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.

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