Why DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

By: Michael Rowe, Sr. Director of DSCSA/Serialization Services, Two Labs

After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes.

For years, manufacturers have been preparing for this moment - building serialization infrastructure, integrating EPCIS systems, and validating trading partner data. But as 2025 ends with the entirety of the enhanced track and trace requirements going into effect for all stakeholders (sans dispensers with less than 25 FTEs), the question isn’t whether the technology is in place. It’s whether your teams are trained, your processes are defined, and your partners are aligned to handle exceptions.

System Maintenance Challenges

While many companies feel that selecting and implementing a serialization solution and connecting to their CMO partners, 3PL and customers, the DSCSA project is “complete,” the reality is ongoing governance and maintenance of your DSCSA systems (and those your partners use) are still required. Ongoing system validation is needed as the solution providers go through version updates (not just upfront validation will suffice, as the serialization solution vendor needs to fit into your overall ongoing Computer Systems Validation activities). Serialization data exchanges also expose weaknesses in a firm’s ability to govern master data appropriately, as upstream packaging changes now trigger new data updates not just in internal systems, but also with downstream partners.

As product information or even customer information (like addresses) changes, they now require cross-coordination in multiple systems and with all of your partners. Without a single source of truth for many of these details, it means several spreadsheets, typos and misinformation that can permeate and create issues, and product quarantines. Even day-to-day operational scanning causes major operational failures that become much more difficult to unwind because the serialization systems are designed to prevent records from being altered, since these are compliance records. So, companies need to understand how to make changes in their databases and have the right “change control” processes in place to ensure data integrity and flexibility. And in some cases, the solutions themselves have limited capabilities to make data corrections.

Exception Handling Has Become the New Compliance Benchmark

When systems break down (and they will), compliance today hinges less on system implementation and more on operational execution. That shift is exposing a new set of challenges. Exception handling has always been discussed as a “future anxiety,” but the issues are now here. Missing EPCIS transmissions, unreadable barcodes, and inconsistent data from partners are no longer edge cases; they’re daily realities.

With the major wholesalers reporting that roughly 2% of all receipts arrive without data they can use, that’s over 60 million units of product that are getting quarantined per year. And when these exceptions occur, the actual test isn’t whether a company is technically compliant, but whether your team is prepared to know how to respond quickly.

Too often, the breakdown happens not just in a failed connection, but in the silence that follows a failed transaction. A warehouse team receives product without valid outbound data and doesn’t know who to notify. A scanning error is identified, and not enough people know how to correct a file. A suspect product is flagged but sits idle because the escalation pathway isn’t clear. These moments create compliance gaps and expose the disconnect between policy and practice. And here is the thing: supply chain disruptions have always occurred and will continue to, but the level of precision that is now required under DSCSA makes resolving them that much more complex.

Fragmented Enforcement is Raising the Stakes

What complicates this even further is that enforcement isn’t centralized. While federal guidelines outline the DSCSA framework, wholesalers and state boards enforce their expectations - often on separate timelines. This pressure is especially acute for mid-sized companies. Many designed their systems to meet federal deadlines, not to keep pace with shifting distributor requirements.

Simultaneously, state pharmacy boards require SOP documentation and exception-handling protocols as part of licensure reviews - meaning a manufacturer can pass a federal audit and still be blocked from distributing product. The result is a fragmented compliance environment in which companies must navigate three clocks at once: federal, wholesaler, and state-level enforcement. The operational burden of staying aligned across all three continues to grow.

Compliance Failures Are Business Risks

Over the years, we’ve seen how quickly regulatory observations turn into operational disruptions. When DSCSA compliance isn’t built into the day-to-day — when SOPs sit untested, and trading partner checks aren’t enforced — it doesn’t take long for cracks to show. A Form 483 tied to these gaps doesn’t just live in an audit report. It becomes part of the public record. It gets flagged during diligence. It gets passed around boardrooms and trading partner reviews.

These citations are increasingly triggering consequences that go far beyond paperwork. We’ve seen manufacturers scramble to salvage timelines after a failed state inspection. We’ve seen wholesale partners pause distribution until questions are resolved. And we’ve seen the ripple effect — when compliance issues cast doubt on a company’s broader operational maturity, partners and investors hesitate. They want to know that what’s under the hood is ready to scale, not just compliant on paper.

This isn’t theoretical anymore. DSCSA compliance is being treated as a proxy for overall readiness - and when it’s missing, the business impact is immediate.

Execution – Not Just Infrastructure — Will Define Readiness

A common misconception across the industry is that compliance ends at go-live. In reality, that’s when the hard part begins. Having a serialization database solution or leveraging your 3PL for operational tasks doesn’t guarantee readiness. When EPCIS data fails to transmit, is it caught? When the serialized status is unclear, does the product ship anyway? These are no longer what-ifs - they play out daily as enforcement matures.

At industry forums, including the 2025 HDA Traceability Seminar, it became clear that while most manufacturers have completed the foundational work, many are still unprepared for what happens when that foundation is tested. Conversations focused less on building systems and more on managing failure: What happens when trading partners disagree on serialized status? How should the product be handled when EPCIS records are out of sync? Who decides when to halt or release a shipment?

These are not technical problems but rather strategic operational questions that can be coupled with compliance consequences if not figured out. And they require answers that are tested, documented, and embedded in daily workflows. The organizations that succeed in this next phase of DSCSA readiness will not be the ones with the cleanest implementation roadmap, but the ones that can prove - under pressure - that they know how to respond.