California's E-Pedigree Law Preempted
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.