Draft for consultation: Expanded scope list

This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.

On this page

About the list

The List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 of the proposed amendments to the Food and Drug Regulations (FDR), also known as the Expanded Scope List, would apply certain regulatory provisions to drugs that are currently outside the shortage framework.

The provisions concern:

Drugs on the Expanded Scope List may also require shortage prevention and mitigation plans (C.01.014.81), safety stocks (C.01.014.83 to C.01.014.85) and demand surge reporting (C.01.014.91) if they meet additional conditions.

For information on drug shortages, consult:

Which drugs would be included in the list

The list would have 2 parts:

The list would only include drugs or classes of drugs for which a shortage or discontinuation could present a risk of injury to human health.

Health Canada interprets a risk of injury to health due to a shortage as the likelihood that the interruption, lack or delay of treatment due to a shortage could cause harm to human health.

Health Canada would not include the drugs that are currently within scope of the shortage framework that are:

Health Canda would hold a separate consultation on the specific drugs to be added to the Expanded Scope List after the regulations are published in Canada Gazette, Part II. Examples of the types of drugs that may be added to the list include:

  • pediatric analgesics
  • acetylsalicylic acid when sold or recommended as a platelet aggregation inhibitor

How the list would be maintained

This list would be incorporated by reference in the proposed regulations. Health Canada would maintain and update this list as required in line with our Incorporation by reference policy.

Changes made to the Expanded Scope List through the incorporation by reference policy process would be implemented in a way that gives regulated parties time to come into compliance with new requirements. Stakeholders, including market authorization holders (MAHs) and drug establishment licence (DEL) holders, are strongly encouraged to participate in the public consultation process.

Table 1: List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 of the Food and Drug Regulations (Expanded Scope List)
Part 1. Individual drugs
Medicinal ingredient(s) Route(s) of administration Qualifier Effective date
N/A N/A N/A N/A
Part 2. Classes of drugs
Drug class Qualifier Effective date
N/A N/A N/A

Page details

Date modified: