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Manufacturer Notice
Federal Register Notices | Policy Releases | Forms | Reports | Section 340B of the Public Health Service Act
2012
Mylan Speciality's Adjustment of Prices to 340B Entities (PDF - 29 KB) 10/29/2012
Purchasing Limitations for Toprol XL (PDF - 36 KB) 09/17/2012
Zyprexa® Limited Distribution System (PDF - 38 KB) 07/28/2012
Purchasing Limitations for Nexium® IV (PDF- 35 KB) 06/14/2012
Discontinuation of Refludan® (PDF - 115 KB ) 05/31/2012
Purchasing Limitations for Toprol XL (PDF - 52 KB ) 05/15/2012
Dava Pharmaceuticals to Pay U.S. $11 Million to Settle False Claims Act Allegations (02/08/2012)
2011
Astra USA, Inc. v. Santa Clara County Supreme Court Opinion (PDF - 137 KB) 04/01/2011
Yaz® Limited Distribution System (PDF - 21 KB) 03/30/2011
Adjustment of 340B Ceiling Prices for Santarus, Inc. (PDF - 14 KB) 03/10/2011)
Pulmicort Respules® Allocation Management Program (PDF - 11 KB) 02/11/2011
Re-Calculation of 340B Ceiling Prices for Biogen Idec (PDF - 19 KB) 02/04/2011
2010
Notice Regarding Refunds of 340B Overchargers for Products Manufactured by Impax (PDF - 9 KB) 11/23/2010
Notice Regarding Adjustment of 340B Prices for Products Of Upsher-Smith (PDF - 14 KB) 05/24/2010
Payments for 340B Participants that Purchased Certain Bristol-Myers Squibb Products (PDF - 112 KB) 04/04/2010
2009
Limitations on Sales of Venofer® (PDF - 18 KB) 10/29/2009Refunds to Section 340B Program Participants for Gris-PEG® (PDF - 20 KB) 08/28/2009
PHS Pricing Adjustments for three Vectibix® NDC Products (PDF - 34 KB) 08/03/2009
Settlement with Eli Lilly regarding the off-label marketing of Zyprexa® (PDF - 1.2 MB) 01/15/2009
2008
Settlement with Cephalon for Off-Label Marketing of Drugs (PDF - 1.6 MB) 09/29/2008
Yasmin® Limited Distribution System (PDF - 21 KB) 09/30/2008
Warner-Chilcott 340B Pricing Errors (PDF - 45 KB) 09/05/2008
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
