340B PATIENTS Act of 2025
The 340B PATIENTS Act of 2025 (S. 2372) seeks to strengthen and clarify the 340B Drug Discount Program by ensuring that drug manufacturers must provide discounted drugs to eligible covered entities (like hospitals and clinics) regardless of how or where the drug is dispensed. This expressly covers dispensing through contract pharmacies, which many covered entities use to reach patients. The bill also prohibits manufacturers from placing conditions on discounted purchases and adds stricter enforcement tools, including civil monetary penalties for certain violations and a new process that lets covered entities bring claims of violations. Regulators would be required to issue implementing rules within 180 days of enactment. Overall, the bill aims to safeguard access to 340B discounts, particularly for patients who rely on contract pharmacies and specialty medications.
Key Points
- 1Clarifies that manufacturers must offer 340B discounts on drugs purchased by covered entities regardless of the dispensing location or method, including through contract pharmacies; and prohibits conditions on purchasing or using discounted drugs that would restrict delivery, location, or mechanisms of purchase.
- 2Explicitly allows covered entities to contract with pharmacies to dispense 340B drugs on the entity’s behalf, with the same 340B requirements applying to those contract-pharmacy arrangements.
- 3Establishes specific prohibitions on conditions that could limit distribution or impose data/reporting requirements, and adds a new category of enforcement related to contract pharmacies.
- 4Creates civil monetary penalties for violations other than overcharges (up to $2,000,000 per day of violation, with factors to determine penalties and ongoing daily assessment until the violation ends); mandates that penalties be set by regulations within 180 days of enactment.
- 5Requires the Secretary to promulgate regulations within 180 days to allow covered entities to file claims of violations under an established process, expanding oversight and recourse for entities.