You are about to prescribe or dispense a product to the person under your care. Is it considered a drug or a medical device? Can it be sold with or without a prescription? The answers may seem obvious, but they are not!
It’s the role of Health Canada to determine whether a product is a drug and whether a medical prescription is required to obtain it.
This federal institution defines a drug as a product “sold for use in the treatment or prevention of a disease or its symptoms.” The list of drugs is available online in the Drug Product Database (DPD). Toothpastes help prevent cavities, so are they drugs? Not quite! According to Health Canada, the classification of a product takes into account “not only how it produces its therapeutic effect, but also its composition, characteristics, and intended use as presented on the market and perceived by users.”
Toothpastes used to have Drug Identification Numbers (DINs), but they now have Natural Product Numbers (NPNs). In Canada, natural health products (NHPs), like drugs and foods, are regulated under the Food and Drugs Act. The list of NHPs can be found in the Licensed Natural Health Products Database (LNHPD). Some products appear in the LNHPD at a lower concentration and in the DPD at a higher concentration, such as hydrocortisone cream and vitamin D.
There is a list of drugs that require a prescription in Canada, the Prescription Drug List (PDL), which is available online. It contains some interesting information.
On June 2, 2026, Health Canada amended the listing for “melatonin or its salts” in the PDL to include all sleep-related uses in children and adolescents under 18 years of age. As a result, under federal law, the same ingredient, melatonin, may be an NHP for adults and a prescription drug for sleep-related pediatric use. If a product does not appear on the Prescription Drug List, even if it is a drug and has a DIN, no prescription is required for its sale.
Health Canada categorizes drugs under various schedules, including narcotics, controlled substances, prescription drugs, radiopharmaceuticals, biologics, ethicals , and over-the-counter (OTC) products.
Professionals should remain attentive! A drug may fall under two categories. Some biologics, such as adalimumab, are considered both biologics (Schedule D) and prescription drugs. Ethicals are drugs that do not legally require a prescription, but that are generally prescribed by a physician in a hospital or emergency care setting. Acetylcysteine, injectable sodium chloride, and hemodialysis solutions are examples of ethicals.
Health Canada classifies drugs under different schedules, but provinces and territories also have their own scheduling systems, which further restrict public access to medications. For example, the Adacel® vaccine (tetanus-diphtheria-pertussis) is classified as a biologic by Health Canada, but it does not appear on the Prescription Drug List. The National Association of Pharmacy Regulatory Authorities (NAPRA) classifies this product as Schedule II, meaning pharmacist intervention is required. Alberta, however, has unscheduled it, which means it can be sold without a prescription and without mandatory pharmacist intervention in that province.
Figure 1. Regulations that apply to natural health products, biologic drugs, pharmaceutical drugs, food, medical devices and cosmetics products under the Food and Drugs Act.
There is another category of products known as medical devices. These include, for example, intrauterine devices that do not release hormones. Some ophthalmic drops used to treat dry eye were once drugs with DINs. Most are now considered NHPs with NPNs, but a few are classified as medical devices! This is the case for Systane Balance® ophthalmic drops. The Medical Devices Active Licence Listing (MDALL) is also available online.
Medical devices do not appear on the Prescription Drug List, but insurers may require a prescription to reimburse these products. Sometimes, the line between a drug and a medical device is so thin that Health Canada has published guidance entitled Classification of Products at the Drug-Medical Device Interface.
The data team at Vigilance Santé does the sorting for you! We comb through the databases to provide accurate information in RxVigilance's Information and Coverage module : “Is it a narcotic? A prescription drug? A medical device?” We have the answer for you!