All products regulated by the Food and Drug Administration (FDA) that are imported into the United States will now be subject to inspection, according to a new policy from US Customs and Border Protection (CBP). The updated approach ends the previous exemption for “de minimis shipments,” which allowed low-value imports of FDA-regulated items to bypass review.
CBP stated that de minimis shipments had been used as a channel for bringing in pill presses, dangerous narcotics, and other illicit goods. With this change, all such products—regardless of their value—will undergo review to ensure compliance with FDA requirements.
The policy is expected to affect academic medical centers as well as start-up biotechnology and pharmaceutical companies that rely on imported biological samples for research purposes.
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