The 340B PATIENTS Act of 2024

This bill amends the Public Health Service Act to ensure that drug manufacturers must offer 340B discounted pricing to covered entities regardless of how or where the drug is dispensed, and prohibits manufacturers from placing conditions on a covered entity's ability to purchase and use 340B drugs. It also clarifies that covered entities may use contract pharmacies to dispense 340B drugs to patients.

Sec. 3, Ensuring the accessibility of drugs under the 340B program: The bill amends section 340B(a) to require manufacturers to offer 340B pricing regardless of the manner or location of dispensing, and prohibits manufacturers from placing conditions on a covered entity's purchase or use of 340B drugs, such as limits on delivery, purchase mechanisms, or where drugs are dispensed, unless the Secretary approves. It also adds a new paragraph stating that these requirements apply when a covered entity uses contract pharmacies to dispense 340B drugs to patients.

Sec. 3, Manufacturer compliance: The bill amends section 340B(d) to add civil monetary penalties for manufacturers that knowingly and intentionally violate the requirements of subsection (a)(1) or (a)(11) (other than overcharges). Penalties are up to $2,000,000 per day of violation, determined by the Secretary based on factors like the nature and extent of the violation and harm caused, and continue until the violation ends. The Secretary must issue regulations within 180 days to allow covered entities to assert claims of such violations.