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  1. Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act Law and Policies

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Newly Added Guidances and Policy Documents

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

Date Published Type Title Additional Information
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

CDER Alert: 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

CDER Alert: 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7/06/2022 Draft Guidance Identifying Trading Partners Under the Drug Supply Chain Security Act Notice of Availability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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