The Food and Drugs Act e-Learning Module is one in a series of learning modules that the College has introduced. It is an overview of key principles in the Food and Drugs Act and its related regulations. We recommend that you view this module and refer to the legislation as required, as well as the practice policies and guidelines applicable to the FDA and the resources available on the Health Canada website.
The estimated running time is approximately 90 minutes but will depend on your individual pace.
Please note that the FDA e-Learning module is only a tool to support learning the FDA and its regulations and is not a comprehensive study resource. It is important to refer to the official legislation for more detailed and current information.
For the slide illustrating the organization of Health Canada’s Health Products and Food Branch (HPFB), please note changes made by the federal government:
- the Therapeutic Products Directorate is renamed the Pharmaceutical Drugs Directorate
- the Medical Devices Bureau is now the Medical Devices Directorate and directly under the HPFB
- the Natural Health Products Directorate is renamed the Natural and Non-prescription Health Products Directorate and now includes non-prescription drugs and disinfectants.
Under the section Health Canada Drug Product Database, an example was used to illustrate the search function of this database. As noted, examples are for demonstration purposes and changes may occur. Since this example was created, the drug product Tramacet® has been discontinued and the drug tramadol was moved from the Prescription Drug List to Schedule I of the Controlled Drugs and Substances Act and listed in the Schedule of the Narcotic Control Regulations.
March 26, 2020:
Important update regarding the novel coronavirus (Covid-19) pandemic
Health Canada has issued pharmacists a temporary Controlled Drugs and Substances Act (CDSA) Subsection 56(1) Class Exemption for Patients, Practitioners and Pharmacists Prescribing and Providing Controlled Substances in Canada during the Coronavirus Pandemic from the provisions of:
- Subsection 31(1), and section 37 of the Narcotic Control Regulations (NCR)
- Sections G.03.002 and G.03.006 of Part G of the Food and Drug Regulations (FDR)
- Paragraphs 52 (c) and (d), subsection 54(1) of the Benzodiazepines and Other Targeted Substances Regulations.
Effective October 17, 2017:
- NAPRA has updated their website which has changed its overall appearance and that of the National Drug Schedules. The video embedded in this module was created before this change. However, the basic content and navigation of the drug schedules remains similar.
Practice Policies, Guidelines and Other Resources
Pharmacy practice policies, guidelines and tools were developed to support the legislation and its regulations. Please refer to the OCP website for further resources and tools that are applicable to the FDA and to the Health Canada website to support your understanding of the legislation.