FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them.
Among the items the agency will move on quickly are: ● establishing a unique facility identifier (UFI) that will be used to identify foreign and domestic facilities, and eventually excipient manufacturers ● promulgating rules or guidance for notifying FDA when drugs that are on the market threaten injury or death, or have been lost, counterfeited or stolen, and ● defining what constitutes delay or denial of an FDA inspection that would render drugs manufactured at the facility in question unavailable for sale in the U.S.
Reviewing the challenges of implementing Title VII at the April 30-May 1 “ExcipientFest” conference in Baltimore, Maryland, sponsored by the International Pharmaceutical Excipients Council (IPEC), Office of Global Regulatory Operations and Policy (GO) Senior Advisor Susan de Mars explained why particular facets were designated as priorities.
Some of the items, she explained, are “foundational,” and are required to be in place before other provisions can be implemented. Others are high priority based on their public health impact.
At the Baltimore meeting, de Mars provided a history of the globalization initiatives begun in the last few years and explained how each of the 18 sections of FDASIA’s Title VII is important in supporting the agency’s goals in the global supply chain arena, how their implementation is being prioritized, and the implementation resource challenges (see box below).
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