340B PATIENTS Act of 2025
The 340B PATIENTS Act of 2025 would strengthen and clarify the 340B Drug Discount Program. It would explicitly require drug manufacturers to offer discounted pricing for 340B drugs purchased by covered entities (hospitals, clinics, and health centers) regardless of how or where the drugs are dispensed, and it would prohibit manufacturers from placing conditions on purchase or use of those drugs that could limit access, delivery, or acceptable dispensing practices. The bill also codifies contract pharmacies as an eligible dispensing channel under 340B, meaning the same pricing rules and protections apply when a covered entity contracts with outside pharmacies to dispense 340B drugs to its patients. In addition, the bill creates enforceable penalties for violations by manufacturers (including civil monetary penalties for certain violations) and provides a mechanism for covered entities to bring claims of violations. It directs the Secretary to issue implementing regulations within 180 days of enactment. Overall, the aim is to preserve access to 340B discounts across dispensing channels, ensure contract pharmacies operate under the same protections as direct dispensing, and strengthen oversight of manufacturer compliance.
Key Points
- 1Expands 340B pricing applicability to contract pharmacies: Covered entities that contract with pharmacies to dispense 340B drugs must have those discounts apply at or below the applicable ceiling price, just as with direct purchases.
- 2Prohibits restrictive conditions by manufacturers: Manufacturers may not impose conditions that limit delivery, dispensing location, mechanisms of purchase, data submission, or otherwise impede access to 340B drugs if those conditions are not approved in advance by the Secretary or reflect standard business practices.
- 3Codifies protections and dispensing arrangements: Clarifies that covered entities may contract with pharmacies to dispense 340B-purchased drugs and that the same 340B requirements apply to contract pharmacies as to direct purchases.
- 4Enforcement and penalties: Adds civil monetary penalties for violations (other than mere overcharges), with penalties up to $2,000,000 per day of violation, standards to be set by the Secretary, and a process for covered entities to assert claims of violations.
- 5Implementing regulations: Requires the Secretary to promulgate implementing regulations not later than 180 days after enactment to operationalize these provisions.