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.
Many people and organizations contributed to this successful effort and they all deserve congratulations, but I believe the organizations with the most responsibility for this conclusion is the California State legislature and the California Board of Pharmacy in particular. Without the threat of their pedigree law going into effect starting on January 1, 2015 it is unlikely the effort to pass a federal bill would have been mounted with the necessary conviction by industry and consumer groups.
The signing of H.R. 3204 into law results in the immediate deactivation of the California law and the approximate 30 other state drug pedigree laws (check with each state to confirm that they agree with that interpretation). The patchwork is no more, and the clock starts on the many timed requirements within the Drug Supply Chain Security Act that is Title II of the DQSA that are based on the date of enactment, such as:
“…not later than 1 year after the date of enactment of the Drug Supply Chain Security Act…”
On a related note, earlier this week the California Board of Pharmacy canceled their upcoming December 10, 2013 ePedigree Committee meeting.
I have spent so much of the last 10 years of my career focusing on meeting the requirements of the California pedigree law that I want to send out this special farewell to Virginia Herold, Executive Officer of the California Board of Pharmacy, and Joshua Room, Supervising Deputy Attorney General at the California Department of Justice assigned to the California Board of Pharmacy. It was a pleasure working with you at a distance over these years on this effort.
Your efforts have helped me and the industry better understand that the problems in our supply chain, though they may seem like such a tiny percentage of the massive overall quantity of drugs moving through the U.S. supply chain daily, are real and they can have disastrous effects on innocent people, and that something must be done to protect these patients from those who would criminally jeopardize their health and well-being for their own profit. Thank you for that.
ON TO WASHINGTON
As I pointed out in my essay on Monday morning, the FDA will begin regulating the pharmaceutical supply chain for the first time as it implements the DQSA (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“). I expect the various public hearings/meetings that they will hold will have even more attendees than those California held. Considering that Washington DC, the likely location of those meetings, is so close to the heart of the U.S. pharmaceutical industry (Eastern Pennsylvania and Western New Jersey), I assume those meetings will be packed with participants. Meetings or not, this is going to get real interesting real fast. Stay tuned to RxTrace for complete analysis of it all.