Food and Drug Regulations (C.R.C., c. 870)

Marginal note:Approval

J.01.074 On completion of the review of the application for approval, the Minister must approve the destruction of the restricted drug unless

• (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph J.01.071(b) do not meet the conditions of that paragraph;

• (b) the Minister has reasonable grounds to believe that the restricted drug would not be destroyed;

• (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application;

• (d) the restricted drug or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or

• (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk of the restricted drug being diverted to an illicit market or use.

Documents

Licensed Dealers

Marginal note:Method of recording information

J.01.075 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Marginal note:Information — general

J.01.076 A licensed dealer must record the following information:

• (a) the name, form and quantity of any restricted drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;

• (b) the name, form and quantity of any restricted drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;

• (c) in the case of a restricted drug that the dealer sells or provides,

  • (i) the brand name of the product or the name of the compound containing the restricted drug and the name of the restricted drug,

  • (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any,

  • (iii) the form and quantity of the restricted drug and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages,

  • (iv) the name and municipal address of the person to whom it was sold or provided, and

  • (v) the date on which it was sold or provided;

• (d) the name, form and quantity of any restricted drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages;

• (e) the name and quantity of any restricted drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;

• (f) the name, form and quantity of any restricted drug in stock at the end of each month;

• (g) the name, form and quantity of any restricted drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;

• (h) the name, form and quantity of any restricted drug imported, the date on which it was that the dealer imports, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and

• (i) the name, form and quantity of any restricted drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Marginal note:Explainable loss of restricted drug

J.01.077 A licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities must record the following information:

• (a) the name of the lost restricted drug and, if applicable, the brand name of the product or the name of the compound containing it;

• (b) the form and quantity of the restricted drug and, if applicable, the form of the product or compound containing it, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages;

• (c) the date on which the dealer became aware of the loss; and

• (d) the explanation for the loss.

Marginal note:Destruction

J.01.078 A licensed dealer must record the following information concerning any restricted drug that they destroy at the site specified in their licence:

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

• (b) the name, form and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug;

• (c) the method of destruction; and

• (d) the date of destruction.

Marginal note:Annual report

• J.01.079 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains

  • (a) the name, form and total quantity of each restricted drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each restricted drug that they use to manufacture or assemble a product or compound;

  • (b) the name, form and quantity of each restricted drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and

  • (c) the name, form and quantity of any restricted drug that has been lost in the course of conducting activities during the calendar year.

• Marginal note:Non-renewal or revocation within first three months

  (2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister

  • (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and

  • (b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year 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:Non-renewal or revocation after third month

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

Institutions

Marginal note:Method of recording information

J.01.080 An institution must record any information that it is required to record under this Part using a method that permits an audit of the information to be made at any time.

Marginal note:Information

J.01.081 An institution must record the following information:

• (a) the name and quantity of any restricted drug that the institution orders, the name of the person who placed the order on the institution’s behalf and the date of the order;

• (b) the name and quantity of any restricted drug that the institution receives as well as the name and municipal address of the licensed dealer that sold or provided it and the date on which it was received;

• (c) details of the use of restricted drugs in the institution;

• (d) the names and qualifications of every person who makes use of a restricted drug in the institution; and

• (e) all clinical data with respect to the use of every restricted drug received by the institution.

Drug Received for Identification and Analysis

Marginal note:Method of recording information

J.01.082 A person who records information in accordance with section J.01.083 must do so using a method that permits an audit of the information to be made at any time.

Marginal note:Information

J.01.083 A person who receives a restricted drug in accordance with section J.01.061 must record the following information:

• (a) the name and quantity of the restricted drug, as well as the name and municipal address of the person who provided it to them and the date on which it was received;

• (b) details regarding the identification or analysis of the restricted drug; and

• (c) the names of the persons who handled the restricted drug during the process of identifying or analyzing it.

Record Keeping

Marginal note:Retention period

J.01.084 A licensed dealer, a former licensed dealer, an institution and a person referred to in section J.01.083 must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Marginal note:Location

J.01.085 The documents must be kept

• (a) in the case of a licensed dealer, at the site specified in their licence;

• (b) in the case of an institution, at the institution;

• (c) in the case of a person referred to in section J.01.083, at a location in Canada; and

• (d) in the case of a former licensed dealer, at a location in Canada.

Marginal note:Quality of documents

J.01.086 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Notification of Application for Order of Restoration

Marginal note:Written notification

• J.01.087 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration must be given in writing to the Attorney General by registered mail and be mailed at least 15 days before the date on which the application is to be made to a justice.

• Marginal note:Content of notification

  (2) The notification must specify

  • (a) the name of the justice to whom the application is to be made;

  • (b) the time and place at which the application is to be heard;

  • (c) details concerning the restricted drug or other thing in respect of which the application is to be made; and

  • (d) the evidence on which the applicant intends to rely to establish that they are entitled to possession of the restricted drug or other thing referred to in paragraph (c).