Controlled Substances Regulations (SOR/2025-242)

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:

• The following provision is not in force.

  (a) the name of the person receiving the controlled substance;

• The following provision is not in force.

  (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;

• The following provision is not in force.

  (c) the date of receipt;

• The following provision is not in force.

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

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (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;

• The following provision is not in force.

  (c) the date of the sale or provision;

• The following provision is not in force.

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

• The following provision is not in force.

  (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

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (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;

• The following provision is not in force.

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

• The following provision is not in force.

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

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (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;

• The following provision is not in force.

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

• The following provision is not in force.

  (d) the number assigned to the prescription;

• The following provision is not in force.

  (e) the date of compounding; and

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) the number assigned to the original prescription;

• The following provision is not in force.

  (c) the date of the substitution;

• The following provision is not in force.

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

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (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;

• The following provision is not in force.

  (c) the date of receipt of the order;

• The following provision is not in force.

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

• The following provision is not in force.

  (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:Transportation

182 A hospital that delivers, sends or transports a controlled substance must record the following information:

• The following provision is not in force.

  (a) its name and municipal address;

• The following provision is not in force.

  (b) with respect to the agent or mandatary of the hospital delivering, sending or transporting the controlled substance, their name;

• The following provision is not in force.

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

  • (i) if it is not a person referred to in subparagraph (ii), their name and, if applicable, title, or

  • (ii) 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;

• The following provision is not in force.

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

• The following provision is not in force.

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

• The following provision is not in force.

  (f) the means of transportation used;

• The following provision is not in force.

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

• The following provision is not in force.

  (h) 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

183 A person who destroys a controlled substance in a hospital must record the following information:

• The following provision is not in force.

  (a) their name;

• The following provision is not in force.

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

• The following provision is not in force.

  (c) the municipal address of the hospital;

• The following provision is not in force.

  (d) the date of destruction;

• The following provision is not in force.

  (e) the method of destruction;

• The following provision is not in force.

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

• The following provision is not in force.

  (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.

Marginal note:Method of recording

184 Any person who records any information under sections 175 to 183 must do so using a method that permits an audit of it to be made at any time.

Marginal note:Documents to retain

185 A hospital or, if a hospital ceases its operations, the person who was responsible for those operations on the date those operations ceased must ensure that

• The following provision is not in force.

  (a) any document containing the information that is required to be recorded under sections 175 to 183 is kept for two years after the day on which the last record is recorded in the document;

• The following provision is not in force.

  (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

• The following provision is not in force.

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

Marginal note:Place

186 The documents must be accessible

• The following provision is not in force.

  (a) at the hospital where the information was recorded; or

• The following provision is not in force.

  (b) if that hospital has ceased its operations, at a place in Canada.

Marginal note:Quality of documents

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

Marginal note:Providing documents

188 A hospital or, if a hospital has ceased its operations, 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.

Marginal note:Sale to practitioner

• The following provision is not in force.

  189 (1) The Minister may sell or provide a controlled substance to a practitioner that the Minister has named in a letter of authorization.

• The following provision is not in force.

  Marginal note:Exception — prohibition

  (2) The Minister 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.