Canada Gazette, Part I, Volume 158, Number 23: GOVERNMENT NOTICES
June 8, 2024
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Ministerial Condition No. 21762
Ministerial condition
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the substance 1,3-cyclohexanedimethanamine, N1,N3-bis(2-methylpropylidene)-, Chemical Abstracts Service Registry Number 173904-11-5;
And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),
The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Act, hereby permits the manufacture or import of the substance subject to the conditions of the following annex.
Marc D’Iorio
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment
ANNEX
Conditions
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)
1. The following definitions apply in these ministerial conditions:
- “notifier”
- means the person who has, on January 4, 2024, provided to the Minister of the Environment the prescribed information concerning the substance, in accordance with subsection 81(1) of the Canadian Environmental Protection Act, 1999;
- “substance”
- means 1,3-cyclohexanedimethanamine,N1,N3-bis(2-methylpropylidene)-, Chemical Abstracts Service Registry Number 173904-11-5.
2. The notifier may manufacture or import the substance subject to the present ministerial conditions.
Restrictions
3. The notifier shall not import the substance
- (a) if it is present in a consumer product to which the Canada Consumer Product Safety Act applies; or
- (b) to manufacture a consumer product to which the Canada Consumer Product Safety Act applies unless the substance is chemically reacted into a stable matrix and cured during the manufacture of the consumer product.
4. The notifier shall not manufacture the substance to manufacture a consumer product to which the Canada Consumer Product Safety Act applies unless the substance is chemically reacted into a stable matrix and cured during the manufacture of the consumer product.
5. The notifier shall transfer the physical possession or control of the substance only to a person who agrees to use it in accordance with section 3.
Other requirements
6. The notifier shall, prior to transferring the physical possession or control of the substance to any person,
- (a) inform the person, in writing, of the terms of the present ministerial conditions; and
- (b) obtain, prior to the first transfer of the substance, written confirmation from this person that they were informed of the terms of the present ministerial conditions and they will not manufacture a consumer product to which the Canada Consumer Product Safety Act applies unless the substance is chemically reacted into a stable matrix and cured during the manufacture of the consumer product.
Record-keeping requirements
7. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating
- (a) the use of the substance;
- (b) the quantity of the substance that the notifier manufactures, imports, purchases, distributes, sells and uses;
- (c) the name and address of each person to whom the notifier transfers the physical possession or control of the substance; and
- (d) the written confirmation referred to in paragraph 6(b).
(2) When the notifier learns of a change to the address referred to in paragraph (1)(c), the notifier must update the electronic or paper records mentioned in subsection (1) accordingly within 30 days after learning of the change.
(3) The notifier shall create the electronic or paper records mentioned in subsection (1) no later than 30 days after the date the information or documents become available.
(4) The notifier shall maintain the electronic or paper records mentioned in subsection (1)
- (a) in English, French, or both languages; and
- (b) at the notifier’s principal place of business in Canada, or at the principal place of business in Canada of their representative, for a period of at least five years after they are made.
(5) Any records mentioned in subsection (1) that are kept electronically must be in an electronically readable format.
Coming into force
8. The present ministerial conditions come into force on May 23, 2024.
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice with respect to the availability of an equivalency agreement
Pursuant to subsection 10(4) of the Canadian Environmental Protection Act, 1999, notice is hereby given that the Minister of the Environment makes available, before it is entered into, An Agreement on the Equivalency of Federal and Saskatchewan Regulations for the Control of Greenhouse Gas Emissions from Electricity Producers in Saskatchewan, 2025.
The proposed agreement is available as of June 8, 2024, on the Department of the Environment’s Environmental Registry.
Any person may, within 60 days after the publication of this notice, file with the Minister comments or a notice of objection. All such comments and notices must cite the present notice and its date of publication in the Canada Gazette, Part I, and be sent to the following contact person.
Contact
Karishma Boroowa
Director
Electricity and Combustion Division
Energy and Transportation Directorate
Environment and Climate Change Canada
Email: ECD-DEC@ec.gc.ca
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine
Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;
Therefore, the Minister of Health makes the annexed Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine under subsection 30.1(1)footnote a of the Food and Drugs Act footnote b.
Ottawa, May 17, 2024
Mark Holland
Minister of Health
Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine
Definitions
1 The following definitions apply in this Interim Order.
- natural health product that contains ephedrine or pseudoephedrine
- means a natural health product that contains, as its only medicinal ingredients, ephedrine and its salts, pseudoephedrine and its salts, or any combination of these ingredients and their salts. (produit de santé naturel contenant de l’éphédrine ou de la pseudoéphédrine)
- pharmacist
- has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (pharmacien)
- Regulations
- means the Natural Health Products Regulations. (Règlement)
Words and expressions
2 Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Regulations.
Application
3 (1) Subject to subsection (2), this Interim Order applies to the sale of a natural health product that contains ephedrine or pseudoephedrine.
Non-application — clinical trials
(2) This Interim Order does not apply to the sale of a natural health product that contains ephedrine or pseudoephedrine for the purpose of a clinical trial regulated by Part 4 of the Regulations.
Prohibition — retail sale
4 (1) Subject to subsection (2), a person must not sell on a retail basis a natural health product that contains ephedrine or pseudoephedrine.
Exception
(2) A pharmacist or a person working under the pharmacist’s supervision may sell on a retail basis a natural health product that contains ephedrine or pseudoephedrine if the product is not otherwise accessible to the public.
Prohibition — sale for further sale
5 A person must not sell a natural health product that contains ephedrine or pseudoephedrine to another person that is not a pharmacist for further sale on a retail basis by that other person.
EXPLANATORY NOTE
(This note is not part of the Interim Order.)
Proposal
The Minister of Health made the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine on May 17, 2024, introducing condition-of-sale rules for natural health products (NHPs) containing ephedrine, pseudoephedrine, or ephedrine and pseudoephedrine as their only medicinal ingredients. Under section 30.1(1) of the Food and Drugs Act, the Minister may make an interim order if they believe that immediate action is required to deal with a significant risk, direct or indirect, to health, safety, or the environment.
The National Association of Pharmacy Regulatory Authorities (NAPRA) intends to remove ephedrine and pseudoephedrine (in single-medicinal ingredient products) from its National Drug Schedules (NDS) by June 28, 2024. NAPRA has been removing NHPs from its NDS since 2019 through a stepwise, risk-based approach; these two products represent the last two remaining NHPs on its NDS. Because most provinces’ and territories’ laws refer to NAPRA’s NDS, these changes to the NDS would cause those provincial and territorial laws, and their point-of-sale rules for these types of products, to no longer apply to single-ingredient ephedrine and pseudoephedrine products, creating gaps in oversight across Canada that would expose individuals to significant health and safety risks.
Single-ingredient ephedrine and pseudoephedrine products pose misuse and diversion risks, including as precursors in the illegal production of the controlled substance methamphetamine. Further, products containing both ingredients as their only medicinal ingredients, while not currently marketed, may pose similar risks. The Interim Order is intended to address these risks on an urgent and temporary basis until Health Canada can propose longer-term solutions in further consultation with the provinces and territories.
The Interim Order imposes condition-of-sale measures for NHPs containing ephedrine, pseudoephedrine, or ephedrine and pseudoephedrine as their only medicinal ingredients. The Order’s measures are similar to the measures currently outlined in NAPRA’s NDS and include rules to ensure that only pharmacists (or individuals working under the supervision of pharmacists, such as pharmacy technicians) may sell such products on a retail basis, and only where such products are otherwise not accessible to the public (e.g., behind the counter in a pharmacy). The Interim Order also prohibits persons (i.e., distributors) from selling these NHPs to retail stores other than pharmacies, by limiting such sales to pharmacists.
In accordance with paragraph 30.1(2)(a) of the Act, the Interim Order will remain in effect for 14 days unless it is approved by the Governor in Council, in which case it would remain in effect for up to one year. The Department intends to seek the Governor in Council’s approval of the Interim Order.
Objective
The objective of this Interim Order is to prevent the misuse of NHPs containing ephedrine, pseudoephedrine, or ephedrine and pseudoephedrine as their only medicinal ingredients, including their diversion to the illegal production of the controlled substance methamphetamine, to protect individuals in Canada from significant risks to their health and safety.
Background
All provinces and territories currently require single-ingredient ephedrine and pseudoephedrine products in retail settings to be sold behind the counter in pharmacies, and by pharmacists (or, in some cases, also by individuals working under the supervision of a pharmacist, such as pharmacy technicians), to prevent their misuse and diversion for unlawful purposes. Most provinces and territories achieve this by referring to NAPRA’s NDS in their laws. NAPRA facilitates collaboration for its members (pharmacy regulatory authorities across Canada), to discuss and take national approaches to address common issues in the practice of pharmacy in Canada.footnote 1 The NDS is one such national approach. It is a harmonized national model designed to align provincial and territorial drug schedules so that conditions of sale for drugs are more consistent across Canada.footnote 2 Under NAPRA’s NDS, single-ingredient ephedrine and pseudoephedrine NHPs are Schedule II products, which can only be sold with a pharmacist’s intervention and from areas of a pharmacy inaccessible to the public (e.g., behind the counter). Provinces that do not rely on NAPRA’s NDS (such as Quebec and British Columbia, which maintain their own drug schedules) impose similar and generally more direct obligations for such products through their laws.
When the Natural Health Products Regulations (the Regulations) came into force in 2004, NAPRA began a process to remove NHPs from its NDS, as the Association viewed NHPs as outside the NDS’s scope. In 2021, at Health Canada’s request, NAPRA postponed removing ephedrine and pseudoephedrine NHPs (i.e., single-medicinal ingredient products) from Schedules I and II of its NDS because of these products’ misuse and diversion risks, including as precursors to controlled substances. In 2022, NAPRA removed all NHPs from Schedules I and II of its NDS, except ephedrine and pseudoephedrine products. In 2022, NAPRA informed Health Canada that it intended to remove the remaining ephedrine and pseudoephedrine NHPs from Schedules I and II of its NDS. Finally, in early 2024, NAPRA informed Health Canada that it will be removing ephedrine and pseudoephedrine as single-ingredient entities—the remaining two NHPs—from Schedules I and II of its NDS by June 28, 2024.
Canadian law enforcement agencies have brought to Health Canada’s attention that they have found single-ingredient ephedrine NHPs, in particular authorized 8 mg ephedrine formulations, in clandestine laboratories that manufacture methamphetamine. The availability of precursors such as ephedrine and pseudoephedrine represents a major area of concern for Canadian law enforcement in dealing with clandestine labs.footnote 3 Easier access to ephedrine and pseudoephedrine as a retail drug, especially single-ingredient products, often translates into increased development of smaller labs.footnote 4 When NAPRA removes these products from its NDS, many provinces’ and territories’ laws will no longer require professional intervention by pharmacists when selling such products at the retail level, and that they only be sold from areas inaccessible to the public. Health Canada expects that, without federal intervention, greater access to these products, including in larger quantities, would exacerbate these products’ misuse and diversion risks, thereby creating significant health and safety risks to individuals in Canada.
Implications
Description of the Interim Order
In response to these immediate and significant risks to the health and safety of individuals in Canada, the Interim Order imposes measures across Canada, largely to align with those outlined in Schedule II of NAPRA’s NDS, on an urgent, temporary basis, while Health Canada considers longer-term solutions.
The Interim Order prohibits persons from selling NHPs containing ephedrine, pseudoephedrine, or both ingredients as their only medicinal ingredients on a retail basis, except pharmacists or individuals working under the supervision of a pharmacist, and only if such products are otherwise not accessible to the public (e.g., behind the counter in a pharmacy). For the purposes of this Interim Order, the phrase “selling on a retail basis” captures retail entities who resell such products for end-use and generally to the general public. The Interim Order does not capture individuals or entities who sell (distribute) these products through, for example, a patient-provider relationship in accordance with their scope of practice under provincial or territorial law, such as health care practitioners (including physicians and nurse practitioners) providing care to their patients (including in hospital, remote, and other clinical settings).
The Interim Order is technologically neutral (i.e., its prohibitions and exceptions apply to both physical and online settings), even where it seeks to ensure a pharmacist’s intervention in the sale of these NHPs to prevent their misuse and diversion. For example, such products may still be sold where (1) they are distributed through a remote dispensing location, where the pharmacist (or a person working under the supervision of the pharmacist) is physically present in either the remote dispensing location or in the pharmacy that operates the remote dispensing location, and where (2) a pharmacy sells such products online—but only where the pharmacist or a person working under the supervision of the pharmacist still intervenes in that sale. Here, such products are also otherwise not accessible to the public.
The Interim Order defines “pharmacist” to have the same meaning as in Part C of the Food and Drug Regulations, i.e., a person who is registered or otherwise entitled under the laws of a province (or a territory) to practise pharmacy and is practising pharmacy in that province (or territory).
Further, the Interim Order prohibits persons from selling NHPs containing ephedrine, pseudoephedrine, or both ingredients as their only medicinal ingredients, to a person that is not a pharmacist for further sale on a retail basis (by that other person).footnote 5 In other words, this prohibition applies to distributors under the Regulations when selling these products to retailers.footnote 6 Again, “on a retail basis” does not include a health care practitioner distributing these products to their patients when providing health care in accordance with their scope of practice under provincial or territorial law. While this prohibition exceeds the status quo based on NAPRA’s NDS, this rule closes an existing federal regulatory gap between distributors of these NHPs and the types of persons to whom they may sell such products. Even though provincial and territorial laws generally prohibit non-pharmacy retailers from selling these products to the public, nothing currently prohibits distributorsfootnote 7 from selling such products to non-pharmacy retailers. This rule would improve the Department’s compliance and enforcement activities in this space and complement the Interim Order’s other measures by targeting different points in the supply chain.
Lastly, for greater certainty, the Interim Order makes explicitly clear that it does not apply to the sale of these NHPs for the purposes of a clinical trial regulated by Part 4 of the Regulations, as this Part already imposes adequate conditions-of-sale rules for these products when sold for the purposes of a clinical trial.
Compliance and Enforcement
Health Canada will conduct compliance and enforcement activities through a risk-based approach, in alignment with existing departmental policies such as the Compliance and enforcement policy for health products in order to protect the health and safety of individuals in Canada.
Impact on Stakeholders
The Interim Order likely impacts some distributors’ sales channels because it limits the types of retail stores to whom distributors may sell these NHPs. Prior to the Interim Order, federal law did not prohibit distributors from selling these NHPs to non-pharmacy retailers, even though non-pharmacy retailers should not be able to sell these products to consumers under provincial and territorial law (and now cannot lawfully sell these products to consumers under the Interim Order). Health Canada is aware of a few licensed distributors who were, prior to the Interim Order, selling these NHPs on a wholesale basis to non-pharmacy retailers. Prohibiting distributors from selling these NHPs to non-pharmacy retailers, and non-pharmacy retailers from selling these NHPs to consumers, will bring clarity and a consistent minimum of requirements across the provinces and territories. As a result of the Interim Order, distributors who were selling these NHPs to non-pharmacy retailers may redirect those sales to pharmacies to prevent revenue losses.
From a consumer perspective, greater clarity under the Interim Order concerning the wholesale and retail sale of these NHPs likely affects some consumers’ ease of access to these products—but only in terms of where they may access them, i.e., through pharmacies on a retail basis. This consequence, which flows from greater clarity in the law, is necessary to prevent the misuse and diversion of these NHPs and protect the health and safety of individuals in Canada.
Consultation
Provincial and Territorial Governments & Regulatory Authorities
Health Canada consulted provincial and territorial ministries, representatives from those provinces’ and territories’ pharmacy regulatory authorities, and NAPRA on March 13, 2024, and April 4, 2024. The purpose of these consultations was to discuss potential federal measures to maintain the status quo relating to current point-of-sale measures for single-ingredient ephedrine and pseudoephedrine NHPs, to prevent their misuse and diversion.
Overall, the participants expressed broad support for federal conditions-of-sale measures in response to NAPRA’s removal of single-ingredient ephedrine and pseudoephedrine products from its NDS, including the measure prohibiting distributors from selling to retail stores other than pharmacies (that goes beyond NAPRA’s NDS), which participants identified as a regulatory gap.
Canadian Pharmacists Association
Health Canada also consulted the Canadian Pharmacists Association on March 18, 2024, and April 4, 2024. The purposes of these consultations were to (1) share information regarding the implementation of potential federal measures that would maintain status quo for point-of-sale measures relating to single-ingredient ephedrine and pseudoephedrine NHPs, and (2) provide a summary of the first engagement session with provincial and territorial ministries and pharmacy regulatory authorities.
The Association expressed strong support for the proposed approach, indicated its interest in being consulted further throughout the development of the Interim Order, and offered Health Canada its support in communicating a federal measure to their members once in place.
Key Industry Associations
Health Canada also consulted key industry associations that represent NHP licence holders on April 23, 2024. The purpose of this consultation was to present the potential federal measures to these stakeholders, as the Interim Order would limit the types of retailers to whom distributors may sell such products. During the consultation, these stakeholders did not express any concerns regarding the proposed measures and noted that current provincial and territorial laws are somewhat unclear and inconsistent across jurisdictions.
Contact
Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, ON
K1A 0K9
Address Locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca
PRIVY COUNCIL OFFICE
Appointment opportunities
We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.
We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.
The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.
Current opportunities
The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.
| Position | Organization | Closing date |
|---|---|---|
| Director | Bank of Canada | |
| Director | Canada Foundation for Sustainable Development Technology | |
| Director | Canada Infrastructure Bank | |
| Director | Canada Lands Company Limited | |
| Chairperson | Canada Mortgage and Housing Corporation | |
| Director | Canada Mortgage and Housing Corporation | |
| President | Canada Mortgage and Housing Corporation | |
| Director | Canadian Air Transport Security Authority | |
| Director | Canadian Commercial Corporation | |
| Director | Canadian Energy Regulator | |
| Chief Commissioner | Canadian Human Rights Commission | |
| Member | Canadian Institutes of Health Research | |
| President | Canadian Institutes of Health Research | |
| Chairperson | Canadian Museum for Human Rights | |
| President | Canadian Nuclear Safety Commission | |
| Director | Canadian Race Relations Foundation | |
| Director | Canadian Tourism Commission | |
| Chairperson | Canadian Transportation Accident Investigation and Safety Board | |
| Member | Copyright Board | |
| Executive Head | Employment Insurance Board of Appeal | June 20, 2024 |
| Member | Employment Insurance Board of Appeal | June 20, 2024 |
| Regional Coordinator | Employment Insurance Board of Appeal | June 20, 2024 |
| Director | Export Development Canada | |
| Commissioner | Financial Consumer Agency of Canada | |
| Commissioner | First Nations Tax Commission | |
| Director (Federal) | Halifax Port Authority | |
| Deputy Chairperson and Member, Refugee Appeal Division | Immigration and Refugee Board | |
| Member | Independent Advisory Board on Eligibility for Journalism Tax Measures | |
| Vice-Chairperson | Independent Advisory Board on Eligibility for Journalism Tax Measures | |
| Chairperson | Laurentian Pilotage Authority | |
| Commissioner | Law Commission of Canada | |
| Parliamentary Librarian | Library of Parliament | |
| Chairperson | National Advisory Council on Poverty | |
| Member (Children’s Issues) | National Advisory Council on Poverty | |
| Member | National Arts Centre Corporation | |
| Chairperson | National Seniors Council | |
| Member | National Seniors Council | |
| Member | Natural Sciences and Engineering Research Council | |
| Canadian Representative | North Atlantic Salmon Conservation Organization | |
| Director of Public Prosecutions | Office of the Director of Public Prosecutions | |
| Administrator | Ship-source Oil Pollution Fund and Fund for Railway Accidents Involving Designated Goods | |
| Chief Statistician | Statistics Canada | |
| Chairperson | VIA Rail Canada Inc. |