DSCSA Compliance Is About More Than EPCIS: Why Operational Readiness Matters Before May 27

The May 27, 2025 Drug Supply Chain Security Act (DSCSA) enforcement deadline is rapidly approaching—and with it, the end of the grace period for partial or incomplete compliance. While much of the industry conversation has centered on EPCIS file exchange, the real challenge is bigger than sending files. DSCSA compliance means validating live connections, ensuring complete and accurate data, and confirming that every downstream partner is receiving usable information—without errors, gaps, or delays.

For manufacturers, the risk of overlooking these details is significant. It’s not enough to assume that data is flowing; compliance requires proof. You must know that your product and transactional data are aligned with trading partner expectations, or you risk being flagged for noncompliance. That misalignment can lead to more than a slap on the wrist or fines, token or otherwise.

Rejected Shipments = Disrupted Revenue

Several major wholesalers, including members of the "Big 3," have made it clear: they will not accept shipments that arrive without the requisite DSCSA data. Products without compliant EPCIS files may (will?) be rejected and returned on arrival. For manufacturers, this raises an urgent question—what would a rejected truckload mean for your monthly revenue or your inventory planning?

The impact could be immediate and severe: delayed payments, unavailable stock for customers, missed SLAs with claw-back clauses and unexpected costs from re-routing or re-shipping inventory. And that’s just the start.

Poor Data Damages Customer Relationships

Beyond revenue implications, data quality directly affects customer trust. Quarantined or delayed product due to missing or invalid EPCIS data disrupts downstream operations. Pharmacies and hospitals don’t want to wait for medicine, and they don’t want to chase down technical issues. If a manufacturer or distributor consistently causes problems, customers will seek more reliable partners—potentially shifting their business to competitors that’ve demonstrated strong adherence to compliance requirements.

Have You Operationalized DSCSA?

DSCSA is no longer a project on the roadmap—it must be a part of your day-to-day operations. If a trading partner submits a verification request, are you prepared to respond within the required 24-hour window? Have you assigned internal ownership for EPCIS data quality and error correction? Do you have clearly defined processes—and actual people—in place to manage these responsibilities?

These aren’t hypothetical scenarios. They are legal requirements. And the FDA is watching.

Avoid the Avoidable

At LSPedia, we help pharmaceutical companies move from DSCSA theory to DSCSA practice. Whether you're using our OneScan™ Suite or evaluating other systems, the time to act is now. This means confirming that your connections are live, your data is flowing cleanly, and your downstream partners are confident in your compliance.

Avoid costly disruptions. Avoid reputational damage. Avoid the avoidable.

Now is the time to assess your readiness, close the gaps, and ensure that your DSCSA strategy works—before enforcement begins.

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