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  5. Drug Supply Chain Security Act (DSCSA)
  6. Drug Supply Chain Security Act Law and Policies
  1. Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act Law and Policies

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DSCSA Policies

FDA has issued the following guidance and policy documents since the Drug Supply Chain Security Act (DSCSA) was enacted in 2013.

Visit FDA’s implementation of DSCSA requirements and public health emergencies and DSCSA requirements for more information.

Date Published Type Title Additional Information
6/12/2024 Notice Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period  
12/6/2023 Final Guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Notice of Availability
11/20/2023 Notice Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements; Request for Information and Comments  
9/6/2023 Final Guidance DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry Notice of Availability
9/1/2023 Final Guidance Compliance Policy Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies

Notice of Availability

FDA Statement: DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems
8/31/2023 Final Guidance Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Notice of Availability
8/28/2023 Final Guidance Compliance Policy Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies

Notice of Availability

FDA Statement: DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems
8/4/2023 Final Guidance Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Notice of Availability
3/16/2023 Final Guidance Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry Notice of Availability
9/23/2022 Final Guidance 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 Notice of Availability
7/06/2022 Draft Guidance Identifying Trading Partners Under the Drug Supply Chain Security Act Notice of Availability
3/10/2022 Draft Guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Notice of Availability
2/4/2022 Proposed Rule National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers

Notice of Availability

Announcement

Webinar

Extension of Comment Period
2/4/2022 Proposed Rule Certain Requirements Regarding Prescription Drug Marketing

Notice of Availability

Announcement
2/4/2022 Proposed Rule; Withdrawal Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Withdrawal

Notice of Availability

Announcement
2/4/2022 Final Guidance Guidance: Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers

Notice of Availability

Announcement
6/3/2021 Final guidance Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability Notice of Availability
FDA in Brief
6/3/2021 Final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Notice of Availability
FDA in Brief
10/22/2020 Final Guidance Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Notice of Availability
4/30/2020 Final Guidance Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency  
9/23/2019 Final Guidance Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry Notice of Availability
7/3/2019 Notice Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information  
9/19/2018 Final Guidance Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF - 254 KB)

Notice of Availability

FDA In Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain
9/19/2018 Final Guidance Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 319 KB)

Notice of Availability

FDA in Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain
2/28/2018 Draft Guidance Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170 KB)   Notice of Availability
7/20/2017 Notice Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments  
4/28/2017 Notice

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

  
2/16/2017 Final Guidance Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy Guidance for Industry Notice of Availability
1/9/2017 Draft Guidance Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers: Guidance for Industry Notice of Availability
10/28/2015 Final Guidance DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance for Industry (Revised) Notice of Availability
12/23/2014 Final Guidance DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry  Notice of Availability
12/8/2014  Draft Guidance  Drug Supply Chain Security Act Implementation--Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Notice of Availability

Webinar

 

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