Inside the Cold Chain: Redefining Pharmaceutical Distribution

Chris Anderson
Director of Quality Management, Cardinal Health 

The following is a summary of a presentation called 2025 Q2 Pharma Industry Update by Chris Anderson at a Leading Minds Network Seminar in Boston June 2025. 

At first glance, a vial of medicine in a delivery truck might seem like a simple thing. But behind that small package lies a complex, high-stakes system—one that Chris Anderson has spent his career trying to make safer, smarter, and more efficient. As a quality systems and temperature management expert at Cardinal Health and a key figure on the United States Pharmacopeia (USP) Packaging and Distribution Expert Committee, Anderson has a front-row seat to the evolving challenges of pharmaceutical cold chain logistics.
At the 2025 Leading Minds Network seminar in Boston, he pulled back the curtain on this underappreciated part of healthcare—and issued a call for change to pharma, life science healthcare and logistics industry experts.

“Why Isn’t Distribution at the Table?”

When Anderson first joined USP over a decade ago, he was struck by how absent distribution professionals were from key conversations.That 90% represents an enormous share of the pharmaceutical economy—$814 billion in 2024 alone. And within that, cold chain products are exploding. Four of the top five drugs by sales volume in the U.S. require storage at 2–8°C. Yet, as Anderson pointed out, many policies and standards still fail to reflect the scale, speed, and complexity of the distribution sector.

“You’re writing policies that impact distribution,” he told the room at one of his earliest committee meetings. “But you're doing it for the 10% of product that goes direct from manufacturer to pharmacy—not the 90% that moves through wholesale distributors like us.”

Mail Order or Mayhem?

One of Anderson’s more pointed critiques came in the form of a simple question: “Would you trust your medicine to mail order?”

The concern? A lack of visibility into temperature excursions during last-mile delivery. Products may sit in hot mailboxes or cold porches for hours—conditions that can compromise drug efficacy and patient safety. And yet, mail-order fulfillment now represents 28% of all U.S. prescription sales.

As Anderson sees it, more attention must be paid to the unique risks of mail order, especially when it comes to temperature-sensitive drugs. “It’s not that the model can’t work,” he said. “But right now, there’s just not enough consistency in how temperature control is managed—or monitored.”

A New Era of Standards

Much of Anderson’s presentation centered around the evolution of USP’s guidance, particularly the General Chapters <659> and <1079>. These chapters are the regulatory backbone for temperature control, storage, and distribution of pharmaceuticals.

Among the most notable changes:

• USP <659> is being revised to expand the definition of Controlled Room Temperature from 20–25°C to 15–25°C—bringing the U.S. in line with European and Japanese pharmacopeias and potentially reducing energy costs in the supply chain.
• USP <1079.2> addresses how mean kinetic temperature (MKT) can be used to evaluate short-term temperature excursions. Anderson noted that MKT data must be used carefully—not as a way to ignore daily deviations, but to support sound, science-based decision-making.
• USP <1079.5>, expected soon, will provide detailed guidance on lane qualification—validating shipping routes based on environmental conditions and transport times.

These updates are the result of years of collaboration, including extensive feedback from the FDA, international partners, and working groups like ANVISA in Brazil. “We’re not writing rules [guidance] in a vacuum,” Anderson explained. “We’re building them with scientists from around the world.”

Managing the Unmanageable

Temperature excursions are an unavoidable part of pharmaceutical logistics. Couriers miss handoffs. Flights get delayed. Trailers overheat. The question isn’t whether excursions happen—it’s how companies respond when they do.

At Cardinal Health, Anderson’s team handles hundreds of these incidents each year. Each one can affect dozens of products and manufacturers, requiring a complex web of phone calls, data analysis, and risk evaluations.

“We contact the manufacturers, check their stability data, and assess the risk,” he said. “But it takes time—and sometimes, all we get back is a blanket statement: ‘Not recommended for use.’ Even if it was just one degree over the limit for an hour.”

That’s where technology comes in. Anderson believes artificial intelligence and thermal modeling—the ability to simulate internal package temperatures based on outside conditions—will be game changers. “We can’t afford to throw away millions of dollars in product that might still be viable,” he said. “Thermal modeling helps us make smarter, faster decisions.”

Lane Mapping vs. Real-Time Monitoring

Given the scale of Cardinal Health’s operations—more than 150 million shipments annually—it’s not feasible to track every single package in real time. Instead, the company relies on a system of lane mapping, which categorizes shipping routes by risk, season, and geography.

“If you’ve qualified the lane, you don’t need to monitor every shipment,” Anderson explained. “You know the conditions, you’ve tested the worst-case scenario, and you have confidence in your process.”

The soon-to-be-published USP <1079.5> will formalize this concept, providing guidance on how to qualify lanes using scientific data. Reports from groups like the Healthcare Distribution Alliance (HDA) as well as white papers and guidance documents from the International Safe Transit Association (ISTA) cover lane mapping as a best practice—particularly for wholesalers operating on slim margins.

Profit Margins, Packaging, and Practicality

Operating margins for wholesale distributors hover around 1–2%. That means even small changes—like a $1 increase in shipping materials—can have significant financial consequences.

Reusable packaging, while environmentally friendly, poses its own challenges. “If it adds cost or complexity, it has to be justified,” Anderson said. “That’s why we’re investing in thermal modeling and qualification instead of just throwing money at new boxes.”

The [thermal] model predicted results within six-tenths of a degree of the real-world data. That’s the kind of accuracy we need.

He shared one success story: working with a packaging manufacturer to develop a plant-based phase-change material for totes, which took three years to qualify. When they later used thermal modeling to simulate performance, the model predicted results within six-tenths of a degree of the real-world data. “That’s the kind of accuracy we need,” Anderson said.

A Call for Clarity

One recurring frustration for Anderson and his peers is inconsistent product labeling. “We see everything from ‘store below 77 °F’ to ‘store between 8 and 25 °C’ with no reference to USP standards,” he said. “That’s a problem.”

Without clear guidance, distributors are left guessing—or rejecting shipments outright. Some manufacturers even change storage requirements by product strength, adding confusion for pharmacies and patients alike.

“We’re not asking for miracles,” Anderson said. “Just pick a category—frozen, refrigerated, or controlled room temp—and give us excursion data. That’s how we keep product moving safely.”

Looking Ahead: Data, Dialogue, and Disruption

In closing, Anderson emphasized that the future of pharmaceutical distribution isn’t just about new technology—it’s about collaboration.

He praised groups like ISTA and the HDA for publishing free, accessible white papers that define best practices. He also highlighted USP’s work with APEC countries to build toolkits for emerging markets.

But perhaps his most important message was this: distributors, manufacturers, and regulators must communicate more openly, share data more freely, and align more consistently if the industry is to meet the growing demands of global pharmaceutical care.

“This isn’t just about compliance,” Anderson said. “It’s about protecting patient health. If the cold chain breaks down, people suffer. And that’s something none of us can afford.”