Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of these products was limited to physicians, dentists, veterinary surgeons and pharmacists. The regulatory amendments were made as part of Canada’s obligations under the Canada–United States–Mexico Agreement (CUSMA) and the passing of the CUSMA Implementation Act, which we reported on previously.
Samples of narcotics, controlled substances, or prescription drugs containing cannabis continue to be prohibited.
Distribution of samples to the general public
The distribution of samples of both NPDs and NHPs is limited to those on certain prescribed lists, which are incorporated by reference into the FDR and NHPR:
- List A: List of Certain Natural Health Products for Distribution as Samples; and
- List D: List of Certain Non-prescription Drugs for Distribution as Samples.
The lists include products for low risk topical acne therapy products, medicated skin care products, diaper rash products, anti-dandruff products, antiseptic skin cleansers, athlete’s foot treatments and sunscreens, as well as low-risk toothpastes, mouthwashes, and throat lozenges, with well-established safety and efficacy profiles. This is in line with Canada’s obligations under CUSMA.
The distribution of samples directly to the general public is limited to persons over 18 years of age, even if the product carries an authorized use for a younger population. Health Canada’s rationale for the age restriction was that it was required to mitigate risks of misuse and to prevent the unsolicited distribution and direct targeting of NPDs and NHPs as samples to children and youth in the absence of adult supervision.
So long as the age restriction is respected, distribution of samples is otherwise not restricted by the venue and may occur through retail outlets, at organized events (trade shows, campus events, or sports and entertainment events) or, as part of charitable activities or public health initiatives.
Expansion of scope of professionals that can receive samples
The regulatory amendments now permit the distribution of samples of NPDs and NHPs to pharmacists and “practitioners”, as defined in the FDR. The definition of practitioner encompasses anyone who is able to prescribe within their province in accordance with provincial and territorial law. For drugs not on List A or List D, conditions for the distribution of samples that were in place under the FDR are similarly introduced to the NHPR: namely, a requirement for the practitioner or pharmacist to sign an order for samples and a requirement for the person who distributes the samples to maintain records of that distribution for at least two years, with limited exceptions. Samples of prescription drugs may also only be distributed to a practitioner or pharmacist if that person has the provincial authority to prescribe that product.
Note, however, that Health Canada does not consider the further distribution of a drug as a sample from a practitioner or a pharmacist to their patient to be a distribution to a consumer. Instead, this kind of distribution is viewed as a professional activity and is therefore regulated by the provincial or territorial scope of practice. Therefore, the age restriction of 18 years or more does not apply in respect of their patients in a healthcare setting.
All sample products, including those distributed to pharmacists and practitioners, are required to have a minimum expiry date of 30 days from the date of distribution and must meet all other regulatory licensing and labeling requirements, as well as any additional parameters set out in their terms of market authorization.
Health Canada has published a summary of a guidance document explaining these changes, as well as a brief overview of the process to amend List A and List D. The complete document is expected to be published in July.