340B Drug Pricing Program

340B Rebate Model Pilot Program

The Office of Pharmacy Affairs (OPA) has approved manufacturers’ plans for participation in the 340B Rebate Model Pilot Program. Please visit the 340B Rebate Model Pilot Program webpage for details.

Guidance to 340B providers in Texas

Public health emergency declaration by the Secretary

We recognize that circumstances surrounding disaster relief efforts warrant flexibility for entities eligible for participation in the 340B Program. Therefore, eligible entities in Texas may immediately enroll for the 340B Program during the Public Health Emergency Declaration by the Secretary, rather than having to wait for the normal quarterly registration period. We believe this will enable these entities to meet the needs of the residents affected by these disasters.

Contact: If you are in the listed states and would like to enroll, email the 340B Prime Vendor Program or call 1-888-340-2787.

The 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.

News

340B program regulations

Ceiling Price and Manufacturer Civil Monetary Penalties Final Rule; Effective Date Change (PDF - 209 KB) 11/30/2018
Ceiling Price and Manufacturer Civil Monetary Penalties Final Rule (PDF - 289 KB) 01/05/2017
Delegation of Authority Under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA) (PDF - 169 KB) 01/05/2017
Administrative Dispute Resolution Final Rule (PDF - 272 KB) 12/14/2020

Contact OPA

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

Contact the 340B Prime Vendor Program

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

Email sign-up

Date Last Reviewed:

November 2025

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