340B Program Requirements

Federal Register Notices | Policy Releases | Section 340B of the Public Health Service Act | Program Updates

To purchase drugs at the 340B price, covered entities must meet the following ongoing requirements: 

Keep 340B OPAIS information accurate and up to date. Register new outpatient facilities and contract pharmacies as they are added.

Recertify eligibility every year.

Prevent diversion to ineligible patients (PDF). Covered entities must not resell or otherwise transfer 340B drugs to ineligible patients.

Duplicate Discount Prohibition Manufacturers are prohibited from providing a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must accurately report how they bill Medicaid fee-for-service drugs on the Medicaid Exclusion File, as mandated by 42 USC 256b(a)(5)(A)(i).

Prepare for program audits. Maintain auditable records documenting compliance with 340B Program requirements. Covered entities are subject to audit by manufacturers or the federal government. Any covered entity that fails to comply with 340B Program requirements may be liable to manufacturers for refunds of the discounts obtained.