LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Nasarenko: We talked about what DSCSA is. It's the Drug and Supply Chain Security Act. It went into law about 10 years ago essentially to protect the patient or consumer from counterfeit drugs. It has different milestones as it goes through, and the final milestone is actually in November of this year. It's for serialized unit traceability with an interoperable data exchange. We talked about different data elements of DSCSA beyond what it is such as the complexity of it, how you have to work and interact with your trading partners. Recently, there's been activity from FDA in establishing a stabilization period. Essentially, from November of this year to November of next year, there will be a one year period to help implement, troubleshoot, and mature so it's not deemed as a delay. It's really to help the industry set up and prepare for DSCSA.