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Federal Register Notices

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

2016 Notices

Ceiling Price and Manufacturer Civil Monetary Penalties Notice of Proposed Rulemaking; Reopening of Comment Period (PDF 193 KB) 04/19/2016

2015 Notices

Omnibus Guidance; Proposed Guidance (PDF - 288 KB)  08/28/2015

2012 Notices

Notice Regarding Section 340B of the Public Health Service Act Registration Period (PDF - 177 KB) 07/24/2012

2010 Notices

Advance Notice of Proposed Rulemaking for 340B Drug Pricing Program Administrative Dispute Resolution Process (PDF - 138.5 KB) 09/20/2010

Advance Notice of Proposed Rulemaking for 340B Drug Pricing Program Manufacturer Civil Monetary Penalties (PDF - 143.5 KB) 09/20/2010

Final Notice Regarding 340B Drug Pricing Program: Contract Pharmacy Services (PDF - 275.6 KB) 03/05/2010

2009 Notices

Final Notice Regarding the 340B Drug Pricing Program; Children's Hospitals) (PDF - 74.8 KB) 09/01/2009

2000 Notices

Notice Regarding the Section 340B Drug Pricing Program – Program Guidance Clarification (Duplicate Discounts) (PDF - 125 KB) 03/15/2000

Notice Regarding HRSA Grant Requirement – Participation in the 340B Drug Pricing Program (PDF - 121 KB) 02/09/2000

1998 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 (State ADAP) Rebate Option (PDF - 37.5 KB) 06/29/1998

1996 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Manufacturer Audit Guidelines and Dispute Resolution Process (PDF - 57.4 KB) 12/12/1996

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility (PDF - 31.3 KB) 10/24/1996

1995 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 New Drug Pricing (PDF - 23.5 KB) 10/02/1995

1994 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Outpatient Hospital Facilities (PDF - 1.21 MB) 09/19/1994

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Entity Guidelines (PDF - 1.87 MB) 05/13/1994

1993 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Duplicate Discounts and Rebates on Drug Purchases (PDF - 751.8 KB) 06/23/1993 – See also Program Guidance Clarification (Duplicate Discounts) (PDF - 125 KB) 65 FR 13983, 03/15/2000

Guidance Regarding Section 602 of the Veterans Health Care Act of 1992 Limitation on Prices of Drugs Purchased by Covered Entities (PDF - 1.95 MB) 05/07/1993

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)
apexusanswers@340bpvp.com