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Earlier this year, the FDA called on the life sciences and healthcare industry to design and deliver pilot projects for an electronic, interoperable system that can identify and trace prescription drugs as they are distributed across the United States in support of the DRUG SUPPLY CHAIN SECURITY ACT (DSCSA).
After a rigorous screening process, a team comprising six strategic technology partners has been selected to participate in a pilot program. The pilot team includes supply chain technology leaders RXTRANSPARENT, SYSTECH, T-SYSTEMS, FARMATRUST, CRYPTOWERK, and CALQLOGIC.
Called “The Optimal Solution – a Federated Approach to Trusted Transactions in the Interoperable DSCSA,” the program will provide the FDA and the industry with a fully interoperable solution that can be used to identify, track and trace prescription pharmaceuticals throughout the US supply chain. The collective approach is designed to meet and excel regulatory requirements with a solution that includes:
- Utilizing a digital e-Fingerprint® layer of security to create an immutable track and trace ledger that improves visibility and enhances counterfeiting detection at the product level
- Capturing the Internet of Things (IOT) and Cold Chain information to leverage data for additional consumer insight and analytics
- Deploying blockchain as the infrastructure to enable interoperability providing a reliable foundation for trust in data that has been elusive with other technologies
The pilot duration is proposed as six months with the final FDA presentation anticipated for Fall 2019.