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

Packaging, Labelling and Transportation

Marginal note:Packaging — sale and provision

• J.01.062 (1) A licensed dealer that sells or provides a restricted drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

• Marginal note:Packaging — transport and export

  (2) A licensed dealer that transports or exports a restricted drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

• Marginal note:Exception

  (3) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

Marginal note:Labelling

• J.01.063 (1) A licensed dealer that sells or provides a restricted drug must ensure that its package is labelled so that its inner and outer labels show

  • (a) the proper name or, if there is no proper name, the name of the drug;

  • (b) the net contents of the package;

  • (c) the unit strength of the drug and the number of units per package, if applicable;

  • (d) the lot number of the drug;

  • (e) the expression “Restricted Drug”; and

  • (f) the name and municipal address of the manufacturer or assembler of the drug.

• Marginal note:Exception

  (2) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

• Marginal note:Non-application

  (3) The labelling requirements set out in section C.01.004 do not apply to a restricted drug.

Marginal note:Transport

J.01.064 A licensed dealer must, in taking delivery of a restricted drug that they have imported or in making delivery of a restricted drug,

• (a) take any measures that are necessary to ensure the security of the drug while it is being transported;

• (b) use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as of the signatures of every person handling it until it is delivered to the consignee;

• (c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and

• (d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Thefts, Losses and Suspicious Transactions

Marginal note:Protective measures — licences and permits

J.01.065 A licensed dealer must take any measures that are necessary to ensure the security of any licence or permit in their possession.

Marginal note:Protective measures — restricted drugs

J.01.066 The following persons must take any measures that are necessary to ensure the security of any restricted drugs in their possession:

• (a) a licensed dealer;

• (b) an institution;

• (c) a qualified investigator who possesses the restricted drug for the purpose of clinical testing or laboratory research in an institution; and

• (d) a person exempted under section 56 of the Act with respect to the possession of the restricted drug.

Marginal note:Theft or loss — licences and permits

J.01.067 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Marginal note:Theft or loss — restricted drugs

• J.01.068 (1) Subject to subsection (2), any person referred to in section J.01.066 who becomes aware of a theft or loss of a restricted drug must

  • (a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and

  • (b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

• Marginal note:Explainable loss — licensed dealer

  (2) Subsection (1) does not apply to 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.

Marginal note:Suspicious transaction

• J.01.069 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a restricted drug to an illicit market or use:

  • (a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;

  • (b) the name and municipal address of the other party to the transaction;

  • (c) details of the transaction, including its date and time, its type, the name and quantity of the restricted drug and, in the case of a product or compound, the quantity of every restricted drug that it contains;

  • (d) in the case of a product that contains the restricted drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2, if any; and

  • (e) a detailed description of the reasons for those suspicions.

• Marginal note:Good faith

  (2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

• Marginal note:Non-disclosure

  (3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Marginal note:Partial protection against self-incrimination

J.01.070 A report made under any of sections J.01.067 to J.01.069, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction of Restricted Drugs

Marginal note:Destruction at site

J.01.071 A licensed dealer that intends to destroy a restricted drug at the site specified in their licence must ensure that the following conditions are met:

• (a) the licensed dealer obtains the prior approval of the Minister;

• (b) the destruction occurs in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):

  • (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and

  • (ii) a person who works for or provides services to the licensed dealer and holds a senior position;

• (c) 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

• (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the restricted drug was completely destroyed, to which each signatory must add their name in printed letters.

Marginal note:Destruction elsewhere than at site

J.01.072 A licensed dealer that intends to destroy a restricted drug elsewhere than at the site specified in their licence must ensure that the following conditions are met:

• (a) the licensed dealer obtains the prior approval of the Minister;

• (b) the licensed dealer takes any measures that are necessary to ensure the security of the restricted drug while it is being transported in order to prevent its diversion to an illicit market or use;

• (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;

• (d) 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

• (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the restricted drug was completely destroyed and containing

  • (i) the municipal address of the place of destruction,

  • (ii) the name and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,

  • (iii) the method of destruction,

  • (iv) the date of destruction, and

  • (v) the names in printed letters and signatures of that person and the other person who was present at the destruction.

Marginal note:Application for prior approval

• J.01.073 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a restricted drug:

  • (a) their name, municipal address and dealer’s licence number;

  • (b) the proposed date of destruction;

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

  • (d) a brief description of the method of destruction;

  • (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph J.01.071(b) and information establishing that they meet the conditions of that paragraph;

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

  • (g) the form and quantity of the restricted drug or the product or compound containing it 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.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

  • (b) include an attestation by that person that

    • (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and

    • (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

• Marginal note:Additional information and documents

  (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.