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Complying with DSCSA 2023 will require health systems and pharmacies to make several changes to the way they operate.
The final phase of DSCSA traceability requirements will go into effect on November 27, 2023. DSCSA 2023 item-level traceability requirements are a step change over pharmacies’ current 2015 lot-level requirements, introducing significant operational and regulatory challenges around:
- Storing serialized TI and TS in an electronic database
- Achieving secure, interoperable, electronic unit-level traceability
- Using product identifiers for verification and suspect product investigation
- Tracing products across their complete life cycle
- Ensuring trade partners are authorized and credentialed
Here are the three key takeaways from our recent webinar, "DSCSA 2023: Requirements, Necessary Capabilities, and the Path to Predicting Drug Shortages," that will help you better understand the the path forward to implement these capabilities and achieve DSCSA 2023 compliance:
- DSCSA is a network challenge. The big challenge hindering product tracing through the medicine supply chain historically is the way data is shared. A network helps establish a common data model across the supply chain, not just within the four walls of your organization. This not only fosters compliant product data exchange, but also empowers other operational improvements.
- DSCSA 2023 requires more from health systems and pharmacies. Compared to 2015, dispensers will need a solution that delivers a wide array of new capabilities. This spans product serialization and master data exchange, product verification and tracing, serialized process intelligence and operations, and other capabilities for delivering business value. Health systems and pharmacies will need to incorporate these capabilities without disrupting their operations.
- A DSCSA solution deployed on a network platform creates opportunities. While many health systems and pharmacies are concerned first and foremost with compliance, establishing a foundation for exchanging information across the supply chain can help digitalize other core processes. With pristine data flowing, dispensers will be better equipped to do everything from executing faster drug recalls to enhancing inventory visibility to prevent shortages.
TraceLink has developed a network-based solution designed to facilitate data exchange between all members of the pharmaceutical supply chain. In fact, one dispenser with $5.4 billion in revenue partnered with TraceLink has had tremendous success–this non-profit health system has received and reconciled more than 180,000 serialized products and integrated with 17 suppliers for electronic DSCSA-compliant data exchange.
Interested in learning more about DSCSA 2023 from a panel of subject matter experts and your industry peers? Sign up for our DSCSA webinar series today–we’ve got a special track dedicated specifically for:
