Over the last year, the pharmacy supply chain has been bracing for DSCSA. While terms like, “interoperability” and “track and trace” have been swirling around the industry for a while now, there are still some misconceptions about what it means for pharmacies. This has only intensified after the FDA announced a stabilization period, which will be in effect until November 27, 2024. Although this provides pharmacies with more time, it does not mean there isn't work to be done now. To ensure your pharmacy is ready for DSCSA, here are answers to your frequently asked questions:
To achieve supply chain interoperability, all trading partners will need to establish secure, electronic data exchanges to track the entire path of a product. This means, serialized, unit-level data will need to accompany each prescription drug, every time it changes ownership, including:
As a result, pharmacies will need to be able to send and receive unit-level data for every drug purchased using the new Electronic Product Code Information Services (EPCIS) standard.
By requiring the entire pharmacy supply chain to establish these data connections, a drug’s complete history can be easily traced. That way, damaged, illegitimate, or potentially dangerous products can be identified and removed from the US supply chain. This is critical to ensure patient safety.
First, you'll need to obtain a GS1 Global Location Number (GLN) for your store. This is used to identify specific parties and locations and provide information about “Who” or “Where” a product has been as it moves through the supply chain. You can learn how to obtain a GLN in this Quick Reference Guide.
Please Note: Some wholesalers have begun the GLN registration process on behalf of their pharmacy customers. We recommend checking with your primary wholesaler before applying.
Yes! The FDA extension is intended to be a grace period for dispensers and trading partners. During this time, the expectation is that everyone within the supply chain will continue to work on implementing the new processes and ensure they are working properly over the next year. In fact, it’s essential not to slow down your efforts because establishing these data exchanges can take time. You’ll want to ensure that they have been thoroughly tested and are fully operational before the November 27, 2024, deadline.
As with anything else within your pharmacy’s workflow, trying to manage this data manually can cost you in the long run by:
Over the last several months, BestRx has been working behind the scenes on solutions to help you stay compliant. We are preparing to launch these solutions later this year, so you can easily incorporate DSCSA requirements into your pharmacy’s workflow. This includes the following software enhancements:
Plus, we're working on integrations with InfiniTrak and LSPedia, two comprehensive DSCSA compliance platforms.
We know you have a lot on your plate, but putting off your DSCSA requirements will only leave you open to unnecessary risks and scrambling next year. To learn more about all the ways BestRx can help your pharmacy stay compliant, request a free demo!