As DSCSA requires dispensers to receive, verify and store product identifiers, any issues with capturing data can cause delays in getting patients their medicine. R1.3 provides streamlined sourcing data for simpler messages, a drop shipment indicator to streamline receiving, and machine-readable signal of the message format to help systems automatically process incoming data accurately.
The DSCSA Implementation Suite helps pharmaceutical supply chain organizations strengthen compliance while improving operational efficiency. It provides clear, practical guidance on applying GS1 Standards, including Electronic Product Code Information Services (EPCIS), to streamline data exchange, reduce integration challenges, and enhance end-to-end traceability. Developed with input from industry leaders, the suite offers practical guidelines and reference materials that support consistent standards adoption within everyday business processes, enabling smoother partner collaboration, higher data quality, and a more secure supply chain.
To support consistent adoption, industry leaders are asking trading partners to continue meeting the minimum requirements of Release 1.2 while strongly advocating for the adoption of Release 1.3 to improve interoperability and data quality. The phased rollout of Release 1.3 is organized by class of trade to minimize system and operational impact. It begins with dispensers, who benefit first from enhanced capabilities and serve as the critical downstream checkpoint for serialized data. As wholesalers and manufacturers join in later phases, the industry advances toward a smooth, low-risk transition to full adoption of the enhanced standard.
DSCSA R1.3 Role-Based Impact Across the Pharmaceutical Supply Chain:
- Dispensers: Q3/2026
- Wholesaler: Q4/2026
- Manufacturers: Q1/2027
Have Products Available For Your Patients
Keep Product Movement Accurate and Secure Across the Supply Chain
As DSCSA requires wholesalers to exchange complete serialized data and maintain interoperability at every handoff, any break in accuracy can disrupt downstream operations and compromise product legitimacy. R1.3 strengthens these processes with clearer outbound EPCIS requirements, improved verification support, better exception handling, and more consistent sourcing details, helping wholesalers protect supply chain integrity and ensure partners receive the accurate data they need to move products with confidence.
Strengthen Accuracy From the Start of the Supply Chain
As DSCSA pushes manufacturers to capture and share precise serialized product data, any gaps in outbound accuracy can cascade downstream, creating delays, misalignments, and verification hurdles for partners. R1.3 helps close those gaps by aligning outbound EPCIS events, improving choreography guidance, tightening conformance checks, and enhancing exception management so issues can be detected and resolved sooner. This supports cleaner data handoffs and more reliable package level traceability across the supply chain.
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.