What are Drug Schedules?
Drug Schedules are a classification tool for drugs, substances, and certain chemicals that are used to make drugs. They are distinct drug categories that are defined by medical use and each specific drug’s potential for abuse and dependency. For example, on a scale of I to III, drugs categorized within Schedule I show a high risk of psychological and physical dependence, and accordingly, those in Schedule III pose the least amount of risk for drug abuse.1
Drug Scheduling in Canada
In 1995, the National Association of Pharmaceutical Regulatory Authorities endorsed a proposal for a national drug scheduling model for each province and territory so that drugs could be sold across the country with consistent regulations. This proposal later became the National Drug Schedules Program, which consists of three schedules, or four categories of drugs, established factors for each schedule, a standard process for scheduling, and a National Drug Scheduling Advisory Committee (NDSAC) responsible for scheduling recommendations.2
Narcotics and controlled substances are not included in the NDS, as they are scheduled according to a different regulatory framework within the the Controlled Drugs and Substances Act (CDSA) and under Narcotic Control Regulations.3
Drug Scheduling Process
The Health Products and Food branch of Health Canada determines which health products will be marketed in Canada, and whether or not they require prescriptions for consumer use. This list of products includes drugs, medical devices, disinfectants, and sanitizers with disinfectant claims. Without authorization from Health Canada, a drug or drug accessories manufacturer is not permitted to sell its products within the country.4
After Health Canada has determined whether or not a particular drug can be sold within Canada and also assigned it a Drug Identification Number (DIN), decisions regarding where the product can be sold become the responsibility of individual provinces, territories, and NAPRA, under advisement from the NDSAC.
While reviewing products already approved by Health Canada, NAPRA may choose to be more restrictive in its scheduling of drugs, but never less so than the standards that have been already federally determined.5
How are Drugs in Canada Defined?
As classified by the National Food and Drugs Act, drugs are:
- prescription and non-prescription pharmaceuticals;
- biologically-derived products like vaccines, blood derived products, and products produced through biotechnology;
- tissues and organs;
- disinfectants; and
Classified drugs include “any substance or mixture of substances manufactured, sold, or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
- restoring, correcting or modifying organic functions in human beings or animals; or
- disinfection in premises in which food is manufactured, prepared or kept.”6
Vitamins and mineral supplements and therapeutic herbal products are also considered drugs by the Food and Drugs Act, but are regulated as natural health products under the Natural Health Products Regulations and not as drugs under Food and Drug Regulations.7
Canada’s National Drug Schedules
Canada’s National Drug Schedules have three schedules, or four categories: Schedule I, Schedule II, Schedule III, and Unscheduled.8
Schedule I Drugs
- require a prescription for sale;
- are provided to the public by a pharmacist following diagnosis and professional intervention; and
- are controlled in a regulated environment as defined by provincial pharmacy legislation.
Schedule II Drugs
- do not require a prescription;
- are less strictly regulated than Schedule I Drugs;
- require professional intervention from a pharmacist at point of sale;
- sometimes require a professional referral; and
- are available only from a pharmacist and must be stored where there is no public access or opportunity for patient self-selection.
Schedule III Drugs
- are available without a prescription;
- may pose some risks in some self-selection situations;
- are sold on store shelves under the direct supervision of the pharmacist; and
- are subject to any local professional requirements that increase the degree of control in the professional services area.
- can be sold without professional supervision;
- inform the consumer about making a safe and effective choice;
- are labeled clearly, with instructions for use;
- are not included in Schedules I, II or III; and
- may be sold from any retail outlet.9
Need More Information?
To learn more about the NDS process in Canada, please visit: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/questions-answers.html
For notices regarding changes to the Prescription Drug List, please visit: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes.html
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