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Controlled Substances Regulations (SOR/2025-242)

Regulations are current to 2026-10-19 and last amended on 2026-10-01. Previous Versions

Practitioners

Prescriptions

Marginal note:Conditions

 A practitioner may issue a written prescription that they sign and date or a verbal prescription if

  • (a) the practitioner is treating, in their professional capacity, the individual for whom, or the animal for which, the prescription is issued; and

  • (b) the controlled substance set out in the prescription is needed to treat the individual’s or animal’s medical condition.

Sale of Controlled Substances

Marginal note:Sale to licensed dealer

  •  (1) A practitioner may sell or provide a controlled substance to a licensed dealer if,

    • (a) in the case of a controlled substance previously returned by an individual for the purposes of destruction,

      • (i) the licensed dealer is specialized in destruction, and

      • (ii) the practitioner first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (2); and

    • (b) in the case of any other controlled substance,

      • (i) one of the following conditions is met:

        • (A) the licensed dealer is the one that sold or provided that controlled substance to the practitioner, or

        • (B) the practitioner sells or provides the controlled substance for the purposes of testing or destruction, and

      • (ii) the practitioner first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (2).

  • Marginal note:Written orders

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

    • (a) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;

    • (b) with respect to the practitioner, 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 4, its name, form and quantity;

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

      • (i) subject to subparagraph (iv), its name or, if applicable, brand name,

      • (ii) subject to subparagraph (iv), its form, strength and quantity,

      • (iii) subject to subparagraph (iv), its drug identification number, if any, and

      • (iv) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and

    • (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Marginal note:Sale to Minister

 A practitioner 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 practitioner, 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 4, its name, form and quantity; and

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

    • (i) its name or, if applicable, brand name,

    • (ii) its form, strength and quantity, and

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

Marginal note:Sale to individual

  •  (1) A practitioner may sell or provide a controlled substance, other than a restricted drug, 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; and

    • (b) the practitioner first issues a written prescription for the individual for whom, or the animal for which, the controlled substance is sold or provided.

  • Marginal note:Restricted drugs

    (2) A practitioner may sell or provide a restricted drug to an individual for their own use if

    • (a) the practitioner is treating the individual in their professional capacity; and

    • (b) the practitioner has received a copy of the letter of authorization in which they are named.

Administration of Controlled Substances

Marginal note:General condition

  •  (1) A practitioner may administer a controlled substance, other than a restricted drug, to an individual or animal if the practitioner first issues a written prescription.

  • Marginal note:Restricted drugs

    (2) A practitioner may administer a restricted drug to an individual if

    • (a) the practitioner is treating the individual in their professional capacity; and

    • (b) the practitioner has received a copy of the letter of authorization in which they are named.

Marginal note:Emergency supply

  •  (1) A practitioner of medicine who is responsible for an emergency supply must ensure that

    • (a) the emergency supply does not contain a restricted drug; and

    • (b) they have an agent or mandatary who is present at the place where the emergency supply is stored and who will, under their direction, administer the controlled substance under their control.

  • Marginal note:Administration — conditions

    (2) In an emergency, the agent or mandatary of the practitioner of medicine may administer a controlled substance from the emergency supply to an individual if

    • (a) the practitioner of medicine has directed the agent or mandatary to administer the controlled substance; or

    • (b) the agent or mandatary follows written directives provided by the practitioner of medicine with respect to the administration of the controlled substance.

Packaging and Labelling

Marginal note:Receipt of substance from individual

 A practitioner 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 practitioner has authorized have access and that is marked in a manner that is sufficient to identify the container.

Storage

Marginal note:Authorized access

  •  (1) Subject to subsection (2), a practitioner who stores a controlled substance must ensure that

    • (a) they store the controlled substance in a secure location in the place where they practise; and

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

  • Marginal note:Emergency supply

    (2) A practitioner of medicine who stores an emergency supply need only ensure that

    • (a) they take all reasonable measures to ensure that the place of storage is secure; and

    • (b) only the practitioner of medicine and their agent or mandatary have access to that secure place.

Delivery, Sending and Transportation

Marginal note:Authorization

 A practitioner may deliver, send or transport a controlled substance.

Marginal note:Requirements during transportation

 A practitioner 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 that is 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

 A practitioner must take all reasonable measures to ensure the security of any controlled substance in their possession.

Marginal note:Loss or theft — agent or mandatary

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

  • Marginal note:Written report

    (2) If a practitioner 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 practitioner 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 practitioner 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

  •  (1) The destruction of a controlled substance may be carried out by a practitioner only if the following conditions are met:

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

      • (i) a pharmacist, pharmacy technician or intern,

      • (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:Exception — open ampule

    (2) A practitioner may, without a witness, destroy the remainder of a controlled substance that is contained in an open ampule and that will not be administered.

  • Marginal note:Substance returned by individual

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

Documents

Application

Marginal note:Scope

 The requirements set out in sections 141 to 152 apply to a practitioner with respect to the following controlled substances:

  • (a) if the practitioner is not practising in a hospital, a narcotic, controlled drug or targeted substance; and

  • (b) a restricted drug.

Information

Marginal note:Substances received

 A practitioner who receives a controlled substance, other than one that has been previously returned by an individual for the purposes of destruction, must record the following information:

  • (a) with respect to the person from whom the controlled substance is received, their name and, if applicable, title, as well as their municipal address;

  • (b) the date of receipt;

  • (c) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and

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

    • (i) its name or, if applicable, brand name,

    • (ii) its form, strength and quantity, and

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

Marginal note:Substances sold — persons other than individuals

 A practitioner who sells or provides a controlled substance to a person, other than an individual referred to in section 143, must record

  • (a) the practitioner’s name;

  • (b) with respect to the person, their name and, if applicable, title, as well as their municipal address;

  • (c) the date of the sale or provision;

  • (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and

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

    • (i) subject to subparagraph (iv), its name or, if applicable, brand name,

    • (ii) subject to subparagraph (iv), its form, strength and quantity,

    • (iii) subject to subparagraph (iv), its drug identification number, if any, and

    • (iv) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Marginal note:Substances prescribed, administered or sold — individuals

  •  (1) A practitioner who conducts the following activities must record the information set out in subsection (2):

    • (a) prescribe or administer a controlled substance to an individual or an animal; or

    • (b) sell or provide a controlled substance to an individual for their own use, for the use of another individual or for an animal.

  • Marginal note:Information

    (2) The information that must be recorded is the following:

    • (a) the practitioner’s name;

    • (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;

    • (c) in the case of an administration, sale or provision of a restricted drug to an individual, their name;

    • (d) the date of the prescription, administration, sale or provision;

    • (e) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;

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

      • (i) its name or, if applicable, brand name,

      • (ii) its form, strength and quantity,

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

      • (iv) if the finished product that is sold or provided, other than one containing a restricted drug, is intended for administration by the individual to themselves or the animal, and if the dose exceeds the following, a statement to that effect:

        • (A) in the case of a finished product containing a controlled drug or narcotic, three times the maximum daily dosage recommended by the producer of the product or, if the producer has not recommended a maximum daily dosage, three times the generally recognized maximum daily therapeutic dosage for that product, or

        • (B) in the case of a finished product containing a targeted substance, five times the usual daily dose for the product.

 

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