Is it legal to import medicines into the U.S. from other countries?
No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act and is illegal. Unapproved new drugs are any drugs — including foreign-made versions of U.S. approved drugs — that have not been manufactured in accordance with and pursuant to an FDA approval. FDA recognizes that some individuals may seek treatment with an unapproved new drug in a foreign country and may wish to continue such treatment upon their return to the USA. Likewise, FDA recognizes some individuals suffer from conditions for which no FDA approved treatment exist. FDA has developed a guidance that identifies circumstances under which FDA may consider allowing entry of such drugs.
No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act and is illegal. Unapproved new drugs are any drugs — including foreign-made versions of U.S. approved drugs — that have not been manufactured in accordance with and pursuant to an FDA approval. FDA recognizes that some individuals may seek treatment with an unapproved new drug in a foreign country and may wish to continue such treatment upon their return to the USA. Likewise, FDA recognizes some individuals suffer from conditions for which no FDA approved treatment exist. FDA has developed a guidance that identifies circumstances under which FDA may consider allowing entry of such drugs. Generally referred to as the personal importation policy, this guidance provides FDA field offices the opportunity to exercise enforcem
No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act and is illegal. Unapproved new drugs are any drugs — including foreign-made versions of U.S. approved drugs — that have not been manufactured in accordance with and pursuant to an FDA approval. FDA recognizes that some individuals may seek treatment with an unapproved new drug in a foreign country and may wish to continue such treatment upon their return to the USA. Likewise, FDA recognizes some individuals suffer from conditions for which no FDA approved treatment exist. FDA has developed a guidance that identifies circumstances under which FDA may consider allowing entry of such drugs. Generally referred to as the Personal Import Policy, found in Chapter 9-2 Coverage of Personal Importations, this guidance provides FDA
