At a conference on clinical trials in New England, the U.S. Customs and Border Protection (CBP) warned researchers about common legal mistakes when transporting materials for clinical research. Sean Smith from the CBP highlighted that transporting biological materials incorrectly can pose risks of infectious diseases and biological threats to the U.S.
Last year, the CBP seized a large amount of drugs, mostly illegal ones, but also some that were not properly documented. Smith mentioned that they are finding more biological materials being imported without following regulations.
Baljeet Kaur from the CBP explained that many of these non-compliant materials are for research or are finished products. These materials often need approval from several agencies. Items seized have included genetic materials and preserved animal tissues. Even if these materials are for legitimate research, they require proper documentation to avoid being seen as threats.
Smith emphasized that a common misunderstanding is believing that if a product is approved by one agency like the FDA, it is automatically approved for import. However, many products need approval from multiple agencies.
He also mentioned that transporting primate, fish, and wildlife products needs special declarations. To import biological materials legally, people should obtain permits from the USDA and/or the CDC. Medications can only be imported if they are for personal use. Following these steps ensures safe transport of research materials and protects the U.S. border.
The conference covered various topics about U.S. clinical research, including rare disease studies and international trials.