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Federal Register Notices

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

2013 Notices

Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program (PDF - 267 KB) 07/23/2013

2012 Notices

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

2011 Notices

Notice of Proposed Rulemaking for Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program (PDF - 200.2 KB) 05/20/2011

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

2007 Notices

Notice Regarding the 340B Drug Pricing Program; Children's Hospitals (PDF - 62.8 KB) 07/09/2007

Notice Regarding 340B Drug Pricing Program - Contract Pharmacy Services (PDF - 67.1 KB) 01/12/2007

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Definition of "Patient") (PDF - 65.5 KB) 01/12/2007

2004 Notices

Statement of Organization, Functions and Delegations of Authority (PDF - 143. 5KB) 09/21/2004

2003 Notices

OIG Compliance Program Guidance for Pharmaceutical Manufacturers (PDF - 113.5 KB) 05/05/2003

Pharmaceutical Manufacturers Overcharged 340B-Covered Entities (PDF - 416.2 KB) 03/10/2003

2000 Notices

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

Notice Regarding the Section 340B Drug Pricing Program – Program Guidance Clarification (PDF - 125.7 KB) 03/15/2000

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

1998 Notices

Notice Regarding HRSA Grant Requirement – Participation in the 340B Drug Pricing Program (PDF - 33.2 KB) 10/22/1998

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

1997 Notices

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 (State ADAP) Rebate Option (PDF - 20.3 KB) 08/29/1997

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

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Guidelines Regarding Contract Pharmacy Services (PDF - 64.9 KB) 08/23/1996 – Replaced by Contract Pharmacy Services (PDF - 275.6 KB) 75 FR 10272 (03/05/2010)

1995 Notices

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Contracted Pharmacy Services (PDF - 24.8 KB) 11/01/1995

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

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility (PDF - 32.3 KB) 08/03/1995

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 New Drug Pricing (PDF - 25 KB) 05/26/1995

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

Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Manufacturer Audit Guidelines and Informal Dispute Resolution (PDF -1.58 MB) 06/10/1994

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

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Inclusion of Outpatient Hospital Facilities (PDF - 740.5 KB) 06/06/1994

1993 Notices

Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Entity Guidelines (PDF - 1.46 MB) 12/29/1993

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

Notice Regarding Section 602 of the Veterans Health Care Act of 1992, Duplicate Discounts and Rebates on Drug Purchases (PDF - 753.3 KB) 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

Questions, contact ApexusAnswers@340BPVP.com or call 1-888-340-2787 Monday through Friday 8:30am to 6:30pm