Controlled Substances Regulations (SOR/2025-242)

Marginal note:Definitions

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  1 (1) The following definitions apply in these Regulations.

  Act

  Act means the Controlled Drugs and Substances Act. (Loi)

  adult

  adult means an individual who is 18 years of age or older. (adulte)

  advertisement

  advertisement includes any representation by any means for the purpose of promoting, directly or indirectly, the sale or other disposal of a controlled substance. (publicité)

  cannabis offence

  cannabis offence means

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    (a) an offence under subsection 9(1) or (2), 10(1) or (2), 11(1) or (2), 12(1), (4), (5), (6) or (7), 13(1) or 14(1) of the Cannabis Act; or

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    (b) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction relative au cannabis)

  CAS registry number

  CAS registry number means the identification number assigned to a chemical by the Chemical Abstracts Service, a division of the American Chemical Society. (numéro d’enregistrement CAS)

  competent authority

  competent authority means a public authority of a foreign country that is authorized under the laws of that country to approve the importation or exportation of controlled substances into or from that country. (autorité compétente)

  container

  container means an immediate container of a controlled substance, unless otherwise specified, but does not include a collection container. (contenant)

  controlled drug

  controlled drug means a substance set out in Schedule 2. (drogue contrôlée)

  destroy

  destroy, in relation to a controlled substance, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)

  drug identification number

  drug identification number means the identification number assigned to a drug under paragraph C.01.014.2(1)(a) of the Food and Drug Regulations. (identification numérique)

  emergency medical service vehicle

  emergency medical service vehicle means any conveyance authorized under the laws of a province to transport individuals to hospitals and on which emergency medical services are provided. (véhicule de service médical d’urgence)

  emergency supply

  emergency supply means a controlled substance that is stored in a place that is either in a remote area where emergency medical treatment is not readily available or in an emergency medical service vehicle. (approvisionnement d’urgence)

  finished product

  finished product means a finished product that contains a controlled substance set out in any of Schedules 1 to 4, that is in a form that is intended to be administered to an individual or animal and, in the case of a finished product that does not contain a restricted drug, that

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    (a) has a drug identification number; or

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    (b) is compounded by a pharmacist or pharmacy technician in accordance with these Regulations. (produit fini)

  government laboratory

  government laboratory means a forensic or toxicology laboratory that is operated by the government of Canada or of a province and in which analytical testing involving controlled substances is conducted. (laboratoire public)

  health professional

  health professional means an individual who is entitled under the laws of a province to practise a profession in a health care field and who is practising in that province. (professionnel de la santé)

  hospital

  hospital means a facility

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    (a) that is licensed, approved or designated by a province under the laws of the province to provide health care or treatment to individuals or animals; or

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    (b) that is owned or operated by the government of Canada or of a province and that provides health services. (hôpital)

  intern

  intern means an individual who is entitled under the laws of a province to work as an intern in a health care field, or to work under a designation that the Minister considers equivalent, and who is working as such in that province. (stagiaire)

  international obligation

  international obligation means an obligation relative to a controlled substance set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

  letter of authorization

  letter of authorization means the letter of authorization issued under section C.08.010 of the Food and Drug Regulations. (lettre d’autorisation)

  licensed dealer

  licensed dealer means the holder of a licence issued under subsection 12(1). (distributeur autorisé)

  midwife

  midwife means an individual who is entitled under the laws of a province to practise midwifery and who is practising midwifery in that province. (sage-femme)

  mixture

  mixture means a mixture that contains a controlled substance set out in any of Schedules 1 to 4, but does not include a finished product. (mélange)

  narcotic

  narcotic means a substance set out in Schedule 1. (stupéfiant)

  nurse practitioner

  nurse practitioner means an individual who is entitled under the laws of a province to practise as a nurse practitioner or to practise under an equivalent designation and who is practising as such in that province. For the purposes of this definition, a designation is equivalent when it designates an individual who

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    (a) is a registered nurse;

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    (b) possesses additional training and experience related to health care; and

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    (c) can autonomously make diagnoses, request diagnostic tests and interpret their results, prescribe drugs and perform other specific procedures under the laws of a province. (infirmier praticien)

  order

  order does not include a prescription. (commande)

  particular person

  particular person means a person that, in the course of that person’s operations, unexpectedly receives a controlled substance from an individual for the purposes of destruction. (personne particulière)

  peace officer

  peace officer has the same meaning as in section 2 of the Criminal Code. (agent de la paix)

  person in charge of a government laboratory

  person in charge of a government laboratory means an individual who has responsibility for managing all of a government laboratory’s activities with respect to controlled substances. (responsable d’un laboratoire public)

  person in charge of a hospital

  person in charge of a hospital means an individual who has responsibility for managing all of a hospital’s activities with respect to controlled substances. (responsable d’un hôpital)

  pharmacist

  pharmacist means an individual who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)

  pharmacy technician

  pharmacy technician means an individual who is entitled under the laws of a province to practise as a pharmacy technician or to practise under a designation that the Minister considers equivalent and who is practising as such in that province. (technicien en pharmacie)

  podiatrist

  podiatrist means an individual who is entitled under the laws of a province to practise podiatry or chiropody and who is practising podiatry or chiropody in that province. (podiatre)

  prescription

  prescription means an authorization given by a practitioner that a stated amount of a controlled substance, other than a restricted drug, be sold or provided for the individual named or the animal identified in it. (prescription)

  qualified person in charge

  qualified person in charge means the individual designated under subsection 9(1). (responsable qualifié)

  restricted drug

  restricted drug means a substance that is set out in Schedule 4. (drogue d’utilisation restreinte)

  Security Directive

  Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)

  send

  send does not include sending by mail. (expédition)

  senior person in charge

  senior person in charge means the individual designated under section 8. (responsable principal)

  specialized in destruction

  specialized in destruction, in relation to a licensed dealer, describes a dealer whose licence specifies that it only deals in the destruction of controlled substances. (spécialisé en destruction)

  targeted substance

  targeted substance means a substance set out in Schedule 3. (substance ciblée)

  test kit

  test kit means a kit

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    (a) that contains a controlled substance and an adulterating or denaturing agent;

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    (b) that is used to test for a controlled substance; and

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    (c) the contents of which are not intended or likely to be consumed by, or administered to, an individual or animal. (trousse d’essai)

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  Marginal note:Interpretation — controlled substances

  (2) For the application of these Regulations, a controlled substance refers to any of the following substances:

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    (a) a narcotic;

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    (b) a controlled drug;

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    (c) a targeted substance;

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    (d) a restricted drug.

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  Marginal note:Interpretation — practitioners

  (3) For the purposes of the definition practitioner in subsection 2(1) of the Act, the following persons are prescribed:

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    (a) midwives;

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    (b) nurse practitioners; and

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    (c) podiatrists.

Marginal note:Non-application — member of police force

2 The following persons are exempt from the application of these Regulations if, in respect of their activity, they are exempt from the application of sections 5 to 7.1 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations:

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  (a) a member of a police force, as defined in section 1 of those regulations; or

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  (b) a person acting under the direction and control of that member.

Marginal note:Controlled drug — Part 3 of Schedule 2

3 The Act and these Regulations do not apply in respect of a finished product that contains a controlled drug set out in Part 3 of Schedule 2 and that is

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  (a) in a form that allows the sustained release of an active ingredient over a certain period of time; and

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  (b) intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency.

Marginal note:Authorizations — agents and mandataries

4 An agent or mandatary of a person, including an employee of that person or another person that is acting under a contract with that person, may conduct an activity if the following conditions are met:

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  (a) in the case of the person,

  • (i) the person is authorized under these Regulations to conduct the activity, and

  • (ii) if applicable, the provincial professional regulatory authority of the province in which they are practising does not prohibit the delegation of the activity to the agent or mandatary; and

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  (b) in the case of the agent or mandatary,

  • (i) if applicable, they are authorized by the provincial professional regulatory authority of the province in which they are practising to conduct the activity,

  • (ii) the agent or mandatary does so as part of their role as agent or mandatary or their employment duties and functions or in the performance of their contract, and

  • (iii) the agent or mandatary complies with the requirements that apply to the person referred to in paragraph (a).

Marginal note:Authorized persons

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  5 (1) A person referred to in subsection (2) is authorized to possess any of the following controlled substances if the person has obtained the substance in accordance with these Regulations, in the course of acts conducted in connection with the administration or enforcement of an Act or regulation or from a person exempted under subsection 56(1) of the Act from the application of subsection 5(1) of the Act with respect to that controlled substance:

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    (a) a narcotic set out in Schedule 1;

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    (b) a controlled drug set out in Part 1 of Schedule 2;

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    (c) a targeted substance set out in Part 1 of Schedule 3.

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  Marginal note:Conditions

  (2) An authorized person is

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    (a) a person that conducts an activity, with respect to the controlled substance, that is necessary for their business or the practice of their profession and that is

    • (i) a licensed dealer,

    • (ii) a pharmacist or pharmacy technician, other than one who is practising in a hospital, or

    • (iii) a practitioner who is registered and entitled to practise in

      • (A) the province in which they possess the controlled substance, or

      • (B) a province other than the province in which they possess the controlled substance, if they possess the substance for emergency medical purposes only;

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    (b) a hospital;

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    (c) the Minister;

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    (d) an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the federal government, a provincial government or a university in Canada who possesses the controlled substance in connection with their employment;

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    (e) a particular person that possesses the substance for the purposes of destruction; or

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    (f) an individual who

    • (i) has obtained the controlled substance for their own use, for the use of another individual or for an animal in accordance with a prescription that was issued or obtained in accordance with these Regulations from one of the following persons:

      • (A) a practitioner, or

      • (B) a pharmacist, or

    • (ii) has imported the controlled substance

      • (A) for their own use,

      • (B) for the use and on the behalf of an accompanying individual, or

      • (C) for an animal for which the individual is responsible and that is accompanying the individual.

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  Marginal note:Agent or mandatary — person in paragraph (2)(d)

  (3) An agent or mandatary of a person referred to in paragraph (2)(d) may only have a controlled substance set out in subsection (1) in their possession if

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    (a) they have reasonable grounds to believe that person is a person referred to in paragraph (2)(d); and

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    (b) they possess the controlled substance for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

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  Marginal note:Export

  (4) A licensed dealer, the Minister, a government laboratory or an individual referred to in section 226 may possess a controlled substance, other than a restricted drug, for the purpose of exporting it if the substance was obtained in accordance with these Regulations.

Marginal note:Authorized persons

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  6 (1) The following persons are authorized to possess any restricted drug listed in Part 1 of Schedule 4 if that person has obtained the drug in accordance with these Regulations or in the course of acts conducted in connection with the administration or enforcement of an Act or regulation:

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    (a) a licensed dealer;

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    (b) a pharmacist or pharmacy technician, other than one who is practising in a hospital;

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    (c) a practitioner who is named in a letter of authorization;

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    (d) the Minister;

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    (e) an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the federal government, a provincial government or a university in Canada who possesses the restricted drug in connection with their employment;

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    (f) a particular person that possesses the substance for the purposes of destruction; and

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    (g) an individual who has obtained the restricted drug for their own use from a practitioner named in a letter of authorization.

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  Marginal note:Agent or mandatary — person in paragraph (1)(e)

  (2) An agent or mandatary of a person referred to in paragraph (1)(e) may only have a restricted drug listed in Part 1 of Schedule 4 in their possession if

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    (a) they have reasonable grounds to believe that person is a person referred to in paragraph (1)(e); and

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    (b) they possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

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  Marginal note:Export

  (3) A licensed dealer, the Minister or a government laboratory may possess a restricted drug for the purpose of exporting it if the drug was obtained in accordance with these Regulations.

Marginal note:Activities

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  7 (1) Persons referred to in subsection (2) are required to obtain a dealer’s licence for each site at which that person intends to conduct one of the following activities:

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    (a) producing a controlled substance, unless the person doing so is

    • (i) a pharmacist or pharmacy technician who is compounding a finished product in accordance with these Regulations, or

    • (ii) a government laboratory;

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    (b) packaging, selling, providing, delivering, sending or transporting a controlled substance, unless the person doing so is:

    • (i) a pharmacist or pharmacy technician who is not practising in a hospital,

    • (ii) a practitioner,

    • (iii) a hospital,

    • (iv) the Minister,

    • (v) a government laboratory,

    • (vi) a particular person, or

    • (vii) an individual referred to in section 223 or 224;

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    (c) importing or exporting a controlled substance, unless the person doing so is

    • (i) the Minister,

    • (ii) a government laboratory, or

    • (iii) an individual referred to in section 225 or 226; and

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    (d) destroying a controlled substance, if that is the only activity that the person intends to conduct.

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  Marginal note:Eligible persons

  (2) The persons that are eligible to obtain a dealer’s licence are

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    (a) an individual who ordinarily resides in Canada;

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    (b) an organization that has its head office in Canada or operates a branch office in Canada; or

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    (c) the holder of a position that includes responsibility for controlled substances on behalf of the government of Canada or of a province, a police force, a hospital or a university in Canada.

Marginal note:Senior person in charge

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  8 (1) An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the senior person in charge who has overall responsibility for management of the activities with respect to controlled substances that are specified in the licence application.

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  Marginal note:Qualifications

  (2) Only an individual who has sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the licence application to properly carry out their duties may be designated as a senior person in charge.

Marginal note:Qualified person in charge

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  9 (1) An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the qualified person in charge who is responsible for supervising the activities with respect to controlled substances that are specified in the licence application and for ensuring that those activities comply with these Regulations, as well as with any terms or conditions of the licence and any permit issued under these Regulations.

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  Marginal note:Alternate qualified person in charge

  (2) An applicant for a dealer’s licence may designate an individual, who may be the applicant if the applicant is an individual, as an alternate qualified person in charge who is authorized to replace the qualified person in charge when that person is absent.

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  Marginal note:Qualifications

  (3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:

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    (a) they work at the site specified in the dealer’s licence application;

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    (b) they

    • (i) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or

    • (ii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (i) and hold one of the following assessments that establishes the equivalency of the diploma, certificate or credential to one of the documents referred to in that subparagraph:

      • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or

      • (B) an equivalency assessment issued by an institution or organization that is responsible for issuing equivalency assessments and is recognized by a province;

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    (c) they have sufficient knowledge of and experience with the use and handling of the controlled substances specified in the dealer’s licence application to properly carry out their duties; and

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    (d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence application to properly carry out their duties.

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  Marginal note:Exception

  (4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements set out in paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if

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    (a) no other individual working at the site meets those requirements;

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    (b) those requirements are not necessary for the activities specified in the licence application; and

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    (c) the individual has sufficient knowledge acquired from any combination of education, training and work experience to properly carry out their duties.

Marginal note:Ineligibility

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  10 (1) An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

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    (a) in respect of a designated substance offence, a cannabis offence or any other offence referred to in subsection (2), the individual

    • (i) was convicted as an adult, or

    • (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or

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    (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence, a cannabis offence or any other offence referred to in subsection (2),

    • (i) the individual was convicted as an adult, or

    • (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence.

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  Marginal note:Other offences

  (2) For the purposes of subsection (1), the other offences are

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    (a) an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;

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    (b) an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;

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    (c) the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;

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    (d) an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and

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    (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d).

Marginal note:Application

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  11 (1) An application to obtain a dealer’s licence must be submitted to the Minister and must contain

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    (a) if the licence is requested by

    • (i) an individual, the individual’s name,

    • (ii) an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and

    • (iii) the holder of a position described in paragraph 7(2)(c), the applicant’s name and the title of the position;

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    (b) the municipal address, telephone number and, if applicable, the email address of the site specified in the licence application and, if different from the municipal address, its mailing address;

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    (c) the name, date of birth, telephone number and email address of the proposed senior person in charge;

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    (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,

    • (i) their name, date of birth, telephone number and email address,

    • (ii) the title of their position at the site,

    • (iii) the name and title of the position of their immediate supervisor at the site,

    • (iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and

    • (v) their education, training and work experience that are relevant to their duties;

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    (e) the activities that are to be conducted and the controlled substance in respect of which each of the activities is to be conducted;

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    (f) if the licence is requested in order to produce or package a controlled substance set out in any of Schedules 1 to 4, for each substance,

    • (i) its name, its CAS registry number, if any, as well as its form, the quantity that the applicant intends to produce under the licence and the period during which that quantity would be produced, and

    • (ii) if it is to be produced or packaged for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer;

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    (g) if the licence is requested to produce or package a mixture or finished product, for each 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,

    • (iii) its drug identification number, if any,

    • (iv) if it is to be produced or packaged by or for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer, and

    • (v) if the applicant’s name appears on any label, as defined in section 2 of the Food and Drugs Act, of the finished product, a copy of that label;

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    (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the controlled substance for which the activity is to be conducted and the purpose of the activity;

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    (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and

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    (j) a detailed description of the method of recording information that the applicant proposes to use for the purposes of section 86.

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  Marginal note:Documents

  (2) The application must be accompanied by the following documents:

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    (a) if the applicant is an organization, a copy of

    • (i) the certificate of incorporation or other constituting instrument,

    • (ii) any document filed with the province in which its site is located that states the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and

    • (iii) the permit or licence that is issued by the municipality in which its site is located that authorizes the business to operate, if applicable;

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    (b) individual declarations, signed and dated by each of the proposed senior person in charge, the qualified person in charge and any proposed alternate qualified person in charge, attesting that the signatory is not ineligible for a reason specified in section 10;

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    (c) a document issued by a Canadian police force or by a business that is accredited by the Royal Canadian Mounted Police in relation to each person referred to in paragraph (b) indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 10(1)(a)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii);

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    (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 10(1)(b)(i) or received a sentence as specified in subparagraph 10(1)(b)(ii);

  • The following provision is not in force.

    (e) a declaration, signed and dated by the proposed senior person in charge, attesting that they have the knowledge required under subsection 8(2) and that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 9(3)(c) and (d);

  • The following provision is not in force.

    (f) with respect to the proposed qualified person in charge or any proposed alternate qualified person in charge, a copy of their diploma, certificate or credential referred to in paragraph 9(3)(b) and, if applicable, the equivalency assessment referred to in subparagraph 9(3)(b)(ii); and

  • The following provision is not in force.

    (g) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement set out in paragraph 9(3)(b), a detailed description of the education, training and work experience that is required under paragraph 9(4)(c), together with supporting documents, such as a copy of a course transcript or an attestation by the person who provided the training.

• The following provision is not in force.

  Marginal note:Signature and attestation

  (3) The application must

  • The following provision is not in force.

    (a) be signed and dated by the proposed senior person in charge; and

  • The following provision is not in force.

    (b) include an attestation by that person that

    • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

    • (ii) they have the authority to bind the applicant.

• The following provision is not in force.

  Marginal note:Additional information and documents

  (4) The applicant 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.

Marginal note:Issuance

• The following provision is not in force.

  12 (1) Subject to section 14, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains

  • The following provision is not in force.

    (a) the licence number;

  • The following provision is not in force.

    (b) if the licensed dealer is an individual, their name and, if applicable, title, or if the licensed dealer is an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence;

  • The following provision is not in force.

    (c) the specified activities and, for each activity, the name of the controlled substance that is set out in any of Schedules 1 to 4 or that is contained in a mixture or finished product;

  • The following provision is not in force.

    (d) the municipal address of the site at which the activity is to be conducted;

  • The following provision is not in force.

    (e) the security level at the site, determined in accordance with the Security Directive;

  • The following provision is not in force.

    (f) the effective date of the licence;

  • The following provision is not in force.

    (g) the expiry date of the licence, which must not be later than three years after its effective date;

  • The following provision is not in force.

    (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

    • (i) ensure that an international obligation is respected,

    • (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or

    • (iii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use; and

  • The following provision is not in force.

    (i) if the licensed dealer produces a controlled substance that is set out in any of Schedules 1 to 4, the quantity that the licensed dealer may produce and the production period.

• The following provision is not in force.

  Marginal note:Licence integrity

  (2) A person must not alter or deface in any manner a dealer’s licence.

Marginal note:Validity

13 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Marginal note:Refusal

• The following provision is not in force.

  14 (1) The Minister must refuse to issue a dealer’s licence if

  • The following provision is not in force.

    (a) the applicant does not meet the requirement set out in subsection 7(2);

  • The following provision is not in force.

    (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened

    • (i) a provision of the Act, the Cannabis Act or their regulations, or

    • (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;

  • The following provision is not in force.

    (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

  • The following provision is not in force.

    (d) an activity for which the licence is requested would contravene an international obligation;

  • The following provision is not in force.

    (e) in the case of a narcotic, an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

  • The following provision is not in force.

    (f) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

  • The following provision is not in force.

    (g) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;

  • The following provision is not in force.

    (h) the applicant has not provided the Minister with the information or documents required under subsection 11(4) or before the date specified in the written request referred to in that subsection, or the information or documents that the applicant has provided before that date are not sufficient to complete the review of the licence application;

  • The following provision is not in force.

    (i) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;

  • The following provision is not in force.

    (j) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravenes an international obligation; or

  • The following provision is not in force.

    (k) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Exceptions

  (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (i) if the applicant meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

  • The following provision is not in force.

    (a) the applicant does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and

  • The following provision is not in force.

    (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.

• The following provision is not in force.

  Marginal note:Prior notice

  (3) Before refusing to issue a licence, the Minister must

  • The following provision is not in force.

    (a) provide the applicant with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the applicant’s submissions, if applicable.

Marginal note:Application

• The following provision is not in force.

  15 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections 11(1) and (2).

• The following provision is not in force.

  Marginal note:Signature and attestation

  (2) The application must

  • The following provision is not in force.

    (a) be signed and dated by the senior person in charge of the site specified in the application; and

  • The following provision is not in force.

    (b) include an attestation by that person that

    • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

    • (ii) they have the authority to bind the licensed dealer.

• The following provision is not in force.

  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.

Marginal note:Renewal

• The following provision is not in force.

  16 (1) Subject to section 18, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in subsection 12(1).

• The following provision is not in force.

  Marginal note:Terms or conditions

  (2) When renewing a dealer’s licence, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete a term or condition in order to

  • The following provision is not in force.

    (a) ensure that an international obligation is respected;

  • The following provision is not in force.

    (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or

  • The following provision is not in force.

    (c) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Marginal note:Validity

17 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Marginal note:Refusal

• The following provision is not in force.

  18 (1) The Minister must refuse to renew a dealer’s licence if

  • The following provision is not in force.

    (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);

  • The following provision is not in force.

    (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened

    • (i) a provision of the Act, the Cannabis Act or their regulations, or

    • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;

  • The following provision is not in force.

    (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

  • The following provision is not in force.

    (d) an activity for which the renewal is requested would contravene an international obligation;

  • The following provision is not in force.

    (e) in the case of a narcotic, an activity for which the renewal is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

  • The following provision is not in force.

    (f) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;

  • The following provision is not in force.

    (g) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;

  • The following provision is not in force.

    (h) the licensed dealer has not provided the Minister with the information or documents required under subsection 15(3) or by the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the renewal application;

  • The following provision is not in force.

    (i) 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 renewal application;

  • The following provision is not in force.

    (j) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravened an international obligation; or

  • The following provision is not in force.

    (k) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Exceptions

  (2) The Minister must not refuse to renew a licence under paragraph (1)(b) or (i) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

  • The following provision is not in force.

    (a) the licensed dealer does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and

  • The following provision is not in force.

    (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.

• The following provision is not in force.

  Marginal note:Prior notice

  (3) Before refusing to renew a licence, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Application

• The following provision is not in force.

  19 (1) Before making a change affecting any information that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in subsections 11(1) and (2) that are relevant to the proposed amendment.

• The following provision is not in force.

  Marginal note:Signature and attestation

  (2) The application must

  • The following provision is not in force.

    (a) be signed and dated by the senior person in charge of the site specified in the application; and

  • The following provision is not in force.

    (b) include an attestation by that person that

    • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

    • (ii) they have the authority to bind the licensed dealer.

• The following provision is not in force.

  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.

Marginal note:Amendment

• The following provision is not in force.

  20 (1) Subject to section 22, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.

• The following provision is not in force.

  Marginal note:Terms or conditions

  (2) When amending a dealer’s licence, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete a term or condition in order to

  • The following provision is not in force.

    (a) ensure that an international obligation is respected;

  • The following provision is not in force.

    (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or

  • The following provision is not in force.

    (c) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Marginal note:Validity

21 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Marginal note:Refusal

• The following provision is not in force.

  22 (1) The Minister must refuse to amend a dealer’s licence if

  • The following provision is not in force.

    (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);

  • The following provision is not in force.

    (b) during the 10 years before the day on which the amendment application is submitted, the senior person in charge or qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

  • The following provision is not in force.

    (c) an activity for which the amendment is requested would contravene an international obligation;

  • The following provision is not in force.

    (d) in the case of a narcotic, an activity for which the amendment is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

  • The following provision is not in force.

    (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the amendment is requested;

  • The following provision is not in force.

    (f) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;

  • The following provision is not in force.

    (g) the licensed dealer has not provided the Minister with the information or documents required under subsection 19(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the amendment application;

  • The following provision is not in force.

    (h) 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 amendment application; or

  • The following provision is not in force.

    (i) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Exceptions

  (2) The Minister must not refuse to amend a licence under paragraph (1)(h) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

  • The following provision is not in force.

    (a) the licensed dealer does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and

  • The following provision is not in force.

    (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.

• The following provision is not in force.

  Marginal note:Prior notice

  (3) Before refusing to amend a licence, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Application

• The following provision is not in force.

  23 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:

  • The following provision is not in force.

    (a) a change affecting the security measures in place at the site specified in the dealer’s licence;

  • The following provision is not in force.

    (b) a change affecting the method of recording information referred to in paragraph 11(1)(j);

  • The following provision is not in force.

    (c) the replacement of the senior person in charge;

  • The following provision is not in force.

    (d) the replacement of the qualified person in charge; or

  • The following provision is not in force.

    (e) the replacement or addition of an alternate qualified person in charge.

• The following provision is not in force.

  Marginal note:Information and documents

  (2) The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1):

  • The following provision is not in force.

    (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence or the method of recording information referred to in paragraph 11(1)(j), details of the change;

  • The following provision is not in force.

    (b) in the case of a replacement of the senior person in charge,

    • (i) the information specified in paragraph 11(1)(c), and

    • (ii) the documents specified in paragraphs 11(2)(b) to (e); and

  • The following provision is not in force.

    (c) in the case of a replacement of the qualified person in charge or a replacement or addition of an alternate qualified person in charge,

    • (i) the information specified in paragraph 11(1)(d), and

    • (ii) the documents specified in paragraphs 11(2)(b) to (f).

• The following provision is not in force.

  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.

Marginal note:Approval

• The following provision is not in force.

  24 (1) Subject to section 25, on completion of the review of the application for approval of the change, the Minister must approve the change.

• The following provision is not in force.

  Marginal note:Terms or conditions

  (2) When approving a change, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete a term or condition in order to

  • The following provision is not in force.

    (a) ensure that an international obligation is respected;

  • The following provision is not in force.

    (b) ensure conformity with the requirements associated with the security level specified in the licence; or

  • The following provision is not in force.

    (c) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

Marginal note:Refusal

• The following provision is not in force.

  25 (1) The Minister must refuse to approve the change if

  • The following provision is not in force.

    (a) during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

  • The following provision is not in force.

    (b) the licensed dealer has not provided the Minister with the information or documents required under subsection 23(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the application for approval of the change;

  • The following provision is not in force.

    (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 application for approval of the change; or

  • The following provision is not in force.

    (d) the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Exceptions

  (2) The Minister must not refuse to approve a change under paragraph (1)(c) if the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Prior notice

  (3) Before refusing to approve a change, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Prior notice

• The following provision is not in force.

  26 (1) A licensed dealer must notify the Minister in writing before

  • The following provision is not in force.

    (a) producing or packaging a mixture or finished product that is not set out in the most recent update of the information and label referred to in paragraph 11(1)(g); or

  • The following provision is not in force.

    (b) making a change to a mixture or finished product that is set out in that most recent update, if the change affects any of the information or label that has previously been submitted.

• The following provision is not in force.

  Marginal note:Information and document

  (2) The notice must contain the information that is necessary to update the information or label referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label referred to in that paragraph or, if applicable, a copy of the updated label.

Marginal note:Notice — five days

27 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Marginal note:Notice — 10 days

• The following provision is not in force.

  28 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:

  • The following provision is not in force.

    (a) a person ceases to act as the senior person in charge; or

  • The following provision is not in force.

    (b) the licensed dealer ceases to produce or package a mixture or finished product that is set out in the most recent update of the information and label referred to in paragraph 11(1)(g).

• The following provision is not in force.

  Marginal note:Information and document

  (2) A notice concerning a change referred to in paragraph (1)(b) must contain the information that is necessary to update the information referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label for any other controlled substance.

Marginal note:Notice of cessation of activities

• The following provision is not in force.

  29 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

• The following provision is not in force.

  Marginal note:Content of notice

  (2) The notice must be signed and dated by the senior person in charge and contain the following information:

  • The following provision is not in force.

    (a) the expected date of the cessation of activities at the site;

  • The following provision is not in force.

    (b) a description of the manner in which any remaining controlled substances on the site as of that date will be disposed of by the licensed dealer, including

    • (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, their name and, if applicable, title,

    • (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, their name and, if applicable, title, as well as the municipal address of their site, and

    • (iii) if some or all of them will be destroyed, the anticipated date of destruction and the municipal address of the place at which the destruction is to be carried out;

  • The following provision is not in force.

    (c) the municipal address of the place at which the licensed dealer’s documents will be kept after activities have ceased; and

  • The following provision is not in force.

    (d) the name, municipal address, telephone number and, if applicable, the email address of a person whom the Minister may contact for further information after activities have ceased.

• The following provision is not in force.

  Marginal note:Update

  (3) After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.

Marginal note:Addition or modification

• The following provision is not in force.

  30 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add or modify a term or condition if the Minister has reasonable grounds to believe that it is necessary to do so to

  • The following provision is not in force.

    (a) ensure conformity with the provisions of the Act, the Cannabis Act and their regulations;

  • The following provision is not in force.

    (b) ensure that an international obligation is respected;

  • The following provision is not in force.

    (c) ensure conformity with the requirements associated with the security level specified in the licence; or

  • The following provision is not in force.

    (d) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Prior notice

  (2) Before adding a term or condition to, or modifying a term or condition of, a licence, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

• The following provision is not in force.

  Marginal note:Urgent circumstances

  (3) Despite subsection (2), the Minister may immediately add a term or condition to, or modify a term or condition of, a licence, subject to subsection (4), if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Urgent circumstances — notice

  (4) The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister provides the licensed dealer with a written notice that

  • The following provision is not in force.

    (a) sets out the reasons for the addition or modification;

  • The following provision is not in force.

    (b) gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

Marginal note:Deletion of term or condition

• The following provision is not in force.

  31 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

• The following provision is not in force.

  Marginal note:Notice

  (2) The deletion takes effect as soon as the Minister provides the licensed dealer with a written notice to that effect.

Marginal note:Suspension

• The following provision is not in force.

  32 (1) Subject to subsection (2), the Minister must immediately suspend a dealer’s licence in respect of any activities in relation to any controlled substance if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Notice

  (2) The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that

  • The following provision is not in force.

    (a) sets out the authorized activity and controlled substance that are the subject of the suspension, as well as the reasons for the suspension;

  • The following provision is not in force.

    (b) gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

• The following provision is not in force.

  Marginal note:Reinstatement of licence

  (3) The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

• The following provision is not in force.

  33 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if

  • The following provision is not in force.

    (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);

  • The following provision is not in force.

    (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;

  • The following provision is not in force.

    (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence;

  • The following provision is not in force.

    (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice;

  • The following provision is not in force.

    (e) the licensed dealer has contravened

    • (i) a provision of the Act, the Cannabis Act or their regulations, or

    • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;

  • The following provision is not in force.

    (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

  • The following provision is not in force.

    (g) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of an application relating to the licence; or

  • The following provision is not in force.

    (h) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravened an international obligation.

• The following provision is not in force.

  Marginal note:Exceptions

  (2) The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

  • The following provision is not in force.

    (a) the licensed dealer does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and

  • The following provision is not in force.

    (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.

• The following provision is not in force.

  Marginal note:Prior notice

  (3) Before revoking a licence, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Application

• The following provision is not in force.

  34 (1) A licensed dealer must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:

  • The following provision is not in force.

    (a) their name and, if applicable, title, as well as their municipal address;

  • The following provision is not in force.

    (b) their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;

  • The following provision is not in force.

    (c) the name and municipal address of the proposed customs broker for the licensed dealer, if any;

  • The following provision is not in force.

    (d) the name of the customs office where the importation is anticipated and the proposed date of importation;

  • The following provision is not in force.

    (e) the name and municipal address, in the country of export, of the exporter from whom the controlled substance is being obtained;

  • The following provision is not in force.

    (f) the name of the carrier that is proposed to transport the controlled substance to the customs office where the importation is anticipated;

  • The following provision is not in force.

    (g) each proposed mode of transportation and any proposed country of transit or transhipment;

  • The following provision is not in force.

    (h) in the case of a controlled substance set out in any of Schedules 1 to 4,

    • (i) its name as set out in the dealer’s licence,

    • (ii) its CAS registry number, if any,

    • (iii) if it is a salt, the name of the salt,

    • (iv) its form,

    • (v) its purity and anhydrous content, and

    • (vi) its quantity; and

  • The following provision is not in force.

    (i) 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.

• The following provision is not in force.

  Marginal note:Signature and attestation

  (2) The application must

  • The following provision is not in force.

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

  • The following provision is not in force.

    (b) include an attestation by that person that, to the best of their knowledge,

    • (i) the importation does not contravene the laws of the country of exportation or any country of transit or transhipment, and

    • (ii) all of the information and documents submitted in support of the application are correct and complete.

• The following provision is not in force.

  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.

Marginal note:Issuance

• The following provision is not in force.

  35 (1) Subject to section 37, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains

  • The following provision is not in force.

    (a) the permit number;

  • The following provision is not in force.

    (b) the information set out in subsection 34(1);

  • The following provision is not in force.

    (c) the effective date of the permit;

  • The following provision is not in force.

    (d) the expiry date of the permit, being the earlier of

    • (i) a date specified by the Minister that is not more than 180 days after its effective date, and

    • (ii) the expiry date of the dealer’s licence; and

  • The following provision is not in force.

    (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

    • (i) ensure that an international obligation is respected, or

    • (ii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Permit integrity

  (2) A person must not alter or deface in any manner an import permit.

Marginal note:Validity

36 An import permit is valid until the earliest of

• The following provision is not in force.

  (a) the expiry date set out in the permit,

• The following provision is not in force.

  (b) the date of the suspension or revocation of the permit under section 40 or 41,

• The following provision is not in force.

  (c) the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and

• The following provision is not in force.

  (d) the date of the expiry, suspension or revocation of the export authorization that applies to the controlled substance to be imported and that is issued by the competent authority in the country of export.

Marginal note:Refusal

• The following provision is not in force.

  37 (1) The Minister must refuse to issue an import permit if

  • The following provision is not in force.

    (a) the licensed dealer is not authorized by their dealer’s licence to import the relevant controlled substance or their licence will expire before the date of importation;

  • The following provision is not in force.

    (b) the Minister has reasonable grounds to believe that the importation would contravene an international obligation;

  • The following provision is not in force.

    (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation;

  • The following provision is not in force.

    (d) the licensed dealer has not provided the Minister with the information or documents required under subsection 34(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the permit application;

  • The following provision is not in force.

    (e) 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 permit application;

  • The following provision is not in force.

    (f) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or

  • The following provision is not in force.

    (g) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Prior notice

  (2) Before refusing to issue an import permit, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Providing copy of permit

38 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.

Marginal note:Declaration

39 The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled substance specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:

• The following provision is not in force.

  (a) their name and, if applicable, title;

• The following provision is not in force.

  (b) their dealer’s licence number and the number of the import permit;

• The following provision is not in force.

  (c) the name of the customs office from which the controlled substance was released and the date of the release;

• The following provision is not in force.

  (d) in the case of a controlled substance set out in any of Schedules 1 to 4,

  • (i) its name as set out in the dealer’s licence,

  • (ii) if it is a salt, the name of the salt,

  • (iii) its form, and

  • (iv) its 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:Suspension

• The following provision is not in force.

  40 (1) Subject to subsection (2), the Minister must immediately suspend an import permit if

  • The following provision is not in force.

    (a) the dealer’s licence is suspended;

  • The following provision is not in force.

    (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or

  • The following provision is not in force.

    (c) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment.

• The following provision is not in force.

  Marginal note:Notice

  (2) The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that

  • The following provision is not in force.

    (a) sets out the reasons for the suspension;

  • The following provision is not in force.

    (b) gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

• The following provision is not in force.

  Marginal note:Reinstatement of permit

  (3) The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

• The following provision is not in force.

  41 (1) The Minister must revoke an import permit if

  • The following provision is not in force.

    (a) the dealer’s licence has been revoked;

  • The following provision is not in force.

    (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;

  • The following provision is not in force.

    (c) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 40(2)(c) by the specified date; or

  • The following provision is not in force.

    (d) the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.

• The following provision is not in force.

  Marginal note:Prior notice

  (2) Before revoking an import permit, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Application

• The following provision is not in force.

  42 (1) A licensed dealer must submit to the Minister, before each exportation of a controlled substance, an application for an export permit that contains the following information and document:

  • The following provision is not in force.

    (a) their name and, if applicable, title, as well as their municipal address;

  • The following provision is not in force.

    (b) their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;

  • The following provision is not in force.

    (c) the name and municipal address of the proposed customs broker for the licensed dealer, if any;

  • The following provision is not in force.

    (d) the name of the customs office where the exportation is anticipated and the proposed date of exportation;

  • The following provision is not in force.

    (e) the name and municipal address of the importer in the country of final destination;

  • The following provision is not in force.

    (f) the name of the carrier that is proposed to transport the controlled substance from the customs office where the exportation is anticipated;

  • The following provision is not in force.

    (g) each proposed mode of transportation and any proposed country of transit or transhipment;

  • The following provision is not in force.

    (h) in the case of a controlled substance set out in any of Schedules 1 to 4,

    • (i) its name as set out in the dealer’s licence,

    • (ii) its CAS registry number, if any,

    • (iii) if it is a salt, the name of the salt,

    • (iv) its form,

    • (v) its purity and anhydrous content, and

    • (vi) its quantity;

  • The following provision is not in force.

    (i) 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.

    (j) a copy of the import authorization issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

• The following provision is not in force.

  Marginal note:Signature and attestation

  (2) The application must

  • The following provision is not in force.

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

  • The following provision is not in force.

    (b) include an attestation by that person that, to the best of their knowledge,

    • (i) the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and

    • (ii) all of the information and documents submitted in support of the application are correct and complete.

• The following provision is not in force.

  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.

Marginal note:Issuance

• The following provision is not in force.

  43 (1) Subject to section 45, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains

  • The following provision is not in force.

    (a) the permit number;

  • The following provision is not in force.

    (b) the information set out in paragraphs 42(1)(a) to (i) and the number of the import authorization referred to in paragraph 42(1)(j);

  • The following provision is not in force.

    (c) the effective date of the permit;

  • The following provision is not in force.

    (d) the expiry date of the permit, being the earliest of

    • (i) a date specified by the Minister that is not more than 180 days after its effective date,

    • (ii) the expiry date of the dealer’s licence, and

    • (iii) the expiry date of the import authorization issued by the competent authority in the country of final destination; and

  • The following provision is not in force.

    (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

    • (i) ensure that an international obligation is respected, or

    • (ii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Permit integrity

  (2) A person must not alter or deface in any manner an export permit.

Marginal note:Validity

44 An export permit is valid until the earliest of

• The following provision is not in force.

  (a) the expiry date set out in the permit,

• The following provision is not in force.

  (b) the date of the suspension or revocation of the permit under section 48 or 49,

• The following provision is not in force.

  (c) the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and

• The following provision is not in force.

  (d) the date of the expiry, suspension or revocation of the import authorization that applies to the controlled substance to be exported and that is issued by the competent authority in the country of final destination.

Marginal note:Refusal

• The following provision is not in force.

  45 (1) The Minister must refuse to issue an export permit if

  • The following provision is not in force.

    (a) the licensed dealer is not authorized by their dealer’s licence to export the relevant controlled substance or their dealer’s licence will expire before the date of export;

  • The following provision is not in force.

    (b) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation;

  • The following provision is not in force.

    (c) the licensed dealer has not provided the Minister with the information or documents required under subsection 42(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the permit application;

  • The following provision is not in force.

    (d) 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 permit application;

  • The following provision is not in force.

    (e) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import authorization issued by the competent authority of the country of final destination;

  • The following provision is not in force.

    (f) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or

  • The following provision is not in force.

    (g) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• The following provision is not in force.

  Marginal note:Prior notice

  (2) Before refusing to issue an export permit, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Providing copy of permit

46 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.

Marginal note:Declaration

47 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains the following information:

• The following provision is not in force.

  (a) their name and, if applicable, title;

• The following provision is not in force.

  (b) their dealer’s licence number and the number of the export permit;

• The following provision is not in force.

  (c) the name of the customs office from which the controlled substance was exported and the date of export;

• The following provision is not in force.

  (d) in the case of a controlled substance set out in any of Schedules 1 to 4,

  • (i) its name as set out in the dealer’s licence,

  • (ii) if it is a salt, the name of the salt,

  • (iii) its form, and

  • (iv) its 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:Suspension

• The following provision is not in force.

  48 (1) Subject to subsection (2), the Minister must immediately suspend an export permit if

  • The following provision is not in force.

    (a) the dealer’s licence is suspended;

  • The following provision is not in force.

    (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or

  • The following provision is not in force.

    (c) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.

• The following provision is not in force.

  Marginal note:Notice

  (2) The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that

  • The following provision is not in force.

    (a) sets out the reasons for the suspension;

  • The following provision is not in force.

    (b) gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

• The following provision is not in force.

  Marginal note:Reinstatement of permit

  (3) The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

• The following provision is not in force.

  49 (1) The Minister must revoke an export permit if

  • The following provision is not in force.

    (a) the dealer’s licence has been revoked;

  • The following provision is not in force.

    (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;

  • The following provision is not in force.

    (c) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 48(2)(c) by the specified date; or

  • The following provision is not in force.

    (d) the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.

• The following provision is not in force.

  Marginal note:Prior notice

  (2) Before revoking an export permit, the Minister must

  • The following provision is not in force.

    (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • The following provision is not in force.

    (b) consider the licensed dealer’s submissions, if applicable.

Marginal note:Authorized activities

50 A licensed dealer may conduct the following activities if it does so in accordance with their dealer’s licence and any permit issued under these Regulations:

• The following provision is not in force.

  (a) produce a controlled substance;

• The following provision is not in force.

  (b) sell or provide a controlled substance to

  • (i) another licensed dealer,

  • (ii) with the exception of a restricted drug, a pharmacist, other than one who is practising in a hospital,

  • (iii) a practitioner,

  • (iv) with the exception of a restricted drug, a hospital,

  • (v) a person exempted under subsection 56(1) of the Act with respect to that controlled substance, if there are terms and conditions for the sale or provision by a licensed dealer that are specified in the exemption,

  • (vi) the Minister, or

  • (vii) a government laboratory;

• The following provision is not in force.

  (c) transport, send or deliver a controlled substance; or

• The following provision is not in force.

  (d) import or export a controlled substance.

Marginal note:Packaging — conditions

51 A licensed dealer that packages a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Marginal note:Destruction

52 A licensed dealer specialized in destruction that destroys a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Marginal note:Qualified person in charge present

53 A licensed dealer may conduct an activity in relation to a controlled substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Marginal note:Identification

54 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which it identifies itself in regard to their activities in relation to a controlled substance, including labels, shipping documents, invoices and advertising.

Marginal note:Information and documents

55 A licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any relevant information or document to demonstrate their compliance with the provisions of the Act and these Regulations.

Marginal note:Sale to another licensed dealer

56 A licensed dealer that sells or provides a controlled substance to another licensed dealer may only do so if it first receives from the other licensed dealer a written order that is signed and dated and that contains the following:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) with respect to the licensed dealer selling or providing the controlled substance, their name and, if applicable, title, as well as their municipal address;

• 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 4, its name, form and quantity;

• 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; 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 pharmacist

• The following provision is not in force.

  57 (1) A licensed dealer that sells or provides a controlled substance to a pharmacist may only do so if it first receives from the 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 pharmacist, 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 licensed dealer, their name and, if applicable, title, as well as their municipal address;

  • 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; 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.

• The following provision is not in force.

  Marginal note:Exception — prohibition

  (2) A licensed dealer 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

• The following provision is not in force.

  58 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, to a practitioner may only do so if it first receives from the practitioner 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 practitioner, 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 licensed dealer, their name and, if applicable, title, as well as their municipal address;

  • 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; 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.

• The following provision is not in force.

  Marginal note:Restricted drugs

  (2) A licensed dealer that sells or provides a restricted drug to a practitioner may only do so if

  • The following provision is not in force.

    (a) the licensed dealer first receives a letter of authorization in which it is named;

  • The following provision is not in force.

    (b) the practitioner is named in the letter of authorization and the municipal address of the place where they practise is specified in that letter; and

  • The following provision is not in force.

    (c) the licensed dealer sells or provides the restricted drug only in the quantity specified in the letter of authorization and, if applicable, in the form and strength specified in that letter.

• The following provision is not in force.

  Marginal note:Exception — prohibition

  (3) A licensed dealer 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 hospital

59 A licensed dealer that sells or provides a controlled substance to a hospital may only do so if it first receives from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) 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.

  (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; 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:Sale to exempted person

60 A licensed dealer that sells or provides a controlled substance to a person exempted under subsection 56(1) of the Act with respect to that substance may only do so in accordance with the terms and conditions for the sale or provision by the licensed dealer that are specified in the exemption and if it first receives from the exempted person a copy of that exemption.

Marginal note:Sale to Minister

61 A licensed dealer that sells or provides a controlled substance to the Minister may only do so if it first receives from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• The following provision is not in force.

  (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;

• The following provision is not in force.

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

• 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 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:Sale to government laboratory

62 A licensed dealer that sells or provides a controlled substance to a government laboratory may only do so if it first receives from the government laboratory 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 government laboratory, its name and municipal address;

• The following provision is not in force.

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

• 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 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:Anticipated multiple sales

• The following provision is not in force.

  63 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, may do so more than once in respect of one order, within six months after the order was made, if the order indicates

  • The following provision is not in force.

    (a) the number of sales or provisions;

  • The following provision is not in force.

    (b) the specific quantity for each sale or provision; and

  • The following provision is not in force.

    (c) the intervals between each sale or provision.

• The following provision is not in force.

  Marginal note:Multiple sales — insufficient stock

  (2) A licensed dealer may sell or provide a controlled substance more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the substance ordered, in which case the dealer may sell or provide the quantity of the substance that the dealer has available and sell or provide the balance later.

Marginal note:Orders

64 A licensed dealer that receives an order from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the licensed dealer.

Marginal note:Requirements during transportation

• The following provision is not in force.

  65 (1) A licensed dealer that takes delivery of a controlled substance that it has imported or that delivers, sends or transports a controlled substance to another person may only do so if it

  • The following provision is not in force.

    (a) ensures that its outermost container is inconspicuous, without any mark identifying its contents, and sealed in such a manner that the container cannot be opened without breaking the seal;

  • The following provision is not in force.

    (b) ensures that all inner containers are sealed in such a manner that they cannot be opened without breaking the seal;

  • The following provision is not in force.

    (c) takes all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported;

  • The following provision is not in force.

    (d) uses a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it;

  • The following provision is not in force.

    (e) in the case of an imported controlled substance, delivers, sends or transports it directly to the site specified in their licence after it is released under the Customs Act; and

  • The following provision is not in force.

    (f) in the case of a controlled substance that is to be exported, delivers, sends or transports it directly from the site specified in their licence to the customs office where it will be exported.

• The following provision is not in force.

  Marginal note:Exception

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

Marginal note:Protective measures

66 A licensed dealer must take all reasonable measures to ensure the security of any controlled substance, licence or permit in their possession.

Marginal note:Loss or theft — licences and permits

67 If a licensed dealer becomes aware of a loss or theft of their licence or permit, the dealer must provide a written report to the Minister within 72 hours after becoming aware of the loss or theft.

Marginal note:Loss or theft — agent or mandatary

• The following provision is not in force.

  68 (1) If an agent or mandatary of a licensed dealer becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the licensed dealer immediately.

• The following provision is not in force.

  Marginal note:Written report

  (2) If a licensed dealer becomes aware of a loss of a controlled substance that cannot be explained on the basis of normally accepted business activities, or of a theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the dealer must

  • The following provision is not in force.

    (a) in the case of a loss, provide a written report to the Minister within 72 hours after becoming aware or being notified of the loss; or

  • The following provision is not in force.

    (b) in the case of a theft, provide

    • (i) a written report to a police force within 24 hours after becoming aware or being notified of the theft, and

    • (ii) a written report to the Minister within 72 hours after becoming aware or being notified of the theft, including a confirmation that the report required under subparagraph (i) has been provided.

Marginal note:Suspicious transaction

• The following provision is not in force.

  69 (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 it has reasonable grounds to suspect may be related to the diversion of a controlled substance to an illicit market or use:

  • The following provision is not in force.

    (a) with respect to the licensed dealer,

    • (i) in the case of an individual, their name and, if applicable, title, as well as their municipal address and telephone number, or

    • (ii) in the case of an organization, its name, municipal address and telephone number, as well as the title of the position held by the individual making the report;

  • The following provision is not in force.

    (b) with respect to the other party to the transaction, their name and municipal address;

  • The following provision is not in force.

    (c) details of the transaction, including its date and time, as well as its type;

  • 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;

  • 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; and

  • The following provision is not in force.

    (f) a detailed description of the reasons for the dealer’s suspicions.

• The following provision is not in force.

  Marginal note:Good faith

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

• The following provision is not in force.

  Marginal note:Non-disclosure

  (3) A licensed dealer must not disclose that it has 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

70 A report provided under any of sections 67 to 69, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Marginal note:Destruction at site

71 A licensed dealer that intends to destroy a controlled substance at the site specified in their licence must ensure that the following conditions are met:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) the destruction is carried out 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, or

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

• The following provision is not in force.

  (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

• The following provision is not in force.

  (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 controlled substance was destroyed, to which each signatory must add in printed letters their name and, if applicable, title.

Marginal note:Destruction elsewhere than at site

72 A licensed dealer that intends to destroy a controlled substance elsewhere than at the site specified in their licence must ensure that the following conditions are met:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) the licensed dealer takes all reasonable measures to ensure the security of the controlled substance while it is being transported in order to prevent its diversion to an illicit market or use;

• The following provision is not in force.

  (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods, other than a licensed dealer specialized in destruction, and in the presence of another person working for that business;

• The following provision is not in force.

  (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

• The following provision is not in force.

  (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 controlled substance was destroyed and containing

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

  • (ii) the date of destruction,

  • (iii) the method of destruction,

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

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

    • (A) subject to clause (D), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

    • (B) subject to clause (D), its form, its strength, the number of containers and, if applicable, the number of units per container,

    • (C) subject to clause (D), its drug identification number, if any, and

    • (D) 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, and

  • (vi) the names, in printed letters, and signatures of the person who carried out the destruction and the other person who was present at the destruction.

Marginal note:Application for approval

• The following provision is not in force.

  73 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s approval to destroy a controlled substance:

  • The following provision is not in force.

    (a) their name and, if applicable, title, as well as their municipal address;

  • The following provision is not in force.

    (b) their dealer’s licence number;

  • The following provision is not in force.

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

  • The following provision is not in force.

    (d) the proposed date of destruction;

  • The following provision is not in force.

    (e) a brief description of the method of destruction;

  • The following provision is not in force.

    (f) 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 purposes of paragraph 71(b) and information establishing that they meet the conditions of that paragraph;

  • The following provision is not in force.

    (g) 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.

    (h) 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.

• The following provision is not in force.

  Marginal note:Signature and attestation

  (2) The application must

  • The following provision is not in force.

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

  • The following provision is not in force.

    (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.

• The following provision is not in force.

  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.

Marginal note:Approval

74 On completion of the review of the approval application, the Minister must approve the destruction of the controlled substance unless

• The following provision is not in force.

  (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 purposes of paragraph 71(b) do not meet the conditions of that paragraph;

• The following provision is not in force.

  (b) the Minister has reasonable grounds to believe that the controlled substance would not be destroyed;

• The following provision is not in force.

  (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;

• The following provision is not in force.

  (d) the controlled substance 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

• The following provision is not in force.

  (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk that the controlled substance could be diverted to an illicit market or use.

Marginal note:Substances ordered and received

75 A licensed dealer that orders or receives a controlled substance must record the following information:

• The following provision is not in force.

  (a) the name and, if applicable, title of the individual placing the order for the controlled substance or receiving it;

• The following provision is not in force.

  (b) with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;

• The following provision is not in force.

  (c) the date of the order or receipt;

• 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) 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:Substances sold

76 A licensed dealer that sells or provides a controlled substance must record the following information:

• The following provision is not in force.

  (a) the name and, if applicable, title of the individual 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 4, its name, form and quantity; and

• The following provision is not in force.

  (e) in the case of a controlled substance that is 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 produced or packaged

77 A licensed dealer that produces or packages a controlled substance must record the following information with respect to the substance:

• The following provision is not in force.

  (a) 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.

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

  • (i) its name or, if applicable, its brand name, as well as the name and quantity of the controlled substance it uses to produce the mixture or finished product, or that is contained in the mixture or finished product that it packages,

  • (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 in stock

78 A licensed dealer that stores a controlled substance must record the following information with respect to the substance:

• The following provision is not in force.

  (a) the date on which it is placed in stock;

• 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; and

• The following provision is not in force.

  (c) 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:Written orders

79 A licensed dealer that receives a written order for a controlled substance must record the following information:

• The following provision is not in force.

  (a) the name and, if applicable, title of the individual 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:Transportation

80 A licensed dealer that delivers, sends or transports a controlled substance to another person must record the following information:

• The following provision is not in force.

  (a) the dealer’s name and, if applicable, title, as well as their municipal address;

• The following provision is not in force.

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

• The following provision is not in force.

  (c) with respect to the other person, their name and, if applicable, title;

• 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;

• The following provision is not in force.

  (g) 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.

  (h) 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 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.

Marginal note:Sale to practitioner

• The following provision is not in force.

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

  • The following provision is not in force.

    (a) with respect to the practitioner, 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, 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; and

  • 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.

• The following provision is not in force.

  Marginal note:Exception — prohibition

  (2) A pharmacist 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 hospital

95 A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a hospital if they first receive from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information or, in the case of an emergency, either such a written order or a verbal order from such a person:

• The following provision is not in force.

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

• 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; and

• 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.

Marginal note:Sale to exempted person

96 A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a person exempted under subsection 56(1) of the Act with respect to that controlled substance if

• The following provision is not in force.

  (a) the pharmacist first receives from the exempted person a copy of the exemption;

• The following provision is not in force.

  (b) there are terms and conditions for the sale or provision by the pharmacist that are specified in the exemption; and

• The following provision is not in force.

  (c) the sale or provision is carried out in accordance with those terms and conditions.

Marginal note:Sale to Minister

97 A pharmacist may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• The following provision is not in force.

  (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;

• 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; and

• 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.

Marginal note:Sale to individual

• The following provision is not in force.

  98 (1) A pharmacist may sell or provide a controlled substance to an individual if

  • The following provision is not in force.

    (a) the sale or provision is for the individual’s own use, for the use of another individual or for an animal;

  • The following provision is not in force.

    (b) the controlled substance is in the form of a finished product that does not contain a restricted drug; and

  • The following provision is not in force.

    (c) subject to subsection (2), the pharmacist first receives the following in respect of the controlled substance from one of the following persons:

    • (i) in the case of the individual, a written prescription,

    • (ii) in the case of another pharmacist or a pharmacy technician,

      • (A) a written prescription, or

      • (B) a copy of the document on which the information with respect to a verbal prescription has been recorded under section 117, or

    • (iii) in the case of a practitioner, a written or verbal prescription.

• The following provision is not in force.

  Marginal note:Finished product containing low dose of codeine

  (2) A pharmacist may sell or provide, without a prescription, a finished product containing codeine phosphate to an individual if

  • The following provision is not in force.

    (a) the finished product contains

    • (i) in the case of a finished product in solid form, not more than 8 mg or its equivalent of codeine phosphate per unit, or

    • (ii) in the case of a finished product in liquid form, not more than 20 mg or its equivalent of codeine phosphate per 30 mL;

  • The following provision is not in force.

    (b) the finished product contains

    • (i) two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half of the regular minimum single dose for each such ingredient, or

    • (ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third of the regular minimum single dose for each such ingredient;

  • The following provision is not in force.

    (c) the pharmacist has reasonable grounds to believe that the finished product will only be used for recognized medical purposes; and

  • The following provision is not in force.

    (d) the pharmacist ensures that the following caution or its equivalent is conspicuously and legibly printed on the finished product’s inner label and outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations:

  The following provision is not in force.

  “This product contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner.”

Marginal note:Orders and prescriptions

• The following provision is not in force.

  99 (1) A pharmacist or pharmacy technician may compound a finished product, other than one containing a restricted drug, if they do so for the purpose of fulfilling a prescription and if they first receive the following with respect to the finished product from one of the following persons:

  • The following provision is not in force.

    (a) in the case of an individual, a written prescription;

  • The following provision is not in force.

    (b) in the case of another pharmacist,

    • (i) a written order that is signed and dated and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order,

    • (ii) a written prescription, or

    • (iii) a copy of the document on which the information with respect to a verbal prescription is recorded under section 117;

  • The following provision is not in force.

    (c) in the case of another pharmacy technician,

    • (i) a written prescription, or

    • (ii) a copy of the document on which the information with respect to a verbal prescription is recorded under section 117;

  • The following provision is not in force.

    (d) in the case of a practitioner,

    • (i) if they are not practising in a hospital, a written order that is signed and dated and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order, or

    • (ii) a written or verbal prescription; or

  • The following provision is not in force.

    (e) in the case of a hospital, a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the information set out in subsection (2) or, in the case of an emergency, either such a written order or a verbal order from such a person.

• The following provision is not in force.

  Marginal note:Written orders

  (2) 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 person placing the order,

    • (i) in the case of another pharmacist, their name and the name and municipal address of the place where they practise,

    • (ii) in the case of a practitioner, their name and the name and municipal address of the place where they practise, and

    • (iii) in the case of a hospital, its name and municipal address, as well as the name of the person permitted to place the order on its behalf;

  • The following provision is not in force.

    (b) with respect to the pharmacist or pharmacy technician compounding the finished product, 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) with respect to the finished product,

    • (i) its name, and

    • (ii) its form, strength, the number of containers and, if applicable, the number of units per container; and

  • The following provision is not in force.

    (e) if applicable, a declaration from the other pharmacist that they require the finished product for emergency purposes.

Marginal note:Sale and compounding

100 A pharmacist who sells or provides a controlled substance or who compounds a finished product may, before the sale, provision or compounding, substitute a controlled substance for another controlled substance identified in a prescription, if the pharmacist is authorized to do so under the laws of the province where the sale, provision or compounding takes place.

Marginal note:Extension of prescription

101 A pharmacist may extend a prescription if the new expiration date of the extended prescription is not later than two years after the day on which the pharmacist received the prescription.

Marginal note:Transfer of prescription

102 A pharmacist or pharmacy technician may transfer a prescription to another pharmacist or pharmacy technician if

• The following provision is not in force.

  (a) they transfer it within two years after the day on which the prescription was received; and

• The following provision is not in force.

  (b) they provide

  • (i) in the case of a controlled substance prescribed in writing, the written prescription, or

  • (ii) in the case of a controlled substance prescribed verbally, a copy of the document on which the information with respect to that verbal prescription is recorded under section 117.

Marginal note:Orders and prescriptions

103 A pharmacist or pharmacy technician who receives an order or prescription from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the pharmacist.

Marginal note:Receipt of substance from individual

104 A pharmacist or pharmacy technician who receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom the pharmacist or technician has authorized have access and that is marked in a manner that is sufficient to identify the container.

Marginal note:Authorized access

105 A pharmacist must ensure that

• The following provision is not in force.

  (a) any controlled substance is stored in a secure location at the place where they practise; and

• The following provision is not in force.

  (b) only persons whom the pharmacist has authorized have access to that secure location.

Marginal note:Authorization

106 A pharmacist or pharmacy technician may deliver, send or transport a controlled substance.

Marginal note:Requirements during transportation

107 A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance to another person may only do so if they

• The following provision is not in force.

  (a) ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner sufficient to identify the container;

• The following provision is not in force.

  (b) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and

• The following provision is not in force.

  (c) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Marginal note:Protective measures

108 A pharmacist or pharmacy technician must take all reasonable measures to ensure the security of any controlled substance in their possession.

Marginal note:Loss or theft — agent or mandatary

• The following provision is not in force.

  109 (1) If an agent or mandatary of a pharmacist becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the pharmacist immediately.

• The following provision is not in force.

  Marginal note:Written report

  (2) If a pharmacist becomes aware of a loss or theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the pharmacist must provide a written report to the Minister within 10 days after the day on which they become aware of the loss or theft or are notified.

• The following provision is not in force.

  Marginal note:Partial protection against self-incrimination

  (3) The report, or any evidence derived from it, is not to be used or received to incriminate the pharmacist or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Marginal note:Conditions

• The following provision is not in force.

  110 (1) The destruction of a controlled substance in a pharmacy may only be carried out by a pharmacist or pharmacy technician and if the following conditions are met:

  • The following provision is not in force.

    (a) the destruction is witnessed by another person among the following:

    • (i) a pharmacist, pharmacy technician or intern, including one who is practising in a hospital,

    • (ii) a practitioner, or

    • (iii) any other health professional;

  • The following provision is not in force.

    (b) 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

  • The following provision is not in force.

    (c) immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.

• The following provision is not in force.

  Marginal note:Substance returned by individual

  (2) A pharmacist must, if the destruction of a controlled substance previously returned by an individual or particular person for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.

Marginal note:Substances ordered and received

111 A pharmacist who orders a controlled substance or a pharmacist or pharmacy technician who receives a controlled substance, other than one that has been previously returned by an individual or particular person for the purposes of destruction, must record the following information:

• The following provision is not in force.

  (a) their name;

• The following provision is not in force.

  (b) with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;

• The following provision is not in force.

  (c) the date of the order or 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, 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 sold — persons other than individuals

112 A pharmacist who sells or provides a controlled substance to a person, other than an individual referred to in section 113, must record the following information:

• The following provision is not in force.

  (a) the pharmacist’s name;

• The following provision is not in force.

  (b) with respect to the person, 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, 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) if applicable, the reason for the emergency sale or provision.

Marginal note:Finished product sold — individuals

113 A pharmacist who sells or provides a finished product to an individual for their own use, for the use of another individual or for an animal must record the following information:

• The following provision is not in force.

  (a) the pharmacist’s name;

• 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 the sale or provision;

• The following provision is not in force.

  (f) with respect to the 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.

  (g) if applicable, the number of times that the prescription may be refilled and, if specified, the intervals between refills.

Marginal note:Finished products compounded

114 A pharmacist or pharmacy technician who compounds a finished product 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 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 the finished product; and

• The following provision is not in force.

  (f) with respect to the finished product,

  • (i) its name, and

  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container.

Marginal note:Controlled substance substitutions

115 A pharmacist who 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) their name;

• 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 and prescriptions

116 A pharmacist or pharmacy technician who receives a written order for a controlled substance or a written prescription from a practitioner must record the following information:

• The following provision is not in force.

  (a) the pharmacist’s or pharmacy technician’s name; and

• The following provision is not in force.

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

Marginal note:Verbal orders and prescriptions

117 A pharmacist or pharmacy technician who receives a verbal order for a controlled substance or a verbal prescription must record the following information:

• The following provision is not in force.

  (a) their name;

• The following provision is not in force.

  (b) with respect to the person placing the order or issuing the prescription,

  • (i) in the case of an order from another pharmacist,

    • (A) their name and the name and municipal address of the place where they practise, and

    • (B) a declaration from the other pharmacist that they require the controlled substance for emergency purposes,

  • (ii) in the case of a prescription or order from a practitioner,

    • (A) their name and the name and municipal address of the place where they practise, and

    • (B) if it is an order, a declaration from the practitioner that they require the controlled substance for emergency purposes, or

  • (iii) in the case of an order from a hospital,

    • (A) its name and municipal address, as well as the name of the person permitted to place the order on its behalf, and

    • (B) a declaration from that person that the hospital requires the controlled substance for emergency purposes;

• The following provision is not in force.

  (c) the date of receipt of the order or prescription;

• 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) if applicable, the number of refills authorized in the prescription and, if specified, the interval between refills.

Marginal note:Prescriptions refilled and extended

118 A pharmacist who refills or extends a prescription must record the following information:

• The following provision is not in force.

  (a) their name;

• 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 prescription refill or extension; and

• The following provision is not in force.

  (d) if applicable, the new expiration date of the extended prescription.

Marginal note:Prescription transfers — transferring pharmacist

• The following provision is not in force.

  119 (1) A pharmacist or pharmacy technician who transfers a prescription to another pharmacist or pharmacy technician must record the following information:

  • The following provision is not in force.

    (a) their name;

  • The following provision is not in force.

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

  • The following provision is not in force.

    (c) the number assigned to the prescription;

  • The following provision is not in force.

    (d) the date of the prescription transfer;

  • The following provision is not in force.

    (e) the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and, if specified, the interval between refills; and

  • The following provision is not in force.

    (f) if applicable, the date of the prescription extension and the new expiration date of the extended prescription.

• The following provision is not in force.

  Marginal note:Prescription transfer — receiving pharmacist

  (2) The pharmacist or pharmacy technician who receives the transferred prescription must record the following information:

  • The following provision is not in force.

    (a) their name;

  • The following provision is not in force.

    (b) with respect to the pharmacist or pharmacy technician from whom they receive the transferred prescription, their name and the name and municipal address of the place where they practise;

  • The following provision is not in force.

    (c) the number assigned to the prescription;

  • The following provision is not in force.

    (d) the date of receipt of the prescription;

  • The following provision is not in force.

    (e) the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and, if specified, the interval between refills; and

  • The following provision is not in force.

    (f) if applicable, the date of the prescription extension and the new expiration date of the extended prescription.

Marginal note:Transportation

120 A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance must record the following information:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) if an agent or mandatary of the pharmacist delivers, sends or transports 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 is 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;

• 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, 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.

Marginal note:Destruction

121 A pharmacist or pharmacy technician who destroys a controlled substance 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 place of destruction;

• 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 (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.

Marginal note:Method of recording

122 A pharmacist or pharmacy technician 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

• The following provision is not in force.

  123 (1) A pharmacist who is responsible for the operations of a pharmacy where the information was recorded under these Regulations or, if a pharmacy ceases its operations, the person who was responsible for those operations on the date those operations ceased must, subject to subsection (2), ensure that

  • The following provision is not in force.

    (a) any document containing the information that must be recorded under these Regulations 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; 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.

• The following provision is not in force.

  Marginal note:Substances sold or provided

  (2) All documents regarding the sale or provision of a controlled substance must be kept separately, in sequence as to date and number.

Marginal note:Place

124 The documents must be accessible

• The following provision is not in force.

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

• The following provision is not in force.

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

Marginal note:Quality of documents

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

Marginal note:Providing documents

126 A pharmacist who is responsible for a pharmacy’s operations or, if a pharmacy 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:Conditions

127 A practitioner may issue a written prescription that they sign and date or a verbal prescription if

• The following provision is not in force.

  (a) the practitioner is treating, in their professional capacity, the individual for whom, or the animal for which, the prescription is issued; and

• The following provision is not in force.

  (b) the controlled substance set out in the prescription is needed to treat the individual’s or animal’s medical condition.

Marginal note:Sale to licensed dealer

• The following provision is not in force.

  128 (1) A practitioner may sell or provide a controlled substance 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 for the purposes of destruction,

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

    • (ii) the practitioner 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 (2); 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 practitioner, or

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

    • (ii) the practitioner first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (2).

• The following provision is not in force.

  Marginal note:Written orders

  (2) 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 practitioner, 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 4, 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) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Marginal note:Sale to Minister

129 A practitioner may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• The following provision is not in force.

  (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;

• The following provision is not in force.

  (b) with respect to the practitioner, 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 4, 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:Sale to individual

• The following provision is not in force.

  130 (1) A practitioner may sell or provide a controlled substance, other than a restricted drug, to an individual if

  • The following provision is not in force.

    (a) the sale or provision is for the individual’s own use, for the use of another individual or for an animal; and

  • The following provision is not in force.

    (b) the practitioner first issues a written prescription for the individual for whom, or the animal for which, the controlled substance is sold or provided.

• The following provision is not in force.

  Marginal note:Restricted drugs

  (2) A practitioner may sell or provide a restricted drug to an individual for their own use if

  • The following provision is not in force.

    (a) the practitioner is treating the individual in their professional capacity; and

  • The following provision is not in force.

    (b) the practitioner has received a copy of the letter of authorization in which they are named.

Marginal note:General condition

• The following provision is not in force.

  131 (1) A practitioner may administer a controlled substance, other than a restricted drug, to an individual or animal if the practitioner first issues a written prescription.

• The following provision is not in force.

  Marginal note:Restricted drugs

  (2) A practitioner may administer a restricted drug to an individual if

  • The following provision is not in force.

    (a) the practitioner is treating the individual in their professional capacity; and

  • The following provision is not in force.

    (b) the practitioner has received a copy of the letter of authorization in which they are named.

Marginal note:Emergency supply

• The following provision is not in force.

  132 (1) A practitioner of medicine who is responsible for an emergency supply must ensure that

  • The following provision is not in force.

    (a) the emergency supply does not contain a restricted drug; and

  • The following provision is not in force.

    (b) they have an agent or mandatary who is present at the place where the emergency supply is stored and who will, under their direction, administer the controlled substance under their control.

• The following provision is not in force.

  Marginal note:Administration — conditions

  (2) In an emergency, the agent or mandatary of the practitioner of medicine may administer a controlled substance from the emergency supply to an individual if

  • The following provision is not in force.

    (a) the practitioner of medicine has directed the agent or mandatary to administer the controlled substance; or

  • The following provision is not in force.

    (b) the agent or mandatary follows written directives provided by the practitioner of medicine with respect to the administration of the controlled substance.

Marginal note:Receipt of substance from individual

133 A practitioner who receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom the practitioner has authorized have access and that is marked in a manner that is sufficient to identify the container.

Marginal note:Authorized access

• The following provision is not in force.

  134 (1) Subject to subsection (2), a practitioner who stores a controlled substance must ensure that

  • The following provision is not in force.

    (a) they store the controlled substance in a secure location in the place where they practise; and

  • The following provision is not in force.

    (b) only persons whom the practitioner has authorized have access to that secure location.

• The following provision is not in force.

  Marginal note:Emergency supply

  (2) A practitioner of medicine who stores an emergency supply need only ensure that

  • The following provision is not in force.

    (a) they take all reasonable measures to ensure that the place of storage is secure; and

  • The following provision is not in force.

    (b) only the practitioner of medicine and their agent or mandatary have access to that secure place.

Marginal note:Authorization

135 A practitioner may deliver, send or transport a controlled substance.

Marginal note:Requirements during transportation

136 A practitioner who delivers, sends or transports a controlled substance to another person may only do so if they

• The following provision is not in force.

  (a) ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner that is sufficient to identify the container;

• The following provision is not in force.

  (b) take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and

• The following provision is not in force.

  (c) use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Marginal note:Protective measures

137 A practitioner must take all reasonable measures to ensure the security of any controlled substance in their possession.

Marginal note:Loss or theft — agent or mandatary

• The following provision is not in force.

  138 (1) If an agent or mandatary of a practitioner becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the practitioner immediately.

• The following provision is not in force.

  Marginal note:Written report

  (2) If a practitioner becomes aware of a loss or theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the practitioner must provide a written report to the Minister within 10 days after the day on which they become aware of the loss or theft or are notified.

• The following provision is not in force.

  Marginal note:Partial protection against self-incrimination

  (3) The report, or any evidence derived from it, is not to be used or received to incriminate the practitioner or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Marginal note:Conditions

• The following provision is not in force.

  139 (1) The destruction of a controlled substance may be carried out by a practitioner only if the following conditions are met:

  • The following provision is not in force.

    (a) the destruction is witnessed by another person among the following:

    • (i) a pharmacist, pharmacy technician or intern,

    • (ii) a practitioner, or

    • (iii) any other health professional;

  • The following provision is not in force.

    (b) 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

  • The following provision is not in force.

    (c) immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.

• The following provision is not in force.

  Marginal note:Exception — open ampule

  (2) A practitioner may, without a witness, destroy the remainder of a controlled substance that is contained in an open ampule and that will not be administered.

• The following provision is not in force.

  Marginal note:Substance returned by individual

  (3) A practitioner must, if the destruction of a controlled substance previously returned by an individual for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.

Marginal note:Scope

140 The requirements set out in sections 141 to 152 apply to a practitioner with respect to the following controlled substances:

• The following provision is not in force.

  (a) if the practitioner is not practising in a hospital, a narcotic, controlled drug or targeted substance; and

• The following provision is not in force.

  (b) a restricted drug.

Marginal note:Substances received

141 A practitioner who 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) 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.

  (b) the date of receipt;

• The following provision is not in force.

  (c) 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.

  (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.

Marginal note:Substances sold — persons other than individuals

142 A practitioner who sells or provides a controlled substance to a person, other than an individual referred to in section 143, must record

• The following provision is not in force.

  (a) the practitioner’s name;

• The following provision is not in force.

  (b) with respect to the person, 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 4, its name, form and quantity; and

• 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.

Marginal note:Substances prescribed, administered or sold — individuals

• The following provision is not in force.

  143 (1) A practitioner who conducts the following activities must record the information set out in subsection (2):

  • The following provision is not in force.

    (a) prescribe or administer a controlled substance to an individual or an animal; or

  • The following provision is not in force.

    (b) sell or provide a controlled substance to an individual for their own use, for the use of another individual or for an animal.

• The following provision is not in force.

  Marginal note:Information

  (2) The information that must be recorded is the following:

  • The following provision is not in force.

    (a) the practitioner’s name;

  • 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) in the case of an administration, sale or provision of a restricted drug to an individual, their name;

  • The following provision is not in force.

    (d) the date of the prescription, administration, sale or provision;

  • 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, form and quantity;

  • The following provision is not in force.

    (f) in the case of a finished product,

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

    • (ii) its form, strength and quantity,

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

    • (iv) if the finished product that is sold or provided, other than one containing a restricted drug, is intended for administration by the individual to themselves or the animal, and if the dose exceeds the following, a statement to that effect:

      • (A) in the case of a finished product containing a controlled drug or narcotic, three times the maximum daily dosage recommended by the producer of the product or, if the producer has not recommended a maximum daily dosage, three times the generally recognized maximum daily therapeutic dosage for that product, or

      • (B) in the case of a finished product containing a targeted substance, five times the usual daily dose for the product.

Marginal note:Emergency supply

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

• The following provision is not in force.

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

• The following provision is not in force.

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

• The following provision is not in force.

  (c) 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.

  (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;

• The following provision is not in force.

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

• The following provision is not in force.

  (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:

• The following provision is not in force.

  (a) their name; and

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (b) if an agent or mandatary of the practitioner delivers, sends or transports 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 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;

• The following provision is not in force.

  (d) the municipal address of the place where the controlled substance is 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) 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.

  (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:

• 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 place of destruction;

• 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 4, 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

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

• The following provision is not in force.

  (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;

• 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, 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

• The following provision is not in force.

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

• The following provision is not in force.

  (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.

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:

• The following provision is not in force.

  (a) a midwife;

• The following provision is not in force.

  (b) a podiatrist; and

• The following provision is not in force.

  (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:

• The following provision is not in force.

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

• The following provision is not in force.

  (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.

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

• The following provision is not in force.

  (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

• The following provision is not in force.

  (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:

• The following provision is not in force.

  (a) a pharmacist; or

• The following provision is not in force.

  (b) a practitioner.

Marginal note:Sale to licensed dealer

• The following provision is not in force.

  158 (1) A hospital 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 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

  • 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 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).

• The following provision is not in force.

  Marginal note:Restricted drugs

  (2) A hospital 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 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 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).

• 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 hospital, its name and municipal address;

  • 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,

    • (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) 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

• The following provision is not in force.

  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

  • The following provision is not in force.

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

  • The following provision is not in force.

    (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.

• The following provision is not in force.

  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

• The following provision is not in force.

  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

  • The following provision is not in force.

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

  • The following provision is not in force.

    (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.

• The following provision is not in force.

  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

• The following provision is not in force.

  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:

  • The following provision is not in force.

    (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;

  • The following provision is not in force.

    (b) with respect to the hospital selling or providing the controlled substance, its name and municipal address;

  • 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,

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

    • (iii) its drug identification number, if any; and

  • The following provision is not in force.

    (f) 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.

  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:

  • The following provision is not in force.

    (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;

  • The following provision is not in force.

    (b) with respect to the hospital selling or providing the controlled substance, its name and municipal address;

  • 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; 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:Sale to Minister

162 A hospital may sell or provide a controlled substance to the Minister if the hospital first receives from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• The following provision is not in force.

  (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;

• The following provision is not in force.

  (b) with respect to the hospital, its name and municipal address;

• 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; 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:Sale to individual

163 A hospital may sell or provide a controlled substance, other than a restricted drug, to an individual if

• The following provision is not in force.

  (a) the sale or provision is for the individual’s own use, for the use of another individual or for an animal; and

• The following provision is not in force.

  (b) a practitioner first issues a written or verbal prescription for the individual for whom, or the animal for which, the controlled substance is sold or provided.

Marginal note:Condition

164 A hospital may administer a controlled substance, other than a restricted drug, to an individual or animal if a practitioner first issues a written or verbal prescription.

Marginal note:Orders and prescriptions

• The following provision is not in force.

  165 (1) A hospital may compound a finished product, other than one containing a restricted drug, if it is for the purpose of fulfilling a prescription and,

  • The following provision is not in force.

    (a) if the finished product is compounded at the request of a practitioner, that practitioner first issues a written or verbal prescription; or

  • The following provision is not in force.

    (b) if the finished product is compounded at the request of one of the following persons, in the case of an emergency, the hospital first receives from that person either a written order that is signed and dated and that contains the information set out in subsection (2) or a verbal order:

    • (i) a pharmacist who is not practising in that hospital or another hospital,

    • (ii) a practitioner who is not practising in that hospital or another hospital, or

    • (iii) another hospital, if the order is placed by a person permitted to place an order on its behalf.

• The following provision is not in force.

  Marginal note:Written orders

  (2) 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 person placing the order,

    • (i) if they are a pharmacist, their name and the name and municipal address of the place where they practise,

    • (ii) if they are a practitioner, their name and the name and municipal address of the place where they practise, and

    • (iii) if it is another hospital, its name and municipal address, as well as the name of the person permitted to place the order on its behalf;

  • The following provision is not in force.

    (b) with respect to the hospital receiving the order, its name and municipal address;

  • The following provision is not in force.

    (c) the date of the order;

  • The following provision is not in force.

    (d) with respect to the finished product,

    • (i) its name, and

    • (ii) its form, strength and quantity; and

  • The following provision is not in force.

    (e) a declaration that they require the finished product for emergency purposes or, in the case of another hospital, a declaration from the person placing the order that the other hospital requires the finished product for emergency purposes.

Marginal note:Sale and compounding

166 A hospital that sells or provides a controlled substance or that compounds a finished product may, before the sale, provision or compounding, substitute a controlled substance for another controlled substance identified in a prescription, if it is authorized to do so under the laws of the province where the sale, provision or compounding takes place.

Marginal note:Orders

167 A hospital that receives an order from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the hospital.

Marginal note:Receipt of substance from individual

168 A hospital that receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom it has authorized have access and that is marked in a manner that is sufficient to identify the container.

Marginal note:Authorized access

169 A hospital that stores a controlled substance must ensure that

• The following provision is not in force.

  (a) the controlled substance is stored in a secure location in the hospital; and

• The following provision is not in force.

  (b) only persons whom it has authorized have access to that secure location.

Marginal note:Authorization

170 A hospital may deliver, send or transport a controlled substance.

Marginal note:Requirements during transportation

171 A hospital that delivers, sends or transports a controlled substance to another person may only do so if it

• The following provision is not in force.

  (a) ensures that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner that is sufficient to identify the container;

• The following provision is not in force.

  (b) takes all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and

• The following provision is not in force.

  (c) uses a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.

Marginal note:Protective measures

172 A hospital must take all reasonable measures to ensure the security of any controlled substance in its possession.

Marginal note:Loss or theft — agent or mandatary

• The following provision is not in force.

  173 (1) If an agent or mandatary of a hospital becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the hospital immediately.

• The following provision is not in force.

  Marginal note:Written report

  (2) If a hospital becomes aware of a loss or theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the hospital must provide a written report to the Minister within 10 days after the day on which it becomes aware of the loss or theft or is notified.

• The following provision is not in force.

  Marginal note:Partial protection against self-incrimination

  (3) The report, or any evidence derived from it, is not to be used or received to incriminate the hospital or its agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.