Federal Register Notices | Policy Releases | Section 340B of the Public Health Service Act (PDF - 39 KB) | Program Updates | 340B Program Regulations
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. Register all outpatient facilities and contract pharmacies.
- Re-certify eligibility every year.
- Prevent diversion to ineligible patients (PDF - 31 KB). Covered entities must not resell or transfer 340B drugs to ineligible patients.
- Prevent duplicate discounts. Manufacturers must not provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must report how they bill Medicaid fee-for-service drugs on the Medicaid Exclusion File.
- Prepare for program audits. Maintain auditable records documenting compliance with 340B Program requirements. Manufacturers or the federal government may audit covered entities. Any covered entity that does not 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 not engage in a group purchasing organization for covered outpatient drugs.
The covered entity must notify drug manufacturers and wholesalers that it will now buy outpatient drugs at 340B prices. The wholesalers and manufacturers verify the covered entity's enrollment in 340B OPAIS and must sell its drugs at or below the maximum price determined by the 340B statute.
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