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Under the U.S. Drug Supply Chain Security Act, pharmaceutical manufacturers and their trading partners must establish secure, electronic, and 100% interoperable exchange of serialized compliance data by November 27, 2023. And that deadline is coming up fast! To meet DSCSA compliance requirements, manufacturers must establish new integrations with all downstream trade partners to replace the ASNs currently used to send lot-level compliance data.
For MAHs not using the TraceLink network, building the new integrations will cost $5,000-$15,000 and take 4-8 weeks for each customer/trade partner relationship, and organizations that have not started yet are unlikely to meet the November deadline.
The good news is that TraceLink has the answer: TraceLink can enable any pharmaceutical manufacturer to send the required EPCIS data to all downstream partners with a single integration through the TraceLink network. It’s fast, easy and you can keep your existing serialization software. TraceLink can implement L5 network capabilities in 3-5 weeks and ensure that your organization is compliant before the November deadline. Read our new strategy brief and see how it works!
The TraceLink "Integrate Once, Interoperate with Everyone™" capability means manufacturers can establish a single connection into the network using their preferred transaction type and format. The manufacturer does not have to worry about the ever-changing requirements throughout its customer base. Beyond DSCSA compliance, customers on the TraceLink L5 network experience additional benefits:
- Faster: With more than 290,000 network members, all or most of MAHs’ trading partners are already fully integrated into the TraceLink network, simplifying trade partner onboarding and authentication.
- Better: The TraceLink network and DSCSA compliance solutions are built on a highly scalable cloud platform to process data-intensive EPCIS transactions at no additional cost.
- Lowest Total Cost Ownership: Purpose-built solutions on the network provide interoperable data exchange at the lowest integration costs.
- Future Proof: Continuous investment in network solutions for digital recalls, supply network orchestration, drug shortage predictions, and multienterprise integration extends value beyond serialization and compliance.
Fill out the form to download the strategy brief and learn more!
