21 May 2025 - The US FDA is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First.
Today, the agency is announcing enhancements to the pathway under section 804 of the Federal Food, Drug and Cosmetic Act that allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety.