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U.S. Department of Health and Human Services
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Policy Releases

Federal Register Notices | Manufacturer Notices | Forms | Reports | Section 340B of the Public Health Service Act | Monthly Program Updates


2014-1 Clarification of use of the Medicaid Exclusion File Replaces No. 2013-2 (PDF - 70 KB) 12/12/2014


2013-3 Clarification of Eligibility for Hospitals That Are Not Publicly Owned or Operated (PDF - 184 KB)

2013-2 Clarification on Use of the Medicaid Exclusion File (PDF - 170 KB) 02/07/2013

2013-1 Statutory Prohibition on Group Purchasing Organization Participation (PDF - 227 KB) 02/07/2013


2012-2 Clarification of Covered Entity Eligibility within Accountable Care Organizations (PDF - 37 KB) 05/23/2012 

2012-1.1 Clarification of HRSA Audits of 340B Covered Entities (PDF - 36 KB) 02/08/2013 replaces 2012-1


2011-3 Clarification of Manufacturer Audits of 340B Covered Entities (PDF - 40.4 KB) 11/21/2011

2011-1.1 Clarification of Non-Discrimination Policy (PDF - 38 KB) 05/23/2012 replaces 2011-1

Program Integrity

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

Contact the 340B Prime Vendor Program

340B Prime Vendor Program website
1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET)