Once a covered entity has registered and is approved to participate in the 340B Drug Pricing Program, 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.
To purchase drugs at the 340B price, covered entities must:
340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.
Covered entities are subject to audit by manufacturers or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.
Learn more: Program Integrity
340B Glossary of Terms (PDF - 299 KB)