Category Archives: Pharma Manufacturers

Working With CMOs Under California ePedigree

CMO ZoomImportant 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.So far in RxTrace I have explored the possible implications of the California pedigree law on drug repackagers, 3PLs, VMI relationships and, of course wholesale distributors.  Now let’s take a closer look at the murky world of the contract manufacturing organization (CMO).  I call this world “murky” only because you have to look very carefully at the relationship between a CMO and the contracting manufacturer to fully understand how the pedigree law might be applied.  And even then you are going to have to check with the California Board of Pharmacy because the law is so confusing in this area. Continue reading Working With CMOs Under California ePedigree