The Drug Supply Chain & Security Act, which requires secure, electronic, and interoperable traceability across the US medicine supply chain, is scheduled to go into effect in November 2023. The impact to dispensers (retail pharmacies, health systems, independent pharmacies, etc.) will be significant as they must be prepared to receive item-level traceability information from their suppliers electronically. In addition, suspect product investigations or inquiries from regulatory authorities may require dispensers to verify information about a specific product with the medicine license holder. Achieving and maintaining compliance requires integrations to both direct suppliers (i.e., wholesalers) and indirect suppliers (i.e., pharmaceutical manufacturers) to securely exchange item-level traceability information about medicines used at dispensers.

TraceLink DSCSA Compliance and Product Availability Intelligence Solutions provides a network by which dispensers can easily onboard, integrate, and exchange item-level traceability information with direct and indirect suppliers. TraceLink solutions ensure that dispensers maintain compliance and can respond to regulatory and audit queries efficiently.

Because the TraceLink network, which consists of over 280k healthcare business entities, manages the exchange of information across the US medicine supply chain, it is uniquely positioned to derive intelligence about medicine movement and supply. The TraceLink Product Availability Intelligence Solution uses this information as input into proprietary algorithms that have been proven to detect a drug shortage 90 days in advance - a 9x improvement over what is currently available. No other DSCSA solution provider can provide this insight and value to dispensers.

The TraceLink DSCSA Compliance and Product Availability Intelligence Solution provides a single platform by which dispensers can meet their DSCSA requirements while achieving substantial improvements in detecting drug shortages. Developed and hosted on the Opus Digital Network Platform, the TraceLink solution provides:

• Network: A network of over 280k life science entities that have been onboarded and integrated. These entities can be discovered and linked to the exchange of serialization and traceability information.
• Scalability: High volume transaction processing of billions of serial numbers and events associated with medicine distribution. An active-active deployment model ensures that serialization, traceability, and compliance does not impact the operational efficiency required in medicine manufacturing and distribution.
• Compliance: Applications for secure, electronic, interoperable DSCSA compliance information exchange using EPCIS standards, verification and authorized trade partner credential support. A network-tenant solution ensures that new functionality can be
• Ensuring Supply: A unique network-wide data model digitally representing the flow of medicines into and throughout the United States. This data model can drive collective intelligence solutions to address critical industry issues, such as more advanced predictions of drug shortages.