Controlled Substances Regulations (SOR/2025-242)

Marginal note:Emergency supply

144 A practitioner of medicine who is responsible for an emergency supply must record the following information:

• (a) the name of their agent or mandatary administering the controlled substance;

• (b) the place where the emergency supply is stored;

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

• (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;

• (e) the date of all activities related to that emergency supply; and

• (f) if a controlled substance was administered to an individual, the following information:

  • (i) the name of the individual,

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

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

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

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

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

Marginal note:Written orders

145 A practitioner who receives a written order must record the following information:

• (a) their name; and

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

Marginal note:Transportation

146 A practitioner who delivers, sends or transports a controlled substance must record the following information:

• (a) their name and the name and municipal address of the place where they practise;

• (b) if an agent or mandatary of the practitioner delivers, sends or transports the controlled substance, their name;

• (c) if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:

  • (i) if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal,

  • (ii) if they are a consignee of a restricted drug, their name, or

  • (iii) in any other case, their name and, if applicable title;

• (d) the municipal address of the place where the controlled substance is delivered, sent or transported;

• (e) the date of the delivery, sending or transportation;

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

• (g) 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:Destruction

147 A practitioner who destroys a controlled substance must record the following information:

• (a) their name;

• (b) the name of the witness to the destruction;

• (c) the municipal address of the place of destruction;

• (d) the date of destruction;

• (e) the method of destruction;

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

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

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

  • (ii) subject to subparagraph (iii), its quantity, and

  • (iii) 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.

Recording Information and Retention and Provision of Documents

Marginal note:Method of recording

148 A practitioner who records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.

Marginal note:Documents to retain

149 A practitioner who is responsible for the operations of a place where information was recorded under these Regulations or, if information was recorded at a place where operations have ceased, the person who was responsible for those operations on the date those operations ceased must ensure that

• (a) any document containing the information that they are required to record under these Regulations is kept for two years after the day on which the last record is recorded in the document;

• (b) every written order and prescription is kept, in sequence as to date and number, for two years after the day on which it is received or issued respectively; and

• (c) every declaration, report and letter of authorization is kept for two years after the day on which it is provided or received.

Marginal note:Place

150 The documents must be accessible

• (a) at the place where the information was recorded; or

• (b) if operations have ceased at that place, at a place in Canada.

Marginal note:Quality of documents

151 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Marginal note:Providing documents

152 A practitioner who is responsible for the operations of the place where the information was recorded or, if operations have ceased at a place where information was recorded, the person who was responsible for those operations on the date those operations ceased must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Prescribed Practitioners

Marginal note:Additional conditions

153 In addition to meeting any other requirements set out in these Regulations, the following practitioners who, in accordance with these Regulations and subject to section 154, conduct any activity with respect to a controlled substance, other than a restricted drug, may only do so if they are authorized by the provincial professional regulatory authority to conduct that activity:

• (a) a midwife;

• (b) a podiatrist; and

• (c) a nurse practitioner.

Marginal note:Midwife and podiatrist

154 A midwife or podiatrist must not possess or conduct any activity with respect to the following controlled substances:

• (a) a narcotic set out in subitems 1(1) or (10), 2(1), 5(4) or 10(1) of Schedule 1; or

• (b) a controlled drug set out in item 1 of Part 1 of Schedule 2, items 9 and 10 of Part 2 of that Schedule, or item 1 of Part 3 of that Schedule.

Hospitals

Application and General Conditions for Activities

Marginal note:Application

155 For the purposes of sections 156 to 188, the terms pharmacist, pharmacy technician, intern and health professional, as defined in subsection 1(1), and practitioner, as defined in subsection 2(1) of the Act, are to be read as only including those who are practising in a hospital, except as otherwise provided.

Marginal note:Person in charge

156 A person in charge of a hospital may permit another person to conduct an activity with respect to a controlled substance if

• (a) in the case that the other person is a health professional, they are authorized by the provincial professional regulatory authority to conduct that activity; and

• (b) the other person conducts that activity as part of their duties and functions.

Marginal note:Orders placed on behalf of hospital

157 A person in charge of a hospital may only permit the following persons to order a controlled substance, other than a restricted drug, on the hospital’s behalf:

• (a) a pharmacist; or

• (b) a practitioner.

Sale of Controlled Substances

Marginal note:Sale to licensed dealer

• 158 (1) A hospital may sell or provide a controlled substance, other than a restricted drug, 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 hospital 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 (3); 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 hospital, or

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

    • (ii) the hospital first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (3).

• Marginal note:Restricted drugs

  (2) A hospital may sell or provide a restricted drug to a licensed dealer if

  • (a) the restricted drug was previously returned by an individual for the purposes of destruction;

  • (b) the licensed dealer is specialized in destruction; and

  • (c) the hospital 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 (3).

• Marginal note:Written orders

  (3) 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 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;

  • (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 pharmacist

• 159 (1) A hospital may sell or provide a controlled substance, other than a restricted drug, to a pharmacist, other than one who is practising in a hospital, if

  • (a) the sale or provision is in the case of an emergency; and

  • (b) the hospital first receives from the pharmacist either a written order that is signed and dated and that contains the following information or a verbal order:

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

    • (ii) with respect to the hospital, its name and municipal address,

    • (iii) the date of the order,

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

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

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

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

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

    • (vi) a declaration from the pharmacist that they require the controlled substance for emergency purposes.

• Marginal note:Exception — prohibition

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

Marginal note:Sale to practitioner

• 160 (1) A hospital may sell or provide a controlled substance, other than a restricted drug, to a practitioner, other than one who is practising in a hospital, if

  • (a) the sale or provision is in the case of an emergency; and

  • (b) the hospital first receives from the practitioner either a written order that is signed and dated and that contains the following information or a verbal order:

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

    • (ii) with respect to the hospital, its name and municipal address,

    • (iii) the date of the order,

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

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

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

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

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

    • (vi) a declaration from the practitioner that they require the controlled substance for emergency purposes.

• Marginal note:Exception — prohibition

  (2) A hospital 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 another hospital

• 161 (1) Subject to subsection (2), a hospital may, in the case of an emergency, sell or provide a controlled substance, other than a restricted drug, to another hospital if the hospital first receives from the other hospital a written order that is signed and dated by a person permitted to place an order on the other hospital’s behalf and that contains the following information or a verbal order from such a person:

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

  • (b) with respect to the hospital selling or providing the controlled substance, 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;

  • (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; and

  • (f) a declaration from the person placing the order that the other hospital requires the controlled substance for emergency purposes.

• Marginal note:No emergency

  (2) A hospital may, in circumstances other than an emergency, sell or provide a controlled substance, other than a restricted drug, to another hospital if the hospital is ceasing its operations and if the hospital first receives from the other hospital a written order that is signed and dated by a person permitted to place an order on the other hospital’s behalf and that contains the following information:

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

  • (b) with respect to the hospital selling or providing the controlled substance, 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.