distributing returned product as required under section 582(c)(4)(D) of the FD&C Act. This
represents a one-year delay in enforcement of the requirement for wholesale distributors to verify
a product identifier prior to further distributing that returned product.
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.
1 This guidance has been prepared by the Office Regulatory Policy in the Center for Drug Evaluation and Research
(CDER) in cooperation with the Office of Compliance in CDER, the Center for Biologics Evaluation and Research
(CBER) and the Office of Regulatory Affairs (ORA) at the Food and Drug Administration.
2 Product is defined in section 581(13) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360eee(13)). Return is defined in section 581(17) of the FD&C Act.
3 See section 582(c)(4)(D) of the FD&C Act.

Contains Nonbinding Recommendations
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II. 	BACKGROUND
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into
law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act.
This section established product tracing, product identifier, authorized trading partner, and
verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers
to facilitate the tracing of a product through the pharmaceutical distribution supply chain.
Failure to comply with the requirements of section 582 is prohibited under section 301(t) of the
FD&C Act (21 U.S.C. 331(t)) and subject to enforcement action under the FD&C Act.
An important requirement of the verification scheme outlined in the DSCSA is the verification of
saleable returned product. Under section 582(c)(4)(D) of the FD&C Act, wholesale distributors
must have systems in place that will enable them to verify the product identifier, including the
standardized numerical identifier, on each sealed homogeneous case of saleable returned
product, or, if such product is not in a sealed homogeneous case, on each package of saleable
returned product. A saleable returned product may not be further distributed until the product
identifier is verified.4 The product should be handled as suspect product if the product identifier
is not successfully verified (i.e., it should be quarantined and investigated).5
III. 	COMPLIANCE POLICY FOR VERIFICATION OF SALEABLE RETURNED
PRODUCT
In the years since passage of the DSCSA, including most recently within the past year, FDA has
received comments and feedback from wholesale distributors as well as other trading partners
and stakeholders expressing concern with industry-wide readiness for implementation of the
verification of saleable returned product requirement for wholesale distributors. Specifically,
stakeholders have described challenges with implementation of verification of the product
identifier on saleable returned drug product packages or sealed homogenous cases due to a
number of factors, including: (1) the very large volume of saleable returned product requiring
verification; (2) the need to refine and test verification systems during actual production using
real-time volumes of saleable returned product rather than simply in pilots; and (3) the
complexities of building an interoperable, electronic system with the capabilities to timely and
efficiently verify the large volume of saleable returned products amid immature technologies.
Through FDA’s DSCSA pilot project program, FDA is aware that several pilot participants are
in the early stages of developing and testing interoperable, electronic systems to enable
verification and achieve interoperability between networks.
Given the concerns expressed, FDA recognizes that some wholesale distributors (in collaboration
with other trading partners) may need additional time beyond November 27, 2019, before they
can begin verifying returned products prior to resale or other further distribution as required by
4 See section 582(c)(4)(D) of the FD&C Act.
5 Section 582(c)(4)(A)(i) of the FD&C Act details how wholesale distributors must handle suspect product.

Contains Nonbinding Recommendations
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section 582(c)(4)(D) of the FD&C Act in an efficient, secure, and timely manner. To minimize
possible disruptions in the distribution of prescription drugs in the United States, FDA does not
intend to take action before November 27, 2020, against wholesale distributors who do not verify
a product identifier prior to resale or other further distribution of a package or sealed
homogenous case of product as required by section 582(c)(4)(D) of the FD&C Act.
Additionally, section 582 of the FD&C Act requires certain trading partners (manufacturers,
repackagers, wholesale distributors, and dispensers) to exchange transaction information,
transaction history, and a transaction statement when engaging in transactions involving certain
prescription drugs.6,7 Section 581(27)(E) of the FD&C Act requires that the transaction
statement include a statement that the entity transferring ownership in a transaction had systems
and processes in place to comply with verification requirements under section 582. FDA
recognizes that wholesale distributors may not have systems in place by November 27, 2019, to
enable the wholesale distributor to timely and efficiently comply with the verification of saleable
returned product requirements under section 582(c)(4)(D) of the FD&C Act without potentially
causing a disruption to the pharmaceutical distribution supply chain. Therefore, prior to
November 27, 2020, FDA does not intend to take action against a wholesale distributor for
providing a transaction statement to a subsequent purchaser of product on the basis that such
wholesale distributor does not yet have systems and processes in place to comply with the
saleable return verification requirements under section 582(c)(4)(D).
This compliance policy is limited to the requirements that wholesale distributors verify saleable
returned products prior to further distribution and have verification systems in place to comply
with the requirements of section 582(c)(4)(D) of the FD&C Act; it does not extend to the other
requirements in section 582 of the FD&C Act. For example, it does not affect the requirement
that a wholesale distributor must have verification systems in place to determine whether a
returned product is a suspect product.8 This compliance policy does not affect the requirement
that beginning November 27, 2019, a wholesale distributor may engage in transactions involving
a product only if such product is encoded with a product identifier (except as provided pursuant
to section 582(a)(5) of the FD&C Act).9 This compliance policy does not relieve a manufacturer
of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a
request for verification from a wholesale distributor. Further, beginning November 27, 2019,
wholesale distributors must only accept returned product from a dispenser or repackager if the
wholesale distributor can associate returned product with the transaction information and
transaction statement associated with that product.10
This compliance policy is not applicable with respect to returns of saleable packages and sealed
homogeneous cases of product without product identifiers that were in the pharmaceutical
distribution supply chain before November 27, 2018. The guidance for industry Grandfathering
6 Transaction, transaction history, transaction information, and transaction statement are defined under sections
581(24), (25), (26), and (27) of the FD&C Act.
7 See section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act.
8 See section 582(c)(4)(A) of the FD&C Act.
9 See section 582(c)(2) of the FD&C Act.
10 See section 582(c)(1)(B)(i)(II) of the FD&C Act.

Contains Nonbinding Recommendations
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Policy for Packages and Homogenous Cases of Product Without a Product Identifier (September
2018), addresses such returns.11
11 We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page
at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.