Happy Holidays 2010

I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR.  Due to our family party schedule I don’t expect to post any more essays this year.

I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law.  One of our favorite holiday activities is to debate which ones to see.  Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).

So drive carefully, don’t drink and drive and don’t eat too much.  On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity.  And, OK, you can eat too much just once.

See you next year.

Do We Even Need To Mandate Drug Pedigrees Anymore?

  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.


Drawing by Zsuzsanna Kilian



Currently well over half of the U.S. states have a drug pedigree law of some kind either on the books, in the process of being enacted or proposed in their legislature.  No two laws are exactly the same.  That fact is quite painful for the national participants in the supply chain and it gets a little worse every time a new law is enacted or a change is made to an existing law.  For this reason, the conventional wisdom among many supply chain participants, industry organizations, solution providers, and even the regulators themselves is that a nationwide pedigree law would be better than 50 different local laws.

Many of these entities are in favor of replacing those state laws with one administered by the U.S. Food and Drug Administration (FDA).  I don’t challenge that.  In this essay, I’m challenging the very need for any U.S. pedigree requirement at all.  Let me explain. Continue reading Do We Even Need To Mandate Drug Pedigrees Anymore?