DSCSA 2025 Deadlines Are Approaching — Is Your Team Ready?

With the May 27 deadline for manufacturers behind us, and final 2025 DSCSA enforcement deadlines rapidly approaching – August 27 for wholesale distributors, and November 27 for dispensers – the industry is bracing for impact.

Most of the attention has gone to EPCIS data exchanges, digital credentials, and system readiness. But I want to shift focus for a moment. Let’s talk about process. Because while data matters and systems matter, what’s going to make or break a successful audit (or a drug shortage) is whether your people know what to do when something goes wrong. And right now, based on what the FDA and several state boards of pharmacy have found in recent audits, that “what to do” isn’t always clear. 

What the FDA Is Actually Enforcing During DSCSA Audits

Take a look at the public warning letters the FDA has issued over the past 18 months. In one notable case (yes, the Safe Chain letter), the agency highlighted not just technology failures, but also process ones: no documented standard operating procedure (SOP) for how to investigate a suspect product, no plan for what happens if a partner isn’t authorized, no records kept of prior responses to verification requests. This isn’t unique.

Similar gaps have shown up in inspections of third-party logistics, repackagers, and even dispensers in states like California and Florida, where boards of pharmacy have begun to review DSCSA-readiness as part of broader compliance sweeps. They’re not just asking whether you received EPCIS files.

They’re asking:

  • What did you do with them?

  • Who reviewed them?

  • What happens if a product doesn’t match your expectations?

Counterfeits Are Already in the Supply Chain

This isn’t a theoretical risk. DSCSA is already being used to catch bad actors. The counterfeit Ozempic and Mounjaro incidents? Those weren’t caught by data exchange platforms. They were caught because manufacturers and supply chain partners had investigation and reporting procedures in place — and knew how to act fast. SOPs saved lives. That’s the part of DSCSA that gets lost in tech demos. Serialized data is only as good as the people interpreting it. We’ve seen legitimate manufacturers receive illegitimate returns. We’ve seen hospitals unknowingly dispense diverted product.

In every case, the issue was not just a system breakdown. It was a process breakdown.

DSCSA SOPs: What Your Procedures Should Actually Cover

You don’t need a 40-page policy manual. But you do need to show auditors that you’ve thought through the following, and that your team knows what to do:

  • How do you determine whether a product is suspect or illegitimate?

  • Who conducts the investigation and how is it documented?

  • If you receive a verification request from the FDA or a trading partner, how do you respond within the 24-hour window?

  • How do you confirm that your trading partners are authorized, and that you’re not accidentally buying from someone whose license has lapsed or been revoked?

  • Where do you store these records and who has access?

The Milestone Deadlines Are About More Than Just Tech

The May, August, and November deadlines are less about turning on a system and more about proving you have control. If the FDA or your state board of pharmacy asked for a walkthrough tomorrow, could you show them the following?

  • The last time you received a DSCSA verification request

  • What actions were taken

  • What documentation exists

  • Who on your team is responsible

If the answer is no — or “we’re still figuring that out” — now is the time to close the gap.

Final Thoughts: Don’t Let SOP Gaps Undermine Your DSCSA Compliance

DSCSA isn’t just a compliance checkbox. It’s a chance to prove to regulators, patients, and trading partners that your organization takes drug safety seriously. That starts with building real processes, writing them down, and training your people.

Criterion Consulting can help with all of that, providing the industry expertise to arm your organization with the knowledge of how pharma logistics companies can comply with federal legislation, while unlocking value for your business.

Contact us today to schedule a call and learn more.

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