Canada Gazette, Part I, Volume 158, Number 23: ORDERS IN COUNCIL

June 8, 2024

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Order Approving the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine

P.C. 2024-619 May 31, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, under paragraph 30.1(2)(a)footnote a of the Food and Drugs Actfootnote b, approves the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine, made by the Minister of Health on May 17, 2024.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council approves the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine, made by the Minister of Health on May 17, 2024, which introduced 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 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.

Without this Order in Council, the Interim Order would have, in accordance with paragraph 30.1(2)(a) of the Act, ceased to have effect 14 days after it was made. As a result of this Order in Council, in accordance with paragraphs 30.1(2)(b) to (d) of the Act, the Interim Order will cease to have effect on the earliest of the day on which it is repealed, the day on which regulations having the same effect come into force, or one year after the day on which the Interim Order was made.

Objective

The objective of this Order in Council is to approve the Interim Order, extending its prevention of 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 this Order in Council

This Order in Council approves the Interim Order, extending its effect until the earliest of the day on which it is repealed, the day on which regulations having the same effect come into force, or one year after the day on which the Interim Order was made.

Description of the Interim Order

In response to the 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 the 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 will 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, as extended by this Order in Council, 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, as extended by this Order in Council, 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