Drugs

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
10/25/2018Draft GuidanceVerification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (PDF - 376KB)

Notice of Availability

9/20/2018Final GuidanceProduct 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

9/20/2018Final GuidanceGrandfathering 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

9/20/2018Draft GuidanceProduct Identifiers Under the Drug Supply Chain Security Act - Questions and Answers (PDF - 363 KB)Notice of Availability
5/9/2018Draft GuidanceWaivers, 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
3/2/2018Draft GuidanceStandardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170 KB)  Notice of Availability
3/2/2018Draft GuidanceDefinitions 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
8/21/2017Draft GuidanceIdentifying Trading Partners Under the Drug Supply Chain Security Act, Guidance for IndustryNotice of Availability
7/20/2017NoticePilot 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

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

Webinar
02/29/2016GuidanceRequirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy Guidance for IndustryNotice of Availability
11/02/2015RevisedDSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance for Industry (Revised)Notice of Availability
12/31/2014GuidanceDSCSA 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
11/28/2014Draft GuidanceDSCSA 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

10/08/2014Draft GuidanceThe 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 AnswersNotice of Availability

 

Page Last Updated: 10/30/2018
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