Lots of people across the U.S. pharma supply chain are spending their spare time these days trying to read and understand the U.S. Federal Drug Quality and Security Act (DQSA) that was enacted in November and begins to take effect in a significant way next January (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  I am one of those people.

I have carried a printout of Title II (the Drug Supply Chain Security Act, or DSCSA) of the DQSA around with me ever since it was passed and it is now so dog-eared and marked up that I am about ready to print out another copy.  Only trouble is, I would need most of those markings in the new copy too, so I just keep using the same printout.

My understanding of the law and its implications rises every time I study it.  Sometimes Continue reading Don’t Skip The DQSA Definition of Terms Section →