Supply Chain Safety’s Dual Visions: Pedigree Or Just Serialization
This article was originally published in The Pink Sheet Daily
As Congress considers how to ensure downstream supply chain security, industry groups are looking at a process to link drugs to their manufacturer. But in a recent communication with the Senate HELP Committee, FDA backs a “comprehensive national track-and-trace system.”
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ADUFA reauthorization may become the vehicle to move track and trace and compounding legislation. Reimbursement changes to mitigate shortages appear less likely.
The North Carolina Republican spends more than two hours talking about the user fee bill and other issues in an apparent effort to delay a final vote, but the Senate easily passes it.
Industry groups will continue to search for legislative vehicles to move a national standard that would preempt state laws; near-term, though, manufacturers and distributors must prepare for California pedigree law.