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)
HRSA, Office of Pharmacy Affairs recently conducted a 340B Recertification webinar for Hospital covered entities. Recertification for Hospitals will begin August 5 and end September 9. (Tips for viewing the slide presentation [PDF - 94 KB])
The 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.
Office of Pharmacy Affairs Director Presents to 340B Coalition video
Manufacturers are asked to review their 340B Database records and submit a Manufacturer Change Request Form (PDF - 28 KB) to 340Bpricing@hrsa.gov 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.
Program Update: 340B Resources (8/17/15)
340B Glossary of Terms (PDF - 299 KB)