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The Surprise Consequence of the California Pedigree Law

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The California pedigree law will have a surprising influence on how the pharmaceutical supply chain operates in another state.  I’ll get to that in a minute, but first, the law will change some things about the way the supply chain operates in all states.  Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.

California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide.  That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not.  Voila!  Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.

This almost certain outcome will likely affect the full nationwide supply chain in a couple of interesting ways.


That will be a big change, even outside of California.  Here are some of the things I think we will see happen: Continue reading The Surprise Consequence of the California Pedigree Law