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Your pharmacy’s FDA DSCSA 2023 compliance deadline is November 27, 2023!
Under DSCSA, health systems and retail pharmacies will be required to receive electronic transactions that include serialization and item-level traceability data, and those transactions must match the physical receipt. If the electronic data doesn't match, pharmacies need to quarantine the receipt and resolve any exceptions before the product can be stocked. This process can both disrupt pharmacy operations and hinder the availability of critical medications.
If you want to avoid these disruptions and be compliant with DSCSA on day one, you need to get ready now. Our webinar, “DSCSA 2023 Compliance: What Pharmacies Need to Do NOW!”, provided pharmacies with an overview of the new capabilities required by the DSCSA 2023 mandate as well as a step-by-step guide for achieving compliance. Here are the key takeaways:
- Health systems and pharmacies have new responsibilities under DSCSA 2023. They must exchange TI and TS via secure, interoperable, electronic systems. They need to be able to check for package identifiers to identify pharmaceutical products at the unit level. They must verify product identifiers from trading partners. They need to ensure trading partners can provide TI and TS via a secure, interoperable system on request from authorized agents. They must ensure they can promptly produce TI going back to the manufacturer. And they must be able to address saleable returns by ensuring TI and TS are returned with the product via a secure, interoperable, electronic system.
- New responsibilities require new capabilities. For dispensers to meet these requirements, they’ll need a suite of new capabilities—for example, incorporating compliance information into receiving may require mobile scanning solutions while serialization requires the ability to exchange massive amounts of data at the speed of business. There are also new use case requirements like verifying product and managing DSCSA exceptions that must be accommodated.
- TraceLink provides a complete DSCSA 2023 compliance solution. The TraceLink network platform simplifies fully interoperable and seamless EPCIS data exchange with your suppliers—most of whom are already on the network! Our platform and support services address critical DSCSA 2023 hotspots like managing and exchanging serialized data, meeting compliance requirements for T2 data management, streamlining DSCSA operations and partner collaboration, supporting pharmacy operations personnel with training and support, and providing further business value by predicting drug shortages and speeding recalls.
- Compliance is a continuous journey, so you need continuous support. After implementing the TraceLink DSCSA 2023 compliance solution, the TraceLink Healthcare Operations Services Team (HOST) provides support services and shoulders your compliance workload by managing product, partner, and company master data. The TraceLink Customer Success Team also continues to support health systems and retail pharmacies by sharing monthly statistics and holding quarterly business reviews.
If you want to learn more about how the TraceLink network platform simplifies fully interoperable and seamless EPCIS data exchange with your suppliers, watch the full webinar. You’ll get an overview of the platform and see how fast and easy our supplier onboarding process is.
Start Preparing for DSCSA 2023 Today
TraceLink has a global services team that can quickly execute a DSCSA readiness assessment and recommend the necessary steps to achieve compliance by November 27, 2023. Contact your TraceLink Account Executive or Services Project Manager to get this project started now or email us at DSCSA [at] tracelink.com.
