# Plain Language Summary: Safe and Affordable Drugs from Canada Act of 2021

This bill would allow Americans to legally buy prescription medications directly from pharmacies in Canada and have them shipped to the United States for personal use. Right now, federal law generally prohibits this, even though many Americans do it anyway because Canadian drugs are often significantly cheaper than the same medications sold in the U.S. This bill would change that by creating an official system where the FDA approves specific Canadian pharmacies, and people could import up to a 90-day supply of prescription drugs without breaking the law.

To make this work safely, the bill requires the FDA to set up strict rules within six months of the law passing. Only Canadian pharmacies that meet tough standards would be approved—they'd need to have been in business for at least five years, follow Canadian pharmacy regulations, participate in quality testing programs, and agree to let the FDA test their products to ensure they're safe and effective. The FDA would publish a list of approved pharmacies on its website so people know which ones are legitimate. You'd still need a valid prescription from a U.S. doctor, and the medication would have to be the exact same drug already approved by the FDA in America.

However, the bill has significant limitations on what drugs qualify. You couldn't import controlled substances like painkillers or anxiety medications, injectable drugs, biological products like insulin, or medications that need refrigeration. These restrictions exist because the FDA considers these drugs riskier to import without direct medical supervision. The bill essentially creates a legal pathway for importing common oral prescription medications—like blood pressure pills, cholesterol drugs, or antibiotics—but keeps tighter controls on more complex or potentially dangerous medications.

Safe and Affordable Drugs from Canada Act of 2021

Pingree, Chellie

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.