California's e-pedigree law could ultimately create a de facto standard for unit-level serialization and track and trace of individual prescription drugs. On the other hand, if a U.S. federal rule is issued, that rule could largely preempt California and other state efforts.
No matter how the law, or laws, shake-out, leading national and global pharma firms will find it difficult not to implement national and/or global compliance processes and technology. One major reason is that a few wholesale and distribution companies control the vast majority of shipments, and segregating shipments by state would limit geographical market coverage and entail special handling charges. But it's possible that if a federal law doesn't come, and states proceed with compliance deadlines, smaller companies may be able to make such arrangements with their wholesalers.
But what if a pharmaceutical company can't meet California’s e-pedigree deadline? One theory circulating is that California will work-out a system that would have manufacturers who aren't ready "work out a deal" such as a system of fines, new deadlines and bigger fines of those new deadlines are missed, said Dublin Ohio-based consultant Dirk Rodgers in an educational session at Pack Expo 2012 in Chicago.
