According to the White House website, President Barack Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law a short time ago, bringing to a successful conclusion efforts by the industry and consumer groups to create a national pharmaceutical serialization and track & trace regulation that eliminates the patchwork of state laws in addition to new regulations for compounding pharmacies.
My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill. I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I. If that is what brought you here, sorry, look elsewhere.
“Today the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204). We expect it will be quickly signed into law by the President. This is the culmination of nearly 10 years of effort by HDMA members to preempt all state laws relating to drug pedigrees and track-and-trace systems, to further enhance the security and safety of our nation’s drug supply chain. Since 2004, HDMA has Continue reading U.S. Senate Passes H.R. 3204 With A Voice Vote→
The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts. The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority. It finally looks like it is going to happen.
Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products. This is an expanding category of products so this exemption is worthy of a closer look.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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