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H H S Department of Health and Human Services
Health Resources and Services Administration
Health Resources and Services Administration

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Office of Pharmacy Affairs
Health Resources and Services Administration
5600 Fishers Lane, 08W05A
Rockville, MD 20857

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340B Drug Pricing Program

340B University OnDemand, created by Apexus, is an online educational program designed to support compliance and integrity for all 340B program stakeholders. Topics covered: eligibility, registration, re-certification, pricing, contract pharmacy, implementation and audit preparedness.

HRSA, Office of Pharmacy Affairs issued proposed 340B Drug Pricing Program Omnibus Guidance for notice and comment on Friday, August 28, 2015 in the Federal Register. The proposed guidance addresses key policy issues including eligibility and registration of hospitals and outpatient facilities, individuals eligible to receive 340B drugs (patient definition), drugs eligible for purchase under the Program, prohibition of duplicate discounts, and manufacturer compliance, and others. The proposed guidance will be open for public comment through October 27, 2015. HRSA encourages interested parties and stakeholders to provide comments. Please refer to the Federal Register for instructions on how to submit comments.(PDF - 289 KB)

pictures of prescription drugsThe 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices.

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

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.

New registrations are accepted October 1-15, January 1-15, April 1-15 and July 1-15. 

 Click this image to sign up for 340B e-mail updates


Office of Pharmacy Affairs Director Presents to 340B Coalition video

Watch the September 22, 2015 webinar: 340B Drug Pricing Program Overview: Family Planning Clinics or download the slides (PDF - 203 KB)

Manufacturers are asked to review their 340B Database records and submit a Manufacturer Change Request Form (PDF - 28 KB) to if any updates are necessary. Ensuring the accuracy of information on file with HRSA will facilitate the rollout of the enhanced 340B pricing system later this year.

Manufacturer Notice: Zydus Pharmaceuticals (10/5/15) (PDF - 247 KB)

Program Update: The Medicaid Exclusion File: Important Clarifications (PDF - 49 KB) (10/9/15)

340B Audit Results

FY 2015 Audit Results (updated 10/01/15)

FY 2014 Audit Results (updated 10/01/15)

FY 2013 Audit Results (updated 10/01/15)

FY 2012 Audit Results (updated 06/26/15)

Recertify your 340B registration every year


340B Glossary of Terms (PDF - 299 KB)

Questions, contact or call 1-888-340-2787 Monday through Friday 8:30am to 6:30pm