340B Drug Pricing Program; Administrative Dispute Resolution (PDF) 08/12/2016
Omnibus Guidance; Proposed Guidance (PDF) 08/28/2015
Final Notice Regarding the 340B Drug Pricing Program — Children's Hospitals (PDF - 74 KB) 09/01/2009
Notice Regarding HRSA Grant Requirement – Participation in the 340B Drug Pricing Program (PDF - 121 KB) 02/09/2000
Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Duplicate Discounts and Rebates on Drug Purchases (PDF - 751 KB) 06/23/1993 – See also Program Guidance Clarification (Duplicate Discounts) (PDF - 121 KB) 65 FR 13983, 03/15/2000 and Proposed Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Duplicate Discounts and Rebates on Drug Purchases (PDF - 794 KB) 05/07/1993
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