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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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Contact OPA

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

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340B Drug Pricing Program

HRSA/OPA recently conducted a Welcome webinar for newly enrolled 340B registrants. Topics covered in this webinar includes,

  • Introduction to 340B program
  • 340B Historical legislation
  • Certification/Termination
  • Audit/340B program compliance
  • 340B educational resources

Watch our recent webinar -- 340B Drug Pricing Program: Participation, Eligibility, and Program Integrity for Title X Family Planning Grantees. Re-certification begins May 11, 2016 and ends June 8, 2016.

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.

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


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.

Notice Regarding Recalculated 340B Ceiling Prices for Certain Genentech Products impacted for the time period 3Q 2012 through 2Q 2013 (4/28/16) (PDF - 125 KB)

Manufacturer Notice: Amgen (2/12/16) (PDF 48 KB)

340B Pricing System: Manufacturers 340B Database Verification and Other Updates  4/15/16

Audits of Covered Entity Results

FY 2016 Audit Results 
(updated 4/27/16)

FY 2015 Audit Results 
(updated 4/27/16)

FY 2014 Audit Results 
(updated 4/27/16)

FY 2013 Audit Results 
(updated 4/27/16)

FY 2012 Audit Results 
(updated 2/5/16)

Recertify your 340B registration every year

Contact the 340B Prime Vendor Program

340B Prime Vendor Program website
1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET)