DSCSA Implementation: Product Tracing Requirements
for Dispenrs
— Compliance Policy
Guidance for Industry罗素哲学
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 t of either electronic or written comments on this guidance at any time. Submit electronic comments to
For questions regarding this document, contact CDER Office of Compliance at 301-796-3130 or *************************.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
Center for Biologics Evaluation and Rearch (CBER)
Office of Regulatory Affairs (ORA)
July 2015
Procedural
D SCSA Implementation: Product Tracing Requirements
爱护什么for Dispenrs
—Compliance Policy
雷锋叔叔的故事
Guidance for Industry
Additional copies are available from:
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Food and Drug Administration
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v/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch
Center for Biologics Evaluation and Rearch太原理工研究生院
Office of Regulatory Affairs
July 2015
Procedural
TABLE OF CONTENTS
I.INTRODUCTION (1)
II.BACKGROUND (2)
III.SCOPE OF THIS GUIDANCE (2)
IV.PRODUCT TRACING REQUIREMENTS FOR DISPENSERS – COMPLIANCE POLICY (2)
DSCSA Implementation: Product Tracing Requirements for
Dispenrs — Compliance Policy
Guidance for Industry1
This guidance reprents 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 u 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 address the readiness of dispenrs in the pharmaceutical distribution supply chain to comply with the provisions in ction 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 dispenrs, requirements for the tracing of products through the pharmaceutical distribution supply chain under ction 582(d)(1) of the FD&C Act go into effect on July 1, 2015.2
香港研究生申请This guidance announces the FDA’s intention with regard to enforcement of the product tracing information requirements under ction 582(d)(1) of the FD&C Act.As described below, FDA does not intend to take action against dispenrs 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 requir
ed by ction 582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing information, as required by ction 582(d)(1)(A)(iii) of the FD&C Act. Section IV of this guidance provides further detail about the scope of this compliance policy and FDA’s expectations for dispenrs and trading partners involved in transactions with dispenrs.
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 u 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 of Compliance in the Center for Drug Evaluation and Rearch (CDER) in cooperation with the Center for Biologics Evaluation and Rearch (CBER) and the Office of Regulatory Affairs (ORA) at the Food and Drug Administration.
2 “Dispenr” is defined in ction 581(3) of the FD&C Act (21 U.S.C. 360eee(3)).
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 ctions 581 and 582 to the FD&C Act, ts 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.唐代文
Starting in 2015, trading partners (manufacturers, wholesale distributors, dispenrs and repackagers) are required under ction 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to provide the subquent purchar with product tracing information when engaging in transactions involving certain prescription drugs. Trading partners are 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 ction 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 u of current systems and process.
III.SCOPE OF THIS GUIDANCE
This guidance applies to dispenrs engaged in transactions3 involving “products” as defined under ction 581(13) of the FD&C Act.
IV.PRODUCT TRACING REQUIREMENTS FOR DISPENSERS – COMPLIANCE POLICY
The product tracing requirements in ctions 582(d)(1) of the FD&C Act take effect for dispenrs on July 1, 2015. However, some dispenrs have expresd concern that electronic systems ud to exchange, capture, and maintain product tracing information will not be operational by this effective date. Although the DSCSA allows product tracing information to be exchanged through paper in certain circumstances,4 FDA understands that many dispenrs
3 “Transaction” is defined in ction 581(24) of the FD&C Act.
4 See the draft guidance for industry DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.” For the most recent version of a guidance, check the FDA Drugs guidance Web page at
