HR3162-119

What This Bill Does

The Affordable and Safe Prescription Drug Importation Act targets U.S. drug prices by allowing safe importation of lower-priced prescription drugs. It creates section 804 rules for importers, certified foreign sellers, licensed foreign pharmacies, foreign wholesale distributors, and individuals. Qualifying drugs must be approved and marketed in Canada, the United Kingdom, an EU member state, Switzerland, or another permitted country, have the same active ingredient, route of administration, and strength as a U.S.-approved drug or biosimilar, and meet labeling rules including English labeling. The bill includes certain higher-risk drugs for importers such as insulin, peritoneal dialysis solution, REMS drugs, specified biological products, and intravenously infused drugs, while excluding controlled substances, inhaled surgical anesthetics, and compounded drugs. FDA must publish certified foreign sellers, certify foreign pharmacies and wholesalers, collect fees sized to program costs, allow individuals to import up to a 90-day personal-use supply with a valid U.S. prescription, permit expansion to other countries after safety review, deem compliant labels not misbranded, approve laboratories for random chemical-authenticity testing, and enforce bans on manufacturers charging higher prices to certified foreign sellers, restricting supplies, refusing business, or creating formulation differences to block U.S. importation.

Who Benefits and How

Patients with high prescription drug costs benefit because they can import up to a 90-day supply from certified foreign pharmacies with valid prescriptions. Retail pharmacies benefit because registered dispensers can import qualifying drugs through certified foreign sellers. Wholesale distributors benefit from a legal importation pathway for qualifying prescription drugs. Certified foreign pharmacies benefit from access to U.S. customers if they meet FDA certification, quality, recall, and grievance rules. Employers and health plans may benefit if imported drugs reduce plan spending on covered medicines.

Who Bears the Burden and How

FDA importation staff must certify foreign sellers, run the public website, collect fees, approve laboratories, monitor recalls, and enforce safety rules. Drug manufacturers are barred from discriminating against certified foreign sellers through higher prices, supply restrictions, refusals, or product differences. Importers must register, comply with labeling and authenticity rules, and use qualifying foreign sellers. Licensed foreign pharmacies must validate prescriptions, maintain compliance systems, support quality assurance, report recalls, and resolve grievances. U.S. pharmacies and wholesalers that do not import may face price competition from imported alternatives.

Key Provisions

• Authorizes importation of qualifying prescription drugs from Canada, the United Kingdom, EU member states, Switzerland, and later other permitted countries.
• Defines importers, certified foreign sellers, licensed foreign pharmacies, qualifying drugs, and valid prescriptions.
• Allows individuals to import up to a 90-day personal-use supply with a valid U.S. prescription.
• Requires FDA seller certification, public listings, fees, recall notices, grievance processes, and random laboratory testing.
• Prohibits manufacturer discrimination against certified foreign sellers that supply U.S. importation.