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  1. Drug Supply Chain Integrity

Drug Supply Chain Security Act Law and Policies

Drug Supply Chain Security Act Law and Policies

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
9/20/2018 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

9/20/2018 Final Guidance Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 319 KB)

Notice of Availability

FDA advances policies related to bolstering security of drug products in the U.S. supply chain

9/20/2018 Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers (PDF - 363 KB) Notice of Availability
5/9/2018 Draft Guidance Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 117 KB) Notice of Availability
3/2/2018 Draft Guidance Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170 KB)   Notice of Availability
3/2/2018 Draft Guidance Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (PDF - 283 KB)   Notice of Availability
8/21/2017 Draft Guidance Identifying Trading Partners Under the Drug Supply Chain Security Act, Guidance for Industry Notice of Availability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

 
1/10/2017 Draft Guidance Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers: Guidance for Industry Notice of Availability
12/09/2016 Guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry Notice of Availability

Webinar
02/29/2016 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
11/02/2015 Revised DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance for Industry (Revised) Notice of Availability
12/31/2014 Guidance DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry  Notice of Availability
12/09/2014  Draft Guidance  Drug Supply Chain Security Act Implementation--Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Notice of Availability

Webinar
11/28/2014 Draft Guidance DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information

Notice of Availability

Public Workshop

10/08/2014 Draft Guidance The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers Notice of Availability