Draft for consultation: Expanded scope list
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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:
- drug shortage reporting
- sections C.01.014.9 to C.01.014.93
- 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.01.014.95 to C.01.014.96
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:
- Part 1 would list individual drugs
- Part 2 would list classes of drugs
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:
- 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 (FDA)
- 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)
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.
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 |
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