Manufacturer Notices to Covered Entities

2019

Limited Distribution Notice for NUPLAZID® (pimavanserin) Tablets and Capsules (PDF - 122 KB)

Notice to 340B Covered Entities Related to Axumin™ (NDC # 69932-0001-01) (PDF - 107 KB)

Notice to Covered Entities Regarding Balversa Limited Distribution Plan (PDF - 68 KB)

340B Limited Distribution Notice for OXERVATE (NDC 71981-0020-01) (PDF - 152 KB)

Notice Regarding Recalculated 340B Price for Amphastar Pharmaceuticals, Inc. (PDF - 84 KB)

Prograf and Astagraf XL Limited Distribution System Public Letter (June 2019) (PDF - 313 KB)

Notice Regarding Recalculated 340B Ceiling Prices for The Medicines Company Products (PDF - 88 KB)

Notice Regarding Adjustment of 340B Prices for Purdue Pharma L.P. (PDF - 272 KB)

Millennium Pharmaceuticals Notice Regarding Adjustment of 340B Prices for Velcade (PDF - 44 KB)

Vifor Mircera Notice of End of Limited Distribution Plan (PDF - 273 KB)

BioMarin Pharmaceuticals - Palynziq Notice to Covered Entities of Limited Distribution Plan (PDF - 46 KB)

Catalyst FIRDAPSE® (amifampridine) tablets Notice Regarding Limited Distribution Plan (PDF - 205 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Kedrion Biopharma, Inc. (PDF - 362 KB)

Notice Regarding Panzyga Immune Globulin Intravenous (Human) 10% Liquid Preparation (PDF - 160 KB)

Notice Regarding Recalculated 340B Prices for Sebela Products (PDF - 230 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Purdue Pharma L.P. (PDF - 106 KB)

NOTIFICATION OF SUPPLY ALLOCATION: TICE® BCG (BCG LIVE for intravesical use) (PDF - 54 KB)

Array Biopharma Notice of Defined Distribution Network for BRAFTOVl® (encorafenib) and MEKTOVI* (binimetinib) (PDF - 94 KB)

Insmed Limited Distribution Plan for ARIKAYCE (PDF - 52 KB)

2018

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

Limited Distribution Network for DOPTELET® (avatrombopag) Updated (PDF - 565 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)

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)

2016

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

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

2014

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

2013

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

2011

Yaz® Limited Distribution System (PDF - 21 KB) 03/30/2011

2009

Limitations on Sales of Venofer® (PDF - 18 KB) 10/29/2009

2008

Yasmin® Limited Distribution System (PDF - 21 KB) 09/30/2008

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:  July 2019