How GS1 Standards can help you achieve 2023 Requirements
The Drug Supply Chain Security Act (DSCSA) aims to establish an electronic, interoperable system to help manufacturers, wholesalers, healthcare providers, and dispensers identify and trace prescription drugs as they are distributed in the United States. DSCSA focuses on protecting patients from exposure to prescription drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
By requiring every stakeholder in the pharmaceutical supply chain to maintain and share chain-of-ownership data in a serialized and event-based approach, trading partners can unlock item-level traceability all the way back to the product origin.
Working with supply chain leaders, GS1 US has developed step-by-step playbooks to aid manufacturers, wholesalers, healthcare providers, and dispensers in their readiness for DSCSA:
- Understand the technical requirements for marking your serialized finished drug product with a 2D data matrix barcode (e.g., GS1 DataMatrix).
- Assign, assemble, and share the list of your Global Trade Item Number (GTINs) for your packages
- Set up-up your Global Location Numbers (GLNs) for your corporate and site locations
- Capture GS1 product identifiers when packing and shipping
- For transfer of ownership transactions of your serialized products, understand the technical requirements for exchanging serialized Transaction Information (TI) and Transaction Statement (TS)
- Set up your Trading Partner master data
- Implement and maintain ongoing operational processes for capturing serialized shipments and exchanging serialized transaction information with your trading partners.
- Prepare to verify product identifiers (PI) for your serialized products and implement an operational process to support verification responses.
- Discover if a Global Location Numbers (GLNs) has already been created or set-up your GLN for your corporate and site locations
- Capture GS1 product identifiers when receiving shipments to prepare for your serialized exchange
- Set up your Trading Partner master data
- Implement ongoing operational processes for capturing serialized shipments and exchanging serialized transaction information
- Prepare to verify product identifiers (PI) for your serialized products and implement an operational process to support verification responses PI verification are not for saleable returns but for verification of suspect or illegitimate, exception, or status checks.
Explore our resources to follow these playbooks and implement GS1 Standards to meet 2023 DSCSA requirements!
| Resource | What It Will Help With | Manufacturers | Wholesalers | Healthcare Provider / Dispensers |
|---|---|---|---|---|
| Frequently Asked Questions in Preparing for the U.S. DSCSA | Answering frequently asked questions about identifying, capturing and sharing information to help meet DSCSA requirements. | Yes | Yes | Yes |
| GS1 US DSCSA Implementation Guideline R1.3 | Understanding technical requirements for encoding your product with GS1 Identifiers and how to capture GS1 product identifiers when receiving shipments. | Yes | Yes | Yes |
| Applying Lightweight Messaging Standard for Verification of Product Identifiers | Configuring PI verification business scenarios and technical requirements for responding to verification requests from your direct and indirect trading partners. | Yes | Yes | Yes |
| How to Identify your Location for DSCSA Requirements | Identifying your locations with a Global Location Number to share information related to Transaction Information (TI) and Transaction Statements (TS) and verify product information through a third-party routing system | Yes | Yes | Yes |
| Progress on 2023 DSCSA Interoperability | Understanding the quality of barcodes to ensure scannability by your trading partners | Yes | Yes | Yes |
| GS1 US Implementation Guideline for Pharmaceutical Chain of Custody | Capturing GS1 product identifiers when packing and shipping when working with 3rd party agents (CMOs, CPOs, and 3PLs) | Yes | Yes | Yes |
| GS1 US Pharmaceutical Conformance Test Program | Optimizing the data quality of your EPCIS serialized exchanges with the help of a certified third-party testing service | Yes | Yes | Yes |
| GS1 US DataHub | Sharing, searching, and retrieving GLN information with your trading partners | Yes | Yes | Yes |
*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.