Federal Register Notices

Policy Releases | Section 340B of the Public Health Service Act | Program Updates | 340B Program Regulations

2023 Notices

Registration Requirements in the 340B Drug Pricing Program 10/27/2023

2016 Notices

340B Drug Pricing Program; Administrative Dispute Resolution 08/12/2016

2015 Notices

Omnibus Guidance; Proposed Guidance 08/28/2015

2012 Notices

Notice Regarding Section 340B of the Public Health Service Act Registration Period 07/24/2012

2010 Notices

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 09/01/2009

2000 Notices

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

Notice Regarding HRSA Grant Requirement – Participation in the 340B Drug Pricing Program 02/09/2000

1998 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 (State ADAP) Rebate Option 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 12/12/1996

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility 10/24/1996

1994 Notices

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Outpatient Hospital Facilities 09/19/1994

Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Entity Guidelines 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 06/23/1993 – See also Program Guidance Clarification (Duplicate Discounts) 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 05/07/1993

Guidance Regarding Section 602 of the Veterans Health Care Act of 1992 Limitation on Prices of Drugs Purchased by Covered Entities 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