H.R.447: Affordable and Safe Prescription Drug Importation Act
The Affordable and Safe Prescription Drug Importation Act would instruct the Secretary of Health and Human Services, within 180 days after the enactment of this Act, to issue regulations allowing wholesalers, licensed U.S. pharmacies, and individuals to import qualifying prescription drugs manufactured at FDA-inspected facilities from licensed Canadian sellers. After two years, the Secretary would have the authority to permit importation from countries in the Organisation for Economic Co-operation and Development (OECD) that meet specified statutory or regulatory
standards that are comparable to U.S. standards.
The bill would not permit the importation of controlled substances, anesthetic drugs inhaled during surgery, or compounded drugs. Legally imported drugs under this Act must be purchased from an
FDA-certified foreign seller and have the same active ingredient(s), route of administration, and strength as drugs approved in the U.S. Certain types of drugs, such as certain biologics, could only be
imported by wholesalers or pharmacies.
The Senate companion bill is S. 97.View Full Overview