DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry

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

DSCSA Implementation:
Product Tracing Requirements
for Dispensers
— Compliance Policy
(Revised)
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
http://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 Docket Number FDA-2015-D-2270.
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)
October 2015
Procedural

D SCSA Implementation:
Product Tracing Requirements
for Dispensers
— Compliance Policy
(Revised)
Guidance for Industry
Additional copies are available from:
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Center for Drug Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
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Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-7800
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
Center for Biologics Evaluation and Research
Office of Regulatory Affairs
October 2015
Procedural

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	SCOPE OF THIS GUIDANCE ....................................................................................... 2
IV. 	PRODUCT TRACING REQUIREMENTS FOR DISPENSERS – COMPLIANCE
POLICY ............................................................................................................................. 2

Contains Nonbinding Recommendations
1
DSCSA Implementation: Product Tracing Requirements for
Dispensers — 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 addresses the readiness of dispensers in the pharmaceutical distribution supply
chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee-1(d)(1)) related to the exchange of transaction information,
transaction history, and transaction statements (product tracing information). For dispensers,
requirements for the tracing of products through the pharmaceutical distribution supply chain
under section 582(d)(1) of the FD&C Act took effect on July 1, 2015.2
On July 6, 2015, FDA published a Notice of Availability in the Federal Register (80 FR 38449)
announcing a guidance document entitled “DSCSA Implementation: Product Tracing
Requirements for Dispensers – Compliance Policy.” The guidance described FDA’s intention
with regard to enforcement of the product tracing information requirements under section
582(d)(1) of the FD&C Act. The guidance stated that FDA does not intend to take action against
dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving
product tracing information, prior to or at the time of a transaction, as required by section
582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. As described below,
FDA is extending this compliance policy to transactions that occur before March 1, 2016.
Section IV of this guidance provides further detail about the scope of this compliance policy and
FDA’s expectations for dispensers and trading partners involved in transactions with dispensers.
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 “Dispenser” is defined in section 581(3) of the FD&C Act (21 U.S.C. 360eee(3)).

Contains Nonbinding Recommendations
2
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. 	BACKGROUND
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law.
Section 202 of the DSCSA, which adds new sections 581 and 582 to the FD&C Act, sets forth
new definitions and requirements related to product tracing. The DSCSA outlines critical steps
to build an electronic, interoperable system by November 27, 2023, which will identify and trace
certain prescription drugs as they are distributed within the United States. This system will
enhance FDA’s ability to help protect U.S. consumers by improving detection and removal of
potentially dangerous products from the pharmaceutical distribution supply chain.
Starting in 2015, trading partners (manufacturers, wholesale distributors, dispensers and
repackagers) were required under section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to
provide the subsequent purchaser with product tracing information when engaging in
transactions involving certain prescription drugs. Trading partners were also required to capture
the product tracing information and maintain the applicable information for not less than 6 years
after the date of the transaction.
FDA, in consultation with other appropriate Federal officials and pharmaceutical distribution
supply chain stakeholders, published a draft guidance as required under section 582(a)(2)(A) of
the FD&C Act, entitled “DSCSA Standards for the Interoperable Exchange of Information for
Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing
Information.” This draft guidance established initial standards for the interoperable exchange of
the product tracing information related to each transaction of certain human, finished,
prescription drugs covered by the statute, in paper or electronic format, through the extension
and/or use of current systems and processes.
III. 	SCOPE OF THIS GUIDANCE
This guidance applies to dispensers engaged in transactions3 involving “products” as defined
under section 581(13) of the FD&C Act.
IV. 	PRODUCT TRACING REQUIREMENTS FOR DISPENSERS – COMPLIANCE
POLICY
The product tracing requirements in sections 582(d)(1) of the FD&C Act took effect for
dispensers on July 1, 2015, and FDA published a guidance document on July 6, 2015, stating that
it does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept
ownership of product without receiving the product tracing information, as required by section
3 “Transaction” is defined in section 581(24) of the FD&C Act.

Contains Nonbinding Recommendations
3
582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. However, some
dispensers – primarily smaller, independent pharmacies and health systems – have expressed
concern that they will be unable to comply with these requirements by November 1, 2015. Thus,
FDA recognizes that these dispensers continue to need additional time to work with trading
partners to ensure that the product tracing information required by section 582 is captured and
maintained by dispensers.
FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept
ownership of product without receiving the product tracing information, as required by section
582(d)(1)(A)(i) of the FD&C Act. This compliance policy does not extend to the requirements
under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale
distributors, and repackagers) provide product tracing information to dispensers. In addition, this
compliance policy does not extend to transactions in which dispensers must provide the
subsequent owner with product tracing information, including transaction history, as required by
section 582(d)(1)(A)(ii). If a dispenser has not received product tracing information prior to or at
the time it takes ownership of a product, FDA recommends that the dispenser work with the
previous owner to receive this information. FDA believes that product tracing information
serves as an important tool for dispensers to meet their obligation under section 582(d)(4) to
identify suspect product, quarantine the product, and investigate whether that product is
illegitimate.4
Prior to March 1, 2016, FDA also does not intend to take action against dispensers who do not
capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of
the FD&C Act.
This compliance policy does not extend to other requirements of the FD&C Act, including those
in section 582, such as verification related to suspect and illegitimate product (including
quarantine, investigation, notification and recordkeeping) and requirements related to engaging
in transactions only with authorized trading partners.
4 See the draft guidance for industry Drug Supply Chain Security Act Implementation: Identification of Suspect
Product and Notification. This draft guidance, when finalized, will represent FDA’s current thinking on this topic.