Short Title

1 These Regulations may be cited as the Narcotic Control Regulations.

Interpretation

2 In these Regulations,

Act

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

advertisement

advertisement means any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of a narcotic; (annonce)

common-law partner

common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year; (conjoint de fait)

competent authority

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

designated criminal offence

designated criminal offence means

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

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

• (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;

• (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or

• (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); (infraction désignée en matière criminelle)

designated drug offence

designated drug offence means

• (a) an offence against section 39, 44.2, 44.3, 48, 50.2 or 50.3 of the Food and Drugs Act, as those provisions read immediately before May 14, 1997,

• (b) an offence against section 4, 5, 6, 19.1 or 19.2 of the Narcotic Control Act, as those provisions read immediately before May 14, 1997,

• (c) an offence under Part I of the Act, except subsection 4(1), or

• (d) 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 (c); (infraction désignée en matière de drogue)

diacetylmorphine (heroin)

diacetylmorphine (heroin) includes the salts of diacetylmorphine; (diacétylmorphine (héroïne))

hospital

hospital means a facility

• (a) that is licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness, or

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

immediate container

immediate container means the container that is in direct contact with the narcotic. (contenant immédiat)

inspector

inspector[Repealed, SOR/97-227, s. 1]

international obligation

international obligation means an obligation in respect of a narcotic set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale)

licence

licence[Repealed, SOR/2004-237, s. 1]

licensed dealer

licensed dealer means the holder of a licence issued under section 9.2; (distributeur autorisé)

methadone

methadone includes the salts of methadone; (méthadone)

midwife

midwife has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (sage-femme)

Minister

Minister[Repealed, SOR/97-227, s. 1]

narcotic

narcotic means

• (a) any substance set out in the schedule or anything that contains the substance, or

• (b) in respect of a midwife, nurse practitioner or podiatrist, any substance set out in the schedule, or anything that contains the substance, that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations; (stupéfiant)

nurse practitioner

nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (infirmier praticien)

oral prescription narcotic

oral prescription narcotic[Repealed, SOR/85-588, s. 1]

permit

permit means a permit issued under section 10; (permis)

pharmacist

pharmacist

• (a) means a person who is registered and entitled under the laws of a province

  • (i) to practise pharmacy, and

  • (ii) to operate a pharmacy or dispensary

  and who is operating a pharmacy or dispensary and is practising pharmacy thereunder in that province, and

• (b) includes, for the purpose of sections 3, 31 to 39, subsections 44(1), 45(1) and (2), section 46 and subsections 65(3) and (4), a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province; (pharmacien)

podiatrist

podiatrist has the same meaning as in section 1 of the New Classes of Practitioners Regulations; (podiatre)

practitioner

practitioner[Repealed, SOR/97-227, s. 1]

prescription

prescription means, in respect of a narcotic, an authorization given by a practitioner that a stated amount of the narcotic be dispensed for the person named in the prescription; (ordonnance)

proper name

proper name, with reference to a narcotic, means the name internationally recognized for the narcotic or the name assigned to the narcotic in the latest edition of any generally recognized pharmacopoeia or compendium of drugs; (nom propre)

qualified person in charge

qualified person in charge means the individual with the qualifications specified in subsection 8.3(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)

Security Directive

Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time; (Directive en matière de sécurité)

test kit

test kit means an apparatus

• (a) that contains reagent systems or buffering agents or both,

• (b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and

• (c) the contents of which are not intended for administration to humans; (nécessaire d’essai)

verbal order

verbal order means an order given orally; (commande verbale)

verbal prescription narcotic

verbal prescription narcotic means medication that

• (a) contains in addition to a narcotic two or more medicinal ingredients other than a narcotic in a recognized therapeutic dose,

• (b) is not intended for parenteral administration, and

• (c) does not contain diacetylmorphine (heroin), hydrocodone, methadone, oxycodone or pentazocine. (stupéfiant d’ordonnance verbale)

written order

written order[Repealed, SOR/85-588, s. 1]

Possession

• 3 (1) A person is authorized to have a narcotic in his or her possession where the person has obtained the narcotic under these Regulations, in the course of activities performed in connection with the enforcement or administration of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that narcotic, and the person

  • (a) requires the narcotic for his business or profession and is

    • (i) a licensed dealer,

    • (ii) a pharmacist, or

    • (iii) a practitioner who is registered and entitled to practise in the province in which he has such possession;

  • (b) is a practitioner who is registered and entitled to practise in a province other than the province in which he has such possession and such possession is for emergency medical purposes only;

  • (c) is a hospital employee or a practitioner in a hospital;

  • (d) has obtained the narcotic, other than diacetylmorphine (heroin), for his own use

    • (i) from a practitioner,

    • (ii) pursuant to a prescription that is not issued or obtained in contravention of these Regulations, or

    • (iii) from a pharmacist pursuant to section 36;

  • (e) is a practitioner of medicine who received the narcotic pursuant to subsection 68(3) or (5) and his possession is for a purpose referred to in subsection 68(4) or (6);

  • (f) is an agent of a practitioner of medicine who received the narcotic pursuant to section 68(3) and his possession is for the purpose of complying with subsection 68(5);

  • (g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, peace officer or member of the technical or scientific staff of any department of the Government of Canada or of a province or university and such possession is for the purposes of and in connection with such employment;

  • (h) is a person other than a person referred to in paragraph (e) or (f), is exempted under section 56 of the Act with respect to the possession of that narcotic and whose possession is for a purpose set out in the exemption; or

  • (i) is a person referred to in paragraph 68(4)(b).

• (2) A person is authorized to have a narcotic in his possession where the person is acting as the agent for any person referred to in paragraphs (1)(a) to (e), (h) or (i).

• (2.1) A person is authorized to have a narcotic in his possession where

  • (a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(g); and

  • (b) the possession of the narcotic is for the purpose of assisting that person in the enforcement or administration of an Act or regulation.

• (3) [Repealed, SOR/2012-230, s. 15]

Test Kits Containing Narcotics

4 Any person may sell, possess or otherwise deal in a test kit that contains a narcotic if

• (a) a registration number has been issued for the test kit pursuant to section 6;

• (b) the test kit bears, on its external surface,

  • (i) the manufacturer’s name,

  • (ii) the trade name or trade mark, and

  • (iii) the registration number issued therefor pursuant to section 6;

• (c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

• (d) the registration number has not been cancelled pursuant to section 7.

5 The manufacturer of a test kit that contains a narcotic may apply for a registration number therefor by submitting to the Director an application containing

• (a) particulars of the design and construction of the test kit;

• (b) a detailed description of the narcotic and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

• (c) a statement of the proposed use of the test kit; and

• (d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.

6 Where, on application under section 5, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

• (a) contains a narcotic and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

• (b) contains such small quantities or concentrations of any narcotic substance as to have no significant drug abuse potential,

the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.

7 The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,

• (a) it is necessary to cancel the registration number in the interest of public health; or

• (b) the test kit for which the registration number is issued is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

Dealers’ Licences and Licensed Dealers

• 8 (1) Subject to these Regulations, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a narcotic.

• (2) No licensed dealer may import or export a narcotic without a permit.

8.1 A licensed dealer is authorized to have a narcotic in his possession for the purpose of exporting the narcotic from Canada if he has obtained the narcotic pursuant to these Regulations.

8.2 To be eligible for a dealer’s licence, a person must be

• (a) an individual who ordinarily resides in Canada;

• (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

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

• 8.3 (1) A licensed dealer

  • (a) shall designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to narcotics specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and

  • (b) may designate an alternate qualified person in charge who must work at the premises specified in the licence and have authority to replace the qualified person in charge when that person is absent.

• (2) The qualified person in charge and, if applicable, the alternate qualified person in charge

  • (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

  • (b) shall either

    • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or

    • (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

  • (c) shall not have been convicted, as an adult, within the preceding 10 years, of

    • (i) a designated drug offence,

    • (ii) a designated criminal offence, or

    • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

• 9 (1) To apply for a dealer’s licence, a person shall submit an application to the Minister containing

  • (a) if the licence is sought for

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

    • (ii) a corporation, the corporation’s name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer’s licence or intends to identify itself; and

    • (iii) the holder of a position mentioned in paragraph 8.2(c), the applicant’s name and the title of the position;

  • (b) the address, telephone number and, if applicable, the facsimile number and e-mail address for the premises to which the dealer’s licence would apply and, if different, the mailing address for the premises;

  • (c) the name, date of birth and gender of the individual in charge of the premises;

  • (d) with respect to the proposed qualified person in charge and, if applicable, the proposed alternate qualified person in charge,

    • (i) their name, date of birth and gender,

    • (ii) their academic qualifications, training and work experience relevant to their duties,

    • (iii) their hours of work at the premises,

    • (iv) their title at the premises,

    • (v) the name and title of their immediate supervisor at the premises, and

    • (vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;

  • (e) the name and gender of the individuals authorized to place an order for a narcotic on behalf of the applicant;

  • (f) the activities referred to in section 8 for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;

  • (g) in the case of a product or compound that contains a narcotic but is not a test kit and that would be made or assembled for or by the applicant,

    • (i) the brand name, if any, of each product or compound,

    • (ii) the narcotic in each product or compound,

    • (iii) the strength per unit of the narcotic in each product or compound,

    • (iv) the quantity or package sizes of each product or compound, and

    • (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and licence number of the other dealer;

  • (h) if the licence is sought to produce a narcotic other than a product or compound that contains a narcotic,

    • (i) the name of the narcotic to be produced,

    • (ii) the quantity that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and

    • (iii) if the narcotic would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other dealer;

  • (i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;

  • (j) a detailed description of the method that the applicant proposes to use for recording their narcotic transactions; and

  • (k) for any activity referred to in section 8, other than the activities described in paragraphs (g) and (h), the name of the narcotic and the purpose for carrying out the activity.

• (2) An application for a dealer’s licence must

  • (a) be signed by the individual in charge of the premises to which the licence would apply; and

  • (b) be accompanied by a statement signed by the individual in charge indicating that

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

    • (ii) the individual has the authority to bind the applicant.

• (3) An application for a dealer’s licence must be accompanied by

  • (a) declarations signed by the individual in charge of the premises to which the application applies, the proposed qualified person in charge and, if applicable, the proposed alternate qualified person in charge, stating that they have not been convicted, as an adult, during the preceding 10 years, of

    • (i) a designated drug offence,

    • (ii) a designated criminal offence, or

    • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

  • (b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the previous 10 years, of a designated drug offence or a designated criminal offence;

  • (c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;

  • (d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the proposed qualified person in charge and, if applicable, the proposed alternate qualified person in charge have the knowledge and experience required under paragraph 8.3(2)(a);

  • (e) if the proposed qualified person in charge or, if applicable, the proposed alternate qualified person in charge is not a pharmacist or a practitioner of medicine, dentistry or veterinary medicine registered with a provincial professional licensing authority, a copy of the person’s degree required under subparagraph 8.3(2)(b)(ii) and a copy of the course transcript for that degree;

  • (f) if the applicant’s name appears on the label of a product or compound that contains a narcotic, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations, for each product or compound to which the licence would apply; and

  • (g) if the applicant is a corporation, a copy of

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

    • (ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer’s licence or intends to identify itself.

• (4) The method proposed by the applicant under paragraph (1)(j) must

  • (a) allow for the recording of narcotic transactions in accordance with section 15; and

  • (b) permit the Minister to audit the activities of the licensed dealer with respect to narcotics.

• (5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing

  • (a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years;

  • (b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and

  • (c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.

9.1 The Minister may, on receiving an application made under these Regulations, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

9.2 Subject to section 9.4, the Minister shall, after examining the information and documents required under sections 9 and 9.1, issue a dealer’s licence that contains

• (a) the licence number;

• (b) the name of the holder of the licence or the title of the position they hold, as the case may be, or, if the holder of the licence is a corporation, its corporate name;

• (c) a list of the activities that are permitted;

• (d) the address of the premises at which the licensed dealer may carry on the permitted activities;

• (e) the name of the narcotic for which the activities are permitted;

• (f) the security level at the premises, determined in accordance with the Security Directive;

• (g) the effective date of the licence;

• (h) the expiry date of the licence, which may not be later than three years after its effective date;

• (i) any conditions to be met by the holder of the licence to

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

  • (ii) provide the security level referred to in paragraph (f), or

  • (iii) reduce the potential security, public health or safety hazard, including the risk of the narcotic being diverted to an illicit market or use;

• (j) in the case of a producer of a narcotic, the quantity of the narcotic that may be produced under the licence and the period during which that quantity may be produced; and

• (k) in the case of the maker or assembler of a product or compound that contains a narcotic but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:

  • (i) the licence number,

  • (ii) the brand name, if any, of each product or compound,

  • (iii) the narcotic in each product or compound,

  • (iv) the strength per unit of the narcotic in each product or compound, and

  • (v) the quantity or package sizes of each product or compound.

9.3 A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only narcotics specified in their licence.

• 9.4 (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if

  • (a) the applicant is not eligible under section 8.2;

  • (b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section 16;

  • (c) false or misleading information or false or falsified documents were submitted in or with the application;

  • (d) an activity for which the licence is requested would not be in compliance with an international obligation;

  • (e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a narcotic to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;

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

  • (g) the applicant is in contravention of or has contravened during the preceding 10 years,

    • (i) a provision of the Act or the regulations made or continued under it, or

    • (ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;

  • (h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a narcotic being diverted to an illicit market or use;

  • (i) the individual in charge of the premises, the proposed qualified person in charge or, if applicable, the proposed alternate qualified person in charge has been convicted, as an adult, within the preceding 10 years, of

    • (i) a designated drug offence,

    • (ii) a designated criminal offence, or

    • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

  • (j) the proposed method referred to in paragraph 9(1)(j) is not capable of recording narcotic transactions as required under section 15 or of permitting the Minister to audit the applicant’s activities with respect to narcotics in a timely manner; or

  • (k) the additional information required under section 9.1 has not been provided or is insufficient to process the application.

• (2) Unless it is necessary to do so to protect public health, safety or security, including preventing a narcotic from being diverted to an illicit market or use, the Minister shall not refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant

  • (a) does not have a history of non-compliance with the Act or any regulation made or continued under it; and

  • (b) has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

• 9.5 (1) To apply to renew a dealer’s licence, a licensed dealer shall submit to the Minister

  • (a) the information referred to in paragraphs 9(1)(a) to (k); and

  • (b) the following documents, namely,

    • (i) the documents referred to in paragraphs 9(3)(a) and (d) and, subject to subsection 9(5), the document referred to in paragraph 9(3)(b),

    • (ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph 9(3)(e), and

    • (iii) the original dealer’s licence that is to be renewed.

• (2) An application for renewal must

  • (a) be signed by the individual in charge of the premises to which the renewed dealer’s licence would apply; and

  • (b) be accompanied by a statement signed by the individual in charge indicating that

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

    • (ii) the individual in charge has the authority to bind the applicant.

• (3) Subject to section 9.4, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section 9.1, issue a renewed dealer’s licence that contains the information specified in paragraphs 9.2(a) to (k).

• 9.6 (1) To have its dealer’s licence amended, a licensed dealer shall submit to the Minister

  • (a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section 9 that are relevant to the proposed amendment; and

  • (b) the original dealer’s licence.

• (2) An application for amendment must

  • (a) be signed by the individual in charge of the premises to which the amended dealer’s licence would apply; and

  • (b) be accompanied by a statement signed by the individual in charge indicating that

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

    • (ii) the individual in charge has the authority to bind the applicant.

• (3) Subject to section 9.4, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the holder of the licence to

  • (a) ensure that an international obligation is respected;

  • (b) provide the security level referred to in paragraph 9.2(f) or the new level required as a result of the amendment being implemented; or

  • (c) reduce the potential security, public health or safety hazard, including the risk of the narcotic being diverted to an illicit market or use.

• 9.7 (1) A licensed dealer shall

  • (a) obtain the Minister’s approval before making any of the following changes, namely,

    • (i) a change relating to the security at the premises referred to in the dealer’s licence, or

    • (ii) the replacement or addition of

      • (A) the individual in charge of the premises to which the dealer’s licence applies,

      • (B) the qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer’s licence applies, and

      • (C) an individual authorized to place an order for a narcotic on behalf of the licensed dealer;

  • (b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in

    • (i) the application for the dealer’s licence under section 9,

    • (ii) the application to renew the dealer’s licence under section 9.5, or

    • (iii) the request for approval under paragraph (a); and

  • (c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in

    • (i) the application for the dealer’s licence under section 9,

    • (ii) the application to renew the dealer’s licence under section 9.5, or

    • (iii) the request for approval under paragraph (a).

• (2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:

  • (a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,

    • (i) the information specified in paragraph 9(1)(c), and

    • (ii) the declarations specified in paragraph 9(3)(a) and, subject to subsection 9(5), the documents specified in paragraphs 9(3)(b) and (c);

  • (b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer’s licence applies,

    • (i) the information specified in paragraph 9(1)(d), and

    • (ii) the documents specified in paragraphs 9(3)(a), (d) and (e) and, subject to section 9(5), the documents specified in paragraphs 9(3)(b) and (c); and

  • (c) in the case of the replacement or addition of an individual who is authorized to place an order for a narcotic on behalf of the licensed dealer, the individual’s name and gender.

9.8 The Minister shall revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.

• 9.9 (1) Subject to subsection (2), the Minister shall revoke a dealer’s licence in accordance with section 9.92 if

  • (a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;

  • (b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under these Regulations;

  • (c) the licensed dealer is no longer eligible under section 8.2; or

  • (d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises has been convicted, as an adult, within the preceding 10 years, of

    • (i) a designated drug offence,

    • (ii) a designated criminal offence, or

    • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or

  • (e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a narcotic to an illicit market or use.

• (2) Unless it is necessary to do so to protect public health, safety or security, including preventing a narcotic from being diverted to an illicit market or use, the Minister shall not revoke a dealer’s licence under paragraph (1)(a) or (b) if the licensed dealer

  • (a) has no history of non-compliance with the Act and the regulations made or continued under it; and

  • (b) has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

9.91 The Minister shall suspend a dealer’s licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a narcotic from being diverted to an illicit market or use.

• 9.92 (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under these Regulations, the Minister shall

  • (a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and

  • (b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation.

• (2) The suspension of a dealer’s licence under these Regulations takes effect as soon as the Minister notifies the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension.

• (3) A person who receives a notice of suspension referred to in subsection (2) may, within 10 days after receiving the notice, provide the Minister with reasons why the suspension of the licence is unfounded.

10 The Minister may, upon application therefor, issue a permit to any licensed dealer for the importation or exportation of a narcotic.

11 [Repealed, SOR/2004-237, s. 5]

12 Every licence or permit issued under these Regulations is subject to the condition that the licensed dealer will comply with the provisions of these Regulations.

13 The Minister shall revoke a permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.

• 13.1 (1) Subject to subsection (2), the Minister shall revoke a permit by taking the same measures as those set out in subsection 9.92(1) if

  • (a) any of paragraphs 9.9(1)(a) to (e) applies with respect to the dealer’s licence as it pertains to the narcotic to be imported or exported; or

  • (b) the import or export permit was issued on the basis of false or misleading information or false or falsified documents submitted in support of the application.

• (2) Unless it is necessary to do so to protect public health, safety or security, including preventing a narcotic from being diverted to an illicit market or use, the Minister shall not revoke a permit under paragraph 9.9(1)(a) or (b), or 13.1(1)(b) if the holder meets the conditions set out in paragraphs 9.9(2)(a) and (b).

• (3) The Minister may revoke a permit if the holder fails to comply with the decision of the Minister to suspend the permit under section 13.2 or if the situation giving rise to the suspension is not rectified.

• 13.2 (1) The Minister shall suspend a permit without prior notice if

  • (a) the dealer’s licence as it pertains to the narcotic to be imported or exported has expired or has been suspended or revoked;

  • (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;

  • (c) the Minister has reasonable grounds to believe that the continuation of the permit would present a risk of a narcotic being diverted to an illicit market or use; or

  • (d) the import or export would contravene the laws of the country of export or import, or a country of transit or transhipment.

• (2) A decision of the Minister to suspend a permit, takes effect as soon as the Minister notifies the holder of the decision and provides a written report of the reasons for the suspension.

• (3) A person whose permit is suspended under subsection (1) may, within 10 days after receiving the notice of suspension, provide the Minister with reasons why the suspension is unfounded.

• 14 (1) A dealer’s licence is valid until the earlier of

  • (a) the expiry date set out in the licence, and

  • (b) the revocation or suspension of the licence under section 9.8, 9.9 or 9.91.

• (2) A permit issued under section 10 is valid only for the particular importation or exportation in respect of which it was issued.

15 Every licensed dealer shall keep a record of the following:

• (a) the name and quantity of any narcotic received by the licensed dealer, the name and address of the person who sold or provided it and the date on which it was received;

• (b) the name, quantity and form of any narcotic sold or provided by the licensed dealer, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided;

• (c) the name and quantity of any narcotic used in the making or assembling of a product or compound containing that narcotic, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

• (c.1) the name and quantity of any narcotic produced and the date on which it was placed in stock; and

• (d) the name and quantity of any narcotic in stock at the end of each month.

• 16 (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

  • (a) the premises used or intended to be used in producing, making, assembling or storing a narcotic; and

  • (b) the process and conditions of the producing, making, assembling or storing.

• (2) [Repealed, SOR/2010-221, s. 9]

17 Every licensed dealer shall

• (a) furnish such information respecting the dealings of such person in any narcotic in such form and at such times as the Minister may require;

• (b) produce to an inspector any books, records or documents required to be kept by these Regulations;

• (c) permit an inspector to make copies of or to take extracts from such books, records and documents; and

• (d) permit an inspector to check all stocks of narcotics located on the premises described in the licence of the licensed dealer.

18 Every licensed dealer shall keep in the premises described in the licence full and complete records respecting any narcotic or transaction therein

• (a) for a period of at least two years; and

• (b) in a manner that will enable an audit to be made at any time of such records.

19 Every licensed dealer shall notify the Minister promptly of changes in the following:

• (a) [Repealed, SOR/2010-221, s. 10]

• (b) the premises in which a narcotic is produced, made, assembled or stored; and

• (c) the process and conditions of the producing, making, assembling or storing.

20 Every licensed dealer shall

• (a) provide such protection against loss or theft of any narcotic in his possession as may be required by the Minister; and

• (b) report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof.

21 A licensed dealer may only import into or export out of Canada a narcotic at the place specified in his permit.

22 A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any narcotic intended for export out of Canada.

• 23 (1) Except as provided in subsection (2), a licensed dealer shall, in taking delivery of a narcotic imported by him or in making delivery of a narcotic,

  • (a) take such steps as are necessary to ensure safekeeping of the said narcotic during transit; and

  • (b) use such method of transportation as will ensure an accurate record being kept of the narcotic and of the signatures of any persons having charge of the narcotic until it is delivered to the consignee.

• (2) A licensed dealer may deliver a verbal prescription narcotic by common carrier.

• 24 (1) No licensed dealer shall sell or provide a narcotic to any person except in accordance with this section and sections 27 and 28.

• (2) Subject to section 25, a licensed dealer may sell or provide any narcotic other than diacetylmorphine (heroin) or methadone to

  • (a) another licensed dealer;

  • (b) a pharmacist;

  • (c) a practitioner;

  • (d) a hospital employee or a practitioner in a hospital;

  • (e) a person exempted under section 56 of the Act with respect to the possession of that narcotic; or

  • (f) [Repealed, SOR/2010-221, s. 11]

• (2.1) For the purpose of subsection (2), for greater certainty, a licensed dealer may sell or provide a narcotic to a midwife, nurse practitioner or podiatrist only if the midwife, nurse practitioner or podiatrist is permitted to prescribe or possess the narcotic, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

• (3) Subject to section 25, a licensed dealer may sell or provide methadone to

  • (a) another licensed dealer;

  • (b) a pharmacist;

  • (c) a hospital employee;

  • (c.1) if practising in a hospital, a practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner;

  • (d) a person exempted under section 56 of the Act with respect to the possession of that narcotic; or

  • (e) [Repealed, SOR/2010-221, s. 11]

• (4) Subject to section 25, a licensed dealer may sell or provide diacetylmorphine (heroin) to

  • (a) another licensed dealer;

  • (b) a hospital employee, where that hospital provides care or treatment to persons;

  • (b.1) if practising in a hospital, a practitioner of medicine or dentistry, where that hospital provides care or treatment to persons; or

  • (c) a person exempted under section 56 of the Act with respect to the possession of that narcotic for a scientific purpose.

25 Subject to sections 26 and 36, no licensed dealer shall

• (a) sell or provide a narcotic, other than a verbal prescription narcotic, to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(a);

• (b) sell or provide a verbal prescription narcotic, other than a preparation mentioned in section 36, to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(b);

• (c) sell or provide a preparation mentioned in section 36 to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(c);

• (d) sell or provide a narcotic, other than a verbal prescription narcotic, to a practitioner named in a notice issued by the Minister under subsection 59(1); or

• (e) sell or provide a verbal prescription narcotic to a practitioner named in a notice issued by the Minister under subsection 59(1).

26 Section 25 does not apply to a licensed dealer to whom the Minister has issued a notice of retraction of the notice

• (a) under section 49, in respect of a pharmacist named in a notice issued by the Minister under subsection 48(1); or

• (b) under section 60, in respect of a practitioner named in a notice issued by the Minister under subsection 59(1).

• 27 (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer’s licence, sell or provide a narcotic other than diacetylmorphine (heroin) or methadone to a person referred to in subsection 24(2), sell or provide methadone to a person referred to in subsection 24(3) and sell or provide diacetylmorphine (heroin) to a person referred to in subsection 24(4) if the licensed dealer has, on the premises specified in the licence, received

  • (a) a written order,

  • (b) an order sent through a computer from a remote input device, or

  • (c) a verbal order for verbal prescription narcotics

  that specifies the name and quantity of the narcotic to be supplied.

• (2) A licensed dealer who has received an order referred to in paragraph (1)(a) may sell or provide a narcotic other than diacetylmorphine (heroin) or methadone to a person referred to in subsection 24(2), sell or provide methadone to a person referred to in subsection 24(3) and sell or provide diacetylmorphine (heroin) to a person referred to in subsection 24(4) if

  • (a) the order is signed and dated

    • (i) if the narcotic is to be sold or provided to a person referred to in paragraph 24(2)(a), (b), (c) or (e), 24(3)(a), (b), or (d), or 24(4)(a) or (c), by that person, or

    • (ii) if the narcotic is to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order; and

  • (b) the signature of the person referred to in paragraph (a), if unknown to the licensed dealer, has been verified.

• (3) A licensed dealer who has received an order referred to in paragraph (1)(b) or (c) may provide a narcotic to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.

• (3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in paragraph (1)(b) may provide methadone to the following persons, if the order has been placed by a practitioner exempted under section 56 of the Act with respect to methadone:

  • (a) a hospital employee; or

  • (b) if practising in a hospital, a practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner.

• (4) A licensed dealer may sell or provide a narcotic pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements of subsections (6) and (7).

• (5) A licensed dealer who has received a verbal order referred to in paragraph (1)(c), and has sold or provided a verbal prescription narcotic to a person referred to in paragraph 24(2)(b), (c) or (d), shall immediately record

  • (a) the name of the person to whom the verbal prescription narcotic was sold or provided;

  • (b) if the verbal prescription narcotic was provided to a hospital employee or a practitioner in a hospital, the name of the person who placed the order; and

  • (c) the date the order was received.

• (6) For the purposes of this section, a remote input device shall be a device for transmitting electronically orders for drugs, other than by voice communication, that

  • (a) contains a unique identifying code that can be related to the device and the pharmacist or practitioner in whose possession and care the remote input device has been placed;

  • (b) is in the possession and care of that pharmacist or practitioner; and

  • (c) is designed in such a way that the unique identifying code for the remote input device is an integral part of the circuitry and can only be modified by the dismantling of the device.

• (7) For the purposes of this section, a computer program shall be able to

  • (a) identify the remote input device, the name and address of the pharmacist or practitioner in whose possession and care the remote input device has been placed;

  • (b) identify the pharmacist or practitioner placing the order by means of a code unique to that pharmacist or practitioner;

  • (c) process separately and identify narcotics by the segregation of orders for those narcotics;

  • (d) detect unusual orders and thereby necessitate intervention by the licensed dealer; and

  • (e) necessitate manual intervention by the licensed dealer if one or more of the check procedures fails.

• (8) Where a licensed dealer has received an order referred to in paragraph (1)(b) from a pharmacist or practitioner, he shall, within five working days after filling the order, obtain and keep a receipt that includes

  • (a) the signature of the pharmacist or practitioner who received the narcotic;

  • (b) the date the pharmacist or practitioner received the narcotic; and

  • (c) the name and quantity of the narcotic.

• (9) If a licensed dealer has not obtained a receipt from a pharmacist or practitioner under subsection (8) within the time prescribed by that subsection, the dealer shall not, until after obtaining the receipt, sell or provide a narcotic to the pharmacist or practitioner pursuant to any further

  • (a) order sent through a computer from a remote input device referred to in paragraph (1)(b), or

  • (b) verbal order referred to in paragraph (1)(c) from that pharmacist or practitioner who placed the order for which no receipt has been received.

• 28 (1) No licensed dealer shall sell or provide a narcotic that is not a drug within the meaning of section 2 of the Food and Drugs Act, unless the narcotic is labelled in accordance with the Food and Drug Regulations.

• (2) No licensed dealer shall sell or provide a narcotic, other than a preparation described in section 36, unless the narcotic is securely packed in its immediate container. The container shall be sealed in such a manner that it cannot be opened without breaking the seal.

29 Section 28 does not apply to a test kit that contains a narcotic where a registration number has been issued for the test kit pursuant to section 6 and has not been cancelled pursuant to section 7.

Pharmacists

30 A pharmacist, upon receipt of a narcotic from a licensed dealer, shall forthwith enter in a book, register or other record maintained for such purposes, the following:

• (a) the name and quantity of the narcotic received;

• (b) the date the narcotic was received; and

• (c) the name and address of the person from whom the narcotic was received.

• 31 (1) No pharmacist shall sell or provide narcotics except in accordance with subsections (2), (2.1) and (3) and sections 34 to 36.

• (2) A pharmacist may sell or provide a narcotic other than methadone to a person

  • (a) if the person is exempted under section 56 of the Act with respect to the possession of that narcotic; or

  • (b) if the pharmacist has first received a written order or prescription therefor signed and dated by a practitioner and the signature of the practitioner, where not known to the pharmacist, has been verified by him.

• (2.1) For the purpose of subsection (2), for greater certainty, a pharmacist may sell or provide a narcotic to a midwife, nurse practitioner or podiatrist only if the midwife, nurse practitioner or podiatrist is permitted to prescribe or possess the narcotic, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

• (3) A pharmacist may sell or provide methadone to

  • (a) a licensed dealer;

  • (b) another pharmacist;

  • (c) a hospital employee;

  • (c.1) if practising in a hospital, a practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner;

  • (d) a person exempted under section 56 of the Act with respect to methadone; or

  • (e) a person from whom the pharmacist has received a written order or prescription therefor signed and dated by a practitioner of medicine who is exempted under section 56 of the Act with respect to methadone.

32 Subject to section 33 and despite subsections 31(2) and (3) and sections 34 to 36, no pharmacist shall

• (a) sell or provide a narcotic, other than a verbal prescription narcotic, to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(a);

• (b) sell or provide a verbal prescription narcotic, other than a preparation mentioned in section 36, to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(b);

• (c) sell or provide a preparation mentioned in section 36 to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(c);

• (d) dispense, sell or provide a narcotic, other than a verbal prescription narcotic, to a practitioner or fill a prescription or order for a narcotic, other than a verbal prescription narcotic, from a practitioner, named in a notice issued by the Minister under subsection 59(1); or

• (e) dispense, sell or provide a verbal prescription narcotic to a practitioner or fill a prescription or order for a verbal prescription narcotic from a practitioner, named in a notice issued by the Minister under subsection 59(1).

33 Section 32 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice

• (a) under section 49, in respect of a pharmacist named in a notice issued by the Minister under subsection 48(1); or

• (b) under section 60, in respect of a practitioner named in a notice issued by the Minister to under subsection 59(1).

34 Subject to section 39, a pharmacist may dispense a verbal prescription narcotic on receipt of a prescription or verbal order given by a person whom the pharmacist has taken reasonable precautions to determine is a practitioner.

• 35 (1) Subject to subsection (2), a pharmacist may provide a narcotic to an employee of a hospital or a practitioner in a hospital if the pharmacist receives a written order for the narcotic signed and dated by

  • (a) the pharmacist in charge of the dispensary of the hospital; or

  • (b) a practitioner who is authorized by the person in charge of the hospital to order the narcotic and who, in the case of methadone, is exempted under section 56 of the Act with respect to methadone.

• (2) Before providing a narcotic under subsection (1), the pharmacist receiving the order must know the signature on the order or verify it.

• 36 (1) Subject to subsection (2), a pharmacist may, without a prescription, sell or provide a preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if

  • (a) the preparation 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 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 the regular minimum single dose for each such ingredient; and

  • (b) there is legibly and conspicuously printed on the inner label and the outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations, a caution to the following effect:

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

• (2) No pharmacist shall sell or provide a preparation referred to in subsection (1) if the pharmacist has reasonable grounds to believe that the preparation is to be used for purposes other than recognized medical or dental purposes.

37 A pharmacist shall not use an order or prescription, written or verbal, to dispense a narcotic after the quantity of the narcotic specified in the order or prescription has been dispensed.

38 Where, pursuant to a written order or prescription, a pharmacist dispenses a narcotic, other than dextropropoxyphene or a verbal prescription narcotic, the pharmacist shall forthwith enter in a book, register or other record maintained for such purposes

• (a) the name and address of the person named in the order or prescription;

• (b) the name, quantity and form of the narcotic;

• (c) the name, initials and address of the practitioner who issued the order or prescription;

• (d) the name or initials of the pharmacist who sold or provided the narcotic;

• (e) the date on which the narcotic was sold or provided; and

• (f) the number assigned to the order or prescription.

39 A pharmacist shall, before dispensing a verbal prescription narcotic pursuant to a verbal order or prescription, make a written record thereof, setting forth

• (a) the name and address of the person named therein;

• (b) in accordance with the manner in which it is specified in the prescription, the name and quantity of such oral prescription narcotic or the narcotic and the other medicinal ingredients therein;

• (c) the directions for use given therewith;

• (d) the name, initials and address of the practitioner who issued the order or prescription;

• (e) the name or initials of the pharmacist who dispensed such oral prescription narcotic;

• (f) the date on which such oral prescription narcotic was sold or provided; and

• (g) the number assigned to the order or prescription.

• 40 (1) A pharmacist shall maintain a special narcotic prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions for narcotics dispensed and the written record of all verbal prescription narcotics dispensed pursuant to a verbal order or prescription as provided in section 39.

• (2) A pharmacist shall retain in his possession for a period of at least two years any records which he is required to keep by these Regulations.

41 A pharmacist shall

• (a) furnish such information respecting the dealings of the pharmacist in any narcotic in such form and at such times as the Minister may require;

• (b) make available and produce to an inspector upon request his special narcotic prescription file together with any books, records or documents which he is required to keep;

• (c) permit an inspector to make copies of or to take extracts from such files, books, records or documents; and

• (d) permit an inspector to check all stocks of narcotics on his premises.

42 A pharmacist shall report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof.

43 A pharmacist shall take all reasonable steps that are necessary to protect narcotics on his premises or under his control against loss or theft.

• 44 (1) No pharmacist shall prepare a narcotic unless the Minister has approved the formula thereof, and if such narcotic is a preparation described in section 36, has approved the label and the size of the container in which it will be sold.

• (2) A pharmacist who prepares a narcotic shall, in addition to all other records required to be kept, keep a record of the following:

  • (a) the kind and quantity of any narcotic used in the preparation;

  • (b) the name and quantity of the narcotic prepared; and

  • (c) the date that the prepared narcotic was placed in stock.

• (3) For the purposes of this section, “prepare” does not include the compounding of a narcotic pursuant to a prescription of a practitioner.

• 45 (1) A pharmacist may, on receiving a written order for a narcotic signed and dated by

  • (a) the licensed dealer who sold or provided the narcotic to the pharmacist, return that narcotic to that dealer; or

  • (b) another pharmacist, sell or provide such quantity of the narcotic to that other pharmacist as is specified in the order as being required for emergency purposes.

• (2) A pharmacist shall, immediately after returning, selling or providing a narcotic under subsection (1) or after receiving a narcotic under paragraph (1)(b) or subsection 65(4), enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions.

• (3) A pharmacist shall forthwith after removing, transporting or transferring a narcotic from his place of business to any other place of business operated by him notify the Minister setting out the details thereof.

46 The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act or these Regulations to the provincial professional licensing authority responsible for the registration or authorization of the person to practise their profession

• (a) in the province in which the pharmacist is registered or entitled to practise if

  • (i) the authority submits a written request that states the name and address of the pharmacist, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

  • (ii) the Minister has reasonable grounds to believe that the pharmacist has

    • (A) contravened a rule of conduct established by the authority,

    • (B) been found guilty in a court of law of a designated drug offence or of a contravention of these Regulations, or

    • (C) contravened a provision of these Regulations; or

• (b) in a province in which the pharmacist is not registered or entitled to practise, if the authority submits to the Minister

  • (i) a written request for information that states

    • (A) the name and address of the pharmacist, and

    • (B) a description of the information being sought, and

  • (ii) documentation that shows that the pharmacist has applied to that authority to practise in that province.

47 A pharmacist may make a written request to the Minister to send to the persons and authorities specified in subsection 48(3) a notice, issued under section 48, advising them of one or more of the following requirements:

• (a) recipients of the notice must not sell or provide a narcotic, other than a verbal prescription narcotic, to that pharmacist;

• (b) recipients of the notice must not sell or provide a verbal prescription narcotic, other than a preparation mentioned in section 36, to that pharmacist; and

• (c) the recipients of the notice must not sell or provide a preparation mentioned in section 36 to that pharmacist.

• 48 (1) In the circumstances described in subsection (2), the Minister must issue a notice to the persons and authorities specified in subsection (3) advising them that licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide to the pharmacist named in the notice one or more of the following:

  • (a) a narcotic, other than a verbal prescription narcotic;

  • (b) a verbal prescription narcotic, other than a preparation mentioned in section 36; or

  • (c) a preparation mentioned in section 36.

• (2) The notice must be issued if the pharmacist named in the notice has

  • (a) made a request to the Minister in accordance with section 47 to issue the notice;

  • (b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the pharmacist is practising and that provincial professional licensing authority has requested the Minister in writing to issue the notice; or

  • (c) been found guilty in a court of law of a designated drug offence or of an offence under these Regulations.

• (3) The notice must be issued to

  • (a) all licensed dealers;

  • (b) all pharmacies within the province in which the pharmacist named in the notice is registered and practising;

  • (c) the provincial professional licensing authority of the province in which the pharmacist named in the notice is registered or entitled to practise; and

  • (d) any interested provincial professional licensing authority in another province that has made a request to the Minister to issue the notice.

• (4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the pharmacist named in the notice

  • (a) has contravened any of the provisions of sections 30 to 45 or section 70;

  • (b) has, on more than one occasion, self-administered a narcotic, other than a verbal prescription narcotic, contrary to accepted pharmaceutical practice;

  • (c) has, on more than one occasion, self-administered a verbal prescription narcotic, other than a preparation mentioned in section 36, contrary to accepted pharmaceutical practice;

  • (d) has, on more than one occasion, provided or administered a narcotic, other than a verbal prescription narcotic, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice;

  • (e) has, on more than one occasion, provided or administered a verbal prescription narcotic, other than a preparation mentioned in section 36, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; or

  • (f) is unable to account for the quantity of narcotic for which the pharmacist was responsible under these Regulations.

• (5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until the Minister has

  • (a) consulted with the provincial professional licensing authority of the province in which the pharmacist to whom the notice relates is registered or entitled to practise;

  • (b) given that pharmacist an opportunity to present reasons why the notice should not be issued and considered those reasons; and

  • (c) considered

    • (i) the compliance history of the pharmacist in respect of the Act and the regulations made or continued under it, and

    • (ii) whether the actions of the pharmacist pose a significant security, public health or safety hazard, including the risk of the narcotic being diverted to an illicit market or use.

49 The Minister must provide the licensed dealers, pharmacies and licensing authorities who were issued a notice under subsection 48(1) with a notice of retraction of that notice if

• (a) in the circumstance described in paragraph 48(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was issued by the Minister; or

• (b) in a circumstance described in any of paragraphs 48(2)(b) and (c) and (4)(a) to (f), the pharmacist named in the notice has

  • (i) requested in writing that a retraction of the notice be issued, and

  • (ii) provided a letter from the provincial professional licensing authority of the province, in which the pharmacist is registered or entitled to practise, in which the authority consents to the retraction of the notice.

50 to 52 [Repealed, SOR/2003-134, s. 4]

Practitioners

• 53 (1) No practitioner shall administer a narcotic to a person or animal, or prescribe, sell or provide a narcotic for a person or animal, except as authorized under this section or the Marihuana Medical Access Regulations.

• (2) Subject to subsections (3) and (4), a practitioner may administer a narcotic to a person or animal, or prescribe, sell or provide a narcotic for a person or animal, if

  • (a) the person or animal is a patient under his professional treatment; and

  • (b) the narcotic is required for the condition for which the person or animal is receiving treatment.

• (3) No practitioner shall administer methadone to a person or animal, or prescribe, sell or provide methadone for a person or animal, unless the practitioner is exempted under section 56 of the Act with respect to methadone.

• (4) A practitioner of medicine, dentistry or veterinary medicine shall not administer diacetylmorphine (heroin) to an animal or to a person who is not an in-patient or out-patient of a hospital providing care or treatment to persons, and shall not prescribe, sell or provide diacetylmorphine (heroin) for an animal or such a person.

• 54 (1) A practitioner who sells or provides a narcotic to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the narcotic, keep a record showing the name and quantity of the narcotic sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided, if the quantity of the narcotic exceeds

  • (a) three times the maximum daily dosage recommended by the producer, maker or assembler of the narcotic for that narcotic; or

  • (b) three times the generally recognized maximum daily therapeutic dosage for the narcotic if the producer, maker or assembler has not recommended a maximum daily dosage

• (2) A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it.

55 A practitioner shall

• (a) furnish to the Minister on request such information respecting

  • (i) the use by the practitioner of narcotics received — including the administering, selling or providing of them to a person, and

  • (ii) the prescriptions for narcotics issued by the practitioner, as the Minister may require;

• (b) produce to an inspector on request any records that these Regulations require the practitioner to keep;

• (c) permit an inspector to make copies of such records or to take extracts therefrom;

• (d) permit an inspector to check all stocks of narcotics on the practitioner’s premises;

• (e) retain in his possession for at least two years any record that these Regulations require him to keep;

• (f) take adequate steps to protect narcotics in his possession from loss or theft; and

• (g) report to the Minister any loss or theft of a narcotic within 10 days of the practitioner’s discovery of the loss or theft.

56 [Repealed, SOR/2010-221, s. 14]

57 The Minister shall provide in writing any factual information about a practitioner that has been obtained under the Act or these Regulations to the provincial professional licensing authority responsible for the registration or authorization of the person to practise their profession

• (a) in the province in which the practitioner is registered or entitled to practise if

  • (i) the authority submits a written request that states the name and address of the practitioner, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

  • (ii) the Minister has reasonable grounds to believe that the practitioner has

    • (A) contravened a rule of conduct established by the authority,

    • (B) been found guilty in a court of law of a designated drug offence or of a contravention of these Regulations, or

    • (C) contravened a provision of these Regulations; or

• (b) in a province in which the practitioner is not registered or entitled to practise, if the authority submits to the Minister

  • (i) a written request for information that states

    • (A) the name and address of the practitioner, and

    • (B) a description of the information being sought, and

  • (ii) documentation that shows that the practitioner has applied to that authority to practise in that province.

58 A practitioner may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section 59, advising them of one or more of the following requirements:

• (a) recipients of the notice must not sell or provide a narcotic, other than a verbal prescription narcotic, to that practitioner;

• (b) recipients of the notice must not sell or provide a verbal prescription narcotic to the practitioner;

• (c) pharmacists practising in the notified pharmacies must not fill a prescription or order for a narcotic, other than a verbal prescription narcotic, written by that practitioner; or

• (d) pharmacists practising in the notified pharmacies must not fill a prescription or order for a verbal prescription narcotic from that practitioner.

• 59 (1) In the circumstances described in subsection (2), the Minister must issue a notice to the persons and authorities specified in subsection (3) advising them that

  • (a) licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide to the practitioner named in the notice a narcotic other than a verbal prescription narcotic, a verbal prescription narcotic, or both; or

  • (b) pharmacists practising in the notified pharmacies must not fill a prescription or order from the practitioner named in the notice for a narcotic other than a verbal prescription narcotic, a verbal prescription narcotic, or both.

• (2) The notice must be issued if the practitioner named in the notice has

  • (a) made a request to the Minister in accordance with section 58 to issue the notice;

  • (b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the practitioner is practising and that provincial professional licensing authority has requested the Minister in writing to issue the notice; or

  • (c) been found guilty in a court of law of a designated drug offence or of an offence under these Regulations.

• (3) The notice must be issued to

  • (a) all licensed dealers;

  • (b) all pharmacies within the province in which the practitioner named in the notice is registered and practising;

  • (c) the provincial professional licensing authority of the province in which the practitioner named in the notice is registered or entitled to practise;

  • (d) any interested provincial professional licensing authority in another province that has made a request to the Minister for the notice; and

  • (e) all pharmacies in an adjacent province in which a prescription or order from the practitioner named in the notice may be filled.

• (4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the practitioner named in the notice

  • (a) has contravened any of the provisions of section 53, 54 or 55 or paragraphs 70(a) and (b);

  • (b) has, on more than one occasion, self-administered a narcotic, other than a verbal prescription narcotic, under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted medical, dental or veterinary practice;

  • (c) has, on more than one occasion, self-administered a verbal prescription narcotic under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted medical, dental or veterinary practice;

  • (d) has, on more than one occasion, prescribed, provided or administered a narcotic, other than a verbal prescription narcotic, to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted medical, dental or veterinary practice;

  • (e) has, on more than one occasion, prescribed, provided or administered a verbal prescription narcotic to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted medical, dental or veterinary practice; or

  • (f) is unable to account for the quantity of narcotic for which the practitioner was responsible under these Regulations.

• (5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until the Minister has

  • (a) consulted with the provincial professional licensing authority of the province in which the practitioner to whom the notice relates is registered or entitled to practise;

  • (b) given that practitioner an opportunity to present reasons why the notice should not be issued and considered those reasons; and

  • (c) considered

    • (i) the compliance history of the practitioner in respect of the Act and the regulations made or continued under it, and

    • (ii) whether the actions of the practitioner pose a significant security, public health or safety hazard, including the risk of the narcotic being diverted to an illicit market or use.

60 The Minister must provide the licensed dealers, pharmacies and licensing authorities who were issued a notice under subsection 59(1) with a notice of retraction of that notice if

• (a) in the circumstance described in paragraph 59(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was issued by the Minister; or

• (b) in a circumstance described in any of paragraphs 59(2)(b) and (c) and (4)(a) to (f), the practitioner named in the notice has

  • (i) requested in writing that a retraction of the notice be issued, and

  • (ii) provided a letter from the provincial professional licensing authority of the province, in which the practitioner is registered or entitled to practise, in which the authority consents to the retraction of the notice.

61 and 62 [Repealed, SOR/2003-134, s. 5]

Hospitals

63 A person who is in charge of a hospital shall

• (a) keep or cause to be kept in a book, register or other record maintained for such purposes,

  • (i) the name and quantity of any narcotic received,

  • (ii) the name and address of the person from whom any narcotic was received and the date received,

  • (iii) the name and quantity of any narcotic used in the making or assembling of a product or compound containing that narcotic,

  • (iv) the name and quantity of any product or compound that was made or assembled and that contains that narcotic and the date on which the product or compound was made or assembled,

  • (v) the name of the patient for whom a narcotic, other than dextropropoxyphene or a verbal prescription narcotic, was dispensed;

  • (vi) the name of the practitioner ordering or prescribing a narcotic, other than dextropropoxyphene or a verbal prescription narcotic; and

  • (vii) the date a narcotic, other than dextropropoxyphene or a verbal prescription narcotic was ordered or prescribed and the form and quantity thereof;

• (b) maintain the recorded information in such form as to enable an audit to be made from time to time for a period of not less than two years from the making thereof;

• (c) take all necessary steps to protect narcotics in the hospital against loss or theft, and report to the Minister any loss or theft of narcotics within 10 days of his discovery thereof.

64 A person who is in charge of a hospital shall

• (a) furnish such information respecting the use of narcotics therein, in such form and at such times as the Minister may require;

• (b) produce to an inspector any books, records or documents required by these Regulations to be kept;

• (c) permit an inspector to make copies thereof or take extracts from such books, records and documents; and

• (d) permit an inspector to check all stocks of narcotics in the hospital.

• 65 (1) No person in charge of a hospital shall permit a narcotic to be sold, provided or administered except in accordance with this section.

• (2) Subject to subsection (5), on receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic other than diacetylmorphine (heroin) to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or the person in charge of the animal.

• (3) Subject to subsections (5) and (5.1), the person in charge of a hospital may permit a narcotic to be provided, for emergency purposes, to a hospital employee or practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.

• (4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic other than diacetylmorphine (heroin) to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

• (5) No person in charge of a hospital shall permit methadone to be sold, provided or administered under subsection (2) or (3) unless the prescribing or ordering practitioner is exempted under section 56 of the Act with respect to methadone.

• (5.1) No person in charge of a hospital shall permit a narcotic to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the narcotic or has been verified.

• (6) A person in charge of a hospital may permit a narcotic to be provided to a person who is exempted under section 56 of the Act with respect to the narcotic and who is employed in a research laboratory in the hospital for the purpose of research.

• (7) The person in charge of a hospital providing care or treatment to persons may permit diacetylmorphine (heroin) to be sold, provided or administered to a person under treatment as an in-patient or out-patient of the hospital on receipt of a prescription or a written order signed and dated by a practitioner of medicine or dentistry.

General

66 [Repealed, SOR/97-227, s. 3]

67 The Minister may, upon application therefor, issue a licence to any person who, in the opinion of the Minister, is qualified therefor, to cultivate, gather or produce opium poppy or marihuana for scientific purposes on such terms and conditions as the Minister deems necessary.

• 68 (1) and (2) [Repealed, SOR/99-124, s. 8]

• (3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a narcotic in their possession, provide or deliver the narcotic to

  • (a) a practitioner of medicine, or

  • (b) an agent of that practitioner where the agent is exempted under section 56 of the Act with respect to possession of that narcotic.

• (4) A practitioner of medicine who has received a narcotic pursuant to subsection (3) shall forthwith

  • (a) for the purpose of its identification or analysis, provide or deliver the narcotic to a person exempted under section 56 of the Act with respect to the possession of that narcotic for that purpose; or

  • (b) deliver that narcotic to the Minister or his agent.

• (5) An agent of a practitioner of medicine who has received a narcotic under subsection (3) shall immediately provide or deliver the narcotic

  • (a) to the practitioner of whom he is the agent, or

  • (b) to the Minister or his agent.

• (6) A practitioner of medicine who has received, pursuant to subsection (5), a narcotic from his authorized agent shall forthwith

  • (a) for the purpose of its identification or analysis, provide or deliver the narcotic to a person exempted under section 56 of the Act with respect to the possession of that narcotic for that purpose; or

  • (b) deliver that narcotic to the Minister or his agent.

69 Every person who is exempted under section 56 of the Act with respect to the possession of a narcotic, other than a person to whom a narcotic has been administered, sold, delivered or provided by a practitioner of medicine exempted under section 56 of the Act from the application of any subsection of section 53 with respect to that narcotic, every practitioner of medicine who has received a narcotic under subsection 68(3) or (5) and every agent of a practitioner of medicine who has received a narcotic under subsection 68(3) shall

• (a) keep and retain for a period of two years from the date of the making of the record, a record of

  • (i) the kind, date and quantity of any narcotic purchased or received by him,

  • (ii) the name and address of the person from whom the narcotic was received, and

  • (iii) particulars of the use to which the narcotic was put; and

• (b) furnish such information respecting such narcotics as the Minister may require, and shall permit access to the records required to be kept by these Regulations.

70 No person shall

• (a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol “N” is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof;

• (b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or

• (c) advertise in a pharmacy a preparation referred to in section 36.

71 Any person who violates any provision of these Regulations is guilty of an offence and is liable on summary conviction to a fine not exceeding $500 or to a term of imprisonment not exceeding six months, or to both.

• 72 (1) For the purposes of subsection 24(1) of the Act, notification shall be given in writing to the Attorney General by registered mail.

• (2) The notice referred to in subsection (1) shall be mailed at least 15 clear days prior to the date the application will be made to the magistrate and shall specify

  • (a) the magistrate to whom the application will be made;

  • (b) the time and place where the application will be heard;

  • (c) the narcotic or other thing in respect of which the application is being made; and

  • (d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the narcotic or other thing referred to in paragraph (c).

• 73 (1) The following definitions apply in this section,

  member

  member means any person who is registered, certified or otherwise licensed by a nursing statutory body for the practice of nursing; (membre)

  nursing statutory body

  nursing statutory body means any provincial professional licensing authority that, under the laws of that province, registers, certifies or otherwise licenses a person for the practice of nursing. (organisme régissant la profession d’infirmier)

• (2) The Minister may communicate to a nursing statutory body any information obtained under the Act or these Regulations that involves any member of that body.

• (3) Subsection (2) does not apply to a nurse practitioner.

74 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act, the member or person is, in respect of that conduct, exempt from the application of these Regulations.