Navigating DSCSA Delays

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: Could you describe the latest state of DSCSA implementation guidelines?

Lipari: Like you said, Obama signed it into law in 2013, so we're talking that far back. Even prior to that, we're talking mid 2000s, where, prior to it being federal law, there were individual states that were kind of doing their own thing. There was a big California e-Pedigree push where there was some serialization and aggregation, but very local at the state level. It’s been around coming up on almost 20 years, right of some sort of US serialization push. Originally, the goal line was Nov. 27, 2023. That’s when full implementation—soup, the nuts, everything—would have gone live. Obviously, what happened was, with the state of readiness in the industry, the FDA announced what they called a stabilization period, which was meant to be a time to where all of the trade partners were flexing and testing all the systems they had in place, and that's the key word. Stabilization has a very specific meaning.

You're supposed to be stabilizing the existing systems in place, working out the bugs. Well, you can't stabilize something if you don't have a system in place, so unfortunately, the stabilization period really wound up being a proverbial “kick the can down the road.” There’s been a few up to this point, so DSCSA implementation in general has seen its fair share of delays, whether that be enforcement or non-enforcement, whatever verbiage you want to use. There's been multiple delays in this thing since the beginning.

The stabilization period was really meant for a time when everyone was to work out the kinks in the system so that we could all go live the 27th of November. That didn't happen. We had the announcements back in October—which were the latest round of announcements—where the FDA came out and gave a broader exemption to the industry. This really applied to—this is the language in the exemption—eligible trading partners who have either successfully completed or made documented efforts to complete these connections and data exchange with their trade partners.

Now, we can have a conversation about that language, because how do you enforce something that, but what that really meant was that it was a phased approach. FDA came out and said, hey, listen, we're going to take a step back. We're going to do a phased approach, starting from the front of supply chain to the back of supply chain, where you have your manufacturers that now have until May of 2025, you have your wholesale distributors that now have until August 2025, and now you have your mid-to-large dispensers that have until next November of 2025, so a full year. You have this phased approach for those categories.

The other piece, which was in June, was the announcement about small dispensers, defined as 25 or fewer employees. There's language in there too, which was under some scrutiny within the industry, because it's the corporate entity. The corporate entity that owns the dispenser has a total of 25 or fewer full-time employees, licensed pharmacists, and pharmacy techs. Small dispensers now have until Nov. 27, 2026, so the full breadth of this thing, as it is today, is not going to be realized now for another two years for all the different personas in the supply chain. That's kind of the latest state of implementation timelines.