Client Advisories and Bulletins

Conditional Release Period for FDA-Regulated Products

July 12, 2007
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Attached for your information is a July 3, 2007 Port of Chicago Pipeline from U.S. Customs and Border Protection (“Customs”) on recent amendments to the Customs Regulations imposing a conditional release period of up to 30 days on any food, drug, device or cosmetic released pending a determination of admissibility by the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug, and Cosmetic Act. A related Federal Register notice issued earlier this year is also attached. Under these amendments, which took effect on May 1, 2007, the release of FDA-regulated merchandise from Customs custody is deemed to be a conditional release; these amendments also allow FDA to extend the 30-day conditional release period.