Kim Fluchel
VP of supply chain & compliance products
Inmar

The deadline for DSCSA compliance is approaching. For many in the industry, this moment marks the end of a long regulatory journey. We should see it differently. This isn't a finish line. It's a starting gate.

Having spent 30 years transforming operations across healthcare, manufacturing, and energy, I've seen what happens when visibility improves but workflows don't. The gains are small and the frustration lingers because people stop trusting the tech when the experience hasn't actually changed.

For the first time, we now have unit-level serialization across the drug supply chain. The shift from lot-level tracking to item-level visibility creates a foundation that the pharmacy has never had before. The compliance requirement is important, but it's what we build on top of it that will actually move the profession forward.

Serialization changes what's possible

Before DSCSA, drug tracking stopped at the lot. If a product was recalled, we could identify a general batch, but we often couldn't say exactly which units were on which shelves, in which hospitals, or inside which crash carts. Pharmacy teams scrambled to trace product movement. Documentation was inconsistent. Hours were lost. Risks increased.

With serialization, every sellable unit has its own identity. That means we can know not just what drug it is, but where it went, when it was received, and what action was taken. If a recall is issued, we can trace the affected unit directly to its location and remove it quickly. This kind of precision recall has moved from theory to reality, provided the infrastructure around it is ready.

That's where the real challenge lies. Compliance may be checked off, but if the data sits in disconnected systems, or if the workflows remain manual, we won't see the benefits serialization can offer. DSCSA gives us the data. It's up to us to use it well.

Compliance doesn't guarantee readiness

I walked into a hospital last month and watched them track inventory on paper. In 2025, drug transfers between sister hospitals still happen on handwritten forms, reconciliations are done with clipboards, and audit logs are managed with spreadsheets. This goes beyond inefficiency into dangerous territory, especially when processes rely on individual memory and siloed systems.

In that kind of environment, serialization is limited. You may have the data, but you can't act on it with speed or confidence. What we need is better design, not more software. We need systems that talk to each other, interfaces that present the right information at the right moment, and alerts that trigger action rather than noise.

You can't digitize dysfunction. If your workflows are broken, adding serial numbers just gives you broken workflows with better tracking. While some vendors spread uncertainty about DSCSA readiness, the real question isn't whether you're compliant but whether you're ready to compete in a serialized world.

Credit reconciliation is a clear example

Returns and credits are among the most frustrating areas of pharmacy operations. Retailers send back products, manufacturer policies vary widely, and documentation is incomplete. Disputes that drag on for 6-12 months could be resolved in days with proper serialization.

If we can match a returned product to its serialized ID, we can confirm exactly what was shipped, when it was received, whether it qualifies for credit, and how to process it fairly. When the data is accurate and trusted by both sides, there's no need for negotiation. That transparency changes everything as guesswork becomes clarity and friction becomes resolution.

The real opportunity is intelligence

DSCSA provides a better dataset, but its full value will only be realized when we build systems that turn that data into intelligence.

Pharmacy teams should not have to chase down information during a crisis. They should be supported by systems that surface relevant details, alert them to issues before they escalate, and guide them through resolution. That means building decision support into everyday workflows, whether it's during intake, tray prep, inventory cycles, or product returns.

People don't need AI magic. They need to see how the system reached its conclusion. Give them the alert, show them the supporting data, and let them verify it until they don't need to anymore. That's how trust is earned. The point is to remove the burden of tracking, reconciling, and verifying every single unit, letting clinicians focus on care. Serialization helps with that only if we build systems that use it properly.

What comes next is the real transformation

In pharmacy, we have a chance to get it right. We now have a data layer that tells us what we didn't know before. Now we need to connect it to the way people work. That means simplifying the process, removing unnecessary steps, and creating a system where compliance becomes a byproduct of doing the job well rather than another burden to manage.

We're barely out of the blocks with the real race being to build intelligence on top of compliance. If we treat this as a victory lap instead of a warm-up, we'll miss the transformation pharmacy has needed for years.

DSCSA gives us the data layer that pharmacies have needed for decades. Now we decide whether to use it to check a compliance box or to finally fix what's broken. The starting gun has fired. Time to run.

Kim Fluchel is VP of supply chain & compliance products at Inmar.