Final
Issued by: Health Resources and Services Administration (HRSA)
Federal Register Notices
Policy Releases | Section 340B of the Public Health Service Act | Program Updates
2016 Notices
340B Drug Pricing Program; Administrative Dispute Resolution (PDF - 244 KB) 08/12/2016
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
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 and Proposed Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Duplicate Discounts and Rebates on Drug Purchases (PDF – 795 KB) 05/07/1993
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
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.