Aggregation: meeting the challenge for 2023 DSCSA compliance

Consumer’s demand for trustworthy and safe products continues to drive the need for traceability and transparency worldwide. The fight against counterfeit products will never end; the industry’s response began in earnest a decade ago, when California E-Pedigree became the first effort to ensure delivery of ethical, safe and genuine prescription drugs to consumers, and mitigate the growing tide of counterfeit and black-market products. Starting with the pharmaceutical industries – arguably the most mission-critical sector vulnerable to illicit trade, counterfeiting, diversion and abuse – regulation authorities found their mission and vision to protect manufacturers and patients. The USA FDA DSCSA regulation for full traceability provides guidance on the implementation of pharmaceutical traceability through the entire supply chain. Serialization of packages at the item level was Phase 1 and is now fully implemented. The next Phase, effective in 2023, includes aggregation of items to cases and the reporting of the resulting parent-child relationships. This paper aims to highlight the challenges and benefits of implementing Track & Trace with enhanced aggregation solutions for full traceability. It is important to acknowledge that, due to regulatory requirements, trading agreements and/or internal supply chains management processes, best practices for implementing aggregation may vary from one customer to another per their exportation country, saleable products and current production line configuration status, just to name few criteria.