Drugs, like any other molecule, are affected by exposure to temperature extremes. Hot and cold can both be the enemy of your product’s quality. How much of a risk is this in the ordinary course of events? Let’s think about how a product moves through the supply chain. It leaves your warehouse on a truck to travel to a distribution center, either yours or one belonging to a wholesaler. If the truck is not temperature controlled, it can easily get up to 50 – 60°C (122 – 140°F). This is most assuredly not good for your drug. Now, if the day is cold and the truck is not temperature controlled, it may experience freezing temps. For many products, freezing can be a killer.

Now imagine the same drug on a plane. When the flight reaches its destination, the cargo will be unloaded. It may be subject to customs inspection. It may sit on the tarmac for hours, once again subject to the whims of Mother Nature—perhaps very high temperatures, perhaps freezing.

Regulators have been thinking about this problem for some time. There was a time when some companies argued that exposure to temperature extremes during transport was not their problem; once a product left their loading dock, they no longer owned it so, they reasoned, they didn’t have to be concerned about such problems. But they forgot that, even if they had sold the product to a wholesaler, it was still their company’s name on the label.

Has the FDA provided guidance in this area? Not exactly. When pressed, they refer, not to a guidance, or even a regulation, but to the Food Drug and Cosmetic Act itself, saying that the act of “holding” a drug is subject to Good Manufacturing Practices. In the past this issue often came up when a manufacturing site was inspected prior to the approval of a new, temperature sensitive, drug. More recently, FDA has insisted that submissions for many refrigerated drugs include the results of shipping studies, demonstrating that there are appropriate safeguards in place to ensure that the product quality is not impacted due to exposure to extreme temperatures during the distribution process.

Other regulatory agencies have provided guidance on what is now referred to as Good Distribution Practices, including the EU and WHO. Guidance is also available from non-FDA US sources. Among these are chapters in the United States Pharmacopeia (USP), such as <1079> Good Storage and Distribution Practices, which I had the privilege of helping to write as a member of USPs Expert Committee on Packaging and Distribution. Additionally, there are two PDA technical reports. TR39 is a general overview of the cold chain process and TR53 focuses on the role played by stability data in supporting distribution of drugs. Unfortunately, those technical reports are behind a paywall.

However, I edited TR39 and co-authored TR53, and, in addition, I can bring my experience as an FDA reviewer to bear to help you solve your Cold Chain problems. Contact us today for a free 30-minute consultation.