The United States Federal Food, Drug and Cosmetic Act prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs that have not received FDA approval.
FDA has developed a document entitled “Coverage of Personal Importations” which describes the agency’s policy and the circumstances under which FDA may use discretion and avoid taking legal action against illegally imported drugs.
