Is Your Pharmacy Ready for DSCSA?
Posted on Sep 26, 2023
We’re Answering Your Frequently Asked DSCSA Questions
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:
What are the DSCSA/Interoperability requirements?
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:
- The unique product identifier, serial number, and expiration date.
- Detailed transaction information and a transaction summary.
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.
Why is this information important?
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.
What do I need to do to get started?
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.
Do I need to do anything now, since the deadline has been extended?
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.
Do I need to use a compliance solution, or can I just do this manually?
As with anything else within your pharmacy’s workflow, trying to manage this data manually can cost you in the long run by:
- Tying up staff time verifying data, line by line – not to mention the time that will be lost trying to investigate any discrepancies that are uncovered.
- Increased operational costs, both from product loss when discrepancies can’t be resolved and having to replace products that can’t be verified.
- Leaving yourself open to fines/penalties that may be assessed if you’re audited and not meeting all the requirements.
What is BestRx doing to help pharmacies stay compliant?
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:
- GS1 barcode support throughout the software.
- The ability to capture serialized data when receiving inventory.
- The ability to record serialized data when filling and dispensing prescriptions, and whenever you’re transferring or returning inventory.
- New reports to identify transactions and prescriptions using serial numbers.
- Updating wholesaler connections to receive EPCIS data.
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!