GS1 US DSCSA Implementation Suite

The DSCSA Implementation Suite provides pharmaceutical supply chain stakeholders with the tools needed to implement GS1 Standards, including GS1 Electronic Product Code Information Services (EPCIS), to meet DSCSA requirements. Developed in collaboration with industry leaders, this suite includes the most recent implementation guidelines and supporting reference documents that offer practical guidance for applying standards to business processes.

To support consistent adoption, industry leaders expect trading partners to meet the minimum requirements of Release 1.2, while strongly encouraging implementation of Release 1.3.

A phased sunrise timeline for Release 1.3 is planned to begin after the phased compliance exemption period, starting with Dispensers to ensure downstream readiness, followed by Wholesalers and Manufacturers.

Phased Sunrise Timeline:

  • Dispenser: Q3/2026
  • Wholesaler: Q4/2026
  • Manufacturer: Q1/2027

Documents in the suite include:

Release 1.3 – Recommended for Adoption

Release 1.2 – Minimum Adoption Requirement

GS1 Standards for DSCSA Suppliers Certificate Course

Preparing for DSCSA Requirements?

Register for our GS1 Standards for DSCSA Suppliers Certificate Course

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

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.