The Federal Food, Drug and Cosmetic Act (FFDCA) prohibits the importation or re-importation of prescription drugs into the U.S. from foreign countries by anyone other than the manufacturer.
Congress amended the FFDCA in 2000 to allow pharmacies and wholesalers to import prescriptions if the secretary of Health and Human Services (HHS) determined that the practice would not pose safety risks to the public. As of 2009, HHS has refused to allow importation.
A 2003 Medicare law authorized the Food and Drug Administration (FDA) to allow American consumers to import prescription drugs from Canada for personal use if the secretary of HHS determines that doing so would not pose a risk to public safety. HHS has not taken action as of 2009.
The Food and Drug Administration (FDA) contends that it cannot guarantee the safety of prescription drugs, even American-made ones, imported from other countries, including Canada. Opponents of laws banning importation contend that the FDA exaggerates the safety risk.
Despite the federal ban, some U.S. consumers visiting Canada have purchased lower-priced prescription drugs in Canada and attempted to bring them into the U.S., which violates the FFDCA.
Violations of the FFDCA subject a person to a fine of up to $1,000 and/or up to a year in prison. The FDA's enforcement has been lenient and focuses more on commercial shipments than on individual consumers bringing in drugs for personal use.
Skyrocketing prescription drug prices in the U.S. have fueled interest among many American consumers in importing prescription drugs from Canada, where prices are much lower. Federal law forbids this practice, but loopholes and lenient enforcement make it possible to do so.