This bill, known as the 340B PATIENTS Act of 2025, aims to ensure the accessibility of drugs furnished through the 340B drug discount program. It explicitly clarifies that drug manufacturers must offer discounted prices to covered entities for outpatient drugs, regardless of the manner or location in which those drugs are dispensed. This includes drugs dispensed through contract pharmacies, which the bill affirms are a legitimate means for covered entities to stretch resources and provide comprehensive services to patients. A key provision of the bill prohibits drug manufacturers from placing any conditions on a covered entity's ability to purchase and use discounted drugs. These forbidden conditions include limits on drug delivery, purchase mechanisms, dispensing locations, or requirements for data submission that are not customary business practices or disproportionately impact covered entities. Such conditions would be disallowed unless pre-approved by the Secretary. To enforce these requirements, the bill amends existing law to establish new civil monetary penalties for manufacturers who violate these provisions, specifically those related to imposing conditions on access or restricting contract pharmacy use. These penalties can be substantial, reaching up to $2,000,000 per day for intentional violations. The Secretary is mandated to promulgate regulations within 180 days to establish standards for assessing these penalties and to create a process for covered entities to assert claims of violations.
This bill, known as the 340B PATIENTS Act of 2025, aims to ensure the accessibility of drugs furnished through the 340B drug discount program. It explicitly clarifies that drug manufacturers must offer discounted prices to covered entities for outpatient drugs, regardless of the manner or location in which those drugs are dispensed. This includes drugs dispensed through contract pharmacies, which the bill affirms are a legitimate means for covered entities to stretch resources and provide comprehensive services to patients. A key provision of the bill prohibits drug manufacturers from placing any conditions on a covered entity's ability to purchase and use discounted drugs. These forbidden conditions include limits on drug delivery, purchase mechanisms, dispensing locations, or requirements for data submission that are not customary business practices or disproportionately impact covered entities. Such conditions would be disallowed unless pre-approved by the Secretary. To enforce these requirements, the bill amends existing law to establish new civil monetary penalties for manufacturers who violate these provisions, specifically those related to imposing conditions on access or restricting contract pharmacy use. These penalties can be substantial, reaching up to $2,000,000 per day for intentional violations. The Secretary is mandated to promulgate regulations within 180 days to establish standards for assessing these penalties and to create a process for covered entities to assert claims of violations.