FDA Says Only U.S., Canada & Mexico Firms Eligible for Secure Supply Chain Pilot
The Food and Drug Administration will not allow foreign manufacturers outside of Mexico and Canada to participate in its Secure Supply Chain pilot program, ITT has learned. Although the FDA’s July 20 Federal Register notice did not explicitly say that only U.S., Canadian and Mexican manufacturers could take part, Sara Clark-Lynn of the FDA Office of Public Affairs confirmed that only C-TPAT Tier II and III members are eligible for the pilot program, and acknowledged that “only foreign manufacturers located in Canada and Mexico are eligible to become C-TPAT members.”
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Clark-Lynn did not rule out participation by other foreign manufacturers if the pilot leads to a full program, however. “Experiences with the pilot program, including the requirements for participation, will be evaluated for inclusion in any future program,” she said.
(An early version of a July 20 article in ITT mistakenly said foreign manufacturers would be included in the pilot. Instead, the FDA notice said Tier III C-TPAT members would be included, and did not explicitly address the inclusion of foreign manufacturers.)