Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply chain.

  • The FDA regulates products from more than 150 countries.
  • There are over 130,000 importers into the US, with over 300,000 foreign facilities providing these goods.
  • FDA regulated shipments at more than 300 US portshave quadrupled over ten years.
  • Finished drugs from overseas account for roughly 40% of Pharmaceuticals in the US
  • In 2008, approximatly 80% of Active Pharmaceutical Ingredients (APIs) were from foreign suppliers.

Under FDASIA the FDA will take different approaches. They may request extensive copies of records for review in lieu of actual site inspections. Products will be considered adulterated if they come from a company that has been found to be out of compliance at ANY location, not just the source of that particular product. Vendor qualification efforts are required prior to using products provided by and external source, and written quality agreements with those vendors are expected. Validation of equipment and processes is also expected, as well as equipment/efforts such as temperature monitoring across the entire supply chain.

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