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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

A Final rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation” was published in the Federal Register (PDF - 290 KB) on Thursday, January 5, 2017.

**Update: The final rule was previously effective March 6, 2017. The effective date for this rule was delayed to October 1, 2017 as specified in the final rule published in the Federal Register (PDF - 198 KB). 

The Office of Pharmacy Affairs recently conducted a 340B Recertification webinar for Title X FP and CDC (STD,TB) Grantees. Recertification will begin April 26, 2017 and end May 24, 2017. You may access the webinar via the URL below:

pictures of prescription drugsThe 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.

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

Last Reviewed: May 2017


OPA Monthly Update - January 2017 (PDF - 55 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 Reagarding 340B Pricing for BiCNU (PDF - 76 KB) (December 2016)

HRSA OPA Manufacturer Update 12/15/2016

Notice Regarding Pfizer Defined Oncology Distribution Network (PDF - 99 KB)

Notice Regarding Bristol-Meyers Squibb Limited Distribution Plan for Nulojix (PDF - 24 KB)

Johnson and Johnson Healthcare Systems Inc. Notice regarding 340B Ceiling Prices for 1Q2017 (PDF - 137 KB)

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)