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
- Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.3 Focuses on item-level serialized traceability required for 2023 interoperability. Includes new chapters on EPCIS Conformance testing and the GS1 Lightweight Message Standard for DSCSA verification of returned product identifiers.
- GS1 Schema for US Healthcare EPCIS R1.3
- Addendum: Guidance and XML Examples for Supply Chain Choreographies in Serialized Item-Level Management R1.3
- Addendum: Diagrams and XML Examples for Serialized Item-Level Exception Handling R1.3
- Errata for Release 1.3: Clarifies guidance around netContentDescription found in Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.3.
Release 1.2 – Minimum Adoption Requirement
- Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.2: The previous implementation guideline aligns with the GS1 EPCIS standard version 1.2 and GS1 Core Business Vocabulary (CBV) standard version 1.2.
- Errata for Release 1.2: Clarifies incorrect guidance to populate the eventTime of the transaction event found in Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.2.
- Addendum: Diagrams and XML Examples for Lot-Level Management Exceptions Processing R1.2
- Addendum: Diagrams and XML Examples for Serialized Exceptions Processing R1.2
- GS1 Schema for US Healthcare EPCIS R1.2
*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.