On November 27, 2013, President Obama signed into law the Drug Quality and Security Act, which amends the Federal Food, Drug, and Cosmetic Act. Title II of this law, also known as the Drug Supply Chain Security Act (Act), establishes a timeline for entities involved in the pharmaceutical distribution chain to implement a national track and trace system. Manufacturers and wholesale distributors that transfer ownership of a product will be required to provide the subsequent owner with transaction history, transaction information and a transaction statement in a single document in paper or electronic format. The Act includes requirements to implement an electronic track and trace system that will go into full effect ten years after the Act’s enactment. The Act preempts state pedigree laws.
In response to enactment of the Act, the California Board of Pharmacy (Board) has issued a public notice stating that California's e-Pedigree provisions have been inactivated. The Board also noted that it will sponsor legislation this year to repeal the e-Pedigree provisions that have been inactivated.
Click here to view the public notice.