Track And Trace Could Go Off The Rails Due To Dispenser Exemption
Several groups have problems with a proposed exemption for pharmacists from compliance with potential unit-level tracking standards in the latest track-and-trace proposal.
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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.
CDER Director Janet Woodcock says an industry coalition’s proposal would not meet FDA’s drug tracking needs and is not worth the cost of implementing, even though industry says FDA’s preference is cost-prohibitive.