The Drug Supply Chain Security Act (DSCSA) has transformed the way prescription drugs move through the U.S. supply chain. At the core of this transformation is the Electronic Product Code Information Services (EPCIS)standard, which ensures the interoperable exchange of serialized data at the package level.
But even in a fully digital ecosystem, problems can and do arise.
These problems — called exceptions — represent discrepancies between the physical supply chain and the virtual supply chain records. Exception handling is therefore critical, not only for DSCSA compliance but also for patient safety and supply chain efficiency.
This article provides a deep dive into EPCIS exception handling, exploring categories, root causes, resolution workflows, best practices, technology solutions, and the future of compliance.
Understanding EPCIS Exception Categories
Exceptions can be grouped into four primary categories. Each has different implications for compliance, product flow, and patient safety.
1. Product, No Data
Occurs when physical product arrives without a matching EPCIS file.
- Example: Pallets of ibuprofen arrive, but no serialized file is available.
- Risk: Product cannot be released and must be quarantined.
2. Data, No Product
Occurs when EPCIS data is received, but the physical product is missing.
- Example: File indicates 1,000 serialized units, but only 950 units arrive.
- Risk: May indicate theft, misrouting, or shipping error.
3. Data Issues
Refers to errors in the EPCIS file itself, such as:
- Wrong or outdated GTINs.
- Invalid GLNs.
- Serialization errors (duplicate or missing serials).
- Formatting errors.
4. Damaged Product
Occurs when the product label or barcode is damaged, preventing accurate serialization checks.
- Example: Broken pallets or unreadable 2D barcodes.
Root Causes: Why Exceptions Occur
Exceptions typically stem from three major root causes.
Human Error Factors
- Manual entry errors (wrong GTIN, mistyped serials).
- Mis-picks in warehouses.
- Failure to follow SOPs during scanning or aggregation.
Technology and System Issues
- EPCIS connectivity failures (AS2, SFTP, API).
- Expired digital certificates or missing message acknowledgments (MDNs).
- ERP/WMS integration problems.
Process and Training Gaps
- Inconsistent exception communication between partners.
- No standardized correction workflows.
- Insufficient DSCSA training.
The Exception Resolution Workflow
Exception handling follows a time-bound, structured process to ensure quarantined product is addressed quickly and safely.
Phase 1: Detection and Initial Assessment (Day 1)
- Identify exception during receiving or automated validation.
- Quarantine affected product.
Phase 2: Communication and Notification (Day 1–2)
- Notify trading partner using standardized email templates (with PO, SSCC, GTIN, issue ID).
Phase 3: Investigation and Analysis (Day 2–3)
- Validate EPCIS transmissions.
- Confirm missing or duplicate serials.
- Perform barcode scans or photos.
Phase 4: Resolution Implementation (Day 3–10)
- Issue supplemental EPCIS file (incremental, not full resend).
- Update ERP/WMS systems.
- Release product once validated.
Phase 5: Documentation and Closure (Day 10+)
- Close exception with a full audit trail.
- Use insights for continuous improvement.
Best Practices for Exception Prevention
Prevention begins with both upstream (sending) and downstream (receiving) partners.
Upstream Prevention (Selling Partners)
- Reconcile EPCIS files against physical shipments before release.
- Validate ASN/PO alignment.
- Implement robust barcode verification.
Downstream Prevention (Purchasing Partners)
- Perform immediate EPCIS file validation.
- Train receiving teams on scanning and quarantine.
- Establish shared escalation protocols with suppliers.
Technology Solutions for Exception Management
Advanced Scanning
- Multi-scanning and AR-enabled devices reduce human error.
- Mobile apps replace expensive handheld scanners.
Integration Platforms
- Cloud-based EPCIS hubs manage multiple partner connections.
- Real-time dashboards track exceptions and corrective actions.
Regulatory Considerations and FDA Guidance
Key FDA Expectations
- Exceptions resolved quickly, ideally within 10 business days
- EPCIS standard must be used for data exchange
- Quarantined product cannot be distributed until resolved.
Compliance Implications
- Unresolved exceptions = non-compliance.
- FDA can audit exception handling documentation.
Measuring Exception Handling Performance
Tracking KPIs ensures visibility and improvement.
Key Metrics:
- Mean Time to Resolution (MTTR).
- Exception Rate per 1,000 shipments.
- % Resolved within 10 days.
Continuous improvement metrics:
- Reduction in repeat causes.
- Employee training completion.
- Supplier resolution responsiveness.
Building a Culture of Exception Excellence
- Assign exception coordinators to oversee processes.
- Form cross-functional teams (IT, compliance, operations).
- Deliver regular training with mock exception scenarios.
The Future of EPCIS Exception Handling
- AI-driven exception prediction for proactive alerts.
- Blockchain records for tamper-proof exception logs.
- AR scanning to reduce manual barcode verification.
Conclusion: Excellence in Exception Handling
Exception handling is the bridge between compliance and operational excellence. By categorizing exceptions, addressing root causes, following structured workflows, and embracing technology, organizations can transform exceptions from costly disruptions into opportunities for continuous improvement.
In the DSCSA era, exception excellence equals supply chain resilience — and resilience protects both businesses and patients.
About the Author: Christian Souza is the
Co-Founder of TrackTraceRx
