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

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.

Disproportionate Share Hospitals, freestanding cancer hospitals, and children's hospitals must also refrain from participating in a group purchasing organization for covered outpatient drugs. 

It is the covered entity's responsibility to notify drug manufacturers and wholesalers that it will now purchase outpatient drugs at 340B prices. The wholesalers and manufacturers verify the covered entity’s enrollment on the 340B database and must sell its drugs at or below the maximum price determined under the 340B statute.