FDA Guidances

Stay informed and compliant with the latest Drug Supply Chain Security Act (DSCSA) requirements. This page provides a comprehensive, up-to-date list of all DSCSA guidances issued by the U.S. Food and Drug Administration (FDA), including final and draft documents. Whether you're a manufacturer, wholesaler, dispenser, or third-party logistics provider, these guidances offer critical insights into regulatory expectations and implementation timelines.

2014 Dec 08

Drug Supply Chain Security Act Implementation--Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

Draft Guidance

FDA Guidances

2014 Dec 08

Drug Supply Chain Security Act Implementation--Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

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2014 Dec 23

DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry

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2015 Oct 28

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

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2017 Jan 09

Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers: Guidance for Industry

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2017 Feb 16

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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2017 Apr 28

Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information

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2017 Jul 20

Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments

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2018 Feb 28

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

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2018 Sep 19

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

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2018 Sep 19

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

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2019 Jul 03

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

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2019 Sep 23

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

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2020 Apr 30

Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

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2020 Oct 22

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

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2021 Jun 03

Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

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2021 Jun 03

Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability

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2022 Feb 04

Guidance: Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers

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2022 Feb 04

Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Withdrawal

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2022 Feb 04

Certain Requirements Regarding Prescription Drug Marketing

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2022 Feb 04

National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers

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2022 Mar 10

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

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2022 Jul 06

Identifying Trading Partners Under the Drug Supply Chain Security Act

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2022 Sep 23

Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry

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2023 Mar 16

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

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2023 Aug 04

Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act

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2023 Aug 28

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies

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2023 Aug 31