Section 804 Importation Program Policies and Authorizations
FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs without imposing additional risk to public health and safety.
Actions
FDA authorizations
FDA authorized Florida’s drug importation program under section 804 of the FD&C Act in January 2024:
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