The Gap in DSCSA Readiness

In a video interview with Pharma Commerce, Joe Lipari, direct of product management for Systech, dives into how the Drug Supply Chain Security Act (DSCSA), signed into law by President Obama in 2013, has actually been in development for nearly two decades, with earlier state-level efforts like California’s e-Pedigree push. Initially, the full implementation deadline was set for Nov. 27, 2023, marking the completion of serialization and traceability across the pharmaceutical supply chain. However, due to industry readiness issues, the FDA introduced a “stabilization period” to allow for testing and system adjustments. The stabilization period, meant to iron out bugs, turned into a series of delays, and the implementation date has been pushed back multiple times.

In October 2023, the FDA announced another delay, introducing a phased approach to DSCSA compliance. Manufacturers now have until May 2025 to meet requirements, wholesale distributors until August 2025, and mid-to-large dispensers until November 2025. Small dispensers, defined as those with 25 or fewer employees (including pharmacists and pharmacy technicians), have an extended deadline of November 2026. This phased approach allows different parts of the supply chain to comply gradually, but the full implementation will not be realized until at least 2026.

The FDA’s latest exemption allows eligible trading partners that have either completed or documented efforts to complete data exchange connections to be given some leeway in enforcement. This continues the trend of delays and phased compliance, highlighting ongoing challenges in fully implementing the DSCSA across the industry.

Lipari also explains the penalty for non-compliance, the likelihood that these deadlines put forth by the FDA will be met, and more.A transcript of Lipari’s conversation with PC can be found below.

PC: What do you believe the likelihood is that these deadlines put forth by the FDA will be met?

Lipari: The funny thing is, we were having this conversation back in August and September. The HDA [Healthcare Distribution Allinace] does their Traceability Seminar in DC every year. You have the FDA there and a lot of different legal entities there, and that question continues to be asked of, what are you guys going to do? The answer was, no, there will not be any more delays. And a month later, we have the announcement. History has sort of shown us that any dates within the DSCSA implementation framework are subject to change.

If I was a betting man. I’d have to look at the track record of this implementation and say that I'm not sure if any of the dates will hold. But I mean, from my experience with Systech, we are more on the manufacturing side. A majority of our serialization customers are Big Pharma, mid-, mid-tier pharma. With our traceability platform, we have manufacturers, we have distributors, we have repackagers, CMOs. There is whole breadth of trade partners, but the manufacturers, for the most part, are ready. They've been serializing product for quite some time. They have systems in place to do verification. They have systems in place to handle tracing requests. They have systems in place to electronically share data. You hear from the wholesale distributor—from a KPI perspective—the wholesale distributors ramping up their enablement across their DCs.

In the beginning, you heard numbers and by the end of the stabilization period, definitely those numbers all went in the right direction, as far as how much was enabled, and then furthest downstream, you get to the dispensers. That's really where I think the main problem with readiness lies, and it's a tough space.

In the US, there's something to the tune of 90,000 different dispense locations. That ranges from the CVS and Costcos of the world—which are massive corporations—all the way to your mom and pops, those little pharmacies. I have one in my town, and they're independently owned, a single location, but that doesn't mean they're not exempt from DSCSA. They are the same prescription serialized drugs that are flowing through those facilities, just like CVS. It’s a tough space because of how many different types and the wide range of business types that exist in that space. There was a clear message that the dispense side was not going to be ready. If this thing did get pushed through, [there may have been] calls for patient safety, and what happens with quarantine product if you can't meet the letters of the law? I get that side of it, but there's a piece of me that feels we've been talking about this since 2013, and so how much further can we kick this can down the road?