DSCSA Audits Are Coming: How the Pharmaceutical Supply Chain Can Prepare for May 27, 2025

On May 27, 2025, the Drug Supply Chain Security Act (DSCSA) enters full enforcement for pharmaceutical manufacturers—and everyone in the pharmaceutical supply chain from manufacturers, repackagers, wholesalers and dispensers, have to step up their compliance with DSCSA requirements, including traceability, data exchange, verification, and error resolution.

This is the year of enforcement. And for all trading partners, readiness must be operational, not theoretical.

What Will Auditors Be Looking For?

DSCSA audits are no longer hypothetical. Federal regulators and State Boards of Pharmacy—as well as wholesalers and trading partners—are preparing to verify compliance across the supply chain. They’ll be looking for:

• EPCIS Data Exchange (phased roll-out)
  Are you sending or receiving serialized EPCIS data correctly and consistently? Have all trading partner connections been tested and validated?

• Exception Handling & Error Resolution
  Can you quickly detect and resolve EPCIS errors? Do you have a defined process—and people—responsible for managing exceptions?

• Verification & VRS Connectivity
  Are you able to respond to product verification requests within 24 hours using the Verification Router Service (VRS)? This is a legal requirement under DSCSA.

• Audit-Ready Records
  Is your transaction documentation up to date and easily accessible in case of an audit?

• Partner Interoperability
  Have you confirmed your partners are successfully receiving your data without delays, gaps, or errors?

👉 Read our post on 6 critical DSCSA actions for Manufacturers to take before May 27.

Why This Matters

The consequences of DSCSA noncompliance are significant and may include:

• Rejected or delayed shipments

• Quarantined products

• Lost revenue and strained partner relationships

• Regulatory penalties or enforcement actions

• Long-term damage to trust and brand reputation

One weak link in the traceability chain can disrupt your entire operation—and have ripple effects throughout your network.

Preparing for DSCSA Audits Starts Now

Compliance isn't just about systems—it's about people, processes, and performance. To pass an audit and meet the May 27 deadline, Manufacturers must ensure:

• Validated EPCIS data exchange with all trading partners

• Clear ownership of exception and verification responsibilities

• Staff trained on compliance protocols and tools

• Robust, audit-ready documentation and reporting systems

Even if federal regulators don’t knock on your door on May 28, your trading partners might. Many wholesalers and dispensers are auditing upstream partners to ensure their own compliance.

Conclusion

May 27, 2025, marks more than a regulatory deadline—it marks a new operating reality. For the pharmaceutical supply chain, DSCSA audits demand preparedness, precision, and collaboration.

With the right tools, training, and alignment, you can protect your products, partners, and patients—and move confidently into the fully interoperable future of pharmaceutical distribution.

📌 Need help getting audit-ready?
LSPedia supports DSCSA compliance across the supply chain with powerful automation, real-time error resolution, and complete traceability.

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