Controlled Substances Regulations (SOR/2025-242)

Marginal note:Sale to Minister

162 A hospital may sell or provide a controlled substance to the Minister if the hospital first receives 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 hospital, its name and municipal address;

• (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,

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

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

Marginal note:Sale to individual

163 A hospital 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) a practitioner first issues a written or verbal prescription for the individual for whom, or the animal for which, the controlled substance is sold or provided.

Administration of Controlled Substances

Marginal note:Condition

164 A hospital may administer a controlled substance, other than a restricted drug, to an individual or animal if a practitioner first issues a written or verbal prescription.

Compounding of Finished Products

Marginal note:Orders and prescriptions

• 165 (1) A hospital may compound a finished product, other than one containing a restricted drug, if it is for the purpose of fulfilling a prescription and,

  • (a) if the finished product is compounded at the request of a practitioner, that practitioner first issues a written or verbal prescription; or

  • (b) if the finished product is compounded at the request of one of the following persons, in the case of an emergency, the hospital first receives from that person either a written order that is signed and dated and that contains the information set out in subsection (2) or a verbal order:

    • (i) a pharmacist who is not practising in that hospital or another hospital,

    • (ii) a practitioner who is not practising in that hospital or another hospital, or

    • (iii) another hospital, if the order is placed by a person permitted to place an order on its behalf.

• 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) if they are a pharmacist, their name and the name and municipal address of the place where they practise,

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

    • (iii) if it is another 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 hospital receiving the order, its name and municipal address;

  • (c) the date of the order;

  • (d) with respect to the finished product,

    • (i) its name, and

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

  • (e) a declaration that they require the finished product for emergency purposes or, in the case of another hospital, a declaration from the person placing the order that the other hospital requires the finished product for emergency purposes.

Substitution of Controlled Substances

Marginal note:Sale and compounding

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

Verification of Identity

Marginal note:Orders

167 A hospital that receives an order 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 hospital.

Packaging and Labelling

Marginal note:Receipt of substance from individual

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

Storage

Marginal note:Authorized access

169 A hospital that stores a controlled substance must ensure that

• (a) the controlled substance is stored in a secure location in the hospital; and

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

Delivery, Sending and Transportation

Marginal note:Authorization

170 A hospital may deliver, send or transport a controlled substance.

Marginal note:Requirements during transportation

171 A hospital that delivers, sends or transports a controlled substance to another person may only do so if it

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

• (c) uses 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

172 A hospital must take all reasonable measures to ensure the security of any controlled substance in its possession.

Marginal note:Loss or theft — agent or mandatary

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

• Marginal note:Written report

  (2) If a hospital 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 hospital must provide a written report to the Minister within 10 days after the day on which it becomes aware of the loss or theft or is 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 hospital or its 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

• 174 (1) The destruction of a controlled substance in a hospital may only be carried out, subject to subsection (2), by the person in charge of the hospital, a pharmacist, a pharmacy technician or a practitioner 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,

    • (ii) a practitioner,

    • (iii) any other health professional, or

    • (iv) the person in charge of the hospital;

  • (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 health professional may, without a witness, destroy the remainder of a controlled substance, other than a restricted drug, that is contained in an open ampule and that will not be administered.

• Marginal note:Substance returned by individual

  (3) A hospital 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

Information

Marginal note:Substances received

175 A hospital that 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) the name of the person receiving the controlled substance;

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

• (c) the date of receipt;

• (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,

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

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

Marginal note:Substances sold — persons other than individuals

176 A hospital that sells or provides a controlled substance to a person, other than an individual referred to in section 177, must record the following information:

• (a) the name of the person selling or providing the controlled substance;

• (b) with respect to the person to whom the controlled substance is sold or provided, 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 3, 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) if applicable, the reason for the emergency sale or provision.

Marginal note:Substances sold or administered — individuals

177 A hospital that sells or provides a controlled substance to an individual for their own use, for the use of another individual or for an animal, or that administers a controlled substance to an individual or an animal, must record the following information:

• (a) the name of the person selling, providing or administering the controlled substance;

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

• (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,

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

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

Marginal note:Finished products compounded

178 A hospital that compounds a finished product must record the following information:

• (a) the name of the person compounding the finished product;

• (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) the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;

• (d) the number assigned to the prescription;

• (e) the date of compounding; and

• (f) with respect to the finished product,

  • (i) its name, and

  • (ii) its form, strength and quantity.

Marginal note:Controlled substance substitutions

179 A hospital that substitutes a controlled substance for another controlled substance identified in a prescription must record the following information:

• (a) the name of the person who carries out the substitution;

• (b) the number assigned to the original prescription;

• (c) the date of the substitution;

• (d) the name of the controlled substance identified in the prescription; and

• (e) the name of the substitute controlled substance.

Marginal note:Written orders

180 A hospital that receives a written order for a controlled substance must record the following information:

• (a) the name of the person receiving the order; and

• (b) the date of the order and the date on which it was received.

Marginal note:Verbal orders

181 A hospital that receives a verbal order for a controlled substance must record the following information:

• (a) the name of the person receiving the order;

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

  • (i) their name, municipal address and, in the case of another hospital, the name of the person permitted to place the order on its behalf, and

  • (ii) a declaration that they require the controlled substance for emergency purposes or, in the case of another hospital, a declaration from the person placing the order that the other hospital requires the controlled substance for emergency purposes;

• (c) the date of receipt 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,

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

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