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Affordable and Safe Prescription Drug Importation Act of 2025

USA119th CongressHR-3162| House 
| Updated: 5/1/2025
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (5)
Mark Pocan (Democratic)Ilhan Omar (Democratic)Steve Cohen (Democratic)Lloyd Doggett (Democratic)Chellie Pingree (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The Affordable and Safe Prescription Drug Importation Act of 2025 seeks to address the crisis of high prescription drug prices in the United States by facilitating the importation of more affordable and safe medications. Congress finds that U.S. drug prices are significantly higher than in comparable countries, leading millions of Americans to forgo necessary prescriptions. The bill acknowledges that foreign nations, including Canada, the United Kingdom, European Union members, and Switzerland, have robust drug approval and manufacturing standards, and that the U.S. pharmaceutical supply chain already heavily relies on imported drugs. This legislation amends the Federal Food, Drug, and Cosmetic Act to permit the importation of "qualifying prescription drugs" by wholesale distributors, pharmacies, and individuals. Initially, these drugs can be imported from certified foreign sellers in Canada, the United Kingdom, European Union member states, and Switzerland. Qualifying drugs must have the same active ingredients, route of administration, and strength as U.S.-approved versions, and be labeled in English, excluding controlled substances, anesthetic gases, and compounded drugs. The Secretary of Health and Human Services is tasked with promulgating regulations and certifying foreign sellers, who must meet stringent criteria for safety, quality assurance, and compliance with their home country's laws. Certified foreign sellers must agree to product testing, notify of recalls, and establish grievance resolution processes. Individuals can import a 90-day supply for personal use from certified foreign pharmacies with a valid U.S. prescription. After one year, the Secretary may expand importation to other countries that meet specified safety and regulatory standards. The bill includes strong enforcement mechanisms, making it unlawful for manufacturers to discriminate against certified foreign sellers through pricing or supply restrictions, or to alter drug formulations to prevent importation. It also establishes enhanced penalties, including imprisonment and fines, for individuals or entities operating online websites that fraudulently sell adulterated or counterfeit drugs, or dispense drugs without a valid prescription. The Secretary is authorized to suspend importation if safety concerns arise, and both HHS and the Government Accountability Office (GAO) are required to submit reports on the program's implementation, safety, and cost-savings.
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Timeline

Bill from Previous Congress

HR 116-447
Affordable and Safe Prescription Drug Importation Act

Bill from Previous Congress

HR 117-2181
Affordable and Safe Prescription Drug Importation Act

Bill from Previous Congress

HR 118-8848
Affordable and Safe Prescription Drug Importation Act of 2024
May 1, 2025
Introduced in House
May 1, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 116-447
    Affordable and Safe Prescription Drug Importation Act


  • Bill from Previous Congress

    HR 117-2181
    Affordable and Safe Prescription Drug Importation Act


  • Bill from Previous Congress

    HR 118-8848
    Affordable and Safe Prescription Drug Importation Act of 2024


  • May 1, 2025
    Introduced in House


  • May 1, 2025
    Referred to the House Committee on Energy and Commerce.

Health

Affordable and Safe Prescription Drug Importation Act of 2025

USA119th CongressHR-3162| House 
| Updated: 5/1/2025
The Affordable and Safe Prescription Drug Importation Act of 2025 seeks to address the crisis of high prescription drug prices in the United States by facilitating the importation of more affordable and safe medications. Congress finds that U.S. drug prices are significantly higher than in comparable countries, leading millions of Americans to forgo necessary prescriptions. The bill acknowledges that foreign nations, including Canada, the United Kingdom, European Union members, and Switzerland, have robust drug approval and manufacturing standards, and that the U.S. pharmaceutical supply chain already heavily relies on imported drugs. This legislation amends the Federal Food, Drug, and Cosmetic Act to permit the importation of "qualifying prescription drugs" by wholesale distributors, pharmacies, and individuals. Initially, these drugs can be imported from certified foreign sellers in Canada, the United Kingdom, European Union member states, and Switzerland. Qualifying drugs must have the same active ingredients, route of administration, and strength as U.S.-approved versions, and be labeled in English, excluding controlled substances, anesthetic gases, and compounded drugs. The Secretary of Health and Human Services is tasked with promulgating regulations and certifying foreign sellers, who must meet stringent criteria for safety, quality assurance, and compliance with their home country's laws. Certified foreign sellers must agree to product testing, notify of recalls, and establish grievance resolution processes. Individuals can import a 90-day supply for personal use from certified foreign pharmacies with a valid U.S. prescription. After one year, the Secretary may expand importation to other countries that meet specified safety and regulatory standards. The bill includes strong enforcement mechanisms, making it unlawful for manufacturers to discriminate against certified foreign sellers through pricing or supply restrictions, or to alter drug formulations to prevent importation. It also establishes enhanced penalties, including imprisonment and fines, for individuals or entities operating online websites that fraudulently sell adulterated or counterfeit drugs, or dispense drugs without a valid prescription. The Secretary is authorized to suspend importation if safety concerns arise, and both HHS and the Government Accountability Office (GAO) are required to submit reports on the program's implementation, safety, and cost-savings.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-447
Affordable and Safe Prescription Drug Importation Act

Bill from Previous Congress

HR 117-2181
Affordable and Safe Prescription Drug Importation Act

Bill from Previous Congress

HR 118-8848
Affordable and Safe Prescription Drug Importation Act of 2024
May 1, 2025
Introduced in House
May 1, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 116-447
    Affordable and Safe Prescription Drug Importation Act


  • Bill from Previous Congress

    HR 117-2181
    Affordable and Safe Prescription Drug Importation Act


  • Bill from Previous Congress

    HR 118-8848
    Affordable and Safe Prescription Drug Importation Act of 2024


  • May 1, 2025
    Introduced in House


  • May 1, 2025
    Referred to the House Committee on Energy and Commerce.
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (5)
Mark Pocan (Democratic)Ilhan Omar (Democratic)Steve Cohen (Democratic)Lloyd Doggett (Democratic)Chellie Pingree (Democratic)

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted