Balancing Compliance and Supply Chain Continuity

In a video interview with Pharma Commerce, Heather Zenk, Cencora’s president of supply chain operations & distribution services, describes how today's distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want access to advanced therapies close to home, and distributors play a critical role in making that happen.

A major focus in this effort is maintaining product integrity, especially for cold chain items that must be stored between 2–8°C. Innovations in cold chain management now go beyond temperature tracking; they include predictive maintenance of infrastructure such as freezers and compressors. Distributors not only monitor product temperature but also evaluate the performance and potential failure risks of the equipment that manages the cold chain environment.

Zenk emphasizes the importance of marrying manufacturer data with real-time logistics. For example, if a care site accidentally stores a cold chain product outside the optimal range for a short period, data from the manufacturer can often confirm whether the product remains viable. This responsiveness supports safe patient care and reduces waste.

Another important innovation is the use of reusable cold chain totes, which service over 90% of the US market. These require robust freezing systems and operational oversight to ensure readiness and reliability. Zenk underscores that preventing failure, rather than simply reacting to it, is the next frontier in pharmaceutical distribution. By using data-driven insights and predictive engineering, the distribution process becomes more resilient, ensuring that patients can access vital therapies without delay or compromise.

She also comments on the advanced technologies that are proving most effective in enhancing real-time visibility and operational efficiency; strategies organizations should prioritize to ensure compliance while minimizing disruptions for manufacturers and providers as the DSCSA compliance date approaches; ‘essons learned from recent drug shortages and global disruptions; the practical steps that can be taken in transportation, packaging, and warehousing to meet sustainability goals without compromising reliability or cost-effectiveness; and much more.

A transcript of her conversation with PC can be found below.

PC: As the DSCSA enforcement date approaches (Aug. 27 for wholesale distributors), what strategies should organizations prioritize to ensure compliance while minimizing disruptions for manufacturers and providers?

Zenk: Our strategy and mindset has been that this isn't going to happen overnight, and we all know that—God bless, you've been working on this for 10 years, and we've gone through the gamut of what technology are we going to use? We need some underlying capabilities, data like GLNs. How do you how do we identify a location standardized? How do we use GS1 global standards to do the standardization of packaging? Once we kind of started to get through, okay, what are the key building blocks we need? From a technology point of view, how do we identify sites of care? How do we identify the product, and then how do we start to track it and move it through the network?

Our strategy has always been we take federal particularly, and state regulations, very seriously. We pride ourselves at Cencora on we follow all state and regulatory laws. We also like to highlight where there might be risks, so working across the industry has been key for us too, working with the regulatory agencies at FDA, at the state boards of pharmacy, at EPA, DEA, a lot of the entities that tend to regulate—to let them know where there may be gaps or opportunities for them to lean in to help the industry comply.

As we get into Aug. 27, we're really looking at, how do we keep the supply chain moving? How do we also comply with the law at the same time and make those two strategic pillars not conflict? We're really using the tools that are in the toolkit of DSCSA, and one of them is the waivers and exceptions. We have been very transparent with our manufacturer partners, with the FDA, and sharing where we have data gaps. We've worked with the manufacturers for 10 years to say, serialize the product. Now let's talk about the data and the data accuracy.

First it was just getting a serialized data file—an EPCIS record—from the manufacturer. Then it became, are the records accurate? Let's start to match the physical product scans to the data. Then it became the timing of the data. Is the data coming? when is the product us coming to the warehouse? We have an ability to process it and move it in the supply chain. We're really looking at keeping the supply chain moving, using the waiver and exemptions as a way to say, we have some manufacturers that struggle with accuracy of data still. For those, can we get a waiver and exception, so we know it, and we're saying it to the market, but we're continuing to move the product. Then, how do we also educate the sites of care, all of the pharmacies, all of the hospitals, all of the clinics on this is what you need to do. How you do it is your choice from your regulatory support, but these are the three tasks that you need to do.

How do we work together t say, this is how you access the serialized data? This is how you now initiate a return, so we take our point in place in the education really seriously. Our whole goal is to keep the product moving, keep compliance top of mind, and front and forward. And if we can keep those two things going, I think for us, huge success.

I will also say this started kind as a burden and a regulatory thing. I think a lot of the market has said the US supply chain is the safest supply chain on the planet. We really looked at it as this is a way you transform the pharmaceutical supply chain. The connections we have with the manufacturer, we didn't have as connections 10 years ago. Healthcare system didn't use GS1 global standards, and now we are. This has really elevated, whether I think we want to admit it or not, it's elevated the connection between the trading partners. It's elevated a standard way to transact, and it's really made the supply chain more robust, more secure, and stronger. I'm not sure we thought that started when we started this. It's interesting to see the outcome of this.