Encapsulation of products at the capsule filling area
Encapsulation of products at the capsule filling area
DSCSA Compliance
The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain. This helps prevent harmful drugs from entering the U.S. drug supply chain, detect harmful drugs if they do enter the supply chain and enable rapid response to remove harmful drugs from the supply chain to protect patients.
Lot-Level Traceability
Sanofi uses TraceLink’s ProductTrack to store and record DSCSA information for lot-level traceability. All Advanced Shipping Notices (ASNs), which contain relevant lot-level DSCSA information, are available via EDI and through the TraceLink portal. If you already have a connection with TraceLink, you will begin receiving TZIELD transactions from Sanofi NA starting April 1. Access the TraceLink portal
If you do not have an existing TraceLink connection, you can register here. This portal service is provided at no charge to you. For EDI connections, please contact TraceLink directly.
Serial-Level Traceability
For serial-level traceability, Sanofi uses Antares’ Track4 solution to send and receive GS1 EPCIS data. If you are not yet connected with us and would like to start receiving EPCIS data, please email us at Serialization24@Sanofi.com.
For customers not connected via EPCIS, Sanofi provides access to relevant data through our portal. Access the DSCSA Portal. If you do not have an existing connection to the portal, please email Serialization24@Sanofi.com to get started.
Enhanced Verification
Sanofi utilizes the Verification Router Service (VRS) for verification requests. If you are not using the VRS, you can also request verifications through the Sanofi DSCSA Portal or by emailing Serialization24@Sanofi.com.
Sanofi DSCSA Portal Features
The Sanofi DSCSA Portal is designed to simplify interactions with Authorized Trading Partners (ATPs), including pharmacies, wholesalers, and third-party logistics providers, by facilitating DSCSA requests.
- ATP Validation: Under DSCSA, all trading partners must be "authorized" with appropriate state and/or federal registrations. The Sanofi DSCSA Portal makes it easy to verify ATP status and supports OCI-compliant verifiable credentials.
- Verification Requests: Every saleable prescription drug package includes a product identifier with a GTIN, serial number, lot number, and expiration date. The Sanofi DSCSA Portal allows you to verify products at the package level.
- Trace Requests: Under DSCSA, trading partners are required to provide transaction information and a transaction statement during certain transactions. You can request this information through the portal or via email under specific circumstances.
For more information on serial data, verification, or trace requests, visit this page.
Additional Resources
For more information on DSCSA, please consult the following resources:
Contact Us
For questions or additional information, please reach out to us at Serialization24@Sanofi.com.