What Schedule of Subscription is Clozaril

Clozaril (clozapine) is classified as Schedule F in Australia, and Schedule III in Canada.

In the United States, clozapine products like Clozaril are not classified as controlled substances and are not scheduled under the Controlled Substances Act (CSA). Prescriptions for Clozaril do not require special schedules or licenses.

However, due to significant risks associated with clozapine such as agranulocytosis, prescribers, pharmacists, patients, and treatment facilities must be certified under the Clozapine REMS program, which has the following requirements:

  • Prescribers must have privileges to prescribe clozapine, certify patient enrollment in the REMS program and commit to comply with the REMS protocol including frequency of monitoring. Only psychiatrists should prescribe Clozaril, or other physicians working closely with a psychiatrist.
  • Pharmacists must be certified to dispense clozapine, counsel patients on the medication guide, and monitor for situations requiring an alert to be placed. Pharmacies must maintain a log linking patients with the respective prescriber.
  • Patients and caregivers must understand risks and comply with blood monitoring through an initial ANC (absolute neutrophil count) prior to starting treatment, weekly ANC monitoring for 6 months, biweekly for the next 6 months, and monthly there after. The patient must be willing and able to have their blood drawn as needed.
  • Treatment facilities must ensure that procedures are in place to comply with the REMS requirements if they are involved in prescribing, monitoring or dispensing Clozaril.
  • Distributors must only supply Clozaril to pharmacies and healthcare facilities that are certified in the Clozapine REMS program.
  • Manufacturers must ensure compliance with all REMS requirements and training of stakeholders. Novartis, as the drug manufacturer for Clozaril in the US, operates the Clozapine REMS program.
  • A database identifies patients and records date and result of each ANC to track compliance with safety monitoring. Prescribers and pharmacies must report patient deaths or hospitalizations promptly to the REMS program.

So in summary, while clozapine itself is not a scheduled or controlled substance, regulatory safeguards are in place to ensure it is only used appropriately under tight safety controls due to risks. The Clozapine REMS aims to restrict access to certified and monitored use of Clozaril based on demonstrated knowledge of protocols to maximize benefits relative to risks for each patient.

There are various forms of drugs available, such as tablets or liquids, and each may have a separate patient information leaflet (PIL) for different doses. It is important to refer to the PIL for the specific form and dose of the drug that you have been prescribed.

You can search for further information and PILs on websites such as:

  • The British National Formulary (BNF)
  • Electronic medicines compendium (emc)
  • The National Library of Medicine's DailyMed
  • The Food and Drug Administration (FDA) 
  • Different drug forms like tablets or liquids have specific patient information leaflets (PIL) for various doses. Refer to the PIL for your prescribed drug form and dose.

    Search for PILs on websites like:


    • ANSM (Agence nationale de sécurité du médicament et des produits de santé): ansm.sante.fr


    • AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): aemps.gob.es


    • BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): bfarm.de


    For questions about your medication:

    • Consult your doctor, a healthcare professional, or a pharmacist


    • Contact SOS Médecins: 3624
    • For mental health support, contact SOS Suicide: 01 45 39 40 00

    Belgium (French)

    Switzerland (French)

    • La Main Tendue: 143
    • Website: 143.ch

    Canada (French)

    • Centre de prévention du suicide du Québec: 1 866 APPELLE (1 866 277-3553)
    • Website: cpsquebec.ca


    • Contact emergency number: 112
    • For mental health support, contact Teléfono de la Esperanza: 717 003 717


    • Contact emergency number: 112
    • For mental health support, contact Telefonseelsorge: 0800 111 0 111 or 0800 111 0 222


    • Contact emergency number: 112
    • For mental health support, contact Telefono Amico: 199 284 284


    • Contact emergency number: 112
    • For mental health support, contact 113 Zelfmoordpreventie: 0800 0113


    • Contact emergency number: 112
    • For mental health support, contact Sos Voz Amiga: 21 354 45 45, 91 280 26 69, or 96 352 46 60

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