Section 56 Exemption Extension

The current Health Canada section 56 exemption that was set to expire on September 30, 2020 has been extended to September 30, 2021. This exemption provides practitioners with the authority to issue a verbal prescription for controlled substances. There are no changes to the exemption and as previous, Health Canada can terminate this exemption depending on the current conditions if the Minister deems that such suspension is necessary to protect public health, safety or security. If necessary, the Minister may change the terms and conditions of this exemption. Should this be the case, you will be informed. View the update here.

Amendments to FDRs

In recent changes made to the Food and Drug Regulations (FDRs), Nurse Practitioners will be included as a “practitioner” to whom drug samples may be distributed.

On March 13, 2020, Bill C-4 (the Canada–United States–Mexico Agreement Implementation Act) received Royal Assent and came into effect July 1, 2020. The Canada-United States-Mexico Agreement (CUSMA) included regulatory commitments specific to products recognized as being at the interface of cosmetics and drugs. Among other things, the Act amends section 14 of the Food and Drugs Act (i.e., the prohibition on the distribution of drugs as samples).

Corresponding amendments were made to the Food and Drug Regulations (FDRs), including amendments to section C.01.048, to permit the distribution of drugs as samples to a “practitioner”. “Practitioner” is now defined in the FDRs, referring to a person who is entitled under the laws of a province or territory to treat patients with a prescription drug; therefore will include Nurse Practitioners as a “practitioner” to whom drug samples may be distributed. These changes permit distribution of drugs as samples to clients, as a matter falling within the Nurse Practitioner’s scope of practice. Other practitioners with prescribing authority under provincial and territorial law but who could not (prior to these amendments being made) receive samples of prescription drugs and NPDs include chiropodists (podiatrists), optometrists, naturopaths and midwives.

As part of the CUSMA implementation, Health Canada established a guidance document on the distribution of drugs as samples, as well as lists of the specific non-prescription drugs and natural health products that can be distributed as samples directly to consumers. Health Canada also established a list of the non-prescription drugs for which additional (i.e., identity and confirmatory) testing is not required upon importation and may be directly shipped to retailers or wholesalers.

Further to this guidance document, Health Canada wishes to advise interested stakeholders of the steps that are being undertaken to expand the lists of products described above, as follows:

1. Amend List A: List of Certain Natural Health Products for Distribution as Samples to include all currently authorized products in the product categories set out in the CUSMA and meeting the identified criteria, i.e., for topical use, localized and non-systemic effect, and meets the definition of a “cosmetic”.

2. Amend List D: List of Certain Non-prescription Drugs for Distribution as Samples to include all currently authorized products in the product categories set out in the CUSMA and meeting the identified criteria, i.e., for topical use, localized and non-systemic effect, and meets the definition of a “cosmetic”.

3. Amend the List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply to include all currently authorized products in the product categories set out in the CUSMA and meeting the identified criteria, i.e., for topical use, localized and non-systemic effect, and meets the definition of a “cosmetic”.

If you have any questions, please contact the Natural and Non-prescription Health Products Directorate at: hc.nnhpd.consultation-dpsnso.sc@canada.ca.

Review CUSMA’s “Information Session on the Notice of Proposal to expand lists of certain products for distribution as samples” from July 23, 2020. More information on the amendments here.

NPs Can Prescribe Medical Cannabis

With the legalization of recreational cannabis on October 17, 2018, new Cannabis Regulations have replaced the Access to Cannabis for Medical Purposes Regulations (ACMPR). Under the new regulations, a nurse practitioner is defined as an authorized health care provider and is not restricted, under the laws of the province in which they practice, from authorizing the use of cannabis.  The Saskatchewan Registered Nurses Association (SRNA) has determined that it is within the NPs scope of practice whom have the appropriate knowledge, skills and competencies to safely authorize the use of medical cannabis for Saskatchewan clients.

It is important NPs educate clients on the risks, side effects, safe transportation and storage of medical cannabis. NPs are required to adhere to employer policy for authorizing the use of medical cannabis. Clients authorized by their health care provider are still able to access cannabis for medical purposes by:

Additional resources for NPs:

SRNA Nursing Advisors are available to discuss practice questions about cannabis. To contact the SRNA for practice advice, please call: 1-800-667-9945 or 306-359-4200 (ask to speak to a practice advisor), or you can email at practiceadvice@srna.org

NPs Can Prescribe Mifegymiso

Mifegymiso is an antihormonal medication consisting of two medications (mifepristone and misoprostol) that work together to block the effects of progesterone for termination of early pregnancy.

Health Canada recently broadened the interpretation of Mifegymiso prescriber to include prescribing health professional, resulting in Nurse Practitioners having the legal authority to prescribe Mifegymiso within Canada. The Saskatchewan Registered Nurses Association (SRNA) has determined that it is within the NP’s scope of practice whom have the appropriate knowledge, skills and competencies to prescribe Mifegymiso to Saskatchewan patients.

Additional resources for NPs:

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