Updated House Track-And-Trace Draft Bill Would Require Unit-level Tracking – Or Would It?

 
• By Cathy Dombrowski

Authors of draft legislation slated for May 8 subcommittee markup add requirement for FDA rules on an interoperable electronic tracking system at the package level, but without a date for final rules and a 14-year wait for proposed regs.

A revised draft House bill on tracking drug products through the supply chain adds authority for FDA to require tracing at the package level – but pushes out proposed rules for that step for nearly a decade and a half.

In contrast, a pending Senate proposal would require tracing at the package, or unit, level to be well under way...

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