HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period
In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.
PC: As the end of the stabilization period approaches, what best practices should compliance teams consider?
Bernstein: It depends on whose shoes you're standing in. If you're a dispenser, you should know where your data is being held, because sometimes the wholesaler is holding the data. Sometimes you may have a solution provider, so that goes back to the SOPs and making sure that your employees know where they can get the data if they need to, and that they know how to verify the product identifier, because now, starting in November, for most cases, the product identifier will be on the package and available to be able to verify with the manufacturer if it's the accurate and the correct product identifier.
They should have been able to do that before, and they were able to do it before, but now, the product identifier will be on the transaction documentation that's traveling with the product. Having those relationships with your trading partners [is important] because it's all about who you're doing business with, in order to have that confidence in the transaction and knowing that you're getting legitimate product.
That actually goes back to another best practice, which is making sure that you have the systems and processes in place to identify suspect and illegitimate product, along with what to do if you find it. The supply chain should have been doing this since 2015, but now this is more important than ever, as now the whole supply chain has moved on, and DSCSA has matured.
