In Canada, the sale and distribution of methadone is regulated under the Controlled Drugs and Substances Act (CDSA) and the Narcotic Control Regulations (NCR). Pursuant to the NCR, physicians are prohibited from prescribing methadone for opioid dependence or analgesia until they have been explicitly exempted from this prohibition under section 56 of the CDSA by the Minister of Health. So those physicians who prescribe methadone as a regular part of their practice must apply for a general exemption from the prohibition in the regulations. This regulatory approach was implemented in response to a perceived increased risk of diversion for methadone in the early 1970s.
On Friday, March 17, 2017, Health Canada issued a class exemption to section 56 of the CDSA for practitioners prescribing methadone to inpatients in a hospital setting. In short, practitioners no longer have to obtain a temporary methadone s.56 exemption in order to continue the treatment of a patient who is admitted to a hospital and was taking methadone prior to the hospitalization. The terms and conditions applicable to this exemption are available on the Health Canada website at:
Key Messages from CSHP
CSHP has been advocating this class exemption since 2010. It first provided comments on a technical discussion document from Health Canada, then participated in a teleconference on changes proposed by Health Canada to the exemption process to authorize methadone use in hospitals, and subsequently wrote to Health Canada to reiterate its position in support of a class exemption. Since then, CSHP educated the Federation of Medical Regulatory Authorities of Canada about the shortcomings of the process for individual temporary exemptions and persisted in pressing the Office of Controlled Substance for a class exemption.
- Letter to stakeholders regarding the issuance of a Section 56 class exemption for practitioners prescribing methadone to inpatients in a hospital setting
- Lettre aux partenaires à propos de l’émission d’une exemption émise en vertu de l’article 56 pour les praticiens qui prescrivent de la méthadone à des patients hospitalisés
- Agenda Item Summary, CSHP/CPhA Joint Bilateral Meeting with the Marketed Health Products Directorate, Health Canada, on December 2, 2013
- Record of Decisions, CSHP/CPhA Joint Bilateral Meeting with the Marketed Health Products Directorate, Health Canada, on December 2, 2013