All-electronic, interoperable data exchange is the core of the FDA’s Enhanced Drug Distribution Security (EDDS) initiative. Trading partners must be able to exchange required Transaction Information (TI) and Transaction Statements (TS) in a secure, electronic, interoperable manner
All trading partners—including dispensers—must have the ability to verify a suspect or illegitimate product identifier upon request from a trading partner, federal agency, or state agency or to submit a request for verification from a trading partner. As verification is expected at the serialized package level, this requires a highly scalable solution that can capture and process large volumes of serialized product data within the mandated 24-hour response time
Beginning on November 27, 2023, T3 information (Transaction Information, Transaction Statement, and Transaction History) will be only available electronically. Dispensers are also required to capture and maintain all Transaction Information and Transaction Statements for not less than 6 years. The FDA will not grant immunity after November 27, 2023, to drug supply companies who are not phase II ready.
The act requires all trading partners to be able to track and trace the transaction history of every medication that passes through to pharmacy to the end patient. The Drug Supply Chain Security Act (DSCSA) outlines product tracing requirements for manufacturers, repackagers, wholesale distributors and dispensers (pharmacies).
By November 27, 2023, all authorized trading partners will be required to implement an interoperable exchange, interoperable verification and interoperable tracing.
Services Team: Our DSCSA services team are trained to support large transaction sets resulting large supply chain community. Our services team can monitor and support verification.
We can mobilize a support team within 24 hours to help you start your compliance program.
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