Controlled Substances Regulations (SOR/2025-242)

Marginal note:Sale to practitioner

• 94 (1) A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a practitioner if they first receive from the practitioner a written order that is signed and dated and that contains the following information or, in the case of an emergency, either such a written order or a verbal order:

  • (a) with respect to the practitioner, their name and the name and municipal address of the place where they practise;

  • (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;

  • (c) the date of the order;

  • (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

  • (e) in the case of a finished product,

    • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

    • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

    • (iii) its drug identification number, if any.

• Marginal note:Exception — prohibition

  (2) A pharmacist must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.

Marginal note:Sale to hospital

95 A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a hospital if they first receive from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information or, in the case of an emergency, either such a written order or a verbal order from such a person:

• (a) with respect to the hospital, its name and municipal address, as well as the name and title of the person placing the order;

• (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;

• (c) the date of the order;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

• (e) in the case of a finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any.

Marginal note:Sale to exempted person

96 A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a person exempted under subsection 56(1) of the Act with respect to that controlled substance if

• (a) the pharmacist first receives from the exempted person a copy of the exemption;

• (b) there are terms and conditions for the sale or provision by the pharmacist that are specified in the exemption; and

• (c) the sale or provision is carried out in accordance with those terms and conditions.

Marginal note:Sale to Minister

97 A pharmacist may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;

• (b) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;

• (c) the date of the order;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

• (e) in the case of a finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any.

Marginal note:Sale to individual

• 98 (1) A pharmacist may sell or provide a controlled substance to an individual if

  • (a) the sale or provision is for the individual’s own use, for the use of another individual or for an animal;

  • (b) the controlled substance is in the form of a finished product that does not contain a restricted drug; and

  • (c) subject to subsection (2), the pharmacist first receives the following in respect of the controlled substance from one of the following persons:

    • (i) in the case of the individual, a written prescription,

    • (ii) in the case of another pharmacist or a pharmacy technician,

      • (A) a written prescription, or

      • (B) a copy of the document on which the information with respect to a verbal prescription has been recorded under section 117, or

    • (iii) in the case of a practitioner, a written or verbal prescription.

• Marginal note:Finished product containing low dose of codeine

  (2) A pharmacist may sell or provide, without a prescription, a finished product containing codeine phosphate to an individual if

  • (a) the finished product contains

    • (i) in the case of a finished product in solid form, not more than 8 mg or its equivalent of codeine phosphate per unit, or

    • (ii) in the case of a finished product in liquid form, not more than 20 mg or its equivalent of codeine phosphate per 30 mL;

  • (b) the finished product contains

    • (i) two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half of the regular minimum single dose for each such ingredient, or

    • (ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third of the regular minimum single dose for each such ingredient;

  • (c) the pharmacist has reasonable grounds to believe that the finished product will only be used for recognized medical purposes; and

  • (d) the pharmacist ensures that the following caution or its equivalent is conspicuously and legibly printed on the finished product’s inner label and outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations:

  “This product contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner.”

Compounding of Finished Products

Marginal note:Orders and prescriptions

• 99 (1) A pharmacist or pharmacy technician may compound a finished product, other than one containing a restricted drug, if they do so for the purpose of fulfilling a prescription and if they first receive the following with respect to the finished product from one of the following persons:

  • (a) in the case of an individual, a written prescription;

  • (b) in the case of another pharmacist,

    • (i) a written order that is signed and dated and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order,

    • (ii) a written prescription, or

    • (iii) a copy of the document on which the information with respect to a verbal prescription is recorded under section 117;

  • (c) in the case of another pharmacy technician,

    • (i) a written prescription, or

    • (ii) a copy of the document on which the information with respect to a verbal prescription is recorded under section 117;

  • (d) in the case of a practitioner,

    • (i) if they are not practising in a hospital, a written order that is signed and dated and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order, or

    • (ii) a written or verbal prescription; or

  • (e) in the case of a hospital, a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order from such a person.

• Marginal note:Written orders

  (2) The information that must be contained in the written order is the following:

  • (a) with respect to the person placing the order,

    • (i) in the case of another pharmacist, their name and the name and municipal address of the place where they practise,

    • (ii) in the case of a practitioner, their name and the name and municipal address of the place where they practise, and

    • (iii) in the case of a hospital, its name and municipal address, as well as the name of the person permitted to place the order on its behalf;

  • (b) with respect to the pharmacist or pharmacy technician compounding the finished product, their name and the name and municipal address of the place where they practise;

  • (c) the date of the order;

  • (d) with respect to the finished product,

    • (i) its name, and

    • (ii) its form, strength, the number of containers and, if applicable, the number of units per container; and

  • (e) if applicable, a declaration from the other pharmacist that they require the finished product for emergency purposes.

Substitution of Controlled Substances

Marginal note:Sale and compounding

100 A pharmacist who sells or provides a controlled substance or who compounds a finished product may, before the sale, provision or compounding, substitute a controlled substance for another controlled substance identified in a prescription, if the pharmacist is authorized to do so under the laws of the province where the sale, provision or compounding takes place.

Prescriptions

Marginal note:Extension of prescription

101 A pharmacist may extend a prescription if the new expiration date of the extended prescription is not later than two years after the day on which the pharmacist received the prescription.

Marginal note:Transfer of prescription

102 A pharmacist or pharmacy technician may transfer a prescription to another pharmacist or pharmacy technician if

• (a) they transfer it within two years after the day on which the prescription was received; and

• (b) they provide

  • (i) in the case of a controlled substance prescribed in writing, the written prescription, or

  • (ii) in the case of a controlled substance prescribed verbally, a copy of the document on which the information with respect to that verbal prescription is recorded under section 117.

Verification of Identity

Marginal note:Orders and prescriptions

103 A pharmacist or pharmacy technician who receives an order or prescription from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the pharmacist.

Packaging and Labelling

Marginal note:Receipt of substance from individual

104 A pharmacist or pharmacy technician who receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom the pharmacist or technician has authorized have access and that is marked in a manner that is sufficient to identify the container.

Storage

Marginal note:Authorized access

105 A pharmacist must ensure that

• (a) any controlled substance is stored in a secure location at the place where they practise; and

• (b) only persons whom the pharmacist has authorized have access to that secure location.

Delivery, Sending and Transportation

Marginal note:Authorization

106 A pharmacist or pharmacy technician may deliver, send or transport a controlled substance.

Marginal note:Requirements during transportation

107 A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance to another person may only do so if they

• (a) ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner sufficient to identify the container;

• (b) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and

• (c) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Security

Marginal note:Protective measures

108 A pharmacist or pharmacy technician must take all reasonable measures to ensure the security of any controlled substance in their possession.

Marginal note:Loss or theft — agent or mandatary

• 109 (1) If an agent or mandatary of a pharmacist becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the pharmacist immediately.

• Marginal note:Written report

  (2) If a pharmacist becomes aware of a loss or theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the pharmacist must provide a written report to the Minister within 10 days after the day on which they become aware of the loss or theft or are notified.

• Marginal note:Partial protection against self-incrimination

  (3) The report, or any evidence derived from it, is not to be used or received to incriminate the pharmacist or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction of Controlled Substances

Marginal note:Conditions

• 110 (1) The destruction of a controlled substance in a pharmacy may only be carried out by a pharmacist or pharmacy technician and if the following conditions are met:

  • (a) the destruction is witnessed by another person among the following:

    • (i) a pharmacist, pharmacy technician or intern, including one who is practising in a hospital,

    • (ii) a practitioner, or

    • (iii) any other health professional;

  • (b) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and

  • (c) immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.

• Marginal note:Substance returned by individual

  (2) A pharmacist must, if the destruction of a controlled substance previously returned by an individual or particular person for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.