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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 - 139 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.

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.


If you use assistive technology, you may not be able to fully access information in this file. For assistance, please email 340B-Communication@hrsa.gov.

Date Last Reviewed:  December 2021