The California Board of Pharmacy made it official late this afternoon. As required by Section 4034.1 of the California Business and Professions Code (CB&PC), the Board posted a public notice late yesterday indicating that sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 of the CB&PC became inoperative due to the enactment of the Federal Drug Quality and Security Act (DQSA) on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). These specific sections of the CB&PC comprise what has been referred to in the industry as “the California Pedigree Law”.
The public notice was mandated by California law within 90 days of federal preemption because the California law included a clause the specified the sequence of events that must happen if/when the federal government were to enact a competing law (see “The Preemption Provisions Built Into The California Pedigree Law“), and that clause was just invoked by the Board. The DQSA also includes preemption language (see “Preemption: What Does It Mean?“).
WHAT ABOUT THE OTHERS?
But what about the more than two dozen other states that have some type of pedigree or track & trace law on their books that appear to have been preempted by the DQSA? Last week I was contacted by at an RxTrace subscriber who has been trying to get someone from the Florida state government to acknowledge that they are no longer able to enforce their pedigree law since the DQSA appears to preempt it. This individual hoped that I would be able to give them the assurance that they could stop fulfilling the requirements of the Florida law, but I cannot give that assurance to anyone. It requires a definitive announcement by the State of Florida. Does anyone think we will get that? Don’t hold your breath.
Companies need to make their own decisions about whether or not to continue complying with the various state pedigree requirements. Will it take a judge in each State to strike down the local pedigree law…after your lawyer presents the DQSA as evidence? I hope no State would take it that far, but who knows? We should all thank the State of California and the Board of Pharmacy for including the preemption clause in their law so that companies can be absolutely confident that it is now inoperative.
The full text of the announcement from the California Board of Pharmacy follows:
“On November 27, 2013, President Obama signed Public Law 113-54. This law contains provisions for a national track and trace system for prescription medication. Included within this law are provisions that preempt California’s e-pedigree requirements. These provisions are in addition to those in the California Business and Professions Code that also preempt California’s provisions should federal legislation in this area be enacted.
“The board is required to post a message about the inactivation of California’s e-pedigree provisions. This notice is provided below; it also will be published in the California Regulatory Notice Register, and posted on our website. Also this year the board will sponsor legislation to repeal the e-pedigree provisions that are now inactive provisions in California law.
“The board thanks the many individuals from pharmaceutical supply chain companies, computer and technology firms, policy makers, staff of the California delegation and the many others who worked with the board over the last 10 years to develop e-pedigree provisions and implement a system to strengthen the integrity of the US drug supply.
“We especially thank the early adopters and those who worked on pilot projects to ensure California’s provisions would be implemented by the coming deadlines. It was a large endeavor and we trust that what was learned to “get ready for California” will be transferable to the national system that is now under development. We are grateful to have played a role in this important area of public safety and health.
“Pursuant to Business and Professions Code section 4034.1, which provides in pertinent part that “[u]pon the effective date of federal legislation . . . addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163(c) – (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative,” and which requires that within 90 days of the enactment of such legislation the board publish a notice regarding the invalidation of these statutes, the California State Board of Pharmacy is hereby publishing notice that federal legislation meeting the requirements of section 4034.1 has been enacted, and that Business and Professions Code sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 became inoperative as of November 27, 2013.”