The javascript used on this site for creative design effects is not supported by your browser. Please note that this will not affect access to the content on this web site.
Skip Navigation
H H S Department of Health and Human Services
Health Resources and Services Administration
Health Resources and Services Administration

A-Z Index  |  Questions?  |  Order Publications

  • Print this
  • Email this

Manufacturer Notices to Covered Entities

2014

Bayer Limited Distribution System for Betaseron (PDF - 66 KB)

2013

Merck Pharmaceutical notice of 340B ceiling price recalculation for Organon products (PDF - 170 KB)

GSK Notice to 340B Covered Entities (PDF - 345 KB) 9/17/2013

Onyx Pharmaceutical Notice of Refund (PDF - 189 KB) 9/05/2013

Notice Regarding Recalculated 340B Ceiling Prices for Genentech Products (PDF - 207 KB) 08/26/2013

Notice of Price Adjustment to PHS Covered Entities (PDF - 459 KB)

Bayer Skyla Letter (PDF - 117 KB) 05/31/2013

IPSEN Important Supply Interruption Information (PDF - 46 KB) 05/21/2013

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

GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data  07/02/2012

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) 10/29/2009

Refunds 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

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