Product Identifier Requirements Under the Drug Supply Chain Security 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.

Product Identifier Requirements
Under the Drug Supply Chain
Security Act –
Compliance Policy
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)
September 2018
Procedural

Product Identifier Requirements
Under the Drug Supply Chain
Security Act –
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., 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/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/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)
September 2018
Procedural

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. INTRODUCTION ...................................................................................................... 1
II. BACKGROUND ........................................................................................................ 2
III. COMPLIANCE POLICY FOR THE PRODUCT IDENTIFIER REQUIREMENT ..
.................................................................................................................................... 2
IV. RELATIONSHIP TO “GRANDFATHERED” PRODUCTS UNDER SECTION
582(a)(5)(A) OF THE FD&C ACT............................................................................. 3

Contains Nonbinding Recommendations
1
Product Identifier Requirements Under the Drug Supply Chain
Security 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 staff responsible for this guidance as listed on the
title page.
I. INTRODUCTION
This guidance describes FDA’s compliance policy with regard to a requirement related to
product identifiers under the Drug Supply Chain Security Act. Specifically, this guidance
addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product
identifier2 to each package3 and homogenous case4 of a product5 intended to be introduced in a
transaction6 into commerce” beginning not later than November 27, 2017.7
The compliance policy set forth in this guidance applies only to the requirement regarding
product identifiers described above. In brief, FDA does not intend to take action against
manufacturers who do not affix or imprint a product identifier to each package and homogenous
case of product before November 27, 2018. This represents a one year delay in enforcement of
the requirement for manufacturers to affix or imprint product identifiers.
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
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 Product identifier is defined in section 581(14) of the FD&C Act (21 U.S.C. 360eee(14)) as a standardized graphic
that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards
developed by a widely recognized international standards development organization, the standardized numerical
identifier, lot number, and expiration date of the product.
3 Package is defined in section 581(11) of the FD&C Act.
4 Homogeneous case is defined in section 581(7) of the FD&C Act. The terms “homogeneous” and “homogenous”
are used interchangeably throughout the DSCSA. FDA has chosen to use only the term “homogenous” throughout
this guidance.
5 Product is defined in section 581(13) of the FD&C Act.
6 Transaction is defined in section 581(24) of the FD&C Act.
7 See section 582(b)(2)(A) of the FD&C Act.

Contains Nonbinding Recommendations
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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. 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 product tracing scheme outlined in the DSCSA is the product
identifier. Section 582 requires that each package and homogenous case of product in the
pharmaceutical distribution supply chain bear a product identifier in both a human-readable form
and on a machine-readable data carrier. The product identifier includes the product’s
standardized numerical identifier,8 lot number, and expiration date. Manufacturers are 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 no later than November 27,
2017. Repackagers are required to do the same no later than November 27, 2018.9
Since product packaged by a manufacturer during the one year delay in enforcement of the
product identifier requirement is also subject to the policy set forth in the final guidance
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product
Identifier (grandfathering policy), trading partners should read that final guidance to understand
how to treat such product for the purposes of the product identifier and verification
requirements.10
III. COMPLIANCE POLICY FOR THE PRODUCT IDENTIFIER REQUIREMENT
8 Standardized numerical identifier is defined in section 581(20) of the FD&C Act as 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.
9 See section 582(e)(2)(A)(i) of the FD&C Act.
10 Final guidance for industry Grandfathering Policy for Packages and Homogenous Cases of Product Without a
Product Identifier. We update guidances periodically. To make sure you have the most recent version of a
guidance, check the FDA Drugs or Biologics guidance web pages at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm .

Contains Nonbinding Recommendations
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In the years since passage of the DSCSA, FDA had received comments and feedback from
manufacturers and other trading partners11 expressing concern with industry-wide readiness for
implementation of the product identifier requirements for manufacturers. Specifically,
stakeholders had described challenges with implementation of manufacturer product identifier
requirements due to: (1) a limited number of vendors have the expertise to provide solutions
related to information technology systems for data management or specific equipment for
packaging or manufacturing lines, and (2) capabilities and readiness of contract facilities that
perform manufacturing operations on behalf of the manufacturer.
Given the concerns expressed, FDA has recognized that some manufacturers may need
additional time beyond November 27, 2017, to ensure that products are properly affixed or
imprinted with a product identifier. To minimize possible disruptions in the distribution of
prescription drugs in the United States, FDA does not intend to take action against manufacturers
who do not affix or imprint a product identifier to each package and homogenous case of product
as required by section 582(b)(2)(A) of the FD&C Act if the package and homogeneous case of
product was packaged by the manufacturer on or after November 27, 2017, but before November
27, 2018.
This compliance policy applies solely to packages and homogenous cases of product without
product identifiers that are packaged by a manufacturer on or after November 27, 2017, but
before November 27, 2018. The compliance policy does not apply to any other provision of
section 582, including the requirement for repackagers to affix or imprint a product identifier on
each package or homogenous case of product intended to be introduced in a transaction into
commerce beginning November 27, 2018.12
IV. RELATIONSHIP TO “GRANDFATHERED” PRODUCTS UNDER SECTION
582(A)(5)(A) OF THE FD&C ACT
FDA has issued the final guidance Grandfathering Policy for Packages and Homogenous Cases
of Product Without a Product Identifier, which outlines the circumstances in which packages and
homogenous cases of product not labeled with a product identifier shall be subject to the
grandfathering exemption set forth in section 582(a)(5)(A) of the FD&C Act (grandfathered).13
Specifically, a package or homogenous case of product without a product identifier that was
packaged by a manufacturer or repackaged by a repackager before November 27, 2018, is
grandfathered as described in that guidance. Trading partners should read the grandfathering
policy for a more detailed description of their responsibilities as they relate to products without a
11 For this guidance, trading partner is defined as described in section 581(23)(A) of the FD&C Act (21 U.S.C.
30eee(23)(A)). Although third-party logistics providers are also considered trading partners under section
581(23)(B) (21 U.S.C. 30eee(23)(B)) of the FD&C Act, the product tracing requirements of section 582 are not
applicable to them.
12 See section 582(e)(2)(A)(i) and (iii) of the FD&C Act.
13 Section 582(a)(5)(A) of the FD&C Act gives FDA the authority to exempt packages and homogenous cases of
product without a product identifier from certain requirements of section 582. See the final guidance for industry
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, for more
information.

Contains Nonbinding Recommendations
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product identifier that were packaged by a manufacturer or repackaged by a repackager before
November 27, 2018.