Draft for consultation: Safety stock 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.

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About the list

The List of Drugs for the Purposes of Section C.01.014.84, also known as the Safety Stock List, would specify drugs subject to the safety stock requirements as per sections C.01.014.84 and C.01.014.85 of the proposed amendments to the Food and Drug Regulations (FDR).

For information on the requirements for safety stocks, consult:

Which drugs would be included in the list

As per subsection C.01.014.83(1), a drug could be added to the list if the Minister has reasonable grounds to believe that:

  1. a shortage of that drug, if it were to occur, could present a serious and imminent risk of injury to human health
  2. it is technically feasible to hold a safety stock of the drug
  3. failure to ensure that a safety stock of the drug is kept in Canada could lead to a shortage that presents a serious and imminent risk of injury to human health

Learn more about Health Canada interprets serious and imminent risk of injury to health due to a shortage in our Draft for consultation: Guide to safety stocks.

The list would have two parts:

Health Canada would hold a separate consultation on the specific drugs to be added to the Safety Stock List after the regulations are published in Canada Gazette, Part II. Examples of drugs and routes of administration that may be added to the list include:

  • atropine (intramuscular, intravenous, subcutaneous)
  • epinephrine (intracardiac, intramuscular, intratracheal, intraspinal, intravenous, subcutaneous)
  • heparin (intravenous, subcutaneous)
  • isoniazid (oral)
  • magnesium sulfate (intramuscular, intravenous)
  • meropenem (intravenous)
  • naloxone (intramuscular, intravenous, subcutaneous)
  • norepinephrine (intravenous)
  • oxytocin (intramuscular, intravenous)
  • vitamin K1 (intramuscular, intravenous subcutaneous)

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 Safety Stock List through the incorporation by reference policy process would be implemented in a way that gives market authorization holders (MAHs) time to come into compliance with new requirements. Stakeholders, including MAHs, are strongly encouraged to participate in the public consultation process.

Table 1: List of Drugs for the Purposes of Section C.01.014.84 of the Food and Drug Regulations (Safety Stock List)
Part 1. Drugs that require a 3-month safety stock
Drug identification number (DIN) Brand name of drug, medicinal ingredient(s) Manufacturer name Dosage form, strength, route(s) of administration
N/A N/A N/A N/A
Part 2. Drugs for which different variables are used to calculate the quantity of safety stock required
Column 1: New reference period (number of months) Column 2: Total number of months of stock to be held Drug identification number (DIN) Brand name of drug, medicinal ingredient(s) Manufacturer name Dosage form, strength, route(s) of administration
N/A N/A N/A N/A N/A N/A

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