HR 478
116th Congress
House
Health
Administrative law and regulatory procedures
Canada
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Government information and archives
Prescription drugs
Trade restrictions
Safe and Affordable Drugs from Canada Act of 2019
Everywhere this bill has been
3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 25, 2019
Referred to the Subcommittee on Health.
Jan 10, 2019
Referred to the House Committee on Energy and Commerce.
Jan 10, 2019
Introduced in House
Plain-English summary
Safe and Affordable Drugs from Canada Act of 2019
This bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy if the drug
- is dispensed by a pharmacist licensed in Canada;
- is purchased for personal use in quantities not greater than a 90-day supply;
- is filled using a valid prescription issued by a physician licensed to practice in the United States; and
- has the same active ingredients, route of administration, dosage form, and strength as a prescription drug approved by the FDA.
Under the bill, certain drugs may not be imported, including controlled substances and biological products.
The bill establishes a certification process for approving Canadian pharmacies. The FDA must publish a list of approved Canadian pharmacies.
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
2