Expanded scope list
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About the list
The List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition “Drug” in Subsection C.01.014.8(1) of the Food and Drug Regulations applies certain regulatory provisions to drugs that are currently outside the shortage framework. It is also known as the Expanded Scope List.
The provisions concern:
- reporting drug shortages and discontinuations
- sections C.01.014.9 to C.01.014.91
- the prohibition on drug establishment licence (DEL) holders from selling a drug intended for the Canadian market for consumption or use outside Canada if it would cause or exacerbate a shortage
- sections C.01.014.94 to C.01.014.95
For information on drug shortages, consult:
- Guide to reporting drug shortages and discontinuations (GUI-0120)
Which drugs are included on the list
The list has 2 parts:
- Part 1 lists individual drugs
- Part 2 lists classes of drugs
The list only includes 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.
The list does not include drugs that are already within scope of the shortage framework. These drugs are:
- listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances Act
- on the Prescription Drug List
- listed in Schedules C and D of the Food and Drugs Act
- known as radiopharmaceuticals and biological drugs
- permitted to be sold without a prescription but are to be administered only under the supervision of a practitioner
- commonly referred to as “ethical” drugs (for example, hemodialysis solutions, pre-filled syringes with epinephrine for severe allergic reactions, MRI contrast agents)
How the list is maintained
This list is incorporated by reference in the regulations. Health Canada maintains and updates this list in accordance with the Incorporation by Reference Policy.
Changes made to the Expanded Scope List through the policy process are made in a way that gives regulated parties time to comply with new requirements.
Table 1: List of Drugs for the Purposes of Paragraph (b) and (c) of the Definition “Drug” in Subsection C.01.014.8 (1) of the Food and Drug Regulations
| Medicinal ingredient or ingredients | Route of administration | Qualifier | Effective date |
|---|---|---|---|
| Nil | Nil | Nil | Nil |
| Drug class | Qualifier | Effective date |
|---|---|---|
| Nil | Nil | Nil |