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.

A person receiving 340B drugs must be a patient of the covered entity. However, unique circumstances may be considered to decide if an individual fits the definition of patient (PDF - 31 KB), and if they qualify to receive 340B drugs.

The 340B registration and pricing databases are known as the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Authorized users of 340B OPAIS must have a user account with appropriate roles and permissions granted by HRSA.

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Covered entities must meet these requirements to purchase drugs at 340B prices: Keep 340B Office of Pharmacy Affairs Information System (OPAIS) records accurate and up to date.

Can the receipt of in-kind contributions through section 317 or 318 of the Public Health Service Act (PHSA) qualify an entity for participation in the 340B Drug Pricing Program? What are in-kind contributions for purposes of 340B Program eligibility?

HRSA’s 340B Program audits review covered entity compliance with several statutory provisions, including eligibility status, duplicate discounts, and diversion in accordance with sections 340B (a) (4), (5) (A) and (B) of the PHSA.

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Our website provides resources to help 340B Program stakeholders with navigating the 340B Program, including registration and implementation, requirements compliance, program integrity, and more:

Learn about the 340B Administrative Dispute Resolution (ADR) and read the final rule’s new requirements and procedures.