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Manufacturer Notices to Covered Entities

2021

Notification of Supply Allocation: Vidaza (azacitidine) (PDF - 148 KB)

Notice Regarding Refunds to 340B Covered Entities (PDF - 75 KB)

Mytesi Notice of Distribution Network (PDF - 463 KB)

Notification of Global Shortage of Actemra IV (tocilizumab) (PDF - 67 KB)

BioMarin - Notice of Refund to 340B Covered Entities (PDF - 27 KB)

Notice of Limited Distribution for Pegcetacoplan (PDF - 138 KB)

Novartis Notice of 340B Price Adjustment (PDF - 25 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Novo Nordisk Inc (PDF - 105 KB)

Updated Notice Regarding Limited Distribution Plan for AYVAKIT (avapritinib) (PDF - 520 KB)

Purdue Notification to Covered Entities of Price Recalculations (PDF - 191 KB)

SpecGX LLC (Mallinckrodt) Notice to Covered Entities of Price Recalculations (PDF - 511 KB)

Verity Notice to Covered Entities of Continuation of Limited Distribution Plan for TRELSTAR (PDF - 140 KB)

Chartwell RX LLC Notice to Covered Entities of Price Recalculations (PDF - 106 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Xellia Pharmaceuticals (US) LLC (PDF - 127 KB)

Takeda Notification of Updated Limited Distribution Plan for Iclusig (PDF - 159 KB)

Civica Notice to Covered Entities of Price Recalculation (PDF - 121 KB)

340B Distribution Notice for Nulibry™ (PDF - 146 KB)

Pharmaceutical Associates Inc. Notice to Covered Entities of Price Recalculations (PDF - 158 KB)

Update to 2021 Distribution Plan for Bausch Health Branded Rx NDCs – Renewed Availability through Amerisource Bergen (PDF - 200 KB)

Esperion Notice to Covered Entities of Price Recalculations (PDF - 102 KB)

GSK Notice to Covered Entities of Price Recalculations (PDF - 69 KB)

Notice Regarding Adjustment of 340B Ceiling Prices for Certain Products of Hikma Pharmaceuticals USA, Inc. (PDF - 245 KB)

Beach Products Inc. Labeler 00486 Recalculation K Phos (PDF - 79 KB)

eTon Pharmaceuticals Notice of Limited Distribution Plan for ALKINDI SPRINKLE (PDF - 139 KB)

2020

Notice Regarding Recalculated 340B Covered Entities for Certain Products of Westminster Pharmaceuticals (PDF - 222 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Kedrion Biopharma Inc. (PDF - 694 KB)

Purdue Notice to Covered Entities of Price Changes for Labeler 59011/67618 (PDF - 511 KB)

Notice Regarding Limited Distribution Plan for Ketorolac Tromethamine Nasal Spray (Sprix® Nasal Spray) (PDF - 420 KB)

UPDATED NOTIFICATION OF SUPPLY ALLOCATION: TICE® BCG BCG LIVE (for intravesical use) (PDF - 135 KB)

REVISED Notice to 340B Covered Entities Regarding BALVERSA® Limited Distribution Plan (PDF - 97 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Novo Nordisk Inc. (PDF - 116 KB)

Limited Distribution Notice for EVRYSDI (risdiplam) (PDF - 50 KB)

MorphoSys Notice to 340B Covered Entities Regarding MONJUVI® (tafasitamab-cxix) for Injection for Intravenous Use (PDF - 131 KB)

Notice Regarding Recalculated 340B Ceiling Prices for Chiesi USA, Inc. Products Impacted for the Time Period 3Q2016 – 1Q2020 (PDF - 623 KB)

Notice to 340B Covered Entities Regarding Uplizna™ (inebilizumab-cdon) Limited Distribution Network (PDF - 358 KB)

Notice Regarding Recalculated 340B Ceiling Prices for Certain Products of Astellas Pharma US, Inc. (PDF - 127 KB)

Notice Regarding Offer of Refunds to 340B Covered Entities for Purchases of NuvaRing® (PDF - 146 KB)

Notice to 340B Covered Entities: Zestril® Limited Distribution (PDF - 110 KB)

Sunovion Pharmaceuticals, Inc. Limited Distribution Network for KYNMOBI™ (PDF - 77 KB)

Notice to 340B Covered Entities Regarding PALYNZIQ™ (PDF - 62 KB)

Notice on Otezla Replacement NDCs (PDF - 93 KB)

Notice of Price Adjustment to 340B Covered Entities That Purchased L. Perrigo Company Covered Outpatient Drugs Bearing Labeler Code 00113 (PDF - 89 KB)

Taiho Oncology Inc. Notice of Limited Distribution Network (PDF - 130 KB)

Notice of Price Adjustment to 340B Covered Entities That Purchased ZEVALIN® from Q3 2009 through Q2 2020 (PDF - 91 KB)

Limited Distribution Notice for Opsumit, Tracleer, Uptravi, Veletri, Ventavis, and Zavesca
(PDF - 138 KB)

Limited Distribution Plan Notice for Cialis® (tadalafil) Erectile Dysfunction NDCs (PDF - 111 KB)

Notice Regarding Limited Distribution Network for Nourianz (Istradefylline) (PDF - 64 KB)

Alternative Distribution Plan for Certain Bausch Health NDCs and Notice of Covered Entity Refunds (PDF - 126 KB)

Incyte Limited Distribution Network for Pemazyre (PDF - 33 KB)

Incyte Updated Defined Distribution Network for Jakafi (PDF - 40 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Lupin Pharmaceuticals Inc. (PDF - 519 KB)

Notice of Distribution Model for Qinlock™ (PDF - 328 KB)

UPDATED NOTIFICATION OF SUPPLY ALLOCATION: TICE® BCG BCG LIVE (for intravesical use) (PDF - 181 KB)

Notice of Price Adjustment to PHS Covered Entities (PDF - 34 KB)

Removal of Program Astagraf Limited Distribution Plan (PDF - 229 KB)

Purdue Pharma L.P. and its subsidiaries Aviro Health L.P. and Adlon Therapeutics L.P. Notice of adjusted 340B Prices (PDF - 270 KB)

Bayer Healthcare Limited Distribution Plan for Adempas (PDF - 49)

Limited Distribution Network for DOPTELET® (avatrombopag) Updated 2020 (PDF - 554 KB)

Vertex Pharmaceuticals Inc. Notice of Limited Distribution Plan (PDF - 132 KB)

Notice for Resticted Distribution Network for Sublocade (PDF - 158 KB)

Exelixis Notice of Distribution Model for Cabometyx (PDF - 154 KB)

Notice Regarding Repatha Replacement (PDF - 80 KB)

Updated Notice of Distribution Model for Cometriq (PDF - 132 KB)

Notice of Change in Distribution Model for TYMLOS® (PDF - 545 KB)

Notice Regarding Recalculated 340B ceiling prices for Apotex Corp (PDF - 15 KB)

Distribution Plan for certain generic products for Bausch Health (PDF - 111 KB)

Limited Distribution Notice for NUPLAZID® (pimavanserin) Tablets and Capsules (PDF - 67 KB)

Notice Regarding Recalculated 340B Ceiling Prices for Certain Products of Astellas Pharma US, Inc. (PDF - 167 KB)

Notice of Change in Distribution Model for Kitabis™ Pak (NDC 24492-850-56) (PDF - 347 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Purdue Pharma L.P. and Avrio Health L.P. (PDF - 256 KB)

Notice to 340B Covered Entities Regarding Replacement NDCS For Enbrel® (PDF - 95 KB)

2019

Notice to 340B Covered Entities That Purchased Xspire Products (PDF - 135 KB)

340B Limited Distribution Notice for Corlanor® (ivabradine) Oral Solution 5 mg (NDC 55513-0813-28) (PDF - 82 KB)

Updated Notice to 340B Covered Entities Regarding Panzyga Immune Globulin Intravenous (Human) ifas 10% Liquid Preparation (PDF - 73 KB )

Notice to 340B Covered Entities Regarding Cutaquig Immune Globulin Subcutaneous (Human)-hipp 16.5% Solution (PDF - 113 KB)

Notice of Change in Distribution Model for Adrenalin and Vasostrict (PDF - 339 KB)

Notice to 340B Covered Entities Regarding Calcium Acetate (Generic) Capsules (PDF - 86 KB)

Updated 340B Limited Distribution Notice for Xermelo (PDF - 147 KB)

340B Notice Regarding Updated Limited Distribution Plan for Nulojix (belatacept) (PDF - 132 KB)

Daiichi Sankyo Notice to 340B Covered Entities Regarding Turalio™ (PDF - 38 KB)

Notice to 340B Covered Entities Regarding GAMMAKED [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] (PDF - 79 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)

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)

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 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)

2008-2015

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

If you use assistive technology, you may not be able to fully access information in these files. For assistance, please email 340B-Communication@hrsa.gov.

Date Last Reviewed:  September 2021