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 the manufacturer or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts or cause the covered entity to be removed from the 340B Program.
Stakeholders Letter: Program Integrity 02/10/2012 (PDF - 122 KB)
Clarification of HRSA Audits of 340B Covered Entities (PDF - 59 KB) 03/05/2012
Clarification of Manufacturer Audits of 340B Covered Entities (PDF - 31 KB) 11/21/2011