Notice to Stakeholders – Opioid warning sticker and patient information handout requirements come into force on October 23, 2018

October 1^st, 2018
Our reference number: 18-113393-207

Canada's Food and Drug Regulations were recently amended to require that a warning sticker and patient information handout be provided to patients, at the time of sale, with all prescription opioids that appear in Part A of the “List of Opioids”.These requirements come into force on October 23, 2018.^{Footnote *} 

Both the warning sticker and the patient information handout must meet the specifications of the source document entitled ‘Information for Patients Concerning Opioids’, which is published on the Government of Canada’s website. Pharmacists and practitioners are responsible for obtaining or producing copies of the sticker and handout in order to meet these new requirements.

Opioids dispensed under the supervision of a practitioner, such as in a hospital setting, are not required to have a warning sticker and patient information handout. Opioids which are authorized and used for the treatment of an opioid use disorder are also exempt from this requirement, as specified on Part A of the List of Opioids.

To facilitate the successful implementation of these requirements, Health Canada has already published a guidance document to assist impacted stakeholders. Please refer to this document for answers to questions related to these requirements.

For additional information, please contact:

Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B, 2^nd Floor
Ottawa, Ontario
K1A 0K9

E-mail: HC.bcans.enquiries.SC@canada.ca