PART 3
PRACTITIONERS

To patients only

58. A practitioner may, with respect to a targeted substance, prescribe it for or administer it to an individual or animal, or sell, provide, send, deliver or transport it to or for an individual or for the benefit of an animal, only if

(a) the individual or animal is a patient that the practitioner is treating in their professional capacity; and

(b) the targeted substance is required to treat the individual's or animal's medical condition.

Emergency supply

59. (1) A practitioner of medicine may store an emergency supply of targeted substances at a remote location where emergency medical treatment is not readily available or in an emergency medical service vehicle, if the practitioner has an agent at that location or in the vehicle who will control and administer the targeted substances on behalf of, and under the direction of, the practitioner.

Emergency use

(2) When aid is being provided to an individual in an emergency, the agent of the practitioner of medicine may administer a targeted substance from the emergency supply to the individual if

(a) a practitioner of medicine has, by telephone or other means, directed the agent to administer the targeted substance; or

(b) the agent follows written directives provided by the practitioner with respect to the administration of the targeted substance.

Records -- practitioner

60. (1) A practitioner must keep the following records:

(a) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name, the quantity and strength per unit of any targeted substance received from a licensed dealer, pharmacist or hospital and the date on which it is received;

(b) the name and address of the licensed dealer, pharmacist or hospital that sold or provided the targeted substance;

(c) if a transaction involves a quantity of targeted substance that exceeds five times the usual daily dose for the substance, the disposition of the targeted substance and the date of its disposition; and

(d) in the case of an emergency supply referred to in subsection 59(1), the name of the administering agent, the location of the emergency supply, the name, quantity and strength per unit of each targeted substance, the date of all transactions related to that emergency supply and the name of the individual to whom the targeted substance was administered.

Records -- agent

(2) In respect of the administration of a targeted substance from an emergency supply referred to in subsection 59(1), the agent of the practitioner must keep the following records:

(a) the name, strength per unit and quantity of each targeted substance administered and the date on which it was administered;

(b) the name of the individual to whom the targeted substance was administered; and

(c) the name of the agent of the practitioner who administered the targeted substance.

Obligations -- agents

61. (1) An agent of a practitioner of medicine referred to in subsection 59(1) must

(a) take reasonable steps to protect any targeted substance in their possession from loss and theft; and

(b) inform the practitioner without delay of any loss or theft of a targeted substance.

Obligations -- practitioner of medicine

(2) A practitioner of medicine who is informed by their agent of loss or theft of a targeted substance must inform the Minister in accordance with section 7.

Request for renunciation

62. A practitioner who does not wish to receive or have possession of targeted substances may make a written request to the Minister to send to licensed dealers and pharmacies a notice issued under section 79 that states that

(a) recipients of the notice must not sell or provide any targeted substance to that practitioner; and

(b) pharmacists practising in the notified pharmacies must not fill a prescription or order for any targeted substance written by that practitioner.

PART 4
HOSPITALS

Authorization

63. (1) A hospital may, in accordance with this Part, sell, provide, administer, send, deliver or transport a targeted substance.

Ordering targeted substances

(2) No person may order a targeted substance on behalf of a hospital other than a pharmacist or practitioner practising in the hospital who is authorized by the person in charge of the hospital to order targeted substances for the hospital.

Provision or administration to a patient

64. The person in charge of a hospital must not permit a targeted substance to be sold, provided or administered to a patient or animal under treatment as an in-patient or an out-patient of the hospital except pursuant to a prescription or other authorization of a practitioner practising in the hospital.

Supply to non-patients

65. (1) A pharmacist practising in a hospital or an individual who is authorized by the person in charge of a hospital to fill orders for targeted substances on behalf of the hospital may, on receipt of an order specifying the name, quantity and, if applicable, strength per unit of a targeted substance from any of the following persons, sell or provide the targeted substance to that person without a prescription:

(a) subject to subsection (2),

(i) a licensed dealer who

(A) sold or provided the substance, or

(B) is licensed to destroy targeted substances other than those that the licensed dealer produced, made, assembled, sold or provided,

(ii) a practitioner, if the practitioner states that the substance is required because of a delay or shortfall in an order for the substance placed with a licensed dealer or pharmacist,

(iii) a pharmacist, if the pharmacist states that the substance is required because of a delay or shortfall in an order for the substance placed with a licensed dealer, or

(iv) another hospital, if the order is placed by a pharmacist practising in the other hospital or a practitioner who is authorized to order the targeted substance on behalf of the other hospital and the order states that the substance is required because of a delay or shortfall in an order placed with a licensed dealer or a pharmacist;

(b) the Minister, if the order is a written order signed on the Minister's behalf; and

(c) a person to whom an exemption with respect to the targeted substance has been granted under section 56 of the Act, if

(i) the person is an employee of or associated with the hospital, and

(ii) the order is a written order accompanied by a copy of the exemption.

Verbal orders

(2) In the circumstances set out in paragraph (1)(a), if the order is verbal, the pharmacist practising in the hospital or the individual who is authorized by the person in charge of the hospital to fill orders for the targeted substance on behalf of the hospital must, before filling the order, record the following information:

(a) the date on which the order was received;

(b) the name and address of the person placing the order;

(c) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name;

(d) the quantity of the targeted substance ordered; and

(e) their name.

Information

66. The person in charge of a hospital must record, or cause to be recorded, the following information:

(a) the brand name or, if the targeted substance does not have a brand name, the specified name, the quantity of any targeted substance received by the hospital and the date on which it was received;

(b) the name and address of the licensed dealer, pharmacist or other hospital that sold or provided the targeted substance;

(c) the disposition of the targeted substance and the date of its disposition; and

(d) the name and address of any out-patient to whom a targeted substance is sold or provided under section 64.

Closure

67. Where a hospital closes or the pharmacy department within a hospital is closed, in which a targeted substance has been stored, the person in charge of the hospital must, not later than 10 days after the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved.

PART 5
INDIVIDUALS

Importation -- Canadian residents

68. (1) An individual who is a resident of Canada may, at the time of the individual's return to Canada from a foreign country, import a targeted substance that is in their possession at the time of entry if

(a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

(b) the individual is importing the substance

(i) for their own use,

(ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

(iii) for the use of an animal for which the individual is responsible and which is travelling with them;

(c) the substance is imported to meet the medical needs of the individual or animal for whose benefit it is prescribed;

(d) the substance is declared to a customs office at the port of entry into Canada at the time of import; and

(e) the quantity being imported does not exceed the lesser of

(i) a single course of treatment, and

(ii) a 90-day supply, based on the usual daily dose.

Importation -- foreign residents

(2) An individual who is a resident of a foreign country may, at the time that the individual enters Canada, import a targeted substance that is in their possession at the time of entry if

(a) the requirements set out in paragraphs (1)(a) to (d) are met; and

(b) the quantity imported is the least of

(i) the content of the container,

(ii) a 90-day supply, based on the usual daily dose, and

(iii) the usual daily dose multiplied by the number of days that the individual will stay in Canada.

Export

69. An individual may, at the time of their departure from Canada, export a targeted substance that is in their possession at the time of departure if

(a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

(b) the individual is exporting the substance

(i) for their own use,

(ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

(iii) for the use of an animal for which the individual is responsible and which is travelling with them;

(c) the substance is required to meet the medical needs of the individual or animal for whose benefit it is prescribed; and

(d) the quantity exported does not exceed the lesser of

(i) a single course of treatment, and

(ii) a 90-day supply, based on the usual daily dose.

PART 6
TEST KITS

Authorization

70. (1) A person may sell, provide, send, deliver, transport, import or export a test kit if

(a) a registration number has been issued for the test kit under subsections 72(1) or 75(2) and the number has not been cancelled under section 74;

(b) the test kit is labelled with

(i) the registration number, and

(ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,

(A) the name and address of the maker or assembler or, in the case where the test kit is made or assembled pursuant to a custom order, the name and address of the person for whom the test kit was custom made or assembled, and

(B) a brand name; and

(c) the test kit is sold, provided, sent, delivered, transported, imported or exported for a medical, laboratory, industrial, educational, law enforcement or research purpose.

Individual

(2) A person who does not hold a dealer's licence may possess a test kit that contains a targeted substance set out in Part 2 of Schedule 1 if the test kit is labelled with its registration number.

Application for a registration number

71. (1) To apply for a registration number, a person who makes or assembles a test kit that contains a targeted substance or, in the case where the test kit is made or assembled pursuant to a custom order, the person for whom the test kit was made or assembled must submit the following information to the Minister:

(a) the brand name of the test kit;

(b) the proposed use and a description of the design of the test kit;

(c) a detailed description of the targeted substance contained in the test kit, including

(i) the specified name for the substance,

(ii) if the substance is a salt, the name of the salt, and

(iii) the quantity of the substance;

(d) a detailed description of each other substance contained in the test kit, including

(i) the name of each substance,

(ii) if the substance is a salt, the name of the salt, and

(iii) the quantity of each substance; and

(e) the directions for use of the test kit.

Attestation of signatory

(2) An application for the registration of a test kit must

(a) be signed by an individual authorized by the applicant for that purpose; and

(b) indicate that all the information submitted in support of the application is correct and complete to the best of the signatory's knowledge.

Issuance of a registration number

72. (1) Subject to subsection (2), the Minister must, after examining the information and documents required under sections 11 and 71, issue a registration number for the test kit to the applicant if the applicant demonstrates that the test kit is designed to be used solely for a medical, laboratory, industrial, educational, law enforcement or research purpose.

Refusal

(2) The Minister must refuse to issue a registration number if the Minister has reasonable grounds to believe that

(a) the test kit poses a significant security, public health or safety hazard, including the risk of the targeted substance in the test kit being diverted to an illicit market or use, because

(i) the total amount of the targeted substance in the test kit is too high, or

(ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption of the targeted substance in the test kit by a human or animal or the administration of that substance to a human or animal; or

(b) the test kit is likely to be used for a purpose other than those set out in subsection (1).

Effect of the registration number

73. The requirement in subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations that a symbol be displayed on the label of a targeted substance does not apply to a test kit that contains a targeted substance if a registration number has been issued under subsection 72(1) or 75(2) for that test kit and is displayed on the label.

Cancellation

74. (1) The Minister must cancel the registration number of a test kit if

(a) the Minister receives a notice from the holder of the registration number stating that it has ceased all activities referred to in section 70 with respect to the test kit;

(b) the test kit is a medical device and is no longer approved for sale in Canada under the Medical Devices Regulations; or

(c) there exists a reason set out in paragraph 72(2)(a).

Non-compulsory cancellation

(2) The Minister may cancel the registration number of a test kit if the Minister determines that the test kit is being used for a purpose other than a medical, laboratory, industrial, educational, law enforcement or research purpose and, after considering the nature and extent of that other purpose, concludes that it poses a significant security, public health or safety hazard, including the risk of the targeted substance being diverted to an illicit market or use.

Effect of cancellation

(3) When a registration number issued for a test kit is cancelled, the cancelled registration number

(a) must not be displayed on the label of any test kit made or assembled after the cancellation; and

(b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of.

Application for a new number

75. (1) If a registration number issued for a test kit has been cancelled under subsection 74(1) or (2), the maker or assembler of the test kit or, where the test kit is made or assembled pursuant to a custom order, the person for whom the test kit was custom made or assembled

(a) may, after a period of 90 days following the cancellation, apply to the Minister for the issuance of a new registration number; and

(b) must, in support of the application, provide the Minister with proof that the circumstance that gave rise to the cancellation has been corrected.

New number

(2) The Minister, after examining the application and supporting proof referred to in subsection (1), must issue a new registration number for the test kit unless there exists a circumstance set out in paragraph 74(1)(b) or (c) or subsection 74(2).

Notice to the Minister

76. The holder of a registration number for a test kit issued under subsection 72(1) or 75(2) must inform the Minister in writing, within 30 days after the event, if they have

(a) ceased all activities referred to in section 70 with respect to the test kit;

(b) transferred the making or assembly of the test kit to another person;

(c) increased the quantity of targeted substance in the test kit;

(d) changed the brand name of the test kit;

(e) altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or

(f) substituted a new adulterating or denaturing agent.

PART 7
TARGETED SUBSTANCES IN TRANSIT OR TRANSHIPMENT

Application

77. (1) If a targeted substance is being shipped from one country of export to another country of export by a route that requires it to be in transit through Canada or to be transhipped in Canada, the exporter in the country of export or an agent in Canada of that exporter must apply to the Minister for a permit for transit or transhipment by providing the following information:

(a) the name, address and telephone number of the exporter in the country of export;

(b) the name, address and telephone number of the person who will be responsible for the targeted substance while it is in Canada;

(c) with respect to the targeted substance for which the permit is requested,

(i) its specified name,

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

(iii) if applicable, its brand name,

(iv) the quantity,

(v) in the case of a raw material, its purity, and

(vi) if applicable, its anhydrous content;

(d) the expected date of transit or transhipment in Canada;

(e) the name of the Canadian port of entry and exit;

(f) each mode of transportation that is to be used in Canada for the targeted substance; and

(g) in the case of a transhipment, the address, if applicable, of every place in Canada at which the targeted substance will be stored during the transhipment and the expected duration of each storage.

Supporting documentation

(2) An application referred to in subsection (1) must be accompanied by

(a) a copy of the export permit issued by a competent authority in the country of export; and

(b) a copy of the import permit issued by a competent authority in the country of final destination.

Attestation of signatory

(3) An application referred to in subsection (1) must

(a) be signed by a person who is authorized for that purpose by the exporter, including an agent in Canada of that exporter; and

(b) state that all the information submitted in support of the application is correct and complete to the best of the signatory's knowledge.

Permit for transit or transhipment

78. (1) Subject to subsection (2), after examining the information and documents required under sections 11 and 77, the Minister must issue a permit for transit or transhipment that contains the following information:

(a) the name, address and telephone number of the exporter in the country of export;

(b) the name, address and telephone number of the person who is responsible for the targeted substance while it is in Canada;

(c) the specified name, quantity, purity and strength per unit of the targeted substance;

(d) the countries of export and final destination and the numbers and expiry dates of the export and import permits issued by a competent authority in each of those countries;

(e) the expected date of the transit or transhipment in Canada;

(f) the names of the Canadian ports of entry and exit;

(g) each mode of transportation that is to be used for the targeted substance while in Canada;

(h) in the case of a transhipment, the address, if applicable, of every place in Canada at which the targeted substance may be stored during the transhipment and the duration of each storage; and

(i) the dates of issuance and expiry of the permit.

Refusal to issue a permit

(2) The Minister must refuse to issue a permit for transit or transhipment if the Minister has reasonable grounds to believe that

(a) the issuance of the permit

(i) would not be in conformity with an international obligation,

(ii) would be in contravention of the Act, the regulations, another Act of Parliament, or a law of the country of export, of the country of final destination or of a country of transit or transhipment, or

(iii) could pose a significant security, public health or safety hazard, including the risk of the targeted substance being diverted to an illicit market or use; or

(b) the import permit issued by a competent authority in the country of final destination has expired or has been suspended or revoked.

PART 8
MINISTER

Notice to cease providing targeted substances

79. (1) In the circumstances set out 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 working in the notified pharmacies must not sell or provide any targeted substance to the pharmacist or practitioner named in the notice;

(b) pharmacists working in the notified pharmacies must not fill a prescription or order for any targeted substance written by the practitioner named in the notice; or

(c) both paragraphs (a) and (b) apply with respect to the practitioner named in the notice.

Circumstances

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

(a) made a request to the Minister in accordance with subsection 57(1) or section 62, as the case may be, to issue the notice;

(b) contravened a rule of conduct established by the licensing authority of the province in which the pharmacist or practitioner is practising and that 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 substance offence or of an offence under these Regulations.

Recipients

(3) The notice must be issued to

(a) all licensed dealers;

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

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

(d) any interested licensing authority in another province; and

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

Other circumstances

(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 or practitioner named in the notice

(a) has contravened a provision of the Act or the regulations;

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

(c) has, on more than one occasion, prescribed, provided or administered a targeted substance to a spouse, parent or child, contrary to accepted pharmaceutical, medical, dental or veterinary practice; or

(d) is unable to account for a quantity of targeted substance for which the pharmacist or practitioner was responsible under these Regulations.

Measures before issuance

(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 licensing authority of the province in which the pharmacist or practitioner to whom the notice relates is registered or entitled to practise;

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

(c) considered

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

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

Retraction

80. The Minister must provide the licensed dealers, pharmacies and licensing authorities who were sent a notice under subsection 79(1) with a retraction of that notice if

(a) in the circumstance described in paragraph 79(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or

(b) in the circumstance described in any of paragraphs 79(2)(b) and (c) and (4)(a) to (d), the pharmacist or 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 licensing authority of the province in which the pharmacist or practitioner is registered or entitled to practise in which the authority consents to the retraction of the notice.

Provision of information

81. The Minister may provide in writing any factual information about a pharmacist, a practitioner or a nurse that has been obtained under the Act or these Regulations to the licensing authority responsible for the registration or authorization of the person to practise their profession

(a) in the province in which the pharmacist, practitioner or nurse is registered or entitled to practise if

(i) the authority submits a written request that sets out the name and address of the pharmacist, practitioner or nurse, 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, practitioner or nurse has

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

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

(C) in the case of a pharmacist or practitioner, done any act that the Minister, on reasonable grounds, believes contravenes a provision of these Regulations; or

(b) in a province in which the pharmacist, practitioner or nurse 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, practitioner or nurse, and

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

(ii) documentation that shows that the pharmacist, practitioner or nurse has applied to that authority to practise in that province.

PART 9
COMING INTO FORCE

Coming into force

82. (1) Subject to subsection (2), these Regulations come into force on September 1, 2000.

Exception

(2) Subparagraph 3(b)(ii), paragraphs 20(1)(h) and 21(f), subparagraph 21(i)(ii), paragraph 22(f), subparagraphs 25(3)(b)(ii) and 26(1)(a)(i) and section 73 come into force on September 1, 2001.

SCHEDULE 1
(Subsection 1(1), section 4 and subsections 15(1), 20(1) and 70(2))

PART 1
LIST OF CLASS 1 TARGETED SUBSTANCES

PART 2
LIST OF CLASS 2 TARGETED SUBSTANCES

SOR/2003-38, s. 3.

SCHEDULE 2
(Subsection 1(1)))
SPECIFIED NAMES OF TARGETED SUBSTANCES

SOR/2003-38, s. 4.