At the Outsourcing in Clinical Trials Conference in New England, the US Customs and Border Protection (CBP) highlighted common legal mistakes researchers make when transporting materials for clinical research. Improper transport of biological materials can expose the US to infectious diseases and biological threats, according to Sean Smith from the CBP.
Last year, the CBP seized a large amount of drugs, including 107,510 pounds of non-narcotic drugs. Smith noted an increase in improperly transported biological materials, which are often research-related and regulated by multiple agencies. Confiscated items have included plasmids, animal tissues, and cryo-containers. Even if these materials have legitimate uses, they are considered potential threats without proper documentation.
Many people mistakenly believe that once a product is approved by the US Food and Drug Administration (FDA), it can be freely brought into the country. However, several agencies, including the US Department of Agriculture (USDA), may regulate these products, and all requirements must be met. For instance, products involving primates, fish, and wildlife need a declaration before leaving the country. Additionally, the Department of Transportation has strict rules for importing certain materials. To legally import biological materials, individuals must obtain permits from the USDA or the Centers for Disease Control and Prevention (CDC). Medications can only be carried if they are for personal use.
By following proper procedures, we can ensure the safe transport of necessary materials while protecting US borders. The conference covered various topics about US clinical research, including rare disease recruitment and international trial opportunities.