Verification, Returns, and Investigation Processes: How to Avoid Operational Gridlock

The pharmaceutical industry has spent years preparing for the enhanced traceability requirements of the Drug Supply Chain Security Act. Significant investments have been made in serialization, interoperable data exchange, and supporting technologies to strengthen supply chain visibility and protect patients from counterfeit, diverted, and illegitimate medicines.

For many manufacturers, wholesale distributors, and dispensers, the conversation has now evolved beyond implementation. The challenge is no longer simply achieving compliance, but operating efficiently within a fully traceable supply chain. As the U.S. pharmaceutical supply chain enters this new phase of maturity, organizations are discovering that regulatory compliance and operational excellence are no longer separate objectives. They must be achieved together.

One of the clearest examples of this shift can be seen in three core DSCSA operational processes: product verification, saleable returns, and suspect product investigations. Individually, each process is well defined by the regulation. Collectively, however, they represent a connected operational workflow that directly influences how product, information, and decisions move throughout the supply chain.

When these processes are designed and managed independently, organizations often experience increasing manual effort, growing investigation backlogs, receiving delays, prolonged product quarantine, and unnecessary disruption to product flow. The challenge is rarely the regulation itself. It is the maturity of the operational processes built around it.

Advancing operational maturity requires organizations to move beyond managing verification, saleable returns, and investigations as separate compliance activities and instead design them as a single, integrated operational workflow. They should be supported by integrated data, clearly defined ownership, intelligent exception handling, and streamlined decision-making.

When designed this way, organizations are better positioned not only to satisfy regulatory requirements, but also to maintain throughput, reduce operational friction, and build a more resilient pharmaceutical supply chain.

Beyond Compliance

In our experience, organizations often implement product verification, saleable returns, and suspect product investigations as distinct compliance processes, each supported by its own procedures, systems, and ownership. While this approach helps address individual regulatory requirements, it does not always create an efficient end-to-end operational workflow.

The challenge emerges when an exception moves across these processes. A verification issue can trigger product quarantine, initiate an investigation, delay product disposition, and ultimately impact inventory availability and warehouse operations. Operational maturity is demonstrated not by how well each individual process performs, but by how effectively they work together.

The following sections examine how each process contributes to a connected workflow that supports both regulatory compliance and operational performance.

Product Verification: The First Operational Decision Point

Product verification is often viewed as a compliance checkpoint. Operationally, however, it is the first decision point in the DSCSA workflow. The outcome determines whether product can continue through normal warehouse operations, requires additional review, or must be quarantined pending investigation.

Not all verification exceptions carry the same level of operational or compliance risk. Treating every exception the same often creates unnecessary manual effort, receiving delays, and investigation backlogs. Rather than applying a single workflow to every exception, SCW recommends a risk-based exception triage approach that classifies exceptions according to likely cause and potential impact before assigning them to the appropriate resolution path.

Saleable Returns: Extending the Operational Workflow

Saleable returns are among the most operationally complex DSCSA processes because they determine whether returned products can safely re-enter the pharmaceutical supply chain. Under DSCSA, returned product must be verified before it can be redistributed, making verification an integral part of the returns process rather than a separate operational activity. FDA’s implementation guidance and statutory requirements reinforce this expectation. FDA enhanced DSCSA guidance

One common observation across the industry is that returns are often managed through standalone warehouse processes with separate reviews and exception-handling workflows. This can introduce unnecessary manual handoffs, duplicate investigations, and delays before verified product is returned to available inventory.

Building on FDA’s verification requirements, organizations can create a more efficient saleable-returns process by adopting three operational design principles:

• Verify at receipt. Perform product verification as part of the returns receiving process rather than after the product enters a separate workflow.
• Maintain end-to-end traceability. When cases are opened, partially returned, or repackaged, update aggregation hierarchies and EPCIS records to preserve accurate parent-child packaging relationships throughout the product lifecycle, consistent with GS1 traceability guidance.
• Use a single exception-handling process. Route verification failures identified during returns through the same risk-based triage, ownership, and escalation workflow used for inbound verification, rather than creating a separate investigation process.

Designing returns as an extension of the verification workflow reduces operational complexity, improves inventory availability, and helps organizations maintain both product flow and regulatory compliance.

Suspect Product Investigations: Restoring Operational Flow

Product verification identifies potential exceptions. Saleable returns determine whether returned product can safely re-enter the supply chain. Suspect product investigations provide the structured process for resolving those exceptions and determining the appropriate product disposition. Together, these processes form a continuous operational workflow, where delays at the investigation stage directly impact inventory availability and product flow.

Even well-designed investigation processes can become operational bottlenecks. Common sources of delay include:

• Unclear ownership, resulting in exceptions remaining in investigation queues without timely action
• Undefined internal regulatory response procedures, creating uncertainty around FDA notification and escalation requirements when a product is determined to be illegitimate
• Incomplete investigation records, where activities are documented after the fact rather than in real time, making audit trails more difficult to reconstruct

As discussed in SCW’s DSCSA Exception Handling Playbook, effective investigations depend on clear ownership, standardized workflows, timely documentation, and well-defined escalation paths. Within the broader DSCSA operational workflow, investigations should not function as an isolated compliance activity, but as the mechanism that efficiently resolves exceptions, restores inventory availability, and enables products to continue moving safely through the pharmaceutical supply chain.

Designing an Integrated DSCSA Operational Workflow

Operational maturity is achieved when product verification, saleable returns, and suspect product investigations operate as one connected workflow rather than as independent compliance processes. While each activity serves a distinct regulatory purpose, they should share common data, ownership, and exception-handling processes.

An integrated DSCSA operational workflow is built on five foundational capabilities:

When these capabilities are designed as a single operating model, verification, returns, and investigations become more than individual compliance activities. They become a connected operational workflow that accelerates exception resolution, improves inventory availability, and strengthens both regulatory compliance and operational performance.

Conclusion

As the pharmaceutical industry moves beyond DSCSA implementation, compliance is becoming the baseline rather than the differentiator. The organizations that will realize the greatest value from their serialization investments are those that transform product verification, saleable returns, and suspect product investigations into one connected operational workflow that supports both regulatory compliance and operational excellence.

At SCW, we believe the next stage of DSCSA maturity will be achieved through the combination of robust digital capabilities and well-designed operational processes. Technology provides the foundation. Operational design unlocks its full value. Together, they enable organizations to strengthen compliance, improve operational performance, and build more resilient pharmaceutical supply chains.