Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(C) of the Executive Order 13944
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Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944 *List of drugs for critical care does not include the following: diagnostic agents and medical gases other than isoflurane for general anesthesia + Additional critical inputs have been identified by FDA but have not yet been expressly identified on this list because of the need to consider how to share this additional critical input information in a manner that is consistent with applicable disclosure law while providing our federal partners with the information they need to implement their obligations under the EO IN MCM USE DRUG NAME* DOSAGE FORMS CRITICAL INPUTS ONLY Drug Category: Gastrointestinal Agents Famotidine oral / IV API only (blank cell) Lactulose liquid API only (blank cell) Loperamide oral API only (blank cell) Pantoprazole IV API only (blank cell) Drug Category: Anticonvulsants Phenytoin IV API only (blank cell) Levetiracetam oral / IV API only (blank cell) Drug Category: Antiemetics Ondansetron IV API only (blank cell) Drug Category: Anticoagulants / Antiplatelet Alteplase IV API only (blank cell) Apixaban oral API only (blank cell) Aspirin oral API only (blank cell) Ticagrelor oral API only (blank cell) Enoxaparin SQ API, heparin, crude heparin (blank cell) Heparin IV API and crude heparin (blank cell) Protamine IV API, source proteins (blank cell) Vitamin K IV API only (blank cell) Andexanet alfa injection IV genetically modified variant of human FXa (blank cell) Argatroban IV API only (blank cell) Drug Category: Antimetabolite Hydroxyurea oral API only (blank cell) Drug Category: Chemotherapeutic Cyclophosphamide IV API only (blank cell) Drug Category: Antihistamines Diphenhydramine IV API only (blank cell) Drug Category: Antihypertensives / Cardiovascular Adenosine IV API only (blank cell) Atropine IV API only (blank cell) Amiodarone IV API only (blank cell) Amlodipine oral API only (blank cell) Diltiazem oral / IV API only (blank cell) Esmolol IV API only (blank cell) Furosemide oral / IV API only (blank cell) Hydrochlorothiazide oral API only (blank cell) Hydralazine oral / IV API only (blank cell) Labetalol IV API only (blank cell) Mannitol IV API only (blank cell) Metoprolol oral / IV API only (blank cell) Nitroglycerin oral / IV API only (blank cell) Nitroprusside IV API only (blank cell) Dobutamine IV API only (blank cell) Phenoxybenzamine oral API only (blank cell) Drug Category: Anti-malarial Artesunate IV API only (blank cell) Drug Category: Anti-Microbial Amikacin IV API only (blank cell) Amphotericin B IV API, + (blank cell) Ampicillin IV API only (blank cell) Azithromycin IV API only (blank cell) Cefepime IV API only (blank cell) Ceftazidime IV APIs only (blank cell) Ceftazidime-Avibactam IV APIs only (blank cell) Ceftriaxone IV API only (blank cell) Clindamycin IV API only (blank cell) Daptomycin IV API only (blank cell) Doxycycline oral / IV API only (blank cell) Fluconazole oral / IV API only (blank cell) Micafungin IV API only (blank cell) Linezolid IV API only (blank cell) Levofloxacin oral / IV API only (blank cell) Meropenem IV API only (blank cell) Metronidazole oral / IV API only (blank cell) Piperacillin / Tazobactam IV APIs only (blank cell) Penicillin G IV API only (blank cell) October 30, 2020 1 IN MCM USE DRUG NAME* DOSAGE FORMS CRITICAL INPUTS ONLY Rifampin IV API only (blank cell) Trimethoprim/Sulfamethoxazole oral APIs only (blank cell) Vancomycin oral / IV API only (blank cell) Voriconazole IV API, + (blank cell) Tobramycin Ophthalmic solution 0.3% solution / topical API only (blank cell) Drug Category: Psychiatric Agents Haloperidol IM API only (blank cell) Benztropine oral / IV API only (blank cell) Olanzapine oral API only (blank cell) Drug Category: Antipyretics Acetaminophen oral API only (blank cell) Ibuprofen oral API only (blank cell) Drug Category: Analgesics Codeine liquid API only (blank cell) Fentanyl IV API only (blank cell) Hydromorphone oral / IV API only (blank cell) Morphine IV / elixir API only (blank cell) Lidocaine/Epinephrine solution for SQ local APIs only (blank cell) Drug Category: Antiseptics / Disinfectants Chlorhexidine solution / topical API only (blank cell) Povidone-Iodine 10% Solution solution API only (blank cell) Topical/surface alcohol-based sanitizers topical API only (blank cell) Drug Category: Antivirals Acyclovir IV API only (blank cell) Valganciclovir oral API only (blank cell) Foscarnet IV API only (blank cell) Oseltamivir oral / liquid API only (blank cell) Peramivir IV API only (blank cell) Darunavir/cobicistat oral APIs only (blank cell) Drug Category: Ophthalmic /Glaucoma Timolol Maleate Ophthalmic Solution 0.5% solution API only (blank cell) Drug Category: Pulmonary NEB: API only Albuterol MDI / NEB MDI: API, critical device components, + (blank cell) NEB: API only Ipratropium Bromide MDI / NEB MDI: API, critical device components, + (blank cell) N-acetylcysteine IV Solution API only (blank cell) Surfactant solution API only (blank cell) Drug Category: Chemotherapy / Immunosuppressants / Immunomodulators Tacrolimus oral API, + (blank cell) Mycophenolate Mofetil oral / suspension API only (blank cell) Drug Category: human granulocyte colony-stimulating factor Filgrastim SQ API only (blank cell) Drug Category: Anticholinergic Secretions Glycopyrrolate IV API only (blank cell) Drug Category: Dialysis Agents Continuous Renal Replacement Solution solution API only (blank cell) Drug Category: Glycemic Control Glargine SQ API and master cell bank storage (blank cell) Insulin regular IV API and master cell bank storage (blank cell) Dextrose 50% Injection IV API only (blank cell) Drug Category: Paralytics Cisatracurium IV API only (blank cell) Rocuronium IV API only (blank cell) Vecuronium IV API only (blank cell) Succinylcholine IV API only (blank cell) Drug Category: Reversal Agents Glucagon IV API only (blank cell) Flumazenil IV API only (blank cell) Methylene Blue IV API only (blank cell) Naloxone IV API only (blank cell) Sugammadex IV API only (blank cell) Fomepizole IV API only (blank cell) Drug Category: Sedatives / Hypnotics Dexmedetomidine IV API only (blank cell) Etomidate IV API only (blank cell) October 30, 2020 2 IN MCM USE DRUG NAME* DOSAGE FORMS CRITICAL INPUTS ONLY Ketamine IV API only (blank cell) Lorazepam IV API only (blank cell) Midazolam IV / IM API only (blank cell) Propofol IV API, + (blank cell) Drug Category: Anesthetic Isoflurane gas API only (blank cell) Drug Category: Malignant Hyperthermia Dantrolene IV API only (blank cell) Drug Category: Steroids Dexamethasone IV API only (blank cell) Hydrocortisone oral / IV API only (blank cell) Methylprednisolone IV API only (blank cell) Drug Category: Endocrine Levothyroxine IV API only (blank cell) Propylthiouracil oral API only (blank cell) Zoledronic acid IV API only (blank cell) Desmopressin acetate IV API only (blank cell) Drug Category: Vaccines Rabies Vaccine IM Rabies Virus Strain Flury Lep Antigen, or Virus strain PM-1503-3M Antigen (blank cell) Tetanus Vaccine IM Clostridium tetani toxoid antigen (blank cell) Drug Category: Vasopressors Epinephrine IV / prefilled syringe API, autoinjector (4 applications) (blank cell) Norepinephrine IV API only (blank cell) Phenylephrine IV API only (blank cell) Vasopressin IV API only (blank cell) Drug Category: Volume Expanders Dextrose 5% Water IV API only (blank cell) Dextrose 10% Water IV API only (blank cell) Lactated Ringers (LR) IV API only (blank cell) Sodium Chloride 0.45% IV API only (blank cell) Sodium Chloride 0.9% IV API only (blank cell) Sodium Chloride 3% IV API only (blank cell) Drug Category: Additives Calcium Gluconate IV API only (blank cell) Magnesium Sulfate IV API only (blank cell) Potassium Chloride oral / IV API only (blank cell) Sodium bicarbonate 5% injection IV API only (blank cell) Thiamine IV API only (blank cell) Cyanocobalamin 1000 mcg ml IM API only (blank cell) Sodium Phosphate IV API only (blank cell) Drug Category: Nutrition Intralipid 20% IV API, + (blank cell) Trophamine (AA for infants) IV API only (blank cell) Zinc IV API only (blank cell) Cupric Chloride IV API only (blank cell) Drug Category: Other Octreotide IV API, + (blank cell) Hemin for injection IV Hemin from processed red blood cells (blank cell) Anticoagulants in Blood Bags and storage solutions IV Citrate, phosphate, dextrose, adenine (blank cell) Drug Category: Blood and Blood Products Source plasma further mfr Human plasma (blank cell) Transfusable Blood Components: WB, RBC, Platelets, Plasma, Cryo IV Human venous blood (blank cell) S/D Plasma (Octaplas) IV Pooled human plasma (blank cell) Drug Category: Fractionated Plasma Products Albumin IV Pooled human plasma (blank cell) C-1 esterase inhibitor IV Pooled human plasma, or milk of transgenic rabbits (blank cell) Factor VII, VIII, X, XIII products IV Pooled human plasma or recombinant DNA technology (blank cell) Activated Factor VII IV Pooled human plasma or recombinant DNA technology (blank cell) von Willebrand Factor IV Pooled human plasma or recombinant DNA technology (blank cell) Protein C IV Pooled human plasma or recombinant DNA technology (blank cell) Antithrombin IV Pooled human plasma or recombinant DNA technology (blank cell) Anti-inhibitor coagulant complex IV Pooled human plasma or recombinant DNA technology (blank cell) topical / intra- Fibrin sealant products operative Fibrinogen Human, Human Thrombin (blank cell) Prothrombin complex concentrate IV Human Source Plasma (blank cell) Fibrinogen products IV Human