The Real Cost of DSCSA Compliance

Here’s a number that should get your attention: $5,000 to $20,000. That’s what most pharmaceutical organizations pay compliance consultants to develop a single DSCSA Standard Operating Procedure.

And that’s just the beginning. Add in 3-6 months of your team’s time, countless revision cycles, legal reviews, and the constant anxiety of wondering if you’ve covered everything the FDA expects to see.

Now imagine this scenario: FDA inspectors arrive at your facility for an unannounced inspection. Within the first hour, they ask to review your Drug Supply Chain Security Act procedures. You hand over what you have—maybe it’s outdated, maybe it’s incomplete, maybe it’s a patchwork of documents you’ve been meaning to organize.

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. 

With the final DSCSA exemption deadline looming in May 2025, pharmaceutical manufacturers must act now to comply with the FDA’s interoperability, serialization, and traceability mandates. Non-compliance isn’t just a regulatory headache—it can cause severe disruptions, including halted product sales, costly recalls, and damaged supply chain relationships.

The Drug Supply Chain Security Act (DSCSA) compliance deadlines are fast approaching. Despite the political landscape’s recent shifts, these deadlines remain firmly in place. The regulatory freeze introduced by the Trump administration in January 2025 has generated discussions, but it does not alter these legally mandated timelines. Businesses must continue their preparations to ensure compliance.