Whereas the Minister of Health believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health;

Therefore the Minister of Health makes the annexed Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine under section 30.01‍Footnote ^a of the Food and Drugs ActFootnote ^b.

• Return to footnote ^aS.C. 2024, c. 17, s. 326

• Return to footnote ^bR.S., c. F-27

Ottawa, March 7, 2025

Le ministre de la Santé, Mark Holland Minister of Health

Marginal note:Definitions

• 1 (1) The following definitions apply in this Order.

  combination product

  combination product means a natural health product that contains, among its ingredients, ephedrine or any of its salts, pseudoephedrine or any of its salts, or any combination of those ingredients in combination with one or more other substances listed in Schedule 1 of the Regulations. (produit combiné)

  non-combination product

  non-combination product means a natural health product that contains, as its only medicinal ingredients, ephedrine or any of its salts, pseudoephedrine or any of its salts, or any combination of those ingredients. (produit non combiné )

  pharmacist

  pharmacist has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (pharmacien)

  Regulations

  Regulations means the Natural Health Products Regulations. (Règlement)

• Marginal note:Words and expressions

  (2) Unless the context requires otherwise, words and expressions used in this Order have the same meaning as in the Regulations.

Marginal note:Application

• 2 (1) Subject to subsection (2), this Order applies to the sale of combination products and non-combination products.

• Marginal note:Non-application

  (2) This Order does not apply to

  • (a) the sale of combination products or non-combination products for the purposes of a clinical trial that is subject to Part 4 of the Regulations; or

  • (b) the distribution of combination products or non-combination products as samples under section 103.4 of the Regulations.

Marginal note:Application of Regulations

3 For greater certainty, unless otherwise provided for by this Order, the Regulations apply to combination products and non-combination products, except that the reference to “these Regulations” in paragraphs 18(1)(a) and 39(1)(a) and section 92 of the Regulations are to be read as including a reference to this Order.

Marginal note:Prohibition — retail sale

• 4 (1) Subject to subsections (2) to (4), a person must not sell a combination product or non-combination product at the retail level.

• Marginal note:Exception — non-combination products

  (2) A pharmacist or a person working under the supervision of a pharmacist may sell, at the retail level, a non-combination product that is not accessible to the public for self-selection.

• Marginal note:Exception — combination products offered for self-selection

  (3) A pharmacist or any other person working in a retail location serviced by a pharmacist may sell, at the retail level, a combination product that is accessible to the public for self-selection in the case where a pharmacist is available, at the request of a purchaser or consumer, to discuss the product prior to purchase.

• Marginal note:Exception — combination products not offered for self-selection

  (4) A pharmacist or a person working under the supervision of a pharmacist may sell a combination product at the retail level without making it accessible to the public for self-selection.

Marginal note:Prohibition — further sale

5 A person must not sell a combination product or non-combination product to another person, other than a pharmacist, for further sale at the retail level.

Marginal note:Coming into force

6 This Order comes into force on May 18, 2025, but if it is registered after that day, it comes into force on the day on which it is registered.