On November 27, 2013, President Obama signed House Bill 3204 (HR 3204), also known as the "Drug Quality and Security Act," which amends the Federal Food, Drug, and Cosmetic Act. Title II of HR 3204, also known as the "Drug Supply Chain Security 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. HR 3204 includes requirements to implement an electronic track and trace system that will go into full effect ten years after HR 3204’s enactment. HR 3204 preempts state pedigree laws.
The track and trace timeline requirements will become effective January 1, 2015, with product tracing requirements for manufacturers, repackagers, and wholesale distributors.