DSCSA Compliance Exceptions Management Framework

This guide discusses the management of DSCSA compliance exceptions within the pharmaceutical supply chain. It presents insights from a FutureLink Boston 2025 session led by NNIT/Excellis leaders Scott Potteiger and Dennis Even, who share experiences from over 20 exception strategy engagements involving manufacturers, wholesalers, and dispensers. The document outlines the root causes of common exceptions, including data mismatches and non-standard shipping practices. It details structured methods for diagnosing, documenting, and resolving these exceptions. Additionally, the guide introduces a framework for developing tailored exception playbooks based on risk levels, business models, and partner relationships. The content emphasizes the importance of defining exception types and risk levels as foundational to achieving DSCSA compliance, while also addressing long-term exception management strategies that should encompass scalable processes and virtual returns. This resource aims to assist organizations in effectively managing DSCSA exceptions without disrupting their operations.