Tag Archives: CMO/CPO

Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers

Somethings Gotta GiveEverywhere I traveled this fall I had conversations with people from drug manufacturers who told me their top concern right now is that their contract manufacturers (CMOs) or contract packagers (CPOs) are not taking the actions necessary to be prepared to meet the approaching serialization mandates in the U.S., the E.U. and elsewhere on time.  This threatens the manufacturer’s ability to be ready for those deadlines and they are grasping for something they can do now to fix the situation before it gets too late…if it isn’t too late already. Continue reading Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers

Progress Toward Serialization!?

2014 enough time graph.zoomLast week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz.  You should download a free copy of the report here.  This week I want to look at another interesting finding taken directly from the report.  It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market.  That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.

One of the many questions we asked Continue reading Progress Toward Serialization!?

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