Nonprescription Drugs: Category IV Monographs

A nonprescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Category IV Monographs are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A manufacturer may reference a Category IV Monograph in a drug submission when the product and its labelling are consistent with the information set out in the document.

When a Category IV Monograph does not exist, or when a product or its labelling is outside the scope of a published Category IV Monograph, the sponsor must submit evidence to support the safety, efficacy, and quality of the product when used according to the proposed conditions of use. Examples of these situations include, but are not limited to:

• the directions for use are not provided for in the Category IV Monograph;
• an active ingredient is not provided for in the Category IV Monograph;
• a strength or dose is outside the limits allowable by the Category IV Monograph:
• the product combines aspects of more than one Category IV Monograph which are not explicitly provided for in an individual Category IV Monograph; or
• the proposed product is a New Drug.

Please note that all products are subject to Good Manufacturing Practices outlined in Part C, Division 2 of the Food and Drug Regulations whether or not the drug submission references a Category IV Monograph. For more information on the drug submission process, please refer to the guidance document Guidance for Industry: Management of Drug Submissions.

With the introduction of the Natural Health Products Directorate (NHPD) in 2004, several products previously regulated as drugs are now classified as natural health products. Please consult the Summary of NHP/Drug Classification of TPD Category IV/Labelling Standard Ingredients for a classification list which identifies which ingredients are considered to be either natural health products or drug products.

Please note that if a product contains a combination of both a drug and a natural health product as active ingredients, then the overall product is deemed a drug and the Food & Drug Regulations apply.

As of January 1, 2010, NHPD is now responsible for the regulatory oversight of all natural health products previously classified as drugs under the Food and Drugs Act.

For those products which had previously been captured by a TPD Category IV Monograph or Labelling Standard but which contain active ingredients classified as either drugs or natural health products, TPD and NHPD have undertaken to jointly revise the affected monograph in consultation with external stakeholders. The harmonized monographs will facilitate the regulatory review process and establish consistent guidelines for labelling requirements. A link will take you to the joint TPD/NHPD monograph located on the NHPD Web page.

For all other natural health product ingredients, please consult NHPD’s Compendium of Monographs.