Learn how to implement GS1 Standards, including the GS1 Electronic Product Code Information Services (EPCIS), to help meet DSCSA requirements. This DSCSA Implementation Suite includes the most recent implementation guideline as well as reference documents containing additional guidance on business process applications.*
Documents in the suite include:
Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.3: This most recent implementation guideline focuses on item-level serialized traceability required for 2023 interoperability across the US pharmaceutical industry. Newly introduced chapters in this version of the guideline covering the importance of EPCIS Conformance testing and highlighting the role of GS1 lightweight Message Standard for DSCSA Verification of Returned Product Identifiers.
R1.3 Additional Documentation:
- 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
R1.2 Documentation
- 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.