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HR-3162House2025-05-01Health

Affordable and Safe Prescription Drug Importation Act of 2025

YourVoice.Now Summary

Your MoneyCriminal Justice & Due ProcessCorporate BenefitsTransparency & Accountability

Would let you buy a 90-day supply of your drugs from listed pharmacies in Canada or Europe.

Your Money

Buying your prescriptions abroad — up to a 90-day supply

You would need a prescription from a U.S.-licensed doctor. The drug must be for your own use, not resale. You could order online from a listed pharmacy in Canada, the United Kingdom, Switzerland, or an EU country.

Imported insulin and dialysis fluid — pharmacies here could sell it

Pharmacies and wholesalers here get a wider list than you do. Theirs takes in insulin, dialysis fluid, and drugs given through an IV. Some biologic drugs are on it too.

Countries you may buy from — more could be added later

One year after the rules are final, health officials could open the program to other countries. They would first have to find that the earlier imports were safe. The new country must also test drugs and track bad reactions.

Telehealth-only prescriptions won't qualify — one in-person exam required

The prescription counts only if the person who wrote it examined you face to face at least once. A doctor you have seen only by video could not write one for an imported drug.

Criminal Justice & Due Process

Prison time for fake-drug websites — up to 10 years

This covers selling fake or tainted drugs online to people here. It also covers filling an order with no valid prescription. The fine runs up to $250,000, and the site can sit in any country.

Seizure risk for personal drug imports — waiver rules published

Congress tells health officials to aim enforcement at real threats to public health. The target is not people buying for themselves. Officials could grant waivers and must publish when they hand them out.

Corporate Benefits

Drugmakers charging exporting sellers more — same price as local buyers

A drug maker could not raise the price to a listed foreign seller that ships to the United States. The price must match what local buyers in that country pay, rebates included.

Drugmakers cutting off approved foreign sellers — except during drug shortages

Drug makers could not deny, delay, or hold back supply to a seller because it exports here. Drugs on the national shortage list are left out of this rule.

Drugmakers changing the foreign version — to block imports, now unlawful

Some makers sell a slightly different formula abroad. Building in that difference on purpose to stop imports would become unlawful. The rule covers ingredient, strength, and where the drug is made.

Transparency & Accountability

Public list of approved foreign pharmacies — with address and phone

Health officials would run a website naming each foreign pharmacy cleared to sell here. Wholesalers are listed too. Each entry carries the web address, street address, and phone number.

Public reports on the import program — first one year after rules

The first public report comes a year after the rules are final. After that one lands every two years. A separate review by government auditors looks at safety and at what people saved.

Sellers must name the drug's maker — buyers can ask

Foreign sellers must pass the maker's name and address to the U.S. pharmacy that imports the drug. They must give an individual buyer the same details on request.

More about this bill

You could legally buy your prescriptions from a pharmacy in another country. The bill would let you order up to a 90-day supply for your own use. The pharmacy must be on a list the government publishes. Your doctor must be licensed in a U.S. state. That doctor must also have examined you in person at least once. The countries allowed at the start are Canada, the United Kingdom, Switzerland, and European Union members. What you save depends on the price abroad. The bill is not law yet. It was introduced in the House in May 2025. Pharmacies and drug wholesalers here could import as well, then sell to you. Their list of drugs is wider. It takes in insulin, dialysis fluid, and drugs given through an IV. Some biologic drugs are covered too. An imported drug must match the U.S. version in active ingredient, strength, and how it is taken. The label must be in English. Controlled substances, compounded drugs, and surgical anesthetics stay out. Health officials would write the rules within a year of the bill becoming law. A year after that, they could add more countries to the list. Drug makers would face new limits. They could not charge a foreign seller more because that seller ships to the United States. They could not cut off supply to those sellers. They also could not make the foreign version different just to block imports. Drugs on the national shortage list are exempt. Selling fake drugs online could bring up to 10 years in prison and a $250,000 fine. Officials must halt imports of any drug tied to counterfeits or recalls. Public reports on how the program works would start a year after the rules.

Congressional Summary

This bill expands the categories of prescription drugs that may be imported into the United States and the countries from which such drugs may be imported.Current law allows the Department of Health and Human Services (HHS) to authorize importation of certain eligible prescription drugs from Canada if HHS certifies that doing so would pose no additional risk to public health and safety, among other requirements. HHS long declined to make the requisite certification, citing safety concerns (e.g., contamination, counterfeiting), but ultimately made the certification in 2020 and has since approved one state plan to import drugs.The bill removes the certification requirement and requires HHS to issue regulations that permit importation of qualifying prescription drugs from the United Kingdom, Switzerland, and member states of the European Union, in addition to Canada. After one year, if HHS determines that importation of drugs from these countries has been conducted safely, HHS may authorize importation from other countries that meet certain requirements.The bill also expands the types of prescription drugs eligible for importation to include, for example, biologics such as insulin.Further, the bill allows individuals to use an eligible licensed foreign pharmacy to fill a U.S.-issued prescription for a qualifying drug for personal use. Currently, an individual seeking to import a prescription drug generally must acquire a waiver from HHS.Finally, the bill imposes criminal penalties for websites that sell counterfeit drugs or dispense drugs without a required prescription.

Details

Congress
119th
Chamber
House
Status
summarized
Action
Introduced in House
Action Date
2025-05-01
Date Added
2026-04-06
Source
Congress.gov →

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