Controlled Substances Regulations (SOR/2025-242)

Marginal note:Substances imported

81 A licensed dealer that imports a controlled substance must record the following information:

• The following provision is not in force.

  (a) the date of the importation;

• The following provision is not in force.

  (b) the name and municipal address of the exporter;

• The following provision is not in force.

  (c) the country of exportation and any country of transit or transhipment;

• The following provision is not in force.

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

• The following provision is not in force.

  (e) in the case of a mixture or 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:Substances exported

82 A licensed dealer that exports a controlled substance must record the following information:

• The following provision is not in force.

  (a) the date of the exportation;

• The following provision is not in force.

  (b) the name and municipal address of the importer;

• The following provision is not in force.

  (c) the country of final destination and any country of transit or transhipment;

• The following provision is not in force.

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

• The following provision is not in force.

  (e) in the case of a mixture or 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:Explainable loss of controlled substance

83 A licensed dealer that becomes aware of a loss of a controlled substance that can be explained on the basis of normally accepted business activities or that is notified by their agent or mandatary of such a loss, must record the following information:

• The following provision is not in force.

  (a) the date on which the dealer became aware or was notified of the loss;

• The following provision is not in force.

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

• The following provision is not in force.

  (c) in the case of a mixture or 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; and

• The following provision is not in force.

  (d) the explanation for the loss.

Marginal note:Destruction

84 A licensed dealer that destroys a controlled substance at the site specified in their licence must record the following information:

• The following provision is not in force.

  (a) the name and, if applicable, title of the person who carried out the destruction and of the other persons who were present at the destruction;

• The following provision is not in force.

  (b) the municipal address of the place of destruction;

• The following provision is not in force.

  (c) the date of destruction;

• The following provision is not in force.

  (d) the method of destruction;

• The following provision is not in force.

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

• The following provision is not in force.

  (f) in the case of a mixture or finished product,

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

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

  • (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 to a pharmacist, pharmacy technician, practitioner, hospital or particular person, only the identifier marked on the collection container of the finished product and the number of collection containers.

Marginal note:Monthly report

• The following provision is not in force.

  85 (1) Subject to subsection (2), a licensed dealer must provide to the Minister, within 15 days after the end of each month, a monthly report that contains the name and quantity of each controlled substance

  • The following provision is not in force.

    (a) that is set out in any of Schedules 1 to 4 that the licensed dealer receives, produces, packages, sells, provides, imports, exports or destroys during the month;

  • The following provision is not in force.

    (b) that is contained in a mixture or finished product that the licensed dealer receives, packages, sells, provides, imports, exports or destroys during the month or that the dealer has used to produce a mixture or finished product during the month;

  • The following provision is not in force.

    (c) that is in the physical inventory taken at the site specified in their licence at the end of the month; and

  • The following provision is not in force.

    (d) that has been lost in the course of conducting activities during the month and whose loss can be explained on the basis of normally accepted business activities.

• The following provision is not in force.

  Marginal note:Non-renewal or revocation of licence

  (2) If a licensed dealer’s licence expires without being renewed or is revoked, the dealer must provide to the Minister, within three months after the expiration or revocation, a report in respect of the portion of the month during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Marginal note:Method of recording

86 A licensed dealer that 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

87 A licensed dealer and a former licensed dealer must keep

• The following provision is not in force.

  (a) any document containing the information that it is required to record under these Regulations 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, in sequence as to date and number, for two years after the day on which it is received; and

• The following provision is not in force.

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

Marginal note:Place

88 The documents must be accessible

• The following provision is not in force.

  (a) at the site specified in the licensed dealer’s licence; or

• The following provision is not in force.

  (b) in the case of a document retained by a former licensed dealer, at a place in Canada.

Marginal note:Quality of documents

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

Marginal note:Providing documents

90 A licensed dealer and a former licensed dealer must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Marginal note:Pharmacists practising in hospital

91 For the purposes of sections 92 to 126, the terms pharmacist, pharmacy technician and intern, as defined in subsection 1(1), are to be read as excluding those who are practising in a hospital, except as otherwise provided.

Marginal note:Sale to licensed dealer

• The following provision is not in force.

  92 (1) A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a licensed dealer if

  • The following provision is not in force.

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

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

    • (ii) the pharmacist 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

  • The following provision is not in force.

    (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 pharmacist, or

      • (B) the sale or provision is for the purposes of testing or destruction, and

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

• The following provision is not in force.

  Marginal note:Restricted drugs

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

    (c) the pharmacist 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).

• The following provision is not in force.

  Marginal note:Written orders

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

    (c) the date 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;

  • 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, as well as the name of the controlled substance it contains,

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

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

    • (iv) if the finished product has been previously returned by an individual or particular person 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) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Marginal note:Sale to another pharmacist

• The following provision is not in force.

  93 (1) Subject to subsection (2), a pharmacist may, in the case of an emergency, sell or provide a controlled substance, other than a restricted drug, to another pharmacist if they first receive from the other pharmacist either a written order that is signed and dated and that contains the following information or a verbal order:

  • The following provision is not in force.

    (a) with respect to the other pharmacist placing the order, their name and the name and municipal address of the place where they practise;

  • The following provision is not in force.

    (b) with respect to the pharmacist selling or providing the controlled substance, their name and the name and municipal address of the place where they practise;

  • The following provision is not in force.

    (c) the date 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;

  • The following provision is not in force.

    (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; and

  • The following provision is not in force.

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

• The following provision is not in force.

  Marginal note:No emergency

  (2) A pharmacist may, in circumstances other than an emergency, sell or provide a controlled substance, other than a restricted drug, to another pharmacist if they do so for the purpose of fulfilling a prescription received at the pharmacy where the other pharmacist practises or if the pharmacy where they practise is ceasing its operations and if they first receive from the other pharmacist a written order that is signed and dated and that contains the following information:

  • The following provision is not in force.

    (a) with respect to the other pharmacist placing the order, their name and the name and municipal address of the place where they practise;

  • The following provision is not in force.

    (b) with respect to the pharmacist selling or providing the controlled substance, their name and the name and municipal address of the place where the sale or provision is conducted;

  • The following provision is not in force.

    (c) the number assigned to the prescription, if applicable;

  • The following provision is not in force.

    (d) the date of the order;

  • The following provision is not in force.

    (e) 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.

    (f) 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.

• The following provision is not in force.

  Marginal note:Exception — prohibition

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