HRSA is reopening the comment period for the notice of proposed rulemaking (NPRM) titled "340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties" (80 FR 34583 (June 17, 2015)) for an additional 30 days for the purpose of inviting public comments on several specific areas. The Federal Register notice to re-open the comment period on the NPRM was published on April 19, 2016 (81 FR 22960 (April 19, 2016)) and will be open for public comment through May 19, 2016. HRSA encourages all interested parties and stakeholders to submit comments. Please refer to the Federal Register publication for instructions about how to submit comments.
HRSA/OPA recently conducted a Health Center Update webinar for Health Centers and Look- alikes. Topics covered were registration, EHB, change requests and Audit updates. Access the webinar.
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.
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 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.
Manufacturer Notice: Amgen (2/12/16) (PDF 48 KB)
340B Glossary of Terms (PDF - 299 KB)