The pharmaceutical industry is approaching final Drug Supply Chain Security Act (DSCSA) deadlines: May 27, 2025, marks the start of full enforcement by the U.S Food and Drug Administration (FDA) for manufacturers. That will be followed by enforcement deadlines of August 27 for wholesale distributors and November 27 for dispensers, specifically those with more than 25 full-time pharmacy employees. Most companies have made considerable progress towards serialization, packaging, and electronic data exchange, but one critical operational gap remains: exception handling.

While serialization and traceability lay the groundwork for supply chain visibility, efficient exception handling is essential to keep products flowing downstream. When there is a mismatch between serialized data and the physical product, or a product without data, DSCSA requires those items to be quarantined until the issue is resolved. That delay does not stop at the warehouse; it can slow the movement of vital medications to hospitals, pharmacies, and clinics, especially in a healthcare environment already challenged by drug shortages.

Patient Impact Is Real—and Preventable

When medications do not arrive on time, caregivers at the point-of-care may be forced to delay treatment, scramble for alternatives, or turn patients away altogether. These consequences are not theoretical and insignificant. Exceptions are often caused by packaging errors, mislabeling, inaccurate serialization, scanning issues, and they create bottlenecks that ripple across the system. The result? Increased administrative burden, fractured workflows and, most critically, disrupted access to treatments patients are relying on. Even a seemingly minor delay—resolving a mismatch for just a few high-value oncology units, for instance—can translate to canceled appointments or altered care plans. 

A Common Exception Scenario: Misaligned Packaging Data

Let’s consider a real-world example. A manufacturer ships cases of temperature-sensitive medication to a national distributor. Each case contains 12 serialized vials, as intended. However, during aggregation, a system error causes the case label and shipment data to list only 10 serial numbers. When the shipment is scanned at the distribution center, the physical count doesn’t match the serialized data—triggering an exception.

Because DSCSA prohibits the product from entering inventory with unverified data, the entire case must be quarantined. Now the distributor must contact the manufacturer, launch an investigation, and reconcile the discrepancy. If the manufacturer’s systems lack visibility into packaging-level detail or cannot quickly isolate the event, the resolution could take days. In the meantime, downstream pharmacies may run out of stock—particularly concerning cold chain products that are often difficult to replace quickly.

Why This Still Happens—And How to Fix It

While the industry has invested heavily in systems to generate and transmit DSCSA-compliant data, exceptions occurring even at 1% of transactions can have a significant effect on drug supply as well as internal resource consumption. Managing exceptions involves different operational teams—packaging, quality, compliance, IT—and resolving them can require multiple systems, stakeholders, and coordination points.

Without well-defined exception workflows, manufacturers risk slower response times to partner inquiries, increased volume of rejected shipments and delays that cascade into downstream shortages. 

Proactive Prevention: The Goal Is Fewer Exceptions, Not Just Faster Resolution

While exception handling workflows are necessary to resolve discrepancies quickly, the long-term objective should be to reduce the number of exceptions in the first place. By focusing on data accuracy, clean master data, strong aggregation practices and consistent serialization protocols, manufacturers can prevent many of the mismatches that trigger quarantines and shipment delays. Investing in error prevention at the packaging and data transmission stages lightens the burden on downstream partners and contributes to a more stable, responsive supply chain that better serves patients.

Building Resilience Through Shared Best Practices

To help address these challenges, GS1 US released a new Exceptions Handling Addendum to its DSCSA Implementation Suite. Created by the GS1 Healthcare US Rx Secure Supply Chain workgroup, the Addendum is designed to give trading partners a structured approach to exception resolution. It includes: 

• exception scenarios mapped to common root causes 
• recommendations for using GS1 Electronic Product Code Information Services (EPCIS) event data to track and resolve issues
• workflow models to support triage, investigation, and resolution of exceptions, and
• best practices for cross-partner communication

With these tools, manufacturers can start to build the internal infrastructure and external alignment needed to manage exceptions proactively—not reactively.

Exception Handling Is Now a Core Readiness Indicator

Beyond DSCSA enforcement, optimized exception handling is important for maintaining trust and continuity in the healthcare system. Every unresolved discrepancy represents a potential delay in care. By working collaboratively with supply chain partners to resolve exceptions efficiently and prevent them wherever possible, manufacturers play a vital role in ensuring that safe, verified medications reach the people who need them, when they need them. It’s a shared responsibility that begins with being ready for the last mile.

Tracy Nasarenko, Vice President of Customer Success at GS1 US, leads a collaborative pharmaceutical industry group focused on addressing supply chain challenges and meeting the requirement of the Drug Supply Chain Security Act (DSCSA).