The DSCSA Clock Is Ticking

With roughly three months remaining, the countdown has officially begun for all supply chain partners in the US pharmaceutical ecosystem to achieve full compliance with the Drug Supply Chain Security Act (DSCSA). The policy mandates all pharmaceutical products to have a unique serial number that can track data about their every movement. The DSCSA is about fully securing America’s drug supply and protecting patients from counterfeit, unapproved or potentially dangerous drugs. In 2023, the FDA chose to delay enforcement until November 2024 to minimize disruptions to supply chain productivity and patient care – a move many were quick to celebrate. The original deadline would have caused a number of supply chain complications, including triggering quarantined products to be sent for regulatory reviews and, ultimately, risking delayed patient access to life-saving medications. 

The so-called “stabilization period” was supposed to help pharmaceutical supply chain partners make their systems stable and fully interoperable. What it was not supposed to be is an excuse for trading partners to postpone implementing necessary changes to meet the new deadline. Yet, this is exactly what’s happening. With the stabilization more than halfway over, it is clear that we are not making the progress we need to be making to ensure the supply chain moves smoothly come November 2024. From our view at Cencora, we’ve noticed a large number of manufacturers capable of sending data, but there exists about 20 percent of our national drug codes (NDCs) for which we aren’t getting any data.

So, what can be done to ensure we don’t jeopardize patient access to treatments? We need exceptions, processes and systems to support relevant parties. Aside from the lack of data, exceptions are the biggest concern. Roughly 25 percent of shipments to our network distribution centers are still showing up without data. This means that distributors, like us, must turn the truck away or wait until we get the data before we can receive the products. Given the fact we move more than one billion units of medications per year, this is a large concern.

With the DSCSA, a piece of data must identify each of these one billion products. If that data is not with the medication, the product doesn’t move, creating more bottlenecks to our partners and so on. Then, if these trends were to hold once the DSCSA is fully implemented, approximately one-third of all medications received would need to be quarantined due to non-compliance, which would bring about significant delays from getting treatments to patients who need them. Our plea to manufacturers is that if you aren’t sending complete and accurate data on time, then it is imperative you request a waiver, exception or exemption from the FDA as soon as possible. This will allow manufacturers to still exchange their products without data after November 2024 for a finite amount of time before they must become fully compliant with the DSCSA.

We have dedicated teams across the US and globe who are assisting manufacturer trading partners to achieve compliance through feedback on respective DSCSA transactions. By ensuring manufacturers’ products are not only in compliance with DSCSA, but also that distribution centers and pharmacy customers can begin to use serialized products and the barcodes and packaging can be scanned and utilized, we’ll be able to tackle the new policy with greater confidence. Of course, the DSCSA is changing the way the entire supply chain does business. It’s going to take time to stabilize, and we don’t want to see delays ripple through the supply chain. This is why increased collaboration is key to ensure implementation is successful.

The Healthcare Distribution Association (HDA) has communicated its support of the FDA’s one-year stabilization period but has urged for a stronger position on enforcement because of a lack of urgency from supply chain partners. Specifically, the HDA has asked the FDA to acknowledge the reality of readiness in the supply chain, be clear about its intention to use enforcement approaches after November 27, 2024, and commit to intensive communication strategies during the remainder of the stabilization period. No doubt the clock is ticking, but we’re optimistic that, with continued collaboration from industry stakeholders and persistent reminders to manufacturers and customers about the requirements for DSCSA implementation, we will use the remaining time of the stabilization period wisely. We simply cannot afford to delay further.