Exception Readiness Industry Report: Preparing for the Final DSCSA Phase

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As the deadline for full Drug Supply Chain Security Act (DSCSA) compliance approaches, the pharmaceutical industry faces a monumental challenge: managing the serialized data exchange requirements needed to ensure safe and secure drug distribution. Imagine tracking and tracing trillions of serial numbers across billions of transactions, involving over one hundred thousand trading partners, all in near real-time. With an error rate of less than one percent, we are still looking at over a million potential issues that need resolution.

This volume of exceptions could quickly overwhelm existing support and technology platforms, leading to inefficiencies, waste, and even critical drug shortages. To address this, an open Pilot engagement has been launched, bringing together manufacturers, wholesalers, dispensers, and solution providers in a collaborative effort to prepare for the final phase of DSCSA implementation.

The Pilot Engagement: A Unified Approach to DSCSA Exceptions

The Pilot team has developed a comprehensive framework for handling DSCSA exceptions, built around three core principles:

1. Catching and Detecting Errors: Establishing robust mechanisms to identify errors in serialized data exchanges before they escalate into larger issues.

2. Collaborating and Communicating: Facilitating seamless communication and collaboration among trading partners to address errors effectively and in real-time.

3. Correcting Data for Continued Distribution: Developing streamlined processes to correct transactional data, enabling the uninterrupted flow of products throughout the supply chain.

This unified approach aims to minimize disruption, reduce the potential for waste, and ultimately prevent drug shortages that could impact patient care.

Key Insights from the Pilot

The Pilot has revealed both the current capabilities and limitations of the industry in managing exceptions. While simple transactional errors can often be corrected with existing tools, some issues will require more extensive business rule changes to resolve. The insights gained through this collaborative effort are vital for all stakeholders as we prepare for the DSCSA’s final phase.

Preparing for the Future

The time to act is now. As we move closer to the DSCSA compliance deadline, the lessons learned from this Pilot will be invaluable. By adopting the best practices developed in this collaborative engagement, all stakeholders in the pharmaceutical supply chain can enhance their readiness, minimize risks, and ensure compliance with the DSCSA requirements.

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