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340B PATIENTS Act of 2025

USA119th CongressHR-4581| House 
| Updated: 7/22/2025
Doris O. Matsui

Doris O. Matsui

Democratic Representative

California

Cosponsors (17)
Emanuel Cleaver (Democratic)Maxwell Frost (Democratic)Paul Tonko (Democratic)Shri Thanedar (Democratic)Stephen F. Lynch (Democratic)Jill N. Tokuda (Democratic)Raja Krishnamoorthi (Democratic)Pramila Jayapal (Democratic)Kathy Castor (Democratic)Betty McCollum (Democratic)Eleanor Holmes Norton (Democratic)Sharice Davids (Democratic)James P. McGovern (Democratic)Lori Trahan (Democratic)Gwen Moore (Democratic)Rashida Tlaib (Democratic)Veronica Escobar (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill aims to strengthen the 340B drug discount program by clarifying manufacturer obligations and ensuring drug accessibility for covered entities. It explicitly states that drug manufacturers must offer discounted prices on covered outpatient drugs to eligible entities, regardless of the method or location of dispensing. This includes situations where covered entities utilize contract pharmacies to distribute these vital medications to their patients, a long-standing practice intended to stretch scarce resources and support comprehensive patient care. A key provision of the bill prohibits drug manufacturers from imposing conditions that limit a covered entity's ability to purchase or use discounted drugs. Such prohibited conditions include those that restrict drug delivery, dictate dispensing mechanisms or locations, demand compliance assurances or data, or do not align with customary business practices. The legislation also disallows conditions that disproportionately affect covered entities or have not received prior approval from the Secretary. To ensure compliance, the bill introduces new civil monetary penalties for manufacturers who violate these clarified requirements, specifically regarding conditions on drug access or the use of contract pharmacies. These penalties can reach up to $2,000,000 per day for intentional violations, with the Secretary determining the amount based on the nature and extent of harm. Furthermore, it mandates that the Secretary establish regulations within 180 days to allow covered entities to formally assert claims of such violations.
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Timeline

Bill from Previous Congress

HR 118-7635
The 340B PATIENTS Act of 2024
Jul 22, 2025

Latest Companion Bill Action

S 119-2372
Introduced in Senate
Jul 22, 2025
Introduced in House
Jul 22, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 118-7635
    The 340B PATIENTS Act of 2024


  • July 22, 2025

    Latest Companion Bill Action

    S 119-2372
    Introduced in Senate


  • July 22, 2025
    Introduced in House


  • July 22, 2025
    Referred to the House Committee on Energy and Commerce.

Health

Related Bills

  • S 119-2372: 340B PATIENTS Act of 2025

340B PATIENTS Act of 2025

USA119th CongressHR-4581| House 
| Updated: 7/22/2025
This bill aims to strengthen the 340B drug discount program by clarifying manufacturer obligations and ensuring drug accessibility for covered entities. It explicitly states that drug manufacturers must offer discounted prices on covered outpatient drugs to eligible entities, regardless of the method or location of dispensing. This includes situations where covered entities utilize contract pharmacies to distribute these vital medications to their patients, a long-standing practice intended to stretch scarce resources and support comprehensive patient care. A key provision of the bill prohibits drug manufacturers from imposing conditions that limit a covered entity's ability to purchase or use discounted drugs. Such prohibited conditions include those that restrict drug delivery, dictate dispensing mechanisms or locations, demand compliance assurances or data, or do not align with customary business practices. The legislation also disallows conditions that disproportionately affect covered entities or have not received prior approval from the Secretary. To ensure compliance, the bill introduces new civil monetary penalties for manufacturers who violate these clarified requirements, specifically regarding conditions on drug access or the use of contract pharmacies. These penalties can reach up to $2,000,000 per day for intentional violations, with the Secretary determining the amount based on the nature and extent of harm. Furthermore, it mandates that the Secretary establish regulations within 180 days to allow covered entities to formally assert claims of such violations.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 118-7635
The 340B PATIENTS Act of 2024
Jul 22, 2025

Latest Companion Bill Action

S 119-2372
Introduced in Senate
Jul 22, 2025
Introduced in House
Jul 22, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 118-7635
    The 340B PATIENTS Act of 2024


  • July 22, 2025

    Latest Companion Bill Action

    S 119-2372
    Introduced in Senate


  • July 22, 2025
    Introduced in House


  • July 22, 2025
    Referred to the House Committee on Energy and Commerce.
Doris O. Matsui

Doris O. Matsui

Democratic Representative

California

Cosponsors (17)
Emanuel Cleaver (Democratic)Maxwell Frost (Democratic)Paul Tonko (Democratic)Shri Thanedar (Democratic)Stephen F. Lynch (Democratic)Jill N. Tokuda (Democratic)Raja Krishnamoorthi (Democratic)Pramila Jayapal (Democratic)Kathy Castor (Democratic)Betty McCollum (Democratic)Eleanor Holmes Norton (Democratic)Sharice Davids (Democratic)James P. McGovern (Democratic)Lori Trahan (Democratic)Gwen Moore (Democratic)Rashida Tlaib (Democratic)Veronica Escobar (Democratic)

Energy and Commerce Committee

Health

Related Bills

  • S 119-2372: 340B PATIENTS Act of 2025
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted