The logistics of healthcare and life sciences is a meticulous process that leaves no room for error. Investigational drugs, biologics, devices and patient samples must be transported and stored under exact conditions, with any delay potentially jeopardizing patient safety and clinical trial timelines, and triggering millions in losses. With the tightening of Food and Drug Administration and U.S. Department of Agriculture regulations, cold-chain shipping is a regulatory minefield, turning customs compliance into a board-level risk.

Management of healthcare shipments requires not only logistics expertise but also a deep understanding of regulatory frameworks. FDA and USDA regulations significantly impact the import and export of biological materials and medical products, making customs brokerage knowledge essential for companies engaged in bio/med logistics.

The FDA regulates biologics, clinical trial materials, and pharmaceuticals to ensure their safety, efficacy and security. Meanwhile, the USDA oversees the quality and safety of products that involve animals, agricultural derivative or genetically modified organisms.

Many biopharmaceuticals are derived from biological material, which must be validated by customs brokers to ensure that they’re sourced from compliant suppliers. Understanding both agencies and their requirements is critical for customs brokers who manage the imports and exports of these products. 

Minor Mistakes, Major Errors

With multiple regulatory checkpoints, detailed documentation at every step is critical. Approximately 60% of customs delays of pharmaceutical shipments are caused by incomplete or incorrect documentation. Like a passport, permits can take months to secure, while shipments held at customs often expire before clearance.

Customs brokers are responsible for a variety of boxes that need to be checked. Some bio/med products may require special import/export licenses which brokers must ensure are secured prior to shipment. Additionally, for certain classes of medical devices, prior notifications to FDA must be submitted to prevent delays. Brokers also must be experts in navigating product classification as appropriate Harmonized Tariff System codes must be assigned to achieve customs clearance.

Even a seemingly minor mistake, such as using the wrong classification code, can detain a shipment. The result: delayed clinical trials, compromised patient timelines and hundreds of thousands of dollars in losses. 

For example, a recent clinical shipment was labeled under UN 3245 as “genetically modified organisms” when it should have been classified as “genetically modified microorganisms.” The issue was caught in time, keeping the trial on track.

More Than Just Paperwork

Engineering compliance into every step of the logistics process is the best way to avoid costly and dangerous mistakes. A layered approach, encompassing technology, human oversight and local expertise, ensures that compliance isn’t left to chance.  

Technology has impacted logistics on every level, including booking and tracking systems with built-in regulatory requirements. However, customs compliance can’t be completely automated, as regulations often change, particularly with different destination countries. A trusted customs broker in a destination country — one that provides expertise on local regulations and processes — can save hours, even days. 

Human judgment remains critical. Technology might be able to flag an issue, but it still takes a human specialist to review the flagged items and determine the best course of action to mitigate any risks and ensure compliance.

Lessons Learned

For logistics leaders just beginning to manage international cold-chain shipments, take these three essential steps:

• Be aware of marketing claims by shipping companies. You have to dig into what actually happens. For example, a carrier might claim that it can replenish dry ice, but that capability actually depends on specific hubs and handling procedures.  
• Work with an expert on commodities and the destination country.
• Take the time to evaluate the type of service your shipment needs. There are plenty of less-expensive options when a full specialty cold -hain shipment with replenishment isn’t necessary. Match the service type and level you use with the specifics of the shipment.

Staying compliant with FDA regulations requires more than just following the rules. It demands the right tools to ensure that every step of the process meets strict standards. From specialized packaging to advanced tracking systems, select a partner that provides a wide range of solutions for maintaining compliance during transit.

Josh Medow is chief executive officer of Mercury.