Home »

 
 

Regulatory Guidance

 

2013 Notices

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

Policy Release: Statutory Prohibition on Group Purchasing OrganizationParticipation (PDF – 227 KB) 02/07/2013

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 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