The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

News: FDA Launches Secure Supply Chain Pilot Program

The FDA announced a new pilot program, which will select 100 applicants who will get expedited import clearance for up to 5 of their drugs that have a demonstrably secure supply chain.  Think of it as NEXUS for (FDA-approved!) drugs.  The idea is to decrease overall risk associated with imported drugs by allowing the FDA to focus resources on imports that are not part of the program.

Here’s how it will work:

FDA will assign a qualifier (a unique identifier) to each selected SSC program application, and the Broker/Customs Broker/Filer will transmit the qualifier when filing entry for the product. The qualifier will accompany an AofC [Affirmation of Compliance] code, which FDA has designated as “SSC.” The AofC code identifies the drug product as being part of the SSC pilot program.

Requirements include:

  • If the consignee is subject to section 510, it must be in compliance with registration, listing and cGMP reuqirements, and must have been in compliance over the past 3 years.
  • Both applicants to the SSC pilot program and firms identified in the SSC application must be CTPAT Tier II certified or Tier II pending certification at the time an application is submitted.
  • The Broker/Customs Broker/Filer identified in the SSC pilot application must be qualified for paperless entry filing to FDA’s Operational and Administrative System for Import Support (OASIS)

Here’s the application form (pdf).  Here’s the full Federal Register notice (pdf).  Look like something you’d be interested in?  Let us know…

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