DSCSA Compliance Preparation and Solutions

This white paper outlines the upcoming changes to the Drug Supply Chain Security Act (DSCSA) and emphasizes the importance of early preparation for pharmacies. With enforcement of new regulations postponed until November 27, 2024, pharmacies are encouraged to act promptly to avoid non-compliance and potential penalties. The document details the shift from lot-level to package-level product tracing, highlighting the need for pharmacies to adopt the Electronic Product Code Information Services (EPCIS) standard for data management. It describes the responsibilities of pharmacies, including the tracking of traceable items, maintaining accurate records for six years, and the necessity of quarantining suspect products. Additionally, the paper discusses the features of SureCost’s DSCSA Compliance Package, which integrates with pharmacy operations to streamline compliance processes. The solution aims to minimize disruptions in patient care while ensuring adherence to the updated DSCSA requirements. The paper serves as a guide for pharmacies to understand their obligations and the tools available to meet them effectively.