GS1 US DSCSA Implementation Suite

The “GS1 US Implementation Guideline:  Applying GS1 Standards for DSCSA and Traceability Release 1.2”, instructs users on how to implement GS1 Standards, particularly the GS1 Electronic Product Code Information Services (EPCIS), for DSCSA lot-level management, serialization, and item-level traceability. The DSCSA Implementation Suite includes the guideline as well as three reference documents containing additional guidance on business process applications.*

The four documents in the suite are:

  • GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability
  • Addendum: Guidance and XML Examples for Supply Chain Choreographies in Lot-Level Management
  • Addendum: Diagrams and XML Examples for Lot-Level Management Exceptions Processing
  • Addendum: Diagrams and XML Examples for Serialized Exceptions Processing

Preparing for the Drug Supply Chain Security Act? Attend the GS1 Standards for DSCSA for Suppliers Certificate Course.

To receive your copy, please fill out the form below. 

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*For information about the act, see the 2013 Drug Supply Chain Security Act

For information on the delay enforcement, see the FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. June 30, 2017

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.