Tag: Customs
FDA and CBP to Begin New Pilot Programs
Both the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) are expected to begin pilot programs to give additional benefits to importers who have secured their supply chains and internal controls this September. On August 20, 2013, the FDA announced it will begin accepting applications to participate in its Secure Supply Chain Pilot Program (SSCPP) which will run for two years, from February 2014 through February 2016. CBP has not yet officially announced, but is expected to announce within the next month, that it will begin a test pilot for its Trusted Trader Program.
Through the SSCPP, the FDA hopes to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks. The FDA plans to increase the rate at … Read More »
Agree to Disagree: FDA and Customs Origin and Drug Labeling Requirements
When merchandise is imported into the United States, there is a slew of information required to be reported to United States Customs and Border Protection (Customs) and the Food and Drug Administration (FDA). The information is transmitted electronically, usually by the importer’s designated customs broker. Among the key elements transmitted to Customs and the FDA is the country of origin of the imported product. Unfortunately, the answer to this question is not always easy, and in many cases Customs and the FDA do not agree. While it may not always be possible to reconcile the two agencies’ requirements, compliance with both is nonetheless required.
Country of origin determination and labeling for pharmaceutical products is a prime example of where the FDA and Customs do not see eye-to-eye. The FDA generally defines origin based on the last country of manufacture. Moreover, FDA … Read More »