Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Safe and Affordable Drugs from Canada Act of 2021 This bill requires the Food and Drug Administration (FDA) to allow for the personal importation of prescription drugs from Canada in certain instances. Such a drug must (1) be purchased from an approved Canadian pharmacy and dispensed by a pharmacist licensed in Canada; (2) be purchased by an individual for personal use only and in quantities not to exceed a 90-day supply; (3) be filled using a valid prescription from a physician licensed in a U.S. state; and (4) have the same active ingredients, route of administration, dosage form, and strength as an FDA-approved drug. Certain types of drugs may not be imported under this program, such as controlled substances, biological products, or intravenously injected drugs. An approved pharmacy under this program must be located and licensed in Canada and meet additional requirements, such as participation in ongoing and comprehensive quality assurance programs. The FDA shall publish a list of approved Canadian pharmacies on a website.
Administrative law and regulatory proceduresCanadaDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesPrescription drugsTrade restrictions
Safe and Affordable Drugs from Canada Act of 2021
USA117th CongressHR-832| House
| Updated: 2/5/2021
Safe and Affordable Drugs from Canada Act of 2021 This bill requires the Food and Drug Administration (FDA) to allow for the personal importation of prescription drugs from Canada in certain instances. Such a drug must (1) be purchased from an approved Canadian pharmacy and dispensed by a pharmacist licensed in Canada; (2) be purchased by an individual for personal use only and in quantities not to exceed a 90-day supply; (3) be filled using a valid prescription from a physician licensed in a U.S. state; and (4) have the same active ingredients, route of administration, dosage form, and strength as an FDA-approved drug. Certain types of drugs may not be imported under this program, such as controlled substances, biological products, or intravenously injected drugs. An approved pharmacy under this program must be located and licensed in Canada and meet additional requirements, such as participation in ongoing and comprehensive quality assurance programs. The FDA shall publish a list of approved Canadian pharmacies on a website.
Administrative law and regulatory proceduresCanadaDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesPrescription drugsTrade restrictions