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340B Drug Pricing Program

Statement from the Health Resources and Services Administration Regarding Recent Court Rulings Involving the 340B Program

We are pleased that two of three recent U.S. District Court opinions involving the 340B Program agree with HRSA that three pharmaceutical manufacturers have unlawfully restricted access to 340B discounted drugs by covered entities that dispense medications through contract pharmacy arrangements – the core finding of HRSA's May 17, 2021, Violation Letters.  HRSA respectfully disagrees with the recent District Court opinion finding that two other manufacturers had not violated the statute, and continues to evaluate its options.

COVID-19 Resources

HRSA is working to keep 340B Program participants and stakeholders updated on the latest information regarding the coronavirus disease 2019 (COVID-19). All COVID-19 information related to the 340B Program will appear on the COVID-19 Resources page, and we will update resources as they become available.

In response to the COVID-19 pandemic, HRSA is allowing some entities, upon request and review, to immediately enroll into the 340B Program. HRSA will post a supplemental Medicaid Exclusion File (MEF) (XLSX - 132 KB) every Friday, beginning April 10, 2020 that includes a list of entities who have been approved for immediate enrollment. This list is in addition to the quarterly MEF posted on the 340B Office of Pharmacy Affairs Information System.

Guidance to 340B providers in Louisiana, Mississippi, New Jersey, and New York

Public Health Emergency Declaration by the Secretary

We recognize that circumstances surrounding disaster relief efforts warrant flexibility for entities eligible for participation in the 340B Program.

Therefore, eligible entities in Louisiana, Mississippi, New Jersey, and New York may immediately enroll for the 340B Program during the Public Health Emergency Declaration by the Secretary, rather than having to wait for the normal quarterly registration period.

We believe this will enable these entities to meet the needs of the residents affected by this disaster.

Contact: If you are in the listed states/territories and would like to enroll, email the 340B Prime Vendor Program or call 1-888-340-2787.

The 340B Program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.

Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices.

Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers. See the full list of eligible organizations/covered entities.

To participate in the 340B Program, eligible organizations/covered entities must register and be enrolled with the 340B program and comply with all 340B Program requirements. Once enrolled, covered entities are assigned a 340B identification number that vendors verify before allowing an organization to purchase 340B discounted drugs.


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Date Last Reviewed:  November 2021