Manufacturer Notices to Covered Entities

2018

Biovertiv Replenishment Notice to Covered Entities for Alprolix and Elocate) (PDF - 341 KB)

Limited Distribution Network for DOPTELET® (avatrombopag) (PDF - 29 KB)

Akorn Notice to covered entities potential overcharge Methylene Blue 1% 10ml (PDF - 648 KB)

Agios TIBSOVO® Limited Distribution Plan (PDF - 36 KB)

Recalculated 340B Ceiling Prices for Lilly Products (PDF - 72 KB)

Heritage Pharmaceuticals Limited Distribution Plan Ondansetron (PDF - 326 KB)

Valeant potential overcharge letter labeler 16781 NDC's (PDF - 205 KB)

Notice Regarding Recalculated 340B Ceiling Prices for Genentech Product (PDF - 57 KB)

Shire 340B Ceiling Price Recalculation Notice (PDF - 65 KB)

2017

Almatica Pharma-Tenormin Limited Distribution Plan (PDF - 137 KB)

Incyte Defined Distribution Network for Jakafi (PDF - 134 KB)

Lexicon Pharmaceuticals Limited Distribution Plan for Xermelo (PDF - 86.3 KB)

Johnson and Johnson Healthcare Systems Inc. Notice of 340B Pricing via Cardinal Health Specialty Pharmaceutical Distribution (PDF - 95 KB)

Johnson and Johnson Healthcare Systems Inc. Notice regarding 340B Ceiling Prices for 1Q2017 (PDF - 137 KB)

Neurocrine Biosciences 340B Limited Distribution plan for INGREZZA (PDF - 95 KB)

Notice Regarding Bristol-Meyers Squibb Limited Distribution Plan for Nulojix (PDF - 24 KB)

Notice Regarding Pfizer Defined Oncology Distribution Network (PDF - 99KB)

Vifor Phrama - 340B Notice Regarding Limited Distribution Plan for Mircera® (methoxy polyethylene glycol-epoetin beta) Injection (PDF - 211 KB)

2016

Notice Regarding 340B Pricing for Millennium Pharmaceuticals VELCADE (PDF - 40 KB)

Notice Reagarding 340B Pricing for BiCNU (PDF - 76 KB)

340B Notice of limited distribution plan Exelixis (Cometriq) (PDF - 9 KB)

UPDATE Notice to 340B Covered Entities Regarding Baxalta's VONVENDI (PDF - 129 KB)

340B Notice Regarding Limited Distribution Plan for Imbruvica (ibrutinib) (PDF - 87 KB)

Notice to 340B Covered Entities Regarding 340B Ceiling Prices for Ascend Products (PDF - 114 KB)

Notice to 340B Covered Entities regarding an overcharge that may have occurred for 3 new Valeant NDCs introduced and the issuance of credit (PDF - 75 KB)

Notice Regarding Recalculated 340B Ceiling Prices for Certain Genentech Products impacted for the time period 3Q 2012 through 2Q 2013 (PDF - 125KB)

Notice to 340B Covered Entities Regarding Recalculated 340B Ceiling Price for Amgen Products and Issuance of Credits (PDF - 48 KB)

2015

Notice Regarding Recalculated 340B Ceiling Prices for Zydus Pharmaceuticals, Inc. - Products Impacted for the Time Period 1Q 2012 through 4Q 2014 (PDF - 247 KB)

Notice Regarding 340B Pricing for Heritage Products (PDF - 77 KB)

Notice Regarding Limited Distribution Network for Reylimid, Pomalyst and Thalomid (PDF - 95 KB)

Notice to 340B Covered Entities Regarding Recalculated 340B Ceiling Prices for Galderma Products, and issuance of credits for a refund on overcharges (PDF - 403 KB)

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

Accessibility

Persons using assistive technology may not be able to fully access information in these files. For assistance, please contact HRSA at HRSAAccessibility@hrsa.gov.

Date Last Reviewed:  September 2018