The U.S. Drug Supply Chain Security Act (DSCSA) aims to enhance pharmaceutical traceability, but misalignment exceptions remain a persistent challenge. Exception management, especially for manufacturers is a critical aspect of compliance, yet many in the industry struggle with data discrepancies, reporting delays, and system interoperability issues. This blog explores the current state of the industry, the causes of exceptions, who is responsible, and the ideal approach for resolution.

Understanding Misalignment Exceptions in DSCSA

Misalignment exceptions occur when there are discrepancies in serialized data across trading partners in the supply chain. These discrepancies can stem from missing, incorrect, or delayed data exchanges between manufacturers, wholesalers, and dispensers. If unresolved, exceptions can disrupt product movement, create compliance risks, and delay patient access to critical medications.

Who Is to Blame for DSCSA Exceptions?

No single stakeholder is entirely at fault, but exceptions typically arise from:

1. Manufacturers – Errors in serial number aggregation, missing Electronic Product Code Information Services (EPCIS) data, or incorrect product identifiers.
2. Wholesalers/Distributors – Data processing delays, master data mismatches, or failure to reconcile product data with physical inventory.
3. Dispensers/Pharmacies – Difficulty verifying serialized data due to outdated systems or incomplete data transmissions.
4. Solution Providers – Integration gaps between traceability platforms and trading partner systems, leading to data inconsistencies.

Why Are DSCSA Exceptions Reported Late?

The delay in reporting and resolving exceptions is one of the biggest hurdles to compliance. Some key reasons include:

• Lack of real-time exception detection – Many stakeholders rely on batch processing rather than immediate issue identification.
• Unclear ownership of resolution – Without well-defined responsibilities, companies may hesitate to take corrective action.
• Interoperability issues – Trading partners using different systems may face delays in data synchronization.
• Manual investigation efforts – Exceptions often require human intervention, slowing down the resolution process.

When and How Are DSCSA Exceptions Detected?

Misalignment exceptions can surface at different points in the supply chain:

• Manufacturers – During packaging and serialization, errors like duplicate serial numbers or aggregation mistakes may occur.
• Distributors – Issues arise when receiving serialized shipments that do not match the expected EPCIS data.
• Dispensers – Verification failures at the point of dispensing can flag misalignments.
• Regulatory Audits – The FDA or state boards of pharmacy may identify discrepancies during inspections.

The Ideal Approach to DSCSA Exception Management

To streamline exception management, the industry must focus on three key areas:

Stronger Stakeholder Collaboration

• Clearer Standard Operating Procedures (SOPs) for handling exceptions.
• Well-defined roles and responsibilities to ensure quick resolution.
• Data-sharing agreements to improve communication between trading partners.

Enhanced Technical Support & System Interoperability

• More real-time EPCIS data transmission to reduce delays.
• Adoption of GS1 standards for better data consistency.
• Automation for faster issue detection and resolution.

Conclusion

Misalignment exceptions under DSCSA pose a significant challenge for manufacturers and the broader pharmaceutical supply chain. However, no single entity is solely responsible. Resolution requires better collaboration, robust technology, and regulatory alignment. By implementing proactive exception management strategies, the industry can reduce compliance risks, improve data accuracy, and ultimately enhance patient safety.

Would you like to explore specific best practices for your organization’s exception management strategy? Let’s discuss.