Contents
- Her Excellency the Governor General in Council, on the rec…
- Interpretation
- General
- Possession
- Licensed Dealers
- Pharmacists and Pharmacy Technicians
- Practitioners
- Hospitals
- Minister
- Government Laboratories
- Particular Persons
- Individuals
- Test Kits
- Miscellaneous Provisions
- Repeals
- Coming into Force
- Schedule 1 Narcotics (Subsection 1(1), paragraphs 5(1)(a), 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 57(1)(d), 58(1)(d), 59(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 92(3)(d), 93(1)(d) and (2)(e), 94(1)(d), 95(d), 97(d), 111(d), 112(d), 117(d), 120(g), 121(f), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e) and 144(c), subparagraph 144(f)(ii), paragraphs 146(f), 147(f), 154(a) and 158(3)(d), subparagraphs 159(1)(b)(iv) and 160(1)(b)(iv), paragraphs 161(1)(d) and (2)(d), 162(d), 175(d), 176(d), 177(d), 181(d), 182(g), 183(f), 205(1)(g), 210(d), 213(1)(g) and 218(d), sections 225 and 226 and paragraph 229(1)(c))
- Schedule 2 Controlled Drugs (Subsection 1(1), section 3, paragraphs 5(1)(b), 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 57(1)(d), 58(1)(d), 59(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 92(3)(d), 93(1)(d) and (2)(e), 94(1)(d), 95(d), 97(d), 111(d), 112(d), 117(d), 120(g), 121(f), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e) and 144(c), subparagraph 144(f)(ii), paragraphs 146(f), 147(f), 154(b) and 158(3)(d), subparagraphs 159(1)(b)(iv) and 160(1)(b)(iv), paragraphs 161(1)(d) and (2)(d), 162(d), 175(d), 176(d), 177(d), 181(d), 182(g), 183(f), 205(1)(g), 210(d), 213(1)(g) and 218(d), sections 225 and 226 and paragraph 229(1)(c))
- Schedule 3 Targeted Substances (Subsection 1(1), paragraphs 5(1)(c), 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 57(1)(d), 58(1)(d), 59(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 92(3)(d), 93(1)(d) and (2)(e), 94(1)(d), 95(d), 97(d), 111(d), 112(d), 117(d), 120(g), 121(f), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e) and 144(c), subparagraph 144(f)(ii), paragraphs 146(f), 147(f) and 158(3)(d), subparagraphs 159(1)(b)(iv) and 160(1)(b)(iv), paragraphs 161(1)(d) and (2)(d), 162(d), 175(d), 176(d), 177(d), 181(d), 182(g), 183(f), 205(1)(g), 210(d), 213(1)(g) and 218(d), sections 225 and 226 and paragraph 229(1)(c))
- Schedule 4 Restricted Drugs (Subsections 1(1) and 6(1) and (2), paragraphs 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e), 146(f) and 147(f), section 198, paragraphs 205(1)(g), 210(d), 213(1)(g), 218(d) and 229(1)(c) and item 1 of Part 1 of Schedule 2)
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Controlled Substances Regulations under subsection 55(1) of the Controlled Drugs and Substances Act.notenote
Interpretation
1Definitions#
(1)The following definitions apply in these Regulations.
Act means the Controlled Drugs and Substances Act. (Loi)
adult means an individual who is 18 years of age or older. (adulte)
advertisement includes any representation by any means for the purpose of promoting, directly or indirectly, the sale or other disposal of a controlled substance. (publicité)
cannabis offence means
(a)an offence under subsection 9(1) or (2), 10(1) or (2), 11(1) or (2), 12(1), (4), (5), (6) or (7), 13(1) or 14(1) of the Cannabis Act; or
(b)a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction relative au cannabis)
CAS registry number means the identification number assigned to a chemical by the Chemical Abstracts Service, a division of the American Chemical Society. (numéro d’enregistrement CAS)
controlled drug means a substance set out in Schedule 2. (drogue contrôlée)
destroy, in relation to a controlled substance, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)
drug identification number means the identification number assigned to a drug under paragraph C.01.014.2(1)(a) of the Food and Drug Regulations. (identification numérique)
emergency medical service vehicle means any conveyance authorized under the laws of a province to transport individuals to hospitals and on which emergency medical services are provided. (véhicule de service médical d’urgence)
emergency supply means a controlled substance that is stored in a place that is either in a remote area where emergency medical treatment is not readily available or in an emergency medical service vehicle. (approvisionnement d’urgence)
finished product means a finished product that contains a controlled substance set out in any of Schedules 1 to 4, that is in a form that is intended to be administered to an individual or animal and, in the case of a finished product that does not contain a restricted drug, that
(a)has a drug identification number; or
(b)is compounded by a pharmacist or pharmacy technician in accordance with these Regulations. (produit fini)
government laboratory means a forensic or toxicology laboratory that is operated by the government of Canada or of a province and in which analytical testing involving controlled substances is conducted. (laboratoire public)
health professional means an individual who is entitled under the laws of a province to practise a profession in a health care field and who is practising in that province. (professionnel de la santé)
hospital means a facility
(a)that is licensed, approved or designated by a province under the laws of the province to provide health care or treatment to individuals or animals; or
(b)that is owned or operated by the government of Canada or of a province and that provides health services. (hôpital)
international obligation means an obligation relative to a controlled substance set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)
licensed dealer means the holder of a licence issued under subsection 12(1). (distributeur autorisé)
midwife means an individual who is entitled under the laws of a province to practise midwifery and who is practising midwifery in that province. (sage-femme)
mixture means a mixture that contains a controlled substance set out in any of Schedules 1 to 4, but does not include a finished product. (mélange)
narcotic means a substance set out in Schedule 1. (stupéfiant)
nurse practitioner means an individual who is entitled under the laws of a province to practise as a nurse practitioner or to practise under an equivalent designation and who is practising as such in that province. For the purposes of this definition, a designation is equivalent when it designates an individual who
(a)is a registered nurse;
(b)possesses additional training and experience related to health care; and
(c)can autonomously make diagnoses, request diagnostic tests and interpret their results, prescribe drugs and perform other specific procedures under the laws of a province. (infirmier praticien)
order does not include a prescription. (commande)
particular person means a person that, in the course of that person’s operations, unexpectedly receives a controlled substance from an individual for the purposes of destruction. (personne particulière)
peace officer has the same meaning as in section 2 of the Criminal Code. (agent de la paix)
person in charge of a government laboratory means an individual who has responsibility for managing all of a government laboratory’s activities with respect to controlled substances. (responsable d’un laboratoire public)
person in charge of a hospital means an individual who has responsibility for managing all of a hospital’s activities with respect to controlled substances. (responsable d’un hôpital)
pharmacist means an individual who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)
pharmacy technician means an individual who is entitled under the laws of a province to practise as a pharmacy technician or to practise under a designation that the Minister considers equivalent and who is practising as such in that province. (technicien en pharmacie)
podiatrist means an individual who is entitled under the laws of a province to practise podiatry or chiropody and who is practising podiatry or chiropody in that province. (podiatre)
prescription means an authorization given by a practitioner that a stated amount of a controlled substance, other than a restricted drug, be sold or provided for the individual named or the animal identified in it. (prescription)
qualified person in charge means the individual designated under subsection 9(1). (responsable qualifié)
restricted drug means a substance that is set out in Schedule 4. (drogue d’utilisation restreinte)
Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)
send does not include sending by mail. (expédition)
senior person in charge means the individual designated under section 8. (responsable principal)
specialized in destruction, in relation to a licensed dealer, describes a dealer whose licence specifies that it only deals in the destruction of controlled substances. (spécialisé en destruction)
targeted substance means a substance set out in Schedule 3. (substance ciblée)
test kit means a kit
(a)that contains a controlled substance and an adulterating or denaturing agent;
(b)that is used to test for a controlled substance; and
(c)the contents of which are not intended or likely to be consumed by, or administered to, an individual or animal. (trousse d’essai)
(2)For the application of these Regulations, a controlled substance refers to any of the following substances:
(a)a narcotic;
(b)a controlled drug;
(c)a targeted substance;
(d)a restricted drug.
(3)For the purposes of the definition practitioner in subsection 2(1) of the Act, the following persons are prescribed:
(a)midwives;
(b)nurse practitioners; and
(c)podiatrists.
General
2Non-application — member of police force#
The following persons are exempt from the application of these Regulations if, in respect of their activity, they are exempt from the application of sections 5 to 7.1 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations:
(a)a member of a police force, as defined in section 1 of those regulations; or
(b)a person acting under the direction and control of that member.
3Controlled drug — Part 3 of Schedule 2#
The Act and these Regulations do not apply in respect of a finished product that contains a controlled drug set out in Part 3 of Schedule 2 and that is
(a)in a form that allows the sustained release of an active ingredient over a certain period of time; and
(b)intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency.
4Authorizations — agents and mandataries#
An agent or mandatary of a person, including an employee of that person or another person that is acting under a contract with that person, may conduct an activity if the following conditions are met:
(a)in the case of the person,
(i)the person is authorized under these Regulations to conduct the activity, and
(ii)if applicable, the provincial professional regulatory authority of the province in which they are practising does not prohibit the delegation of the activity to the agent or mandatary; and
(b)in the case of the agent or mandatary,
(i)if applicable, they are authorized by the provincial professional regulatory authority of the province in which they are practising to conduct the activity,
(ii)the agent or mandatary does so as part of their role as agent or mandatary or their employment duties and functions or in the performance of their contract, and
(iii)the agent or mandatary complies with the requirements that apply to the person referred to in paragraph (a).
Possession
Controlled Drugs, Narcotics and Targeted Substances
5Authorized persons#
(1)A person referred to in subsection (2) is authorized to possess any of the following controlled substances if the person has obtained the substance in accordance with these Regulations, in the course of acts conducted in connection with the administration or enforcement of an Act or regulation or from a person exempted under subsection 56(1) of the Act from the application of subsection 5(1) of the Act with respect to that controlled substance:
(a)a narcotic set out in Schedule 1;
(b)a controlled drug set out in Part 1 of Schedule 2;
(c)a targeted substance set out in Part 1 of Schedule 3.
(2)An authorized person is
(a)a person that conducts an activity, with respect to the controlled substance, that is necessary for their business or the practice of their profession and that is
(i)a licensed dealer,
(ii)a pharmacist or pharmacy technician, other than one who is practising in a hospital, or
(iii)a practitioner who is registered and entitled to practise in
(A)the province in which they possess the controlled substance, or
(B)a province other than the province in which they possess the controlled substance, if they possess the substance for emergency medical purposes only;
(b)a hospital;
(c)the Minister;
(d)an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the federal government, a provincial government or a university in Canada who possesses the controlled substance in connection with their employment;
(e)a particular person that possesses the substance for the purposes of destruction; or
(f)an individual who
(i)has obtained the controlled substance for their own use, for the use of another individual or for an animal in accordance with a prescription that was issued or obtained in accordance with these Regulations from one of the following persons:
(A)a practitioner, or
(B)a pharmacist, or
(ii)has imported the controlled substance
(A)for their own use,
(B)for the use and on the behalf of an accompanying individual, or
(C)for an animal for which the individual is responsible and that is accompanying the individual.
(3)An agent or mandatary of a person referred to in paragraph (2)(d) may only have a controlled substance set out in subsection (1) in their possession if
(a)they have reasonable grounds to believe that person is a person referred to in paragraph (2)(d); and
(b)they possess the controlled substance for the purpose of assisting that person in the administration or enforcement of an Act or regulation.
(4)A licensed dealer, the Minister, a government laboratory or an individual referred to in section 226 may possess a controlled substance, other than a restricted drug, for the purpose of exporting it if the substance was obtained in accordance with these Regulations.
Restricted Drugs
6Authorized persons#
(1)The following persons are authorized to possess any restricted drug listed in Part 1 of Schedule 4 if that person has obtained the drug in accordance with these Regulations or in the course of acts conducted in connection with the administration or enforcement of an Act or regulation:
(a)a licensed dealer;
(b)a pharmacist or pharmacy technician, other than one who is practising in a hospital;
(c)a practitioner who is named in a letter of authorization;
(d)the Minister;
(e)an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the federal government, a provincial government or a university in Canada who possesses the restricted drug in connection with their employment;
(f)a particular person that possesses the substance for the purposes of destruction; and
(g)an individual who has obtained the restricted drug for their own use from a practitioner named in a letter of authorization.
(2)An agent or mandatary of a person referred to in paragraph (1)(e) may only have a restricted drug listed in Part 1 of Schedule 4 in their possession if
(a)they have reasonable grounds to believe that person is a person referred to in paragraph (1)(e); and
(b)they possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation.
(3)A licensed dealer, the Minister or a government laboratory may possess a restricted drug for the purpose of exporting it if the drug was obtained in accordance with these Regulations.
Licensed Dealers
Dealer’s Licence
Requirement to Obtain
7Activities#
(1)Persons referred to in subsection (2) are required to obtain a dealer’s licence for each site at which that person intends to conduct one of the following activities:
(a)producing a controlled substance, unless the person doing so is
(i)a pharmacist or pharmacy technician who is compounding a finished product in accordance with these Regulations, or
(ii)a government laboratory;
(b)packaging, selling, providing, delivering, sending or transporting a controlled substance, unless the person doing so is:
(i)a pharmacist or pharmacy technician who is not practising in a hospital,
(ii)a practitioner,
(iii)a hospital,
(iv)the Minister,
(v)a government laboratory,
(vi)a particular person, or
(vii)an individual referred to in section 223 or 224;
(c)importing or exporting a controlled substance, unless the person doing so is
(i)the Minister,
(ii)a government laboratory, or
(iii)an individual referred to in section 225 or 226; and
(d)destroying a controlled substance, if that is the only activity that the person intends to conduct.
(2)The persons that are eligible to obtain a dealer’s licence are
(a)an individual who ordinarily resides in Canada;
(b)an organization 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 controlled substances on behalf of the government of Canada or of a province, a police force, a hospital or a university in Canada.
Preliminary Requirements
8Senior person in charge#
(1)An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the senior person in charge who has overall responsibility for management of the activities with respect to controlled substances that are specified in the licence application.
(2)Only an individual who has sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the licence application to properly carry out their duties may be designated as a senior person in charge.
9Qualified person in charge#
(1)An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the qualified person in charge who is responsible for supervising the activities with respect to controlled substances that are specified in the licence application and for ensuring that those activities comply with these Regulations, as well as with any terms or conditions of the licence and any permit issued under these Regulations.
(2)An applicant for a dealer’s licence may designate an individual, who may be the applicant if the applicant is an individual, as an alternate qualified person in charge who is authorized to replace the qualified person in charge when that person is absent.
(3)Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a)they work at the site specified in the dealer’s licence application;
(b)they
(i)hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(ii)hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (i) and hold one of the following assessments that establishes the equivalency of the diploma, certificate or credential to one of the documents referred to in that subparagraph:
(A)an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B)an equivalency assessment issued by an institution or organization that is responsible for issuing equivalency assessments and is recognized by a province;
(c)they have sufficient knowledge of and experience with the use and handling of the controlled substances specified in the dealer’s licence application to properly carry out their duties; and
(d)they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence application to properly carry out their duties.
(4)An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements set out in paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a)no other individual working at the site meets those requirements;
(b)those requirements are not necessary for the activities specified in the licence application; and
(c)the individual has sufficient knowledge acquired from any combination of education, training and work experience to properly carry out their duties.
10Ineligibility#
(1)An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,
(a)in respect of a designated substance offence, a cannabis offence or any other offence referred to in subsection (2), the individual
(i)was convicted as an adult, or
(ii)was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or
(b)in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence, a cannabis offence or any other offence referred to in subsection (2),
(i)the individual was convicted as an adult, or
(ii)if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence.
(2)For the purposes of subsection (1), the other offences are
(a)an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;
(b)an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;
(c)the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;
(d)an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and
(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).
Issuance of a Licence
11Application#
(1)An application to obtain a dealer’s licence must be submitted to the Minister and must contain
(a)if the licence is requested by
(i)an individual, the individual’s name,
(ii)an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and
(iii)the holder of a position described in paragraph 7(2)(c), the applicant’s name and the title of the position;
(b)the municipal address, telephone number and, if applicable, the email address of the site specified in the licence application and, if different from the municipal address, its mailing address;
(c)the name, date of birth, telephone number and email address of the proposed senior person in charge;
(d)with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,
(i)their name, date of birth, telephone number and email address,
(ii)the title of their position at the site,
(iii)the name and title of the position of their immediate supervisor at the site,
(iv)if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and
(v)their education, training and work experience that are relevant to their duties;
(e)the activities that are to be conducted and the controlled substance in respect of which each of the activities is to be conducted;
(f)if the licence is requested in order to produce or package a controlled substance set out in any of Schedules 1 to 4, for each substance,
(i)its name, its CAS registry number, if any, as well as its form, the quantity that the applicant intends to produce under the licence and the period during which that quantity would be produced, and
(ii)if it is to be produced or packaged for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer;
(g)if the licence is requested to produce or package a mixture or finished product, for each mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)its drug identification number, if any,
(iv)if it is to be produced or packaged by or for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer, and
(v)if the applicant’s name appears on any label, as defined in section 2 of the Food and Drugs Act, of the finished product, a copy of that label;
(h)if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the controlled substance for which the activity is to be conducted and the purpose of the activity;
(i)a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and
(j)a detailed description of the method of recording information that the applicant proposes to use for the purposes of section 86.
(2)The application must be accompanied by the following documents:
(a)if the applicant is an organization, a copy of
(i)the certificate of incorporation or other constituting instrument,
(ii)any document filed with the province in which its site is located that states the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and
(iii)the permit or licence that is issued by the municipality in which its site is located that authorizes the business to operate, if applicable;
(b)individual declarations, signed and dated by each of the proposed senior person in charge, the qualified person in charge and any proposed alternate qualified person in charge, attesting that the signatory is not ineligible for a reason specified in section 10;
(c)a document issued by a Canadian police force or by a business that is accredited by the Royal Canadian Mounted Police in relation to each person referred to in paragraph (b) indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 10(1)(a)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii);
(d)if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 10(1)(b)(i) or received a sentence as specified in subparagraph 10(1)(b)(ii);
(e)a declaration, signed and dated by the proposed senior person in charge, attesting that they have the knowledge required under subsection 8(2) and that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 9(3)(c) and (d);
(f)with respect to the proposed qualified person in charge or any proposed alternate qualified person in charge, a copy of their diploma, certificate or credential referred to in paragraph 9(3)(b) and, if applicable, the equivalency assessment referred to in subparagraph 9(3)(b)(ii); and
(g)if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement set out in paragraph 9(3)(b), a detailed description of the education, training and work experience that is required under paragraph 9(4)(c), together with supporting documents, such as a copy of a course transcript or an attestation by the person who provided the training.
(3)The application must
(a)be signed and dated by the proposed senior person in charge; and
(b)include an attestation by that person that
(i)all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii)they have the authority to bind the applicant.
(4)The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
12Issuance#
(1)Subject to section 14, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains
(a)the licence number;
(b)if the licensed dealer is an individual, their name and, if applicable, title, or if the licensed dealer is an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence;
(c)the specified activities and, for each activity, the name of the controlled substance that is set out in any of Schedules 1 to 4 or that is contained in a mixture or finished product;
(d)the municipal address of the site at which the activity is to be conducted;
(e)the security level at the site, determined in accordance with the Security Directive;
(f)the effective date of the licence;
(g)the expiry date of the licence, which must not be later than three years after its effective date;
(h)any terms and conditions that the Minister has reasonable grounds to believe are necessary to
(i)ensure that an international obligation is respected,
(ii)ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or
(iii)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use; and
(i)if the licensed dealer produces a controlled substance that is set out in any of Schedules 1 to 4, the quantity that the licensed dealer may produce and the production period.
(2)A person must not alter or deface in any manner a dealer’s licence.
13Validity#
A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.
14Refusal#
(1)The Minister must refuse to issue a dealer’s licence if
(a)the applicant does not meet the requirement set out in subsection 7(2);
(b)during the 10 years before the day on which the licence application is submitted, the applicant has contravened
(i)a provision of the Act, the Cannabis Act or their regulations, or
(ii)a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;
(c)during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
(d)an activity for which the licence is requested would contravene an international obligation;
(e)in the case of a narcotic, an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;
(f)the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
(g)the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;
(h)the applicant has not provided the Minister with the information or documents required under subsection 11(4) or before the date specified in the written request referred to in that subsection, or the information or documents that the applicant has provided before that date are not sufficient to complete the review of the licence application;
(i)the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;
(j)information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravenes an international obligation; or
(k)the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)The Minister must not refuse to issue a licence under paragraph (1)(b) or (i) if the applicant meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:
(a)the applicant does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and
(b)the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.
(3)Before refusing to issue a licence, the Minister must
(a)provide the applicant with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and
(b)consider the applicant’s submissions, if applicable.
Renewal of a Licence
15Application#
(1)To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections 11(1) and (2).
(2)The application must
(a)be signed and dated by the senior person in charge of the site specified in the application; and
(b)include an attestation by that person that
(i)all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii)they have the authority to bind the licensed dealer.
(3)The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
16Renewal#
(1)Subject to section 18, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in subsection 12(1).
(2)When renewing a dealer’s licence, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete a term or condition in order to
(a)ensure that an international obligation is respected;
(b)ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or
(c)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
17Validity#
A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.
18Refusal#
(1)The Minister must refuse to renew a dealer’s licence if
(a)the licensed dealer no longer meets the requirement set out in subsection 7(2);
(b)during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened
(i)a provision of the Act, the Cannabis Act or their regulations, or
(ii)a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;
(c)during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
(d)an activity for which the renewal is requested would contravene an international obligation;
(e)in the case of a narcotic, an activity for which the renewal is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;
(f)the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;
(g)the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;
(h)the licensed dealer has not provided the Minister with the information or documents required under subsection 15(3) or by the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the renewal application;
(i)the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application;
(j)information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravened an international obligation; or
(k)the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)The Minister must not refuse to renew a licence under paragraph (1)(b) or (i) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:
(a)the licensed dealer does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and
(b)the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.
(3)Before refusing to renew a licence, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
Amendment of a Licence
19Application#
(1)Before making a change affecting any information that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in subsections 11(1) and (2) that are relevant to the proposed amendment.
(2)The application must
(a)be signed and dated by the senior person in charge of the site specified in the application; and
(b)include an attestation by that person that
(i)all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii)they have the authority to bind the licensed dealer.
(3)The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
20Amendment#
(1)Subject to section 22, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.
(2)When amending a dealer’s licence, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete a term or condition in order to
(a)ensure that an international obligation is respected;
(b)ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or
(c)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
21Validity#
An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.
22Refusal#
(1)The Minister must refuse to amend a dealer’s licence if
(a)the licensed dealer no longer meets the requirement set out in subsection 7(2);
(b)during the 10 years before the day on which the amendment application is submitted, the senior person in charge or qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
(c)an activity for which the amendment is requested would contravene an international obligation;
(d)in the case of a narcotic, an activity for which the amendment is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;
(e)the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the amendment is requested;
(f)the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;
(g)the licensed dealer has not provided the Minister with the information or documents required under subsection 19(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the amendment application;
(h)the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the amendment application; or
(i)the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)The Minister must not refuse to amend a licence under paragraph (1)(h) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:
(a)the licensed dealer does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and
(b)the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.
(3)Before refusing to amend a licence, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
Changes Requiring Prior Approval by the Minister
23Application#
(1)A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a)a change affecting the security measures in place at the site specified in the dealer’s licence;
(b)a change affecting the method of recording information referred to in paragraph 11(1)(j);
(c)the replacement of the senior person in charge;
(d)the replacement of the qualified person in charge; or
(e)the replacement or addition of an alternate qualified person in charge.
(2)The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1):
(a)in the case of a change affecting the security measures in place at the site specified in the dealer’s licence or the method of recording information referred to in paragraph 11(1)(j), details of the change;
(b)in the case of a replacement of the senior person in charge,
(i)the information specified in paragraph 11(1)(c), and
(ii)the documents specified in paragraphs 11(2)(b) to (e); and
(c)in the case of a replacement of the qualified person in charge or a replacement or addition of an alternate qualified person in charge,
(i)the information specified in paragraph 11(1)(d), and
(ii)the documents specified in paragraphs 11(2)(b) to (f).
(3)The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
24Approval#
(1)Subject to section 25, on completion of the review of the application for approval of the change, the Minister must approve the change.
(2)When approving a change, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete a term or condition in order to
(a)ensure that an international obligation is respected;
(b)ensure conformity with the requirements associated with the security level specified in the licence; or
(c)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
25Refusal#
(1)The Minister must refuse to approve the change if
(a)during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
(b)the licensed dealer has not provided the Minister with the information or documents required under subsection 23(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the application for approval of the change;
(c)the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the application for approval of the change; or
(d)the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)The Minister must not refuse to approve a change under paragraph (1)(c) if the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.
(3)Before refusing to approve a change, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
Changes Requiring a Notice to the Minister
26Prior notice#
(1)A licensed dealer must notify the Minister in writing before
(a)producing or packaging a mixture or finished product that is not set out in the most recent update of the information and label referred to in paragraph 11(1)(g); or
(b)making a change to a mixture or finished product that is set out in that most recent update, if the change affects any of the information or label that has previously been submitted.
(2)The notice must contain the information that is necessary to update the information or label referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label referred to in that paragraph or, if applicable, a copy of the updated label.
27Notice — five days#
A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.
28Notice — 10 days#
(1)A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a)a person ceases to act as the senior person in charge; or
(b)the licensed dealer ceases to produce or package a mixture or finished product that is set out in the most recent update of the information and label referred to in paragraph 11(1)(g).
(2)A notice concerning a change referred to in paragraph (1)(b) must contain the information that is necessary to update the information referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label for any other controlled substance.
29Notice of cessation of activities#
(1)A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.
(2)The notice must be signed and dated by the senior person in charge and contain the following information:
(a)the expected date of the cessation of activities at the site;
(b)a description of the manner in which any remaining controlled substances on the site as of that date will be disposed of by the licensed dealer, including
(i)if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, their name and, if applicable, title,
(ii)if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, their name and, if applicable, title, as well as the municipal address of their site, and
(iii)if some or all of them will be destroyed, the anticipated date of destruction and the municipal address of the place at which the destruction is to be carried out;
(c)the municipal address of the place at which the licensed dealer’s documents will be kept after activities have ceased; and
(d)the name, municipal address, telephone number and, if applicable, the email address of a person whom the Minister may contact for further information after activities have ceased.
(3)After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.
Changes to the Terms and Conditions of a Licence
30Addition or modification#
(1)The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add or modify a term or condition if the Minister has reasonable grounds to believe that it is necessary to do so to
(a)ensure conformity with the provisions of the Act, the Cannabis Act and their regulations;
(b)ensure that an international obligation is respected;
(c)ensure conformity with the requirements associated with the security level specified in the licence; or
(d)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)Before adding a term or condition to, or modifying a term or condition of, a licence, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
(3)Despite subsection (2), the Minister may immediately add a term or condition to, or modify a term or condition of, a licence, subject to subsection (4), if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.
(4)The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister provides the licensed dealer with a written notice that
(a)sets out the reasons for the addition or modification;
(b)gives the dealer an opportunity to be heard; and
(c)if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.
31Deletion of term or condition#
(1)The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.
(2)The deletion takes effect as soon as the Minister provides the licensed dealer with a written notice to that effect.
Suspension and Revocation of a Licence
32Suspension#
(1)Subject to subsection (2), the Minister must immediately suspend a dealer’s licence in respect of any activities in relation to any controlled substance if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use.
(2)The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that
(a)sets out the authorized activity and controlled substance that are the subject of the suspension, as well as the reasons for the suspension;
(b)gives the dealer an opportunity to be heard; and
(c)if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.
(3)The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
33Revocation#
(1)Subject to subsection (2), the Minister must revoke a dealer’s licence if
(a)the licensed dealer no longer meets the requirement set out in subsection 7(2);
(b)the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;
(c)the licensed dealer ceases to conduct activities at their site before the expiry of their licence;
(d)the licensed dealer does not take the corrective measures specified in an undertaking or notice;
(e)the licensed dealer has contravened
(i)a provision of the Act, the Cannabis Act or their regulations, or
(ii)a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;
(f)during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);
(g)the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of an application relating to the licence; or
(h)information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravened an international obligation.
(2)The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) if the licensed dealer meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:
(a)the licensed dealer does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and
(b)the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.
(3)Before revoking a licence, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
Import Permit
34Application#
(1)A licensed dealer must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:
(a)their name and, if applicable, title, as well as their municipal address;
(b)their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;
(c)the name and municipal address of the proposed customs broker for the licensed dealer, if any;
(d)the name of the customs office where the importation is anticipated and the proposed date of importation;
(e)the name and municipal address, in the country of export, of the exporter from whom the controlled substance is being obtained;
(f)the name of the carrier that is proposed to transport the controlled substance to the customs office where the importation is anticipated;
(g)each proposed mode of transportation and any proposed country of transit or transhipment;
(h)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name as set out in the dealer’s licence,
(ii)its CAS registry number, if any,
(iii)if it is a salt, the name of the salt,
(iv)its form,
(v)its purity and anhydrous content, and
(vi)its quantity; and
(i)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
(2)The application must
(a)be signed and dated by the qualified person in charge or an alternate qualified person in charge; and
(b)include an attestation by that person that, to the best of their knowledge,
(i)the importation does not contravene the laws of the country of exportation or any country of transit or transhipment, and
(ii)all of the information and documents submitted in support of the application are correct and complete.
(3)The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
35Issuance#
(1)Subject to section 37, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains
(a)the permit number;
(b)the information set out in subsection 34(1);
(c)the effective date of the permit;
(d)the expiry date of the permit, being the earlier of
(i)a date specified by the Minister that is not more than 180 days after its effective date, and
(ii)the expiry date of the dealer’s licence; and
(e)any terms and conditions that the Minister has reasonable grounds to believe are necessary to
(i)ensure that an international obligation is respected, or
(ii)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)A person must not alter or deface in any manner an import permit.
36Validity#
An import permit is valid until the earliest of
(a)the expiry date set out in the permit,
(b)the date of the suspension or revocation of the permit under section 40 or 41,
(c)the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and
(d)the date of the expiry, suspension or revocation of the export authorization that applies to the controlled substance to be imported and that is issued by the competent authority in the country of export.
37Refusal#
(1)The Minister must refuse to issue an import permit if
(a)the licensed dealer is not authorized by their dealer’s licence to import the relevant controlled substance or their licence will expire before the date of importation;
(b)the Minister has reasonable grounds to believe that the importation would contravene an international obligation;
(c)the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation;
(d)the licensed dealer has not provided the Minister with the information or documents required under subsection 34(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the permit application;
(e)the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application;
(f)the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or
(g)the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)Before refusing to issue an import permit, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
38Providing copy of permit#
The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.
39Declaration#
The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled substance specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a)their name and, if applicable, title;
(b)their dealer’s licence number and the number of the import permit;
(c)the name of the customs office from which the controlled substance was released and the date of the release;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name as set out in the dealer’s licence,
(ii)if it is a salt, the name of the salt,
(iii)its form, and
(iv)its quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
40Suspension#
(1)Subject to subsection (2), the Minister must immediately suspend an import permit if
(a)the dealer’s licence is suspended;
(b)the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or
(c)the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment.
(2)The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that
(a)sets out the reasons for the suspension;
(b)gives the dealer an opportunity to be heard; and
(c)if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.
(3)The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
41Revocation#
(1)The Minister must revoke an import permit if
(a)the dealer’s licence has been revoked;
(b)the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
(c)the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 40(2)(c) by the specified date; or
(d)the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.
(2)Before revoking an import permit, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
Export Permit
42Application#
(1)A licensed dealer must submit to the Minister, before each exportation of a controlled substance, an application for an export permit that contains the following information and document:
(a)their name and, if applicable, title, as well as their municipal address;
(b)their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;
(c)the name and municipal address of the proposed customs broker for the licensed dealer, if any;
(d)the name of the customs office where the exportation is anticipated and the proposed date of exportation;
(e)the name and municipal address of the importer in the country of final destination;
(f)the name of the carrier that is proposed to transport the controlled substance from the customs office where the exportation is anticipated;
(g)each proposed mode of transportation and any proposed country of transit or transhipment;
(h)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name as set out in the dealer’s licence,
(ii)its CAS registry number, if any,
(iii)if it is a salt, the name of the salt,
(iv)its form,
(v)its purity and anhydrous content, and
(vi)its quantity;
(i)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(j)a copy of the import authorization issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.
(2)The application must
(a)be signed and dated by the qualified person in charge or an alternate qualified person in charge; and
(b)include an attestation by that person that, to the best of their knowledge,
(i)the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and
(ii)all of the information and documents submitted in support of the application are correct and complete.
(3)The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
43Issuance#
(1)Subject to section 45, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains
(a)the permit number;
(b)the information set out in paragraphs 42(1)(a) to (i) and the number of the import authorization referred to in paragraph 42(1)(j);
(c)the effective date of the permit;
(d)the expiry date of the permit, being the earliest of
(i)a date specified by the Minister that is not more than 180 days after its effective date,
(ii)the expiry date of the dealer’s licence, and
(iii)the expiry date of the import authorization issued by the competent authority in the country of final destination; and
(e)any terms and conditions that the Minister has reasonable grounds to believe are necessary to
(i)ensure that an international obligation is respected, or
(ii)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)A person must not alter or deface in any manner an export permit.
44Validity#
An export permit is valid until the earliest of
(a)the expiry date set out in the permit,
(b)the date of the suspension or revocation of the permit under section 48 or 49,
(c)the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and
(d)the date of the expiry, suspension or revocation of the import authorization that applies to the controlled substance to be exported and that is issued by the competent authority in the country of final destination.
45Refusal#
(1)The Minister must refuse to issue an export permit if
(a)the licensed dealer is not authorized by their dealer’s licence to export the relevant controlled substance or their dealer’s licence will expire before the date of export;
(b)the Minister has reasonable grounds to believe that the exportation would contravene an international obligation;
(c)the licensed dealer has not provided the Minister with the information or documents required under subsection 42(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date are not sufficient to complete the review of the permit application;
(d)the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application;
(e)the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import authorization issued by the competent authority of the country of final destination;
(f)the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or
(g)the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)Before refusing to issue an export permit, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
46Providing copy of permit#
The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.
47Declaration#
The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains the following information:
(a)their name and, if applicable, title;
(b)their dealer’s licence number and the number of the export permit;
(c)the name of the customs office from which the controlled substance was exported and the date of export;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name as set out in the dealer’s licence,
(ii)if it is a salt, the name of the salt,
(iii)its form, and
(iv)its quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
48Suspension#
(1)Subject to subsection (2), the Minister must immediately suspend an export permit if
(a)the dealer’s licence is suspended;
(b)the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or
(c)the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.
(2)The suspension takes effect as soon as the Minister provides the licensed dealer with a written notice that
(a)sets out the reasons for the suspension;
(b)gives the dealer an opportunity to be heard; and
(c)if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.
(3)The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
49Revocation#
(1)The Minister must revoke an export permit if
(a)the dealer’s licence has been revoked;
(b)the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
(c)the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 48(2)(c) by the specified date; or
(d)the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.
(2)Before revoking an export permit, the Minister must
(a)provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and
(b)consider the licensed dealer’s submissions, if applicable.
Authorizations and General Conditions Applicable to Activities
50Authorized activities#
A licensed dealer may conduct the following activities if it does so in accordance with their dealer’s licence and any permit issued under these Regulations:
(a)produce a controlled substance;
(b)sell or provide a controlled substance to
(i)another licensed dealer,
(ii)with the exception of a restricted drug, a pharmacist, other than one who is practising in a hospital,
(iii)a practitioner,
(iv)with the exception of a restricted drug, a hospital,
(v)a person exempted under subsection 56(1) of the Act with respect to that controlled substance, if there are terms and conditions for the sale or provision by a licensed dealer that are specified in the exemption,
(vi)the Minister, or
(vii)a government laboratory;
(c)transport, send or deliver a controlled substance; or
(d)import or export a controlled substance.
51Packaging — conditions#
A licensed dealer that packages a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.
52Destruction#
A licensed dealer specialized in destruction that destroys a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.
53Qualified person in charge present#
A licensed dealer may conduct an activity in relation to a controlled substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.
54Identification#
A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which it identifies itself in regard to their activities in relation to a controlled substance, including labels, shipping documents, invoices and advertising.
55Information and documents#
A licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any relevant information or document to demonstrate their compliance with the provisions of the Act and these Regulations.
Sale of Controlled Substances
56Sale to another licensed dealer#
A licensed dealer that sells or provides a controlled substance to another licensed dealer may only do so if it first receives from the other licensed dealer a written order that is signed and dated and that contains the following:
(a)with respect to the other licensed dealer placing the order, their name and, if applicable, title, as well as their municipal address;
(b)with respect to the licensed dealer selling or providing the controlled substance, their name and, if applicable, title, as well as their municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(f)in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.
57Sale to pharmacist#
(1)A licensed dealer that sells or provides a controlled substance to a pharmacist may only do so if it first receives from the pharmacist a written order that is signed and dated and that contains the following information:
(a)with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
(b)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
(2)A licensed dealer must not sell or provide to the pharmacist a controlled substance that is the subject of a prohibition on the pharmacist’s professional practice imposed by the provincial professional regulatory authority.
58Sale to practitioner#
(1)A licensed dealer that sells or provides a controlled substance, other than a restricted drug, to a practitioner may only do so if it first receives from the practitioner a written order that is signed and dated and that contains the following information:
(a)with respect to the practitioner, their name and the name and municipal address of the place where they practise;
(b)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
(2)A licensed dealer that sells or provides a restricted drug to a practitioner may only do so if
(a)the licensed dealer first receives a letter of authorization in which it is named;
(b)the practitioner is named in the letter of authorization and the municipal address of the place where they practise is specified in that letter; and
(c)the licensed dealer sells or provides the restricted drug only in the quantity specified in the letter of authorization and, if applicable, in the form and strength specified in that letter.
(3)A licensed dealer must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.
59Sale to hospital#
A licensed dealer that sells or provides a controlled substance to a hospital may only do so if it first receives from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information:
(b)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
60Sale to exempted person#
A licensed dealer that sells or provides a controlled substance to a person exempted under subsection 56(1) of the Act with respect to that substance may only do so in accordance with the terms and conditions for the sale or provision by the licensed dealer that are specified in the exemption and if it first receives from the exempted person a copy of that exemption.
61Sale to Minister#
A licensed dealer that sells or provides a controlled substance to the Minister may only do so if it first receives from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:
(a)with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
(b)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address and licence number;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
62Sale to government laboratory#
A licensed dealer that sells or provides a controlled substance to a government laboratory may only do so if it first receives from the government laboratory a written order that is signed and dated and that contains the following information:
(a)with respect to the government laboratory, its name and municipal address;
(b)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address and licence number;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
63Anticipated multiple sales#
(1)A licensed dealer that sells or provides a controlled substance, other than a restricted drug, may do so more than once in respect of one order, within six months after the order was made, if the order indicates
(a)the number of sales or provisions;
(b)the specific quantity for each sale or provision; and
(c)the intervals between each sale or provision.
(2)A licensed dealer may sell or provide a controlled substance more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the substance ordered, in which case the dealer may sell or provide the quantity of the substance that the dealer has available and sell or provide the balance later.
Verification of Identity
64Orders#
A licensed dealer that receives an order from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the licensed dealer.
Delivery, Sending and Transportation
65Requirements during transportation#
(1)A licensed dealer that takes delivery of a controlled substance that it has imported or that delivers, sends or transports a controlled substance to another person may only do so if it
(b)ensures that all inner containers are sealed in such a manner that they cannot be opened without breaking the seal;
(c)takes all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported;
(d)uses a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it;
(e)in the case of an imported controlled substance, delivers, sends or transports it directly to the site specified in their licence after it is released under the Customs Act; and
(f)in the case of a controlled substance that is to be exported, delivers, sends or transports it directly from the site specified in their licence to the customs office where it will be exported.
(2)Subsection (1) does not apply to a test kit that has a registration number.
Security
66Protective measures#
A licensed dealer must take all reasonable measures to ensure the security of any controlled substance, licence or permit in their possession.
67Loss or theft — licences and permits#
If a licensed dealer becomes aware of a loss or theft of their licence or permit, the dealer must provide a written report to the Minister within 72 hours after becoming aware of the loss or theft.
68Loss or theft — agent or mandatary#
(1)If an agent or mandatary of a licensed dealer becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the licensed dealer immediately.
(2)If a licensed dealer becomes aware of a loss of a controlled substance that cannot be explained on the basis of normally accepted business activities, or of a theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the dealer must
(a)in the case of a loss, provide a written report to the Minister within 72 hours after becoming aware or being notified of the loss; or
(b)in the case of a theft, provide
(i)a written report to a police force within 24 hours after becoming aware or being notified of the theft, and
(ii)a written report to the Minister within 72 hours after becoming aware or being notified of the theft, including a confirmation that the report required under subparagraph (i) has been provided.
69Suspicious transaction#
(1)A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that it has reasonable grounds to suspect may be related to the diversion of a controlled substance to an illicit market or use:
(a)with respect to the licensed dealer,
(i)in the case of an individual, their name and, if applicable, title, as well as their municipal address and telephone number, or
(ii)in the case of an organization, its name, municipal address and telephone number, as well as the title of the position held by the individual making the report;
(b)with respect to the other party to the transaction, their name and municipal address;
(c)details of the transaction, including its date and time, as well as its type;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(f)a detailed description of the reasons for the dealer’s suspicions.
(2)No civil proceedings lie against a licensed dealer for having provided the report in good faith.
(3)A licensed dealer must not disclose that it has provided the report or disclose details of it with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.
70Partial protection against self-incrimination#
A report provided under any of sections 67 to 69, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.
Destruction of Controlled Substances
71Destruction at site#
A licensed dealer that intends to destroy a controlled substance at the site specified in their licence must ensure that the following conditions are met:
(a)the licensed dealer obtains the prior approval of the Minister;
(b)the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
(i)the senior person in charge, the qualified person in charge or an alternate qualified person in charge, or
(ii)a person who works for or provides services to the licensed dealer and holds a senior position;
(c)the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d)as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add in printed letters their name and, if applicable, title.
72Destruction elsewhere than at site#
A licensed dealer that intends to destroy a controlled substance elsewhere than at the site specified in their licence must ensure that the following conditions are met:
(a)the licensed dealer obtains the prior approval of the Minister;
(b)the licensed dealer takes all reasonable measures to ensure the security of the controlled substance while it is being transported in order to prevent its diversion to an illicit market or use;
(c)the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods, other than a licensed dealer specialized in destruction, and in the presence of another person working for that business;
(d)the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e)as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the controlled substance was destroyed and containing
(i)the municipal address of the place of destruction,
(ii)the date of destruction,
(iii)the method of destruction,
(iv)in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity,
(v)in the case of a mixture or finished product,
(A)subject to clause (D), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(B)subject to clause (D), its form, its strength, the number of containers and, if applicable, the number of units per container,
(C)subject to clause (D), its drug identification number, if any, and
(D)if the finished product has been previously returned by an individual for the purposes of destruction to a pharmacist, pharmacy technician, practitioner, hospital or particular person, only the identifier marked on the collection container of the finished product and the number of collection containers, and
(vi)the names, in printed letters, and signatures of the person who carried out the destruction and the other person who was present at the destruction.
73Application for approval#
(1)A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s approval to destroy a controlled substance:
(a)their name and, if applicable, title, as well as their municipal address;
(b)their dealer’s licence number;
(c)the municipal address of the place of destruction;
(d)the proposed date of destruction;
(e)a brief description of the method of destruction;
(f)if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purposes of paragraph 71(b) and information establishing that they meet the conditions of that paragraph;
(g)in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity; and
(h)in the case of a mixture or finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction to a pharmacist, pharmacy technician, practitioner, hospital or particular person, only the identifier marked on the collection container of the finished product and the number of collection containers.
(2)The application must
(a)be signed and dated by the qualified person in charge or an alternate qualified person in charge; and
(b)include an attestation by that person that
(i)the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and
(ii)all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.
(3)The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
74Approval#
On completion of the review of the approval application, the Minister must approve the destruction of the controlled substance unless
(a)in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purposes of paragraph 71(b) do not meet the conditions of that paragraph;
(b)the Minister has reasonable grounds to believe that the controlled substance would not be destroyed;
(c)the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application;
(d)the controlled substance or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or
(e)the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk that the controlled substance could be diverted to an illicit market or use.
Documents
Information
75Substances ordered and received#
A licensed dealer that orders or receives a controlled substance must record the following information:
(a)the name and, if applicable, title of the individual placing the order for the controlled substance or receiving it;
(b)with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;
(c)the date of the order or receipt;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction to a pharmacist, pharmacy technician, practitioner, hospital or particular person, only the identifier marked on the collection container of the finished product and the number of collection containers.
76Substances sold#
A licensed dealer that sells or provides a controlled substance must record the following information:
(a)the name and, if applicable, title of the individual selling or providing the controlled substance;
(b)with respect to the person to whom the controlled substance is sold or provided, their name and, if applicable, title, as well as their municipal address;
(c)the date of the sale or provision;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a controlled substance that is a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
77Substances produced or packaged#
A licensed dealer that produces or packages a controlled substance must record the following information with respect to the substance:
(a)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(b)in the case of a mixture or finished product,
(i)its name or, if applicable, its brand name, as well as the name and quantity of the controlled substance it uses to produce the mixture or finished product, or that is contained in the mixture or finished product that it packages,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
78Substances in stock#
A licensed dealer that stores a controlled substance must record the following information with respect to the substance:
(a)the date on which it is placed in stock;
(b)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(c)in the case of a mixture or finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction to a pharmacist, pharmacy technician, practitioner, hospital or particular person, only the identifier marked on the collection container of the finished product and the number of collection containers.
79Written orders#
A licensed dealer that receives a written order for a controlled substance must record the following information:
(a)the name and, if applicable, title of the individual receiving the order; and
(b)the date of the order and the date on which it was received.
80Transportation#
A licensed dealer that delivers, sends or transports a controlled substance to another person must record the following information:
(a)the dealer’s name and, if applicable, title, as well as their municipal address;
(b)if an agent or mandatary of the dealer delivers, sends or transports the controlled substance, their name;
(c)with respect to the other person, their name and, if applicable, title;
(d)the municipal address of the place where the controlled substance will be delivered, sent or transported;
(e)the date of the delivery, sending or transportation;
(f)the means of transportation;
(g)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(h)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
81Substances imported#
A licensed dealer that imports a controlled substance must record the following information:
(a)the date of the importation;
(b)the name and municipal address of the exporter;
(c)the country of exportation and any country of transit or transhipment;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
82Substances exported#
A licensed dealer that exports a controlled substance must record the following information:
(a)the date of the exportation;
(b)the name and municipal address of the importer;
(c)the country of final destination and any country of transit or transhipment;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
83Explainable loss of controlled substance#
A licensed dealer that becomes aware of a loss of a controlled substance that can be explained on the basis of normally accepted business activities or that is notified by their agent or mandatary of such a loss, must record the following information:
(a)the date on which the dealer became aware or was notified of the loss;
(b)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
(c)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(d)the explanation for the loss.
84Destruction#
A licensed dealer that destroys a controlled substance at the site specified in their licence must record the following information:
(a)the name and, if applicable, title of the person who carried out the destruction and of the other persons who were present at the destruction;
(b)the municipal address of the place of destruction;
(c)the date of destruction;
(d)the method of destruction;
(e)in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity; and
(f)in the case of a mixture or finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction to a pharmacist, pharmacy technician, practitioner, hospital or particular person, only the identifier marked on the collection container of the finished product and the number of collection containers.
85Monthly report#
(1)Subject to subsection (2), a licensed dealer must provide to the Minister, within 15 days after the end of each month, a monthly report that contains the name and quantity of each controlled substance
(a)that is set out in any of Schedules 1 to 4 that the licensed dealer receives, produces, packages, sells, provides, imports, exports or destroys during the month;
(b)that is contained in a mixture or finished product that the licensed dealer receives, packages, sells, provides, imports, exports or destroys during the month or that the dealer has used to produce a mixture or finished product during the month;
(c)that is in the physical inventory taken at the site specified in their licence at the end of the month; and
(d)that has been lost in the course of conducting activities during the month and whose loss can be explained on the basis of normally accepted business activities.
(2)If a licensed dealer’s licence expires without being renewed or is revoked, the dealer must provide to the Minister, within three months after the expiration or revocation, a report in respect of the portion of the month during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.
Recording Information and Retention and Provision of Documents
86Method of recording#
A licensed dealer that records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.
87Documents to retain#
A licensed dealer and a former licensed dealer must keep
(a)any document containing the information that it is required to record under these Regulations for two years after the day on which the last record is recorded in the document;
(b)every written order, in sequence as to date and number, for two years after the day on which it is received; and
(c)every declaration, report and letter of authorization for two years after the day on which it is provided or received.
88Place#
The documents must be accessible
(a)at the site specified in the licensed dealer’s licence; or
(b)in the case of a document retained by a former licensed dealer, at a place in Canada.
89Quality of documents#
The documents must be complete and readily retrievable and the information in them must be legible and indelible.
90Providing documents#
A licensed dealer and a former licensed dealer must provide any documents that the Minister requests in the time and manner that the Minister specifies.
Pharmacists and Pharmacy Technicians
Non-application
91Pharmacists practising in hospital#
For the purposes of sections 92 to 126, the terms pharmacist, pharmacy technician and intern, as defined in subsection 1(1), are to be read as excluding those who are practising in a hospital, except as otherwise provided.
Sale of Controlled Substances
92Sale to licensed dealer#
(1)A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a licensed dealer if
(a)in the case of a controlled substance previously returned by an individual or particular person for the purposes of destruction,
(i)the licensed dealer is specialized in destruction, and
(ii)the pharmacist first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3); and
(b)in the case of any other controlled substance,
(i)one of the following conditions is met:
(A)the licensed dealer is the one that sold or provided that controlled substance to the pharmacist, or
(B)the sale or provision is for the purposes of testing or destruction, and
(ii)the pharmacist first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (3).
(2)A pharmacist may sell or provide a restricted drug to a licensed dealer if
(a)the restricted drug was previously returned by an individual or particular person for the purposes of destruction;
(b)the licensed dealer is specialized in destruction; and
(c)the pharmacist first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3).
(3)The information that must be contained in the written order is the following:
(a)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
(b)with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
(f)in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.
93Sale to another pharmacist#
(1)Subject to subsection (2), a pharmacist may, in the case of an emergency, sell or provide a controlled substance, other than a restricted drug, to another pharmacist if they first receive from the other pharmacist either a written order that is signed and dated and that contains the following information or a verbal order:
(a)with respect to the other pharmacist placing the order, their name and the name and municipal address of the place where they practise;
(b)with respect to the pharmacist selling or providing the controlled substance, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(f)a declaration from the other pharmacist that they require the controlled substance for emergency purposes.
(2)A pharmacist may, in circumstances other than an emergency, sell or provide a controlled substance, other than a restricted drug, to another pharmacist if they do so for the purpose of fulfilling a prescription received at the pharmacy where the other pharmacist practises or if the pharmacy where they practise is ceasing its operations and if they first receive from the other pharmacist a written order that is signed and dated and that contains the following information:
(a)with respect to the other pharmacist placing the order, their name and the name and municipal address of the place where they practise;
(b)with respect to the pharmacist selling or providing the controlled substance, their name and the name and municipal address of the place where the sale or provision is conducted;
(c)the number assigned to the prescription, if applicable;
(d)the date of the order;
(e)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(f)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
(3)A pharmacist must not sell or provide to the other pharmacist a controlled substance that is the subject of a prohibition on the other pharmacist’s professional practice imposed by the provincial professional regulatory authority.
94Sale to practitioner#
(1)A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a practitioner if they first receive from the practitioner a written order that is signed and dated and that contains the following information or, in the case of an emergency, either such a written order or a verbal order:
(a)with respect to the practitioner, their name and the name and municipal address of the place where they practise;
(b)with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
(2)A pharmacist must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.
95Sale to hospital#
A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a hospital if they first receive from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information or, in the case of an emergency, either such a written order or a verbal order from such a person:
(b)with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
96Sale to exempted person#
A pharmacist may sell or provide a controlled substance, other than a restricted drug, to a person exempted under subsection 56(1) of the Act with respect to that controlled substance if
(a)the pharmacist first receives from the exempted person a copy of the exemption;
(b)there are terms and conditions for the sale or provision by the pharmacist that are specified in the exemption; and
(c)the sale or provision is carried out in accordance with those terms and conditions.
97Sale to Minister#
A pharmacist may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:
(a)with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
(b)with respect to the pharmacist, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
98Sale to individual#
(1)A pharmacist may sell or provide a controlled substance to an individual if
(a)the sale or provision is for the individual’s own use, for the use of another individual or for an animal;
(b)the controlled substance is in the form of a finished product that does not contain a restricted drug; and
(c)subject to subsection (2), the pharmacist first receives the following in respect of the controlled substance from one of the following persons:
(i)in the case of the individual, a written prescription,
(ii)in the case of another pharmacist or a pharmacy technician,
(A)a written prescription, or
(B)a copy of the document on which the information with respect to a verbal prescription has been recorded under section 117, or
(iii)in the case of a practitioner, a written or verbal prescription.
(2)A pharmacist may sell or provide, without a prescription, a finished product containing codeine phosphate to an individual if
(a)the finished product contains
(i)in the case of a finished product in solid form, not more than 8 mg or its equivalent of codeine phosphate per unit, or
(ii)in the case of a finished product in liquid form, not more than 20 mg or its equivalent of codeine phosphate per 30 mL;
(b)the finished product contains
(i)two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half of the regular minimum single dose for each such ingredient, or
(ii)three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third of the regular minimum single dose for each such ingredient;
(c)the pharmacist has reasonable grounds to believe that the finished product will only be used for recognized medical purposes; and
(d)the pharmacist ensures that the following caution or its equivalent is conspicuously and legibly printed on the finished product’s inner label and outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations:
“This product contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner.”
Compounding of Finished Products
99Orders and prescriptions#
(1)A pharmacist or pharmacy technician may compound a finished product, other than one containing a restricted drug, if they do so for the purpose of fulfilling a prescription and if they first receive the following with respect to the finished product from one of the following persons:
(a)in the case of an individual, a written prescription;
(b)in the case of another pharmacist,
(ii)a written prescription, or
(iii)a copy of the document on which the information with respect to a verbal prescription is recorded under section 117;
(c)in the case of another pharmacy technician,
(i)a written prescription, or
(ii)a copy of the document on which the information with respect to a verbal prescription is recorded under section 117;
(2)The information that must be contained in the written order is the following:
(a)with respect to the person placing the order,
(i)in the case of another pharmacist, their name and the name and municipal address of the place where they practise,
(ii)in the case of a practitioner, their name and the name and municipal address of the place where they practise, and
(b)with respect to the pharmacist or pharmacy technician compounding the finished product, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)with respect to the finished product,
(i)its name, and
(ii)its form, strength, the number of containers and, if applicable, the number of units per container; and
(e)if applicable, a declaration from the other pharmacist that they require the finished product for emergency purposes.
Substitution of Controlled Substances
100Sale and compounding#
A pharmacist who sells or provides a controlled substance or who compounds a finished product may, before the sale, provision or compounding, substitute a controlled substance for another controlled substance identified in a prescription, if the pharmacist is authorized to do so under the laws of the province where the sale, provision or compounding takes place.
Prescriptions
101Extension of prescription#
A pharmacist may extend a prescription if the new expiration date of the extended prescription is not later than two years after the day on which the pharmacist received the prescription.
102Transfer of prescription#
A pharmacist or pharmacy technician may transfer a prescription to another pharmacist or pharmacy technician if
(a)they transfer it within two years after the day on which the prescription was received; and
(b)they provide
(i)in the case of a controlled substance prescribed in writing, the written prescription, or
(ii)in the case of a controlled substance prescribed verbally, a copy of the document on which the information with respect to that verbal prescription is recorded under section 117.
Verification of Identity
103Orders and prescriptions#
A pharmacist or pharmacy technician who receives an order or prescription from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the pharmacist.
Packaging and Labelling
104Receipt of substance from individual#
A pharmacist or pharmacy technician who receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom the pharmacist or technician has authorized have access and that is marked in a manner that is sufficient to identify the container.
Storage
105Authorized access#
A pharmacist must ensure that
(a)any controlled substance is stored in a secure location at the place where they practise; and
(b)only persons whom the pharmacist has authorized have access to that secure location.
Delivery, Sending and Transportation
106Authorization#
A pharmacist or pharmacy technician may deliver, send or transport a controlled substance.
107Requirements during transportation#
A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance to another person may only do so if they
(a)ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner sufficient to identify the container;
(b)take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and
(c)use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.
Security
108Protective measures#
A pharmacist or pharmacy technician must take all reasonable measures to ensure the security of any controlled substance in their possession.
109Loss or theft — agent or mandatary#
(1)If an agent or mandatary of a pharmacist becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the pharmacist immediately.
(2)If a pharmacist becomes aware of a loss or theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the pharmacist must provide a written report to the Minister within 10 days after the day on which they become aware of the loss or theft or are notified.
(3)The report, or any evidence derived from it, is not to be used or received to incriminate the pharmacist or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.
Destruction of Controlled Substances
110Conditions#
(1)The destruction of a controlled substance in a pharmacy may only be carried out by a pharmacist or pharmacy technician and if the following conditions are met:
(a)the destruction is witnessed by another person among the following:
(i)a pharmacist, pharmacy technician or intern, including one who is practising in a hospital,
(ii)a practitioner, or
(iii)any other health professional;
(b)the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(c)immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.
(2)A pharmacist must, if the destruction of a controlled substance previously returned by an individual or particular person for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.
Documents
Information
111Substances ordered and received#
A pharmacist who orders a controlled substance or a pharmacist or pharmacy technician who receives a controlled substance, other than one that has been previously returned by an individual or particular person for the purposes of destruction, must record the following information:
(a)their name;
(b)with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;
(c)the date of the order or receipt;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
112Substances sold — persons other than individuals#
A pharmacist who sells or provides a controlled substance to a person, other than an individual referred to in section 113, must record the following information:
(a)the pharmacist’s name;
(b)with respect to the person, their name and, if applicable, title, as well as their municipal address;
(c)the date of the sale or provision;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
(f)if applicable, the reason for the emergency sale or provision.
113Finished product sold — individuals#
A pharmacist who sells or provides a finished product to an individual for their own use, for the use of another individual or for an animal must record the following information:
(a)the pharmacist’s name;
(b)the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
(c)the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;
(d)the number assigned to the prescription;
(e)the date of the sale or provision;
(f)with respect to the finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(g)if applicable, the number of times that the prescription may be refilled and, if specified, the intervals between refills.
114Finished products compounded#
A pharmacist or pharmacy technician who compounds a finished product must record the following information:
(a)their name;
(b)the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
(c)the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;
(d)the number assigned to the prescription;
(e)the date of compounding the finished product; and
(f)with respect to the finished product,
(i)its name, and
(ii)its form, strength, the number of containers and, if applicable, the number of units per container.
115Controlled substance substitutions#
A pharmacist who substitutes a controlled substance for another controlled substance identified in a prescription must record the following information:
(a)their name;
(b)the number assigned to the original prescription;
(c)the date of the substitution;
(d)the name of the controlled substance identified in the prescription; and
(e)the name of the substitute controlled substance.
116Written orders and prescriptions#
A pharmacist or pharmacy technician who receives a written order for a controlled substance or a written prescription from a practitioner must record the following information:
(a)the pharmacist’s or pharmacy technician’s name; and
(b)the date of the order or prescription and the date on which it was received.
117Verbal orders and prescriptions#
A pharmacist or pharmacy technician who receives a verbal order for a controlled substance or a verbal prescription must record the following information:
(a)their name;
(b)with respect to the person placing the order or issuing the prescription,
(i)in the case of an order from another pharmacist,
(A)their name and the name and municipal address of the place where they practise, and
(B)a declaration from the other pharmacist that they require the controlled substance for emergency purposes,
(ii)in the case of a prescription or order from a practitioner,
(A)their name and the name and municipal address of the place where they practise, and
(B)if it is an order, a declaration from the practitioner that they require the controlled substance for emergency purposes, or
(c)the date of receipt of the order or prescription;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(f)if applicable, the number of refills authorized in the prescription and, if specified, the interval between refills.
118Prescriptions refilled and extended#
A pharmacist who refills or extends a prescription must record the following information:
(a)their name;
(b)the number assigned to the original prescription;
(c)the date of the prescription refill or extension; and
(d)if applicable, the new expiration date of the extended prescription.
119Prescription transfers — transferring pharmacist#
(1)A pharmacist or pharmacy technician who transfers a prescription to another pharmacist or pharmacy technician must record the following information:
(a)their name;
(b)with respect to the other pharmacist or pharmacy technician, their name and the name and municipal address of the place where they practise;
(c)the number assigned to the prescription;
(d)the date of the prescription transfer;
(e)the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and, if specified, the interval between refills; and
(f)if applicable, the date of the prescription extension and the new expiration date of the extended prescription.
(2)The pharmacist or pharmacy technician who receives the transferred prescription must record the following information:
(a)their name;
(b)with respect to the pharmacist or pharmacy technician from whom they receive the transferred prescription, their name and the name and municipal address of the place where they practise;
(c)the number assigned to the prescription;
(d)the date of receipt of the prescription;
(e)the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and, if specified, the interval between refills; and
(f)if applicable, the date of the prescription extension and the new expiration date of the extended prescription.
120Transportation#
A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance must record the following information:
(a)their name and the name and municipal address of the place where they practise;
(b)if an agent or mandatary of the pharmacist delivers, sends or transports the controlled substance, their name;
(c)if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:
(i)if it is not a person referred to in subparagraph (ii), their name and, if applicable, title, or
(ii)if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal;
(d)the municipal address of the place where the controlled substance is delivered, sent or transported;
(e)the date of the delivery, sending or transportation;
(f)the means of transportation;
(g)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(h)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
121Destruction#
A pharmacist or pharmacy technician who destroys a controlled substance must record the following information:
(a)their name;
(b)the name of the witness to the destruction;
(c)the municipal address of the place of destruction;
(d)the date of destruction;
(e)the method of destruction;
(f)in the case of a controlled substance set out in any of Schedules 1 to 3, its name and quantity; and
(g)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
Recording Information and Retention and Provision of Documents
122Method of recording#
A pharmacist or pharmacy technician who records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.
123Documents to retain#
(1)A pharmacist who is responsible for the operations of a pharmacy where the information was recorded under these Regulations or, if a pharmacy ceases its operations, the person who was responsible for those operations on the date those operations ceased must, subject to subsection (2), ensure that
(a)any document containing the information that must be recorded under these Regulations is kept for two years after the day on which the last record is recorded in the document;
(b)every written order and prescription is kept, in sequence as to date and number, for two years after the day on which it is received; and
(c)every declaration and report is kept for two years after the day on which it is provided or received.
(2)All documents regarding the sale or provision of a controlled substance must be kept separately, in sequence as to date and number.
124Place#
The documents must be accessible
(a)at the pharmacy where the information was recorded; or
(b)if that pharmacy has ceased its operations, at a place in Canada.
125Quality of documents#
The documents must be complete and readily retrievable and the information in them must be legible and indelible.
126Providing documents#
A pharmacist who is responsible for a pharmacy’s operations or, if a pharmacy has ceased its operations, the person who was responsible for those operations on the date those operations ceased must provide any documents that the Minister requests in the time and manner that the Minister specifies.
Practitioners
Prescriptions
127Conditions#
A practitioner may issue a written prescription that they sign and date or a verbal prescription if
(a)the practitioner is treating, in their professional capacity, the individual for whom, or the animal for which, the prescription is issued; and
(b)the controlled substance set out in the prescription is needed to treat the individual’s or animal’s medical condition.
Sale of Controlled Substances
128Sale to licensed dealer#
(1)A practitioner may sell or provide a controlled substance to a licensed dealer if,
(a)in the case of a controlled substance previously returned by an individual for the purposes of destruction,
(i)the licensed dealer is specialized in destruction, and
(ii)the practitioner first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (2); and
(b)in the case of any other controlled substance,
(i)one of the following conditions is met:
(A)the licensed dealer is the one that sold or provided that controlled substance to the practitioner, or
(B)the practitioner sells or provides the controlled substance for the purposes of testing or destruction, and
(ii)the practitioner first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (2).
(2)The information that must be contained in the written order is the following:
(a)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
(b)with respect to the practitioner, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
(e)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name,
(ii)subject to subparagraph (iv), its form, strength and quantity,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
(f)in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.
129Sale to Minister#
A practitioner may sell or provide a controlled substance to the Minister if they first receive from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:
(a)with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
(b)with respect to the practitioner, their name and the name and municipal address of the place where they practise;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
130Sale to individual#
(1)A practitioner may sell or provide a controlled substance, other than a restricted drug, to an individual if
(a)the sale or provision is for the individual’s own use, for the use of another individual or for an animal; and
(b)the practitioner first issues a written prescription for the individual for whom, or the animal for which, the controlled substance is sold or provided.
(2)A practitioner may sell or provide a restricted drug to an individual for their own use if
(a)the practitioner is treating the individual in their professional capacity; and
(b)the practitioner has received a copy of the letter of authorization in which they are named.
Administration of Controlled Substances
131General condition#
(1)A practitioner may administer a controlled substance, other than a restricted drug, to an individual or animal if the practitioner first issues a written prescription.
(2)A practitioner may administer a restricted drug to an individual if
(a)the practitioner is treating the individual in their professional capacity; and
(b)the practitioner has received a copy of the letter of authorization in which they are named.
132Emergency supply#
(1)A practitioner of medicine who is responsible for an emergency supply must ensure that
(a)the emergency supply does not contain a restricted drug; and
(b)they have an agent or mandatary who is present at the place where the emergency supply is stored and who will, under their direction, administer the controlled substance under their control.
(2)In an emergency, the agent or mandatary of the practitioner of medicine may administer a controlled substance from the emergency supply to an individual if
(a)the practitioner of medicine has directed the agent or mandatary to administer the controlled substance; or
(b)the agent or mandatary follows written directives provided by the practitioner of medicine with respect to the administration of the controlled substance.
Packaging and Labelling
133Receipt of substance from individual#
A practitioner who receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom the practitioner has authorized have access and that is marked in a manner that is sufficient to identify the container.
Storage
134Authorized access#
(1)Subject to subsection (2), a practitioner who stores a controlled substance must ensure that
(a)they store the controlled substance in a secure location in the place where they practise; and
(b)only persons whom the practitioner has authorized have access to that secure location.
(2)A practitioner of medicine who stores an emergency supply need only ensure that
(a)they take all reasonable measures to ensure that the place of storage is secure; and
(b)only the practitioner of medicine and their agent or mandatary have access to that secure place.
Delivery, Sending and Transportation
136Requirements during transportation#
A practitioner who delivers, sends or transports a controlled substance to another person may only do so if they
(a)ensure that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner that is sufficient to identify the container;
(b)take all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and
(c)use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.
Security
137Protective measures#
A practitioner must take all reasonable measures to ensure the security of any controlled substance in their possession.
138Loss or theft — agent or mandatary#
(1)If an agent or mandatary of a practitioner becomes aware of a loss or theft of a controlled substance, the agent or mandatary must notify the practitioner immediately.
(2)If a practitioner becomes aware of a loss or theft of a controlled substance, or is notified by an agent or mandatary of such a loss or theft, the practitioner must provide a written report to the Minister within 10 days after the day on which they become aware of the loss or theft or are notified.
(3)The report, or any evidence derived from it, is not to be used or received to incriminate the practitioner or their agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.
Destruction of Controlled Substances
139Conditions#
(1)The destruction of a controlled substance may be carried out by a practitioner only if the following conditions are met:
(a)the destruction is witnessed by another person among the following:
(i)a pharmacist, pharmacy technician or intern,
(ii)a practitioner, or
(iii)any other health professional;
(b)the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(c)immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.
(2)A practitioner may, without a witness, destroy the remainder of a controlled substance that is contained in an open ampule and that will not be administered.
(3)A practitioner must, if the destruction of a controlled substance previously returned by an individual for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.
Documents
Application
140Scope#
The requirements set out in sections 141 to 152 apply to a practitioner with respect to the following controlled substances:
(a)if the practitioner is not practising in a hospital, a narcotic, controlled drug or targeted substance; and
(b)a restricted drug.
Information
141Substances received#
A practitioner who receives a controlled substance, other than one that has been previously returned by an individual for the purposes of destruction, must record the following information:
(a)with respect to the person from whom the controlled substance is received, their name and, if applicable, title, as well as their municipal address;
(b)the date of receipt;
(c)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(d)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
142Substances sold — persons other than individuals#
A practitioner who sells or provides a controlled substance to a person, other than an individual referred to in section 143, must record
(a)the practitioner’s name;
(b)with respect to the person, their name and, if applicable, title, as well as their municipal address;
(c)the date of the sale or provision;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(e)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name,
(ii)subject to subparagraph (iv), its form, strength and quantity,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
143Substances prescribed, administered or sold — individuals#
(1)A practitioner who conducts the following activities must record the information set out in subsection (2):
(a)prescribe or administer a controlled substance to an individual or an animal; or
(b)sell or provide a controlled substance to an individual for their own use, for the use of another individual or for an animal.
(2)The information that must be recorded is the following:
(a)the practitioner’s name;
(b)the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
(c)in the case of an administration, sale or provision of a restricted drug to an individual, their name;
(d)the date of the prescription, administration, sale or provision;
(e)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;
(f)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity,
(iii)its drug identification number, if any, and
(iv)if the finished product that is sold or provided, other than one containing a restricted drug, is intended for administration by the individual to themselves or the animal, and if the dose exceeds the following, a statement to that effect:
(A)in the case of a finished product containing a controlled drug or narcotic, three times the maximum daily dosage recommended by the producer of the product or, if the producer has not recommended a maximum daily dosage, three times the generally recognized maximum daily therapeutic dosage for that product, or
(B)in the case of a finished product containing a targeted substance, five times the usual daily dose for the product.
144Emergency supply#
A practitioner of medicine who is responsible for an emergency supply must record the following information:
(a)the name of their agent or mandatary administering the controlled substance;
(b)the place where the emergency supply is stored;
(c)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(d)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any;
(e)the date of all activities related to that emergency supply; and
(f)if a controlled substance was administered to an individual, the following information:
(i)the name of the individual,
(ii)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity, and
(iii)in the case of a finished product,
(A)its name or, if applicable, brand name,
(B)its form, strength and quantity, and
(C)its drug identification number, if any.
145Written orders#
A practitioner who receives a written order must record the following information:
(a)their name; and
(b)the date of the order and the date on which it was received.
146Transportation#
A practitioner who delivers, sends or transports a controlled substance must record the following information:
(a)their name and the name and municipal address of the place where they practise;
(b)if an agent or mandatary of the practitioner delivers, sends or transports the controlled substance, their name;
(c)if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:
(i)if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal,
(ii)if they are a consignee of a restricted drug, their name, or
(iii)in any other case, their name and, if applicable title;
(d)the municipal address of the place where the controlled substance is delivered, sent or transported;
(e)the date of the delivery, sending or transportation;
(f)in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and
(g)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name,
(ii)subject to subparagraph (iv), its form, strength and quantity,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
147Destruction#
A practitioner who destroys a controlled substance must record the following information:
(a)their name;
(b)the name of the witness to the destruction;
(c)the municipal address of the place of destruction;
(d)the date of destruction;
(e)the method of destruction;
(f)in the case of a controlled substance set out in any of Schedules 1 to 4, its name and quantity; and
(g)in the case of a finished product,
(i)subject to subparagraph (iii), its name or, if applicable, brand name,
(ii)subject to subparagraph (iii), its quantity, and
(iii)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
Recording Information and Retention and Provision of Documents
148Method of recording#
A practitioner who records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.
149Documents to retain#
A practitioner who is responsible for the operations of a place where information was recorded under these Regulations or, if information was recorded at a place where operations have ceased, the person who was responsible for those operations on the date those operations ceased must ensure that
(a)any document containing the information that they are required to record under these Regulations is kept for two years after the day on which the last record is recorded in the document;
(b)every written order and prescription is kept, in sequence as to date and number, for two years after the day on which it is received or issued respectively; and
(c)every declaration, report and letter of authorization is kept for two years after the day on which it is provided or received.
150Place#
The documents must be accessible
(a)at the place where the information was recorded; or
(b)if operations have ceased at that place, at a place in Canada.
151Quality of documents#
The documents must be complete and readily retrievable and the information in them must be legible and indelible.
152Providing documents#
A practitioner who is responsible for the operations of the place where the information was recorded or, if operations have ceased at a place where information was recorded, the person who was responsible for those operations on the date those operations ceased must provide any documents that the Minister requests in the time and manner that the Minister specifies.
Prescribed Practitioners
153Additional conditions#
In addition to meeting any other requirements set out in these Regulations, the following practitioners who, in accordance with these Regulations and subject to section 154, conduct any activity with respect to a controlled substance, other than a restricted drug, may only do so if they are authorized by the provincial professional regulatory authority to conduct that activity:
(a)a midwife;
(b)a podiatrist; and
(c)a nurse practitioner.
154Midwife and podiatrist#
A midwife or podiatrist must not possess or conduct any activity with respect to the following controlled substances:
(a)a narcotic set out in subitems 1(1) or (10), 2(1), 5(4) or 10(1) of Schedule 1; or
(b)a controlled drug set out in item 1 of Part 1 of Schedule 2, items 9 and 10 of Part 2 of that Schedule, or item 1 of Part 3 of that Schedule.
Hospitals
Application and General Conditions for Activities
155Application#
For the purposes of sections 156 to 188, the terms pharmacist, pharmacy technician, intern and health professional, as defined in subsection 1(1), and practitioner, as defined in subsection 2(1) of the Act, are to be read as only including those who are practising in a hospital, except as otherwise provided.
156Person in charge#
A person in charge of a hospital may permit another person to conduct an activity with respect to a controlled substance if
(a)in the case that the other person is a health professional, they are authorized by the provincial professional regulatory authority to conduct that activity; and
(b)the other person conducts that activity as part of their duties and functions.
157Orders placed on behalf of hospital#
A person in charge of a hospital may only permit the following persons to order a controlled substance, other than a restricted drug, on the hospital’s behalf:
(a)a pharmacist; or
(b)a practitioner.
Sale of Controlled Substances
158Sale to licensed dealer#
(1)A hospital may sell or provide a controlled substance, other than a restricted drug, to a licensed dealer if
(a)in the case of a controlled substance previously returned by an individual for the purposes of destruction,
(i)the licensed dealer is specialized in destruction, and
(ii)the hospital first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3); and
(b)in the case of any other controlled substance,
(i)one of the following conditions is met:
(A)the licensed dealer is the one that sold or provided that controlled substance to the hospital, or
(B)the hospital sells or provides the controlled substance for the purposes of testing or destruction, and
(ii)the hospital first receives from the licensed dealer a written order that is signed and dated and that contains the information set out in subsection (3).
(2)A hospital may sell or provide a restricted drug to a licensed dealer if
(a)the restricted drug was previously returned by an individual for the purposes of destruction;
(b)the licensed dealer is specialized in destruction; and
(c)the hospital first receives from that licensed dealer specialized in destruction a written order that is signed and dated and that contains the information set out in subsection (3).
(3)The information that must be contained in the written order is the following:
(a)with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;
(b)with respect to the hospital, its name and municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name,
(ii)subject to subparagraph (iv), its form, strength and quantity,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
(f)in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.
159Sale to pharmacist#
(1)A hospital may sell or provide a controlled substance, other than a restricted drug, to a pharmacist, other than one who is practising in a hospital, if
(a)the sale or provision is in the case of an emergency; and
(b)the hospital first receives from the pharmacist either a written order that is signed and dated and that contains the following information or a verbal order:
(i)with respect to the pharmacist, their name and the name and municipal address of the place where they practise,
(ii)with respect to the hospital, its name and municipal address,
(iii)the date of the order,
(iv)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity,
(v)in the case of a finished product,
(A)its name or, if applicable, brand name,
(B)its form, strength and quantity, and
(C)its drug identification number, if any, and
(vi)a declaration from the pharmacist that they require the controlled substance for emergency purposes.
(2)A hospital must not sell or provide to the pharmacist a controlled substance that is the subject of a prohibition on the pharmacist’s professional practice imposed by the provincial professional regulatory authority.
160Sale to practitioner#
(1)A hospital may sell or provide a controlled substance, other than a restricted drug, to a practitioner, other than one who is practising in a hospital, if
(a)the sale or provision is in the case of an emergency; and
(b)the hospital first receives from the practitioner either a written order that is signed and dated and that contains the following information or a verbal order:
(i)with respect to the practitioner, their name and the name and municipal address of the place where they practise,
(ii)with respect to the hospital, its name and municipal address,
(iii)the date of the order,
(iv)in the case of a controlled substance set out any of Schedules 1 to 3, its name, form and quantity,
(v)in the case of a finished product,
(A)its name or, if applicable, brand name,
(B)its form, strength and quantity, and
(C)its drug identification number, if any, and
(vi)a declaration from the practitioner that they require the controlled substance for emergency purposes.
(2)A hospital must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.
161Sale to another hospital#
(1)Subject to subsection (2), a hospital may, in the case of an emergency, sell or provide a controlled substance, other than a restricted drug, to another hospital if the hospital first receives from the other hospital a written order that is signed and dated by a person permitted to place an order on the other hospital’s behalf and that contains the following information or a verbal order from such a person:
(b)with respect to the hospital selling or providing the controlled substance, its name and municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any; and
(2)A hospital may, in circumstances other than an emergency, sell or provide a controlled substance, other than a restricted drug, to another hospital if the hospital is ceasing its operations and if the hospital first receives from the other hospital a written order that is signed and dated by a person permitted to place an order on the other hospital’s behalf and that contains the following information:
(b)with respect to the hospital selling or providing the controlled substance, its name and municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
162Sale to Minister#
A hospital may sell or provide a controlled substance to the Minister if the hospital first receives from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:
(a)with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;
(b)with respect to the hospital, its name and municipal address;
(c)the date of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
163Sale to individual#
A hospital may sell or provide a controlled substance, other than a restricted drug, to an individual if
(a)the sale or provision is for the individual’s own use, for the use of another individual or for an animal; and
(b)a practitioner first issues a written or verbal prescription for the individual for whom, or the animal for which, the controlled substance is sold or provided.
Administration of Controlled Substances
164Condition#
A hospital may administer a controlled substance, other than a restricted drug, to an individual or animal if a practitioner first issues a written or verbal prescription.
Compounding of Finished Products
165Orders and prescriptions#
(1)A hospital may compound a finished product, other than one containing a restricted drug, if it is for the purpose of fulfilling a prescription and,
(a)if the finished product is compounded at the request of a practitioner, that practitioner first issues a written or verbal prescription; or
(b)if the finished product is compounded at the request of one of the following persons, in the case of an emergency, the hospital first receives from that person either a written order that is signed and dated and that contains the information set out in subsection (2) or a verbal order:
(i)a pharmacist who is not practising in that hospital or another hospital,
(2)The information that must be contained in the written order is the following:
(a)with respect to the person placing the order,
(i)if they are a pharmacist, their name and the name and municipal address of the place where they practise,
(ii)if they are a practitioner, their name and the name and municipal address of the place where they practise, and
(c)the date of the order;
(e)a declaration that they require the finished product for emergency purposes or, in the case of another hospital, a declaration from the person placing the order that the other hospital requires the finished product for emergency purposes.
Substitution of Controlled Substances
166Sale and compounding#
A hospital that sells or provides a controlled substance or that compounds a finished product may, before the sale, provision or compounding, substitute a controlled substance for another controlled substance identified in a prescription, if it is authorized to do so under the laws of the province where the sale, provision or compounding takes place.
Verification of Identity
Packaging and Labelling
168Receipt of substance from individual#
A hospital that receives a controlled substance from an individual for the purposes of destruction must keep the substance in a collection container that is in a secure location to which only persons whom it has authorized have access and that is marked in a manner that is sufficient to identify the container.
Storage
Delivery, Sending and Transportation
171Requirements during transportation#
A hospital that delivers, sends or transports a controlled substance to another person may only do so if it
(a)ensures that, if the controlled substance is being delivered, sent or transported to a licensed dealer specialized in destruction, the substance is placed in a container that is sealed in such a manner that it cannot be opened without breaking the seal and is marked in a manner that is sufficient to identify the container;
(b)takes all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported; and
(c)uses a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.
Security
172Protective measures#
A hospital must take all reasonable measures to ensure the security of any controlled substance in its possession.
173Loss or theft — agent or mandatary#
(3)The report, or any evidence derived from it, is not to be used or received to incriminate the hospital or its agent or mandatary in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.
Destruction of Controlled Substances
174Conditions#
(1)The destruction of a controlled substance in a hospital may only be carried out, subject to subsection (2), by the person in charge of the hospital, a pharmacist, a pharmacy technician or a practitioner and if the following conditions are met:
(a)the destruction is witnessed by another person among the following:
(i)a pharmacist, pharmacy technician or intern,
(ii)a practitioner,
(iii)any other health professional, or
(iv)the person in charge of the hospital;
(b)the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(c)immediately following the destruction, the person who carried out the destruction and the witness sign and date a joint declaration attesting that the controlled substance was destroyed, to which each signatory must add their name in printed letters.
(2)A health professional may, without a witness, destroy the remainder of a controlled substance, other than a restricted drug, that is contained in an open ampule and that will not be administered.
(3)A hospital must, if the destruction of a controlled substance previously returned by an individual for the purposes of destruction was not carried out, sell or provide the substance to a licensed dealer specialized in destruction.
Documents
Information
175Substances received#
A hospital that receives a controlled substance, other than one that has been previously returned by an individual for the purposes of destruction, must record the following information:
(a)the name of the person receiving the controlled substance;
(b)with respect to the person from whom the controlled substance is received, their name and, if applicable, title, as well as their municipal address;
(c)the date of receipt;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
176Substances sold — persons other than individuals#
A hospital that sells or provides a controlled substance to a person, other than an individual referred to in section 177, must record the following information:
(a)the name of the person selling or providing the controlled substance;
(b)with respect to the person to whom the controlled substance is sold or provided, their name and, if applicable, title, as well as their municipal address;
(c)the date of the sale or provision;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;
(e)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name,
(ii)subject to subparagraph (iv), its form, strength and quantity,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and
(f)if applicable, the reason for the emergency sale or provision.
177Substances sold or administered — individuals#
A hospital that sells or provides a controlled substance to an individual for their own use, for the use of another individual or for an animal, or that administers a controlled substance to an individual or an animal, must record the following information:
(a)the name of the person selling, providing or administering the controlled substance;
(b)the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
(c)the date of the sale, provision or administration;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
178Finished products compounded#
A hospital that compounds a finished product must record the following information:
(a)the name of the person compounding the finished product;
(b)the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;
(c)the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;
(d)the number assigned to the prescription;
(e)the date of compounding; and
179Controlled substance substitutions#
A hospital that substitutes a controlled substance for another controlled substance identified in a prescription must record the following information:
(a)the name of the person who carries out the substitution;
(b)the number assigned to the original prescription;
(c)the date of the substitution;
(d)the name of the controlled substance identified in the prescription; and
(e)the name of the substitute controlled substance.
180Written orders#
A hospital that receives a written order for a controlled substance must record the following information:
(a)the name of the person receiving the order; and
(b)the date of the order and the date on which it was received.
181Verbal orders#
A hospital that receives a verbal order for a controlled substance must record the following information:
(a)the name of the person receiving the order;
(b)with respect to the person placing the order,
(c)the date of receipt of the order;
(d)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(e)in the case of a finished product,
(i)its name or, if applicable, brand name,
(ii)its form, strength and quantity, and
(iii)its drug identification number, if any.
182Transportation#
A hospital that delivers, sends or transports a controlled substance must record the following information:
(a)its name and municipal address;
(b)with respect to the agent or mandatary of the hospital delivering, sending or transporting the controlled substance, their name;
(c)if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:
(i)if it is not a person referred to in subparagraph (ii), their name and, if applicable, title, or
(ii)if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal;
(d)the municipal address of the place where the controlled substance will be delivered, sent or transported;
(e)the date of the delivery, sending or transportation;
(f)the means of transportation used;
(g)in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and
(h)in the case of a finished product,
(i)subject to subparagraph (iv), its name or, if applicable, brand name,
(ii)subject to subparagraph (iv), its form, strength and quantity,
(iii)subject to subparagraph (iv), its drug identification number, if any, and
(iv)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
183Destruction#
A person who destroys a controlled substance in a hospital must record the following information:
(a)their name;
(b)the name of the witness to the destruction;
(c)the municipal address of the hospital;
(d)the date of destruction;
(e)the method of destruction;
(f)in the case of a controlled substance set out in any of Schedules 1 to 3, its name and quantity; and
(g)in the case of a finished product,
(i)subject to subparagraph (iii), its name or, if applicable, brand name,
(ii)subject to subparagraph (iii), its quantity, and
(iii)if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.
Recording Information and Retention and Provision of Documents
184Method of recording#
Any person who records any information under sections 175 to 183 must do so using a method that permits an audit of it to be made at any time.
185Documents to retain#
A hospital or, if a hospital ceases its operations, the person who was responsible for those operations on the date those operations ceased must ensure that
(a)any document containing the information that is required to be recorded under sections 175 to 183 is kept for two years after the day on which the last record is recorded in the document;
(b)every written order and prescription is kept, in sequence as to date and number, for two years after the day on which it is received or issued respectively; and
(c)every declaration and report is kept for two years after the day on which it is provided or received.
186Place#
The documents must be accessible
(a)at the hospital where the information was recorded; or
(b)if that hospital has ceased its operations, at a place in Canada.
Minister
Authorizations and Conditions Applicable to Activities
Sale of Controlled Substances
189Sale to practitioner#
(1)The Minister may sell or provide a controlled substance to a practitioner that the Minister has named in a letter of authorization.
(2)The Minister must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.
Delivery, Sending and Transportation
Import and Export
192Import#
The Minister may import a controlled substance that is intended to be sold or provided to one of the following persons:
(a)a practitioner named in a letter of authorization; or
(b)a person exempted under subsection 56(1) of the Act with respect to that substance.
Provision of Information to Third Parties
194Provincial government or regulatory authority — entitled persons#
(1)The Minister may provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to any relevant provincial government or to any provincial professional regulatory authority of a province in which the person is or was entitled by that authority to practise their profession, if
(a)the government or authority submits to the Minister a written request that sets out the person’s name and municipal address, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the government or authority;
(b)the Minister has reasonable grounds to believe that the person has
(i)contravened a rule of conduct established by the authority,
(ii)been convicted of a designated substance offence, or
(iii)contravened these Regulations; or
(c)the Minister has reasonable grounds to believe that the provision of the information is necessary to assist the government or authority in monitoring the person’s professional conduct for compliance with the laws of the province for the purpose of protecting public health or safety.
(2)The Minister may provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to any relevant provincial government or any provincial professional regulatory authority of a province in which the person is not entitled by that authority to practise their profession, if the government or authority submits to the Minister
(a)a written request that sets out the person’s name and municipal address and a description of the information being requested; and
(b)a document that shows that
(i)the person has applied to that authority to practise in that province, or
(ii)the government or authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.
195Customs officer#
The Minister may, for the purpose of verifying whether an importation or exportation of a controlled substance complies with these Regulations, provide the following to a customs officer:
(a)information provided in the permit application under section 34, 42, 205 or 213;
(b)information listed on the permit under subsection 35(1), 43(1), 206(1) or 214(1);
(c)information provided in the declaration under section 39, 47, 210 or 218; or
(d)information concerning the suspension or revocation of an import or export permit.
196International Narcotics Control Board#
The Minister may provide to the International Narcotics Control Board any information that is obtained under the Act or these Regulations if the provision would allow Canada to respect its international obligations in relation to controlled substances.
197Competent authorities#
The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it would allow Canada to respect its international obligations in relation to controlled substances, provide to a competent authority
(a)information obtained from a licensed dealer that has applied for or that holds an import or export permit;
(b)information relating to
(i)an import or export permit, or
(ii)an activity specified on a dealer’s licence held by a licensed dealer that has applied for or that holds an import or export permit;
(c)any document that the holder or former holder of an import or export permit is required to retain, including any document that relates to the dealer’s licence that the dealer holds or held; and
(d)a copy of any import or export permit.
Temporary Scheduling
198Restricted drugs#
(2)The Minister may, by order, delete any item or portion of an item from Part 3 of Schedule 4.
(3)An item or portion of an item listed in Part 3 of Schedule 4 to these Regulations is deemed to be deleted on the day on which the equivalent item or portion of an item is no longer listed in Schedule V to the Act.
Government Laboratories
Production
199Authorization#
A government laboratory may produce a controlled substance.
Sale of Controlled Substances
200Sale to licensed dealer#
A government laboratory may sell or provide a controlled substance to a licensed dealer.
201Sale to Minister#
A government laboratory may sell or provide a controlled substance to the Minister.
202Sale to another government laboratory#
A government laboratory may sell or provide a controlled substance to another government laboratory.
Delivery, Sending and Transportation
203Authorization#
A government laboratory may deliver, send or transport a controlled substance.
Import and Export
Authorization
204Condition#
A government laboratory may import or export a controlled substance if it does so in accordance with an import or export permit issued under these Regulations.
Import Permit
205Application#
(1)A government laboratory must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:
(a)the government laboratory’s name and municipal address;
(b)the name and municipal address of the proposed customs broker for the government laboratory, if any;
(c)the name of the customs office where the importation is anticipated and the proposed date of importation;
(d)the name and municipal address, in the country of export, of the exporter from whom the controlled substance is being obtained;
(e)the name of the carrier that is proposed to transport the controlled substance to the customs office where the importation is anticipated;
(f)each proposed mode of transportation and any proposed country of transit or transhipment;
(g)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name,
(ii)its CAS registry number, if any,
(iii)if it is a salt, the name of the salt,
(iv)its form,
(v)its purity and anhydrous content, and
(vi)its quantity; and
(h)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
(2)The application must
(a)be signed and dated by the person in charge of the government laboratory; and
(b)include an attestation by that person that, to the best of their knowledge,
(i)the importation does not contravene the laws of the country of exportation or any country of transit or transhipment, and
(ii)all of the information and documents submitted in support of the application are correct and complete.
(3)The government laboratory must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
206Issuance#
(1)Subject to section 208, on completion of the review of the import permit application, the Minister must issue to the government laboratory an import permit that contains
(a)the permit number;
(b)the information set out in subsection 205(1);
(c)the effective date of the permit;
(d)the expiry date of the permit, which must be not later than 180 days after its effective date; and
(e)any terms and conditions that the Minister has reasonable grounds to believe are necessary to
(i)ensure that an international obligation is respected, or
(ii)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)A person must not alter or deface in any manner an import permit.
207Validity#
An import permit is valid until the earliest of
(a)the expiry date set out in the permit,
(b)the date of the suspension or revocation of the permit under section 211 or 212, and
(c)the date of the expiry, suspension or revocation of the export authorization that applies to the controlled substance to be imported and that is issued by the competent authority in the country of export.
208Refusal#
(1)The Minister must refuse to issue an import permit if
(a)the Minister has reasonable grounds to believe that the importation would contravene an international obligation;
(b)the government laboratory has not provided the Minister with the information or documents required under subsection 205(3) or before the date specified in the written request referred to in that subsection, or the information or documents that it has provided before that date are not sufficient to complete the review of the permit application;
(c)the Minister has reasonable grounds to believe that the government laboratory has submitted false or misleading information or false or falsified documents in or in support of the permit application;
(d)the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or
(e)the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)Before refusing to issue an import permit, the Minister must
(a)provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and
(b)consider the government laboratory’s submissions, if applicable.
209Providing copy of permit#
The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.
210Declaration#
The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled substance specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a)the permit holder’s name;
(b)the number of the import permit;
(c)the name of the customs office from which the controlled substance was released and the date of the release;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name,
(ii)if it is a salt, the name of the salt,
(iii)its form, and
(iv)its quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
211Suspension#
(1)Subject to subsection (2), the Minister must immediately suspend an import permit if
(a)the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or
(b)the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment.
(2)The suspension takes effect as soon as the Minister provides the government laboratory with a written notice that
(a)sets out the reasons for the suspension;
(b)gives the government laboratory an opportunity to be heard; and
(c)if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.
(3)The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
212Revocation#
(1)The Minister must revoke an import permit if
(a)the government laboratory requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
(b)the government laboratory does not carry out the corrective measures specified by the Minister under paragraph 211(2)(c) by the specified date; or
(c)the Minister has reasonable grounds to believe that the government laboratory submitted misleading information or falsified documents in or in support of the application for the permit.
(2)Before revoking an import permit, the Minister must
(a)provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and
(b)consider the government laboratory’s submissions, if applicable.
Export Permit
213Application#
(1)A government laboratory must submit to the Minister, before each exportation of a controlled substance, an application for an export permit that contains the following information and document:
(a)the government laboratory’s name and municipal address;
(b)the name and municipal address of the proposed customs broker for the government laboratory, if any;
(c)the name of the customs office where the exportation is anticipated and the proposed date of exportation;
(d)the name and municipal address of the importer in the country of final destination;
(e)the name of the carrier that is proposed to transport the controlled substance from the customs office where the exportation is anticipated;
(f)each proposed mode of transportation and any proposed country of transit or transhipment;
(g)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name,
(ii)its CAS registry number, if any,
(iii)if it is a salt, the name of the salt,
(iv)its form,
(v)its purity and anhydrous content, and
(vi)its quantity;
(h)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any; and
(i)a copy of the import authorization issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.
(2)The application must
(a)be signed and dated by the person in charge of the government laboratory; and
(b)include an attestation by that person that, to the best of their knowledge,
(i)the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and
(ii)all of the information and documents submitted in support of the application are correct and complete.
(3)The government laboratory must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
214Issuance#
(1)Subject to section 216, on completion of the review of the export permit application, the Minister must issue to the government laboratory an export permit that contains
(a)the permit number;
(b)the information set out in paragraphs 213(1)(a) to (h) and the number of the import authorization referred to in paragraph 213(1)(i);
(c)the effective date of the permit;
(d)the expiry date of the permit, being the earliest of
(i)a date specified by the Minister that is not more than 180 days after its effective date, and
(ii)the expiry date of the import authorization issued by the competent authority in the country of final destination; and
(e)any terms and conditions that the Minister has reasonable grounds to believe are necessary to
(i)ensure that an international obligation is respected, or
(ii)reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)A person must not alter or deface in any manner an export permit.
215Validity#
An export permit is valid until the earliest of
(a)the expiry date set out in the permit,
(b)the date of the suspension or revocation of the permit under section 219 or 220, and
(c)the date of the expiry, suspension or revocation of the import authorization that applies to the controlled substance to be exported and that is issued by the competent authority in the country of final destination.
216Refusal#
(1)The Minister must refuse to issue an export permit if
(a)the Minister has reasonable grounds to believe that the exportation would contravene an international obligation;
(b)the government laboratory has not provided the Minister with the information or documents required under subsection 213(3) or before the date specified in the written request referred to in that subsection, or the information or documents that it has provided before that date are not sufficient to complete the review of the permit application;
(c)the Minister has reasonable grounds to believe that the government laboratory has submitted false or misleading information or false or falsified documents in or in support of the permit application;
(d)the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import authorization issued by the competent authority of the country of final destination;
(e)the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or
(g)the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.
(2)Before refusing to issue an export permit, the Minister must
(a)provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and
(b)consider the government laboratory’s submissions, if applicable.
217Providing copy of permit#
The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.
218Declaration#
The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains the following information:
(a)the permit holder’s name;
(b)the number of the export permit;
(c)the name of the customs office from which the controlled substance was exported and the date of export;
(d)in the case of a controlled substance set out in any of Schedules 1 to 4,
(i)its name,
(ii)if it is a salt, the name of the salt,
(iii)its form, and
(iv)its quantity; and
(e)in the case of a mixture or finished product,
(i)its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii)its form, its strength, the number of containers and, if applicable, the number of units per container, and
(iii)its drug identification number, if any.
219Suspension#
(1)Subject to subsection (2), the Minister must immediately suspend an export permit if
(a)the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or
(b)the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.
(2)The suspension takes effect as soon as the Minister provides the government laboratory with a written notice that
(a)sets out the reasons for the suspension;
(b)gives the government laboratory an opportunity to be heard; and
(c)if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.
(3)The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
220Revocation#
(1)The Minister must revoke an export permit if
(a)the government laboratory requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
(b)the government laboratory does not carry out the corrective measures specified by the Minister under paragraph 219(2)(c) by the specified date; or
(c)the Minister has reasonable grounds to believe that the government laboratory submitted misleading information or falsified documents in or in support of the application for the permit.
(2)Before revoking an export permit, the Minister must
(a)provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and
(b)consider the government laboratory’s submissions, if applicable.
Particular Persons
Sale of Controlled Substances
221Authorization#
A particular person may sell or provide a controlled substance to a licensed dealer, pharmacist or police force for the purposes of destruction.
Delivery, Sending and Transportation
222Authorization#
A particular person may deliver, send or transport a controlled substance to a licensed dealer, pharmacist or police force for the purposes of destruction.
Individuals
223Transportation and provision#
An individual who has obtained, in accordance with the provisions of the Act and its regulations, a controlled substance identified in a prescription for another individual named in that prescription may deliver, transport, sell or provide the substance to that individual.
224Return for destruction#
An individual who has reasonable grounds to believe that a controlled substance in their possession was obtained in accordance with the provisions of the Act and its regulations may, for the purposes of destruction, deliver, transport, sell or provide the substance directly to one of the following persons:
(a)a pharmacist or pharmacy technician, other than one who is practising in a hospital;
(b)a practitioner, other than one who is practising in a hospital;
(c)a hospital; or
(d)a particular person.
225Import#
On entering Canada, an individual may import a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if
(a)the individual is importing the substance
(i)for their own use,
(ii)for the use and on the behalf of an accompanying individual, or
(iii)for administration to an animal for which the individual is responsible and that is accompanying the individual;
(b)the substance is declared to a customs officer at the port of entry into Canada;
(c)the substance, except a finished product referred to in subsection 98(2) that contains low-dose codeine phosphate, is in a container obtained from a health care provider and that container carries a label on which the following information appears:
(i)the name of the individual for whom, or the animal for which, the substance was lawfully obtained,
(ii)the name of the health care provider who authorized the substance to be obtained,
(iii)with respect to the substance,
(A)its name or, if applicable, brand name,
(B)its form, strength and quantity, and
(C)its drug identification number, if any, and
(iv)the daily dose of the substance authorized by the health care provider; and
(d)the imported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.
226Export#
On departing Canada, an individual may export a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if
(a)the individual is exporting the substance
(i)for their own use,
(ii)for the use and on the behalf of an accompanying individual, or
(iii)for administration to an animal for which the individual is responsible and that is accompanying the individual;
(b)the substance, except a finished product referred to in subsection 98(2) that contains low-dose codeine phosphate, is in a container obtained from a health care provider and that container carries a label on which the following information appears:
(i)the name of the individual for whom, or the animal for which, the substance was lawfully obtained,
(ii)the name of the health care provider who authorized the substance to be obtained,
(iii)with respect to the substance,
(A)its name or, if applicable, brand name,
(B)its form, strength and quantity, and
(C)its drug identification number, if any, and
(iv)the daily dose of the substance authorized by the health care provider; and
(c)the exported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.
Test Kits
228Requirement to obtain registration number#
The following persons are required to obtain a registration number for a test kit:
(a)a person that intends to produce a test kit; and
229Application for registration number#
(1)An application to obtain a registration number for a test kit must be submitted to the Minister and contain the following information with respect to the test kit:
(a)its brand name;
(b)a detailed description of its design and construction;
(c)with respect to the controlled substance set out in any of Schedules 1 to 4 and any other substance it contains, their names, forms and quantities;
(d)a description of its proposed use; and
(e)its directions for use.
(2)The application must
(a)be signed and dated by the person authorized by the applicant for that purpose; and
(b)include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.
(3)The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
230Issuance of registration number#
(1)Subject to section 231, on completion of the review of the application for a registration number, the Minister must issue to the applicant a document that sets out a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.
(2)A person must not alter or deface in any manner the document that sets out the registration number.
231Refusal to issue registration number#
(1)The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that
(a)the test kit poses a risk to public health or safety, including the risk that the controlled substance in the test kit could be diverted to an illicit market or use, because
(i)the total amount of the controlled substance is too high, or
(b)the test kit will be used for a purpose other than one referred to in subsection 230(1).
(2)Before refusing to issue a registration number, the Minister must
(a)provide the applicant with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and
(b)consider the applicant’s submissions, if applicable.
232Notice to Minister#
A person must inform the Minister in writing of any of the following facts within 30 days after their occurrence:
(a)the person has ceased to conduct all activities authorized under section 234 with respect to the test kit;
(b)the person has transferred the production of the test kit to another person;
(c)the person has increased the quantity of the controlled substance in the test kit;
(d)the person has changed the brand name of the test kit;
(e)the person has altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or
(f)the person has substituted the adulterating or denaturing agent with another one.
233Cancellation of registration number#
(1)The Minister must cancel the registration number of a test kit if
(a)the Minister receives a notice from the person to whom the document that sets out the registration number was issued, stating that production of the test kit has ceased; or
(b)the Minister has reasonable grounds to believe that one of the circumstances referred to in paragraph 231(1)(a) or (b) exists.
(2)Before cancelling a registration number, the Minister must
(a)provide the person to whom the document that sets out the registration number was issued with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and
(b)consider the person’s submissions, if applicable.
(3)The following rules apply when the registration number of a test kit is cancelled:
(a)in the case of a test kit produced before a cancellation under paragraph (1)(a),
(i)the activities set out in section 234 remain authorized, and
(ii)the registration number must remain on the label of the test kit; and
(b)in the case of a test kit produced either before or after a cancellation under paragraph (1)(b), the registration number must not be displayed on its label.
234Authorized activities#
(1)Any person, other than a person referred to in subsection (2), may possess, sell, provide, transport, send, deliver, import or export a test kit if the following conditions are met:
(a)subject to subparagraph 233(3)(a)(i), the registration number of the test kit has not been cancelled under subsection 233(1);
(b)the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and
(c)the test kit carries a label on which the following information appears:
(i)the registration number of the test kit, and
(ii)in the case of a test kit that is not subject to the labelling requirements set out in the Medical Devices Regulations,
(B)its brand name.
(2)A person referred to in section 2 may possess a test kit.
Miscellaneous Provisions
Advertising
235Restrictions#
A person that advertises a controlled substance may only do so if
(a)the substance is not a restricted drug;
(b)the advertisement is directed to a person that is not part of the general public; and
(c)in the case of a written advertisement,
(i)the advertisement appears in a document distributed to, or in a trade publication for,
(A)a licensed dealer,
(B)a pharmacist, pharmacy technician or practitioner, or
(C)a hospital, and
(ii)the advertisement contains, in a conspicuous place, a legible and intelligible statement that the substance is a controlled substance.
Notification of an Application for an Order of Restoration
236Written notification#
(2)The prior notification must specify
(a)the name of the justice to whom the application is to be made;
(b)the time and place at which the application is to be heard;
(c)details concerning the controlled substance or other thing in respect of which the application is to be made; and
(d)the evidence on which the applicant intends to rely to establish that the applicant is entitled to possession of the controlled substance or other thing referred to in paragraph (c).
Repeals
Coming into Force
Schedule 1 · Narcotics (Subsection 1(1), paragraphs 5(1)(a), 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 57(1)(d), 58(1)(d), 59(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 92(3)(d), 93(1)(d) and (2)(e), 94(1)(d), 95(d), 97(d), 111(d), 112(d), 117(d), 120(g), 121(f), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e) and 144(c), subparagraph 144(f)(ii), paragraphs 146(f), 147(f), 154(a) and 158(3)(d), subparagraphs 159(1)(b)(iv) and 160(1)(b)(iv), paragraphs 161(1)(d) and (2)(d), 162(d), 175(d), 176(d), 177(d), 181(d), 182(g), 183(f), 205(1)(g), 210(d), 213(1)(g) and 218(d), sections 225 and 226 and paragraph 229(1)(c))
Item | Name1 | Opium Poppy (Papaver somniferum), its preparations, derivatives, alkaloids and salts, including(1)Opium(2)Codeine (methylmorphine)(3)Morphine (7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol)(4)Thebaine (paramorphine)and the salts, derivatives and salts of derivatives of the substances set out in subitems (1) to (4), including(5)Acetorphine (acetyletorphine)(6)Acetyldihydrocodeine (4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol acetate)(7)Benzylmorphine (7,8-didehydro-4,5-epoxy-17-methyl-3-(phenylmethoxy) morphinan-6-ol)(8)Codoxime (dihydrocodeinone O-(carboxymethyl)oxime)(9)Desomorphine (dihydrodeoxymorphine)(10)Diacetylmorphine (heroin)(11)Dihydrocodeine (4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol)(12)Dihydromorphine (4,5-epoxy-17-methylmorphinan-3,6-diol)(13)Ethylmorphine (7,8-didehydro-4,5-epoxy-3-ethoxy-17-methylmorphinan-6-ol)(14)Etorphine (tetrahydro-7alpha-(1-hydroxy-1-methylbutyl)-6,14-endo-ethenooripavine)(15)Hydrocodone (dihydrocodeinone)(16)Hydromorphinol (dihydro-14-hydroxymorphine)(17)Hydromorphone (dihydromorphinone)(18)Methyldesorphine (delta-6-deoxy-6-methylmorphine)(19)Methyldihydromorphine (dihydro-6-methylmorphine)(20)Metopon (dihydromethylmorphinone)(21)Morphine-N-oxide (morphine oxide)(22)Myrophine (benzylmorphine myristate)(23)Nalorphine (N-allylnormorphine)(24)Nicocodine (6-nicotinylcodeine)(25)Nicomorphine (dinicotinylmorphine)(26)Norcodeine (N-desmethylcodeine)(27)Normorphine (N-desmethylmorphine)(28)Oxycodone (dihydrohydroxycodeinone)(29)Oxymorphone (dihydrohydroxymorphinone)(30)Pholcodine (3-[2-(4-morpholinyl)ethyl]morphine)(31)Thebacon (acetyldihydrocodeinone)but not including(32)Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts(33)Cyprenorphine (N-(cyclopropylmethyl)-6,7,8,14-tetrahydro-7alpha-(1-hydroxy-1-methylethyl)-6,14-endo-ethenonororipavine) and its salts(34)Nalmefene (17-(cyclopropylmethyl)-4,5alpha-epoxy-6-methylenemorphinan-3,14-diol) and its salts(35)Naloxone (4,5alpha-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one) and its salts(36)Naltrexone (17-(cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one) and its salts(37)Methylnaltrexone (17-(cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinanium) and its salts(38)Naloxegol (4,5alpha-epoxy-6alpha-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)-17-(2-propenyl)morphinan-3,14-diol) and its salts(39)Narcotine (6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-1(3H)-isobenzofuranone) and its salts(40)Papaverine (1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxyisoquinoline) and its salts(41)Poppy seed2 | Coca (Erythroxylum), its preparations, derivatives, alkaloids and salts, including(1)Coca leaves(2)Cocaine (benzoylmethylecgonine)(3)Ecgonine (3-hydroxy-2-tropane carboxylic acid)but not including(4)123I-ioflupane3 | Phenylpiperidines, their intermediates, salts, derivatives and analogues and salts of intermediates, derivatives and analogues, including(1)Allylprodine (3-allyl-1-methyl-4-phenyl-4-piperidinol propionate)(2)Alphameprodine (alpha-3-ethyl-1-methyl-4-phenyl-4-piperidinol propionate)(3)Alphaprodine (alpha-1,3-dimethyl-4-phenyl-4-piperidinol propionate)(4)Anileridine (ethyl 1-[2-(p-aminophenyl)ethyl]-4-phenylpiperidine-4-carboxylate)(5)Betameprodine (beta-3-ethyl-1-methyl-4-phenyl-4-piperidinol propionate)(6)Betaprodine (beta-1,3-dimethyl-4-phenyl-4-piperidinol propionate)(7)Benzethidine (ethyl 1-(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylate)(8)Diphenoxylate (ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate)(9)Difenoxin (1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate)(10)Etoxeridine (ethyl 1-[2-(2-hydroxyethoxy)ethyl]-4-phenylpiperidine-4-carboxylate)(11)Furethidine (ethyl 1-(2-tetrahydrofurfuryloxyethyl)-4-phenylpiperidine-4-carboxylate)(12)Hydroxypethidine (ethyl 4-(m-hydroxyphenyl)-1-methylpiperidine-4-carboxylate)(13)Ketobemidone (1-[4-(m-hydroxyphenyl)-1-methyl-4-piperidyl]-1-propanone)(14)Methylphenylisonipecotonitrile (4-cyano-1-methyl-4-phenylpiperidine)(15)Morpheridine (ethyl 1-(2-morpholinoethyl)-4-phenylpiperidine-4-carboxylate)(16)Norpethidine (ethyl 4-phenylpiperidine-4-carboxylate)(17)Pethidine (ethyl 1-methyl-4-phenylpiperidine-4-carboxylate)(18)Phenoperidine (ethyl 1-(3-hydroxy-3-phenylpropyl)-4-phenylpiperidine-4-carboxylate)(19)Piminodine (ethyl 1-[3-(phenylamino)propyl]-4-phenylpiperidine-4-carboxylate)(20)Properidine (isopropyl 1-methyl-4-phenylpiperidine-4- carboxylate)(21)Trimeperidine (1,2,5-trimethyl-4-phenyl-4-piperidinol propionate)(22)Pethidine Intermediate C (1-methyl-4-phenylpiperidine-4-carboxylate)but not including(23)Carperidine (ethyl 1-(2-carbamylethyl)-4-phenylpiperidine-4-carboxylate) and its salts(24)Oxpheneridine (ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate) and its salts4 | Phenazepines, their salts, derivatives and salts of derivatives including(1)Proheptazine (hexahydro-1,3-dimethyl-4-phenyl-1H-azepin-4-ol propionate)but not including(2)Ethoheptazine (ethyl hexahydro-1-methyl-4-phenylazepine-4-carboxylate) and its salts(3)Metethoheptazine (ethyl hexahydro-1,3-dimethyl-4-phenylazepine-4-carboxylate) and its salts(4)Metheptazine (methylhexahydro-1,2-dimethyl-4-phenylazepine-4-carboxylate) and its salts5 | Amidones, their intermediates, salts, derivatives and salts of intermediates and derivatives, including(1)Dimethylaminodiphenylbutanonitrile (4-cyano-2-dimethylamino-4,4-diphenylbutane)(2)Dipipanone (4,4-diphenyl-6-piperidino-3-heptanone)(3)Isomethadone (6-dimethylamino-5-methyl-4,4-diphenyl-3-hexanone)(4)Methadone (6-dimethylamino-4,4-diphenyl-3-heptanone)(5)Normethadone (6-dimethylamino-4,4-diphenyl-3-hexanone)(6)Norpipanone (4,4-diphenyl-6-piperidino-3-hexanone)(7)Phenadoxone (6-morpholino-4,4-diphenyl-3-heptanone)6 | Methadols, their salts, derivatives and salts of derivatives, including(1)Acetylmethadol (6-dimethylamino-4,4-diphenyl-3-heptanol acetate)(2)Alphacetylmethadol (alpha-6-dimethylamino-4,4-diphenyl-3-heptanol acetate)(3)Alphamethadol (alpha-6-dimethylamino-4,4-diphenyl-3-heptanol)(4)Betacetylmethadol (beta-6-dimethylamino-4,4-diphenyl-3-heptanol acetate)(5)Betamethadol (beta-6-dimethylamino-4,4-diphenyl-3-heptanol)(6)Dimepheptanol (6-dimethylamino-4,4-diphenyl-3-heptanol)(7)Noracymethadol (alpha-6-methylamino-4,4-diphenyl-3-heptanol acetate)7 | Phenalkoxams, their salts, derivatives and salts of derivatives, including(1)Dimenoxadol (dimethylaminoethyl 1-ethoxy-1,1-diphenylacetate)(2)Dioxaphetyl butyrate (ethyl 2,2-diphenyl-4-morpholinobutyrate)(3)Dextropropoxyphene ([S-(R*,S*)]-alpha-[2-(dimethylamino)-1-methylethyl]-alpha-phenylbenzeneethanol, propanoate ester)8 | Thiambutenes, their salts, derivatives and salts of derivatives, including(1)Diethylthiambutene (N,N-diethyl-1-methyl-3,3-di-2-thienylallylamine)(2)Dimethylthiambutene (N,N,1-trimethyl-3,3-di-2-thienylallylamine)(3)Ethylmethylthiambutene (N-ethyl-N,1-dimethyl-3,3-di-2-thienylallylamine)9 | Moramides, their intermediates, salts, derivatives and salts of intermediates and derivatives, including(1)Dextromoramide (d-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine)(2)Diphenylmorpholinoisovaleric acid (2-methyl-3-morpholino-1,1-diphenylpropionic acid)(3)Levomoramide (l-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine)(4)Racemoramide (d,l-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine)10 | Morphinans, their salts, derivatives and salts of derivatives, including(1)Buprenorphine (17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-6,14-ethenomorphinan-7-methanol)(2)Drotebanol (6beta,14-dihydroxy-3,4-dimethoxy-17-methylmorphinan)(3)Levomethorphan (1-3-methoxy-17-methylmorphinan)(4)Levorphanol (1-3-hydroxy-17-methylmorphinan)(5)Levophenacylmorphan (1-3-hydroxy-17-phenacylmorphinan)(6)Norlevorphanol (1-3-hydroxymorphinan)(7)Phenomorphan (3-hydroxy-17-(2-phenylethyl)morphinan)(8)Racemethorphan (d,l-3-methoxy-17-methylmorphinan)(9)Racemorphan (d,l-3-hydroxy-N-methylmorphinan)but not including(10)Dextromethorphan (d-1,2,3,9,10,10a-hexahydro-6-methoxy-11-methyl-4H-10,4a-iminoethanophenanthren) and its salts(11)Dextrorphan (d-1,2,3,9,10,10a-hexahydro-11-methyl-4H-10,4a-iminoethanophenanthren-6-ol) and its salts(12)Levallorphan (l-11-allyl-1,2,3,9,10,10a-hexahydro-4H-10,4a-iminoethanophenanthren-6-ol) and its salts(13)Levargorphan (l-11-propargyl-1,2,3,9,10,10a-hexahydro-4H-10,4a-iminoethanophenanthren-6-ol) and its salts(14)Butorphanol (l-N-cyclobutylmethyl-3,14-dihydroxymorphinan) and its salts(15)Nalbuphine (N-cyclobutylmethyl-4,5-epoxymorphinan-3,6,14-triol) and its salts11 | Benzazocines, their salts, derivatives and salts of derivatives, including(1)Phenazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl- 3-phenethyl-2,6-methano-3-benzazocin-8-ol)(2)Metazocine (1,2,3,4,5,6-hexahydro-3,6,11-trimethyl-2,6-methano-3-benzazocin-8-ol)(3)Pentazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol)but not including(4)Cyclazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(cyclopropylmethyl)-2,6-methano-3-benzazocin-8-ol) and its salts12 | Ampromides, their salts, derivatives and salts of derivatives, including(1)Diampromide (N-[2-(methylphenethylamino)propyl]propionanilide)(2)Phenampromide (N-((1-methyl-2-piperidino)ethyl)propionanilide)(3)Propiram (N-(1-methyl-2-piperidinoethyl)-N-2-pyridylpropionamide)13 | Benzimidazoles, their salts, derivatives and salts of derivatives, including(1)Clonitazene (2-(p-chlorobenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole)(2)Etonitazene (2-(p-ethoxybenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole)(3)Bezitramide (1-(3-cyano-3,3-diphenylpropyl)-4-(2-oxo-3-propionyl-1-benzimidazolinyl)-piperidine)14 | Phencyclidine (1-(1-phenylcyclohexyl)piperidine), its salts, derivatives and analogues and salts of derivatives and analogues, including(1)Ketamine (2-(2-chlorophenyl)-2-(methylamino)cyclohexanone)15 | Fentanyls, their salts, derivatives and analogues and salts of derivatives and analogues, including(1)Acetyl-alpha-methylfentanyl (N-[1-(alpha-methylphenethyl)-4-piperidyl]acetanilide)(2)Alfentanil (N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl]-4-(methoxymethyl)-4-piperidyl]propionanilide)(3)Carfentanil (methyl 4-[(1-oxopropyl)phenylamino]-1-(2-phenethyl)-4-piperidinecarboxylate)(4)p-Fluorofentanyl (4′-fluoro-N-(1-phenethyl-4-piperidyl)propionanilide)(5)Fentanyl (N-(1-phenethyl-4-piperidyl)propionanilide)(6)beta-Hydroxyfentanyl (N-[1-(beta-hydroxyphenethyl)-4-piperidyl]propionanilide)(7)beta-Hydroxy-3-methylfentanyl (N-[1-(beta-hydroxyphenethyl)-3-methyl-4-piperidyl]propionanilide)(8)alpha-Methylfentanyl (N-[1-(alpha-methylphenethyl)-4-piperidyl]propionanilide)(9)alpha-Methylthiofentanyl (N-[1-[1-methyl-2-(2-thienyl)ethyl]-4-piperidyl]propionanilide)(10)3-Methylfentanyl (N-(3-methyl-1-phenethyl-4-piperidyl)propionanilide)(11)3-Methylthiofentanyl (N-[3-methyl-1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide)(12)Remifentanil (dimethyl 4-carboxy-4-(N-phenylpropionamido)-1-piperidinepropionate)(13)Sufentanil (N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide)(14)Thiofentanyl (N-[1-[2-(2-thienyl)ethyl]-4-piperidyl]propionanilide)(15)4-Anilino-N-phenethylpiperidine (ANPP) (N-phenyl-1-(2-phenylethyl)piperidine-4-amine), its derivatives and analogues and salts of derivatives and analogues16 | Tilidine (ethyl-2-(dimethylamino)-1-phenyl-3-cyclohexene-1-carboxylate), its salts, derivatives and salts of derivatives17 | Synthetic cannabinoid receptor type 1 agonists, their salts, derivatives, isomers and salts of derivatives and isomers, including those that fall within the following core chemical structure classes, with the exception of any substance that is identical to any phytocannabinoid and of ((3S)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl)-1-naphthalenyl-methanone (WIN 55,212-3) and its salts:(1)Any substance that has a 2-(cyclohexyl)phenol structure with substitution at the 1-position of the benzene ring by a hydroxy, ether or ester group and further substituted at the 5-position of the benzene ring, whether or not further substituted on the benzene ring to any extent, and substituted at the 3’-position of the cyclohexyl ring by an alkyl, carbonyl, hydroxyl, ether or ester, and whether or not further substituted on the cyclohexyl ring to any extent, including(i)Nabilone ((±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one)(ii)Parahexyl (3-hexyl-6,6,9-trimethyl-7,8,9,10-tetrahydro-6H-dibenzo[b,d]pyran-1-ol)(iii)3-(1,2-dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran-1-ol (DMHP)(iv)5-(1,1-dimethylheptyl)-2-(5-hydroxy-2-(3-hydroxypropyl)cyclohexyl)phenol (CP 55,940)(v)5-(1,1-dimethylheptyl)-2-(3-hydroxycyclohexyl)phenol (CP 47,497)(2)Any substance that has a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including(i)1-pentyl-3-(1-naphthoyl)indole (JWH-018)(ii)1-butyl-3-(1-naphthoyl)indole (JWH-073)(iii)1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)(iv)1-hexyl-3-(1-naphthoyl)indole (JWH-019)(v)1-(4-pentenyl)-3-(1-naphthoyl)indole (JWH-022)(vi)1-butyl-3-(4-methoxy-1-naphthoyl)indole (JWH-080)(vii)1-pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081)(viii)1-(2-morpholin-4-ylethyl)-3-(1-naphthoyl)indole (JWH-200)(ix)1-pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210)(x)1-pentyl-3-(2-methoxy-1-naphthoyl)indole (JWH-267)(xi)1-[(N-methylpiperidin-2-yl)methyl]-3-(1-naphthoyl)indole (AM-1220)(xii)1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201)(xiii)1-(5-fluoropentyl)-3-(4-methyl-1-naphthoyl)indole (MAM-2201)(xiv)1-(5-fluoropentyl)-3-(4-ethyl-1-naphthoyl)indole (EAM-2201)(xv)((3R)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl)-1-naphthalenyl-methanone (WIN 55,212-2)(3)Any substance that has a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted on the pyrrole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including(i)1-pentyl-5-(2-fluorophenyl)-3-(1-naphthoyl)pyrrole (JWH-307)(4)Any substance that has a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including(i)1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)(ii)1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251)(iii)1-pentyl-3-(3-methoxyphenylacetyl)indole (JWH-302)(5)Any substance that has a 3-benzoylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including(i)1-(1-methylpiperidin-2-ylmethyl)-3-(2-iodobenzoyl)indole (AM-2233)(6)Any substance that has a 3-methanone(cyclopropyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the cyclopropyl ring to any extent, including(i)(1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (UR-144)(ii)(1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (5F-UR-144)(iii)(1-(2-(4-morpholinyl)ethyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (A-796,260)(7)Any substance that has a quinolin-8-yl 1H-indole-3-carboxylate structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the quinolin-8-yl ring to any extent, including(i)1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22)(ii)1-(5-fluoropentyl)-8-quinolinyl ester-1H-indole-3-carboxylic acid (5F-PB-22)(8)Any substance that has a 3-carboxamideindazole structure with substitution at the nitrogen atom of the indazole ring, whether or not further substituted on the indazole ring to any extent and whether or not substituted at the carboxamide group to any extent, including(i)N-(adamantan-1-yl)-1-pentyl-1H-indazole-3-carboxamide (AKB48)(ii)N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (5F-AKB48)(iii)N-(1-(aminocarbonyl)-2-methylpropyl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)(iv)N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA)(9)Any substance that has a 3-carboxamideindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted at the carboxamide group to any extent, including(i)N-(adamantan-1-yl)-1-fluoropentylindole-3-carboxamide (STS-135)(ii)N-(adamantan-1-yl)-1-pentylindole-3-carboxamide (APICA)18 | Tapentadol (3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol), its salts, derivatives and isomers and salts of derivatives and isomers19 | Tramadol (2-[(dimethylamino)methyl]-1-(3- methoxyphenyl)cyclohexanol), its salts, isomers and salts of isomers and the following derivatives of tramadol and the salts, isomers and salts of isomers of those derivatives:(1)O-desmethyltramadol (3-[2- [(dimethylamino)methyl]-1-hydroxycyclohexyl]-phenol)(2)N,O-didesmethyltramadol (3-[1-hydroxy-2- [(methylamino)methyl]cyclohexyl]-phenol)20 | AP-237 (1-(4-cinnamylpiperazin-1-yl)butan-1-one), its salts, derivatives and analogues and salts of derivatives and analogues, including:(1)2-methyl-AP-237 (1-(4-cinnamyl-2-methylpiperazin-1-yl)butan-1-one)(2)para-methyl-AP-237 ((E)-1-(4-(3-(p-tolyl)allyl)piperazin-1-yl)butan-1-one)(3)AP-238 (1-(4-cinnamyl-2,6-dimethylpiperazin-1-yl)propan-1-one)21 | Piritramide (1-(3-cyano-3,3-diphenylpropyl)-4-(1-piperidino)piperidine-4-carboxylic acid amide), its salts, derivatives and salts of derivatives
Schedule 2 · Controlled Drugs (Subsection 1(1), section 3, paragraphs 5(1)(b), 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 57(1)(d), 58(1)(d), 59(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 92(3)(d), 93(1)(d) and (2)(e), 94(1)(d), 95(d), 97(d), 111(d), 112(d), 117(d), 120(g), 121(f), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e) and 144(c), subparagraph 144(f)(ii), paragraphs 146(f), 147(f), 154(b) and 158(3)(d), subparagraphs 159(1)(b)(iv) and 160(1)(b)(iv), paragraphs 161(1)(d) and (2)(d), 162(d), 175(d), 176(d), 177(d), 181(d), 182(g), 183(f), 205(1)(g), 210(d), 213(1)(g) and 218(d), sections 225 and 226 and paragraph 229(1)(c))
Item | Name1 | Amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, excluding those substances set out in item 1 of Part 1 of Schedule 4 but including(1)Amphetamine (alpha-methylbenzeneethanamine)(2)Methamphetamine (N,alpha-dimethylbenzeneethanamine)(3)Benzphetamine (N-benzyl-N,alpha-dimethylbenzeneethanamine)2 | Methylphenidate (methyl 2-phenyl-2-(piperidin-2-yl)acetate), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including(1)Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate)(2)Isopropylphenidate (isopropyl 2-phenyl-2-(piperidin-2-yl)acetate)(3)Propylphenidate (propyl 2-phenyl-2-(piperidin-2-yl)acetate)(4)3,4-Dichloromethylphenidate (methyl 2-(3,4-dichlorophenyl)-2-(piperidin-2-yl)acetate)(5)4-Methylmethylphenidate (methyl 2-(4-methylphenyl)-2-(piperidin-2-yl)acetate)(6)4-Fluoromethylphenidate (methyl 2-(4-fluorophenyl)-2-(piperidin-2-yl)acetate)(7)Methylnaphthidate (methyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate)(8)Ethylnaphthidate (ethyl 2-(naphthalen-2-yl)-2-(piperidin-2-yl)acetate)3 | Methaqualone (2-methyl-3-(2-methylphenyl)-4(3H)-quinazolinone) and its salts4 | 4-hydroxybutanoic acid (GHB) and its salts5 | Aminorex (5-phenyl-4,5-dihydro-1,3-oxazol-2-amine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including(1)4-Methylaminorex (4-methyl-5-phenyl-4,5-dihydro-1,3-oxazol-2-amine)(2)4,4’-Dimethylaminorex (4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine)6 | Fenetylline (d,l-3,7-dihydro-1,3-dimethyl-7-(2-[(1-methyl-2-phenethyl)amino]ethyl)-1H-purine-2,6-dione) and its salts7 | Lefetamine ((-)-N,N-dimethyl-alpha-phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers8 | Mecloqualone (2-methyl-3-(2-chlorophenyl)-4(3H)-quinazolinone) and its salts9 | Mesocarb (3-(alpha-methylphenethyl)-N-(phenylcarbamoyl)sydnone imine) and its salts10 | Zipeprol (4-(2-methoxy-2-phenylethyl)-alpha-(methoxyphenylmethyl)-1-piperazineethanol) and its salts11 | Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) and its saltsItem | Name1 | Barbiturates, their salts and derivatives, excluding the substances set out in items 6 and 7 of Part 1 as well as barbituric acid (2,4,6(1H,3H,5H)-pyrimidinetrione) and its salts and 1,3-dimethylbarbituric acid (1,3-dimethyl-2,4,6(1H,3H,5H)-pyrimidinetrione) and its salts, but including(1)Allobarbital (5,5-diallylbarbituric acid)(2)Alphenal (5-allyl-5-phenylbarbituric acid)(3)Amobarbital (5-ethyl-5-(3-methylbutyl)barbituric acid)(4)Aprobarbital (5-allyl-5-isopropylbarbituric acid)(5)Barbital (5,5-diethylbarbituric acid)(6)Butabarbital (5-sec-butyl-5-ethylbarbituric acid)(7)Butalbital (5-allyl-5-isobutylbarbituric acid)(8)Butallylonal (5-(2-bromoallyl)-5-sec-butylbarbituric acid)(9)Butethal (5-butyl-5-ethylbarbituric acid)(10)Cyclobarbital (5-(1-cyclohexen-1-yl)-5-ethylbarbituric acid)(11)Cyclopal (5-allyl-5-(2-cyclopenten-1-yl)barbituric acid)(12)Heptabarbital (5-(1-cyclohepten-1-yl)-5-ethylbarbituric acid)(13)Hexethal (5-ethyl-5-hexylbarbituric acid)(14)Hexobarbital (5-(1-cyclohexen-1-yl)-1,5-dimethylbarbituric acid)(15)Mephobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid)(16)Methabarbital (5,5-diethyl-1-methylbarbituric acid)(17)Propallylonal (5-(2-bromoallyl)-5-isopropyl-barbituric acid)(18)Pentobarbital (5-ethyl-5-(1-methylbutyl)barbituric acid)(19)Phenobarbital (5-ethyl-5-phenylbarbituric acid)(20)Probarbital (5-ethyl-5-isopropylbarbituric acid)(21)Phenylmethylbarbituric Acid (5-methyl-5-phenylbarbituric acid)(22)Secobarbital (5-allyl-5-(1-methylbutyl)barbituric acid)(23)Sigmodal (5-(2-bromoallyl)-5-(1-methylbutyl) barbituric acid)(24)Talbutal (5-allyl-5-sec-butylbarbituric acid)(25)Vinbarbital (5-ethyl-5-(1-methyl-1-butenyl)barbituric acid)(26)Vinylbital (5-(1-methylbutyl)-5-vinylbarbituric acid)2 | Thiobarbiturates, their salts and derivatives, including(1)Thialbarbital (5-allyl-5-(2-cyclohexen-1-yl)-2-thiobarbituric acid)(2)Thiamylal (5-allyl-5-(1-methylbutyl)-2-thiobarbituric acid)(3)Thiobarbituric Acid (2-thiobarbituric acid)(4)Thiopental (5-ethyl-5-(1-methylbutyl)-2- thiobarbituric acid)3 | Chlorphentermine (1-(p-chlorophenyl)-2-methyl-2-aminopropane) and its salts4 | Diethylpropion (2-(diethylamino)propiophenone) and its salts5 | Phentermine (alpha,alpha-dimethylbenzeneethanamine) and its salts6 | Butorphanol (l-N-cyclobutylmethyl-3,14-dihydroxymorphinan) and its salts7 | Nalbuphine (N-cyclobutylmethyl-4,5-epoxy-morphinan-3,6,14-triol) and its salts8 | Pyrovalerone (4′-methyl-2-(1-pyrrolidinyl)valerophenone) and its salts9 | Phendimetrazine (d-3,4-dimethyl-2-phenylmorpholine) and its salts10 | Phenmetrazine (3-methyl-2-phenylmorpholine) and its salts11 | Glutethimide (2-ethyl-2-phenylglutarimide)12 | Pemoline (2-amino-5-phenyl-oxazolin-4-one) and its saltsItem | Name1 | Anabolic steroids and their derivatives, including(1)Androisoxazole (17beta-hydroxy-17alpha-methylandrostano[3,2-c]isoxazole)(2)Androstanolone (17beta-hydroxy-5alpha-androstan-3-one)(3)Androstenediol (androst-5-ene-3beta,17beta-diol)(4)Bolandiol (estr-4-ene-3beta,17beta-diol)(5)Bolasterone (17beta-hydroxy-7alpha,17-dimethylandrost-4-en-3-one)(6)Bolazine (17beta-hydroxy-2alpha-methyl-5alpha-androstan-3-one azine)(7)Boldenone (17beta-hydroxyandrosta-1,4-dien-3-one)(8)Bolenol (19-nor-17alpha-pregn-5-en-17-ol)(9)Calusterone (17beta-hydroxy-7beta,17-dimethylandrost-4-en-3-one)(10)Clostebol (4-chloro-17beta-hydroxyandrost-4-en-3-one)(11)Drostanolone (17beta-hydroxy-2alpha-methyl-5alpha-androstan-3-one)(12)Enestebol (4,17beta-dihydroxy-17-methylandrosta-1,4-dien-3-one)(13)Epitiostanol (2alpha,3alpha-epithio-5alpha-androstan-17beta-ol)(14)Ethylestrenol (19-nor-17alpha-pregn-4-en-17-ol)(15)Fluoxymesterone (9-fluoro-11beta,17beta-dihydroxy-17-methylandrost-4-en-3-one)(16)Formebolone (11alpha,17beta-dihydroxy-17-methyl-3-oxoandrosta-1,4-di-en-2-carboxaldehyde)(17)Furazabol (17-methyl-5alpha-androstano[2,3-c]furazan-17beta-ol)(18)Mebolazine (17beta-hydroxy-2alpha,17-dimethyl-5alpha-androstan-3-one azine)(19)Mesabolone (17beta-[(1-methoxycyclohexyl)oxy]-5alpha-androst-1-en-3-one)(20)Mesterolone (17beta-hydroxy-1alpha-methyl-5alpha-androstan-3-one)(21)Metandienone (17beta-hydroxy-17-methylandrosta-1,4-dien-3-one)(22)Metenolone (17beta-hydroxy-1-methyl-5alpha-androst-1-en-3-one)(23)Methandriol (17alpha-methylandrost-5-ene-3beta,17beta-diol)(24)Methyltestosterone (17beta-hydroxy-17-methylandrost-4-en-3-one)(25)Metribolone (17beta-hydroxy-17-methylestra-4,9,11-trien-3-one)(26)Mibolerone (17beta-hydroxy-7alpha,17-dimethylestr-4-en-3-one)(27)Nandrolone (17beta-hydroxyestr-4-en-3-one)(28)Norboletone (13-ethyl-17beta-hydroxy-18,19-dinorpregn-4-en-3-one)(29)Norclostebol (4-chloro-17beta-hydroxyestr-4-en-3-one)(30)Norethandrolone (17alpha-ethyl-17beta-hydroxyestr-4-en-3-one)(31)Oxabolone (4,17beta-dihydroxyestr-4-en-3-one)(32)Oxandrolone (17beta-hydroxy-17-methyl-2-oxa-5alpha-androstan-3-one)(33)Oxymesterone (4,17beta-dihydroxy-17-methylandrost-4-en-3-one)(34)Oxymetholone (17beta-hydroxy-2-(hydroxymethylene)-17-methyl-5alpha-androstan-3-one)(35)Prasterone (3beta-hydroxyandrost-5-en-17-one)(36)Quinbolone (17beta-(1-cyclopenten-1-yloxy)androsta-1,4-dien-3-one)(37)Stanozolol (17beta-hydroxy-17-methyl-5alpha-androstano[3,2-c]pyrazole)(38)Stenbolone (17beta-hydroxy-2-methyl-5alpha-androst-1-en-3-one)(39)Testosterone (17beta-hydroxyandrost-4-en-3-one)(40)Tibolone ((7alpha,17alpha)-17-hydroxy-7-methyl-19-norpregn-5(10)en-20-yn-3-one)(41)Tiomesterone (1alpha,7alpha-bis(acetylthio)-17beta-hydroxy-17-methylandrost-4-en-3-one)(42)Trenbolone (17beta-hydroxyestra-4,9,11-trien-3-one)2 | Zeranol (3,4,5,6,7,8,9,10,11,12-decahydro-7,14,16-trihydroxy-3-methyl-1H-2-benzoxacyclotetradecin-1-one)
Schedule 3 · Targeted Substances (Subsection 1(1), paragraphs 5(1)(c), 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 57(1)(d), 58(1)(d), 59(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 92(3)(d), 93(1)(d) and (2)(e), 94(1)(d), 95(d), 97(d), 111(d), 112(d), 117(d), 120(g), 121(f), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e) and 144(c), subparagraph 144(f)(ii), paragraphs 146(f), 147(f) and 158(3)(d), subparagraphs 159(1)(b)(iv) and 160(1)(b)(iv), paragraphs 161(1)(d) and (2)(d), 162(d), 175(d), 176(d), 177(d), 181(d), 182(g), 183(f), 205(1)(g), 210(d), 213(1)(g) and 218(d), sections 225 and 226 and paragraph 229(1)(c))
Item | Name1 | Flunitrazepam (5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one) and any of its salts or derivativesItem | Name1 | Benzodiazepines, their salts and derivatives, including(1)Alprazolam (8-chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine)(2)Bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl)- 2H-1,4-benzodiazepin-2-one)(3)Brotizolam (2-bromo-4-(o-chlorophenyl)-9-methyl-6H-thieno[3,2-f]-s-triazolo[4,3-a][1,4]diazepine)(4)Camazepam (7-chloro-1,3-dihydro-3-(N,N-dimethylcarbamoyl)-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one)(5)Chlordiazepoxide (7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide)(6)Clobazam (7-chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4(3H,5H)-dione)(7)Clonazepam (5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one)(8)Clorazepate (7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1H-1,4-benzodiazepine-3-carboxylic acid)(9)Cloxazolam (10-chloro-11b-(o-chlorophenyl)-2,-3,7,11b-tetrahydrooxazolo [3,2-d][1,4]benzodiazepin-6[5H]-one)(10)Delorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-2H-1,-4-benzodiazepin-2-one)(11)Diazepam (7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one)(12)Estazolam (8-chloro-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine)(13)Ethyl Loflazepate (ethyl 7-chloro-5-(o-fluorophenyl)-2,3-dihydro-2-oxo-1H-1,4-benzodiazepine-3-carboxylate)(14)Fludiazepam (7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-methyl-2H-1,4-benzodiazepin-2-one)(15)Flurazepam (7-chloro-1-[2-(diethylamino)ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one)(16)Halazepam (7-chloro-1,3-dihydro-5-phenyl-1-(2,2,-2-trifluoroethyl)-2H-1,4-benzodiazepin-2-one)(17)Haloxazolam (10-bromo-11b-(o-fluorophenyl)-2,3,7,11b-tetrahydrooxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one)(18)Ketazolam (11-chloro-8,12b-dihydro-2,8-dimethyl-12b-phenyl-4H-[1,3]-oxazino-[3,2-d][1,4]benzodiazepine-4,7(6H)-dione)(19)Loprazolam (6-(o-chlorophenyl)-2,4-dihydro-2-[(4-methyl-1-piperazinyl)methylene]-8-nitro-1H-imidazo[1,2-a][1,4]-benzodiazepin-1-one)(20)Lorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one)(21)Lormetazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-1-methyl-2H-1,4-benzodiazepin-2-one)(22)Medazepam (7-chloro-2,3-dihydro-1-methyl-5-phenyl-1H-1,4-benzodiazepine)(23)Midazolam (8-chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine)(24)Nimetazepam (1,3-dihydro-1-methyl-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one)(25)Nitrazepam (1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one)(26)Nordazepam (7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one)(27)Oxazepam (7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one)(28)Oxazolam (10-chloro-2,3,7,11b-tetrahydro-2-methyl-11b-phenyloxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one)(29)Pinazepam (7-chloro-1,3-dihydro-5-phenyl-1-(2-propynyl)-2H-1,4-benzodiazepin-2-one)(30)Prazepam (7-chloro-1-(cyclopropylmethyl)-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one)(31)Quazepam (7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione)(32)Temazepam (7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one)(33)Tetrazepam (7-chloro-5-(cyclohexen-1-yl)-1,3-dihydro-1-methyl-2H-1,4-benzodiazepin-2-one)(34)Triazolam (8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-a][1,4]benzodiazepine)but not including(35)Clozapine (8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine) and any of its salts(36)Flunitrazepam (5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one) and any of its salts or derivatives(37)Olanzapine (2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine) and its salts(38)Clozapine N-oxide (8-chloro-11-(4-methyl-4-oxido-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine) and its salts2 | Clotiazepam (5-(o-chlorophenyl)-7-ethyl-1,3-dihydro-1-methyl-2H-thieno[2,3-e]-1,4-diazepin-2-one) and its salts3 | Ethchlorvynol (ethyl-2-chlorovinyl ethynyl carbinol)4 | Ethinamate (1-ethynylcyclohexanol carbamate)5 | Fencamfamin (d,l-N-ethyl-3-phenylbicyclo[2,2,1]heptan-2-amine) and its salts6 | Fenproporex (d,l-3-[(alpha-methylphenethyl)amino]propionitrile) and its salts7 | Mazindol (5-(p-chlorophenyl)-2,5-dihydro-3H-imidazo[2,1-a]isoindol-5-ol)8 | Mefenorex (d,l-N-(3-chloropropyl)-alpha-methylbenzeneethanamine) and its salts9 | Meprobamate (2-methyl-2-propyl-1,3-propanedioldicarbamate)10 | Methyprylon (3,3-diethyl-5-methyl-2,4-piperidinedione)11 | Pipradrol (alpha,alpha-diphenyl-2-piperidinemethanol) and its salts12 | Zolpidem (N,N,6-trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide) and its salts13 | Carisoprodol (2-((carbamoyloxy)methyl)-2-methylpentyl isopropylcarbamate)
Schedule 4 · Restricted Drugs (Subsections 1(1) and 6(1) and (2), paragraphs 11(1)(f), 12(1)(c) and (i), 34(1)(h), 39(d), 42(1)(h), 47(d), 56(d), 61(d), 62(d) and 69(1)(d), subparagraph 72(e)(iv), paragraphs 73(1)(g), 75(d), 76(d), 77(a), 78(b), 80(g), 81(d), 82(d), 83(b), 84(e), 85(1)(a), 128(2)(d), 129(d), 141(c), 142(d), 143(2)(e), 146(f) and 147(f), section 198, paragraphs 205(1)(g), 210(d), 213(1)(g), 218(d) and 229(1)(c) and item 1 of Part 1 of Schedule 2)
Item | Name1 | The following amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues:(1)N-ethylamphetamine (N-ethyl-alpha-methylbenzeneethanamine)(2)4-methyl-2,5-dimethoxyamphetamine (STP) (2,5-dimethoxy-4,alpha-dimethylbenzeneethanamine)(3)3,4-methylenedioxyamphetamine (MDA) (alpha-methyl-1,3-benzodioxole-5-ethanamine)(4)2,5-dimethoxyamphetamine (2,5-dimethoxy-alpha-methylbenzeneethanamine)(5)4-methoxyamphetamine (4-methoxy-alpha-methylbenzeneethanamine)(6)2,4,5-trimethoxyamphetamine (2,4,5-trimethoxy-alpha-methylbenzeneethanamine)(7)N-methyl-3,4-methylenedioxyamphetamine (MDMA) (N,alpha-dimethyl-1,3-benzodioxole-5-ethanamine)(8)4-ethoxy-2,5-dimethoxyamphetamine (4-ethoxy-2,5-dimethoxy-alpha-methylbenzeneethanamine)(9)5-methoxy-3,4-methylenedioxyamphetamine (7-methoxy-alpha-methyl-1,3-benzodioxole-5-ethanamine)(10)N,N-dimethyl-3,4-methylenedioxyamphetamine (N,N,alpha-trimethyl-1,3-benzodioxole-5-ethanamine)(11)N-ethyl-3,4-methylenedioxyamphetamine (N-ethyl-alpha-methyl-1,3-benzodioxole-5-ethanamine)(12)4-ethyl-2,5-dimethoxyamphetamine (DOET) (4-ethyl-2,5-dimethoxy-alpha-methylbenzeneethanamine)(13)4-bromo-2,5-dimethoxyamphetamine (4-bromo-2,5-dimethoxy-alpha-methylbenzeneethanamine)(14)4-chloro-2,5-dimethoxyamphetamine (4-chloro-2,5-dimethoxy-alpha-methylbenzeneethanamine)(15)4-ethoxyamphetamine (4-ethoxy-alpha-methyl-benzeneethanamine)(16)N-Propyl-3,4-methylenedioxyamphetamine (alpha-methyl-N-propyl-1,3-benzodioxole-5-ethanamine)(17)N-hydroxy-3,4-methylenedioxyamphetamine (N-[alpha-methyl-3,4-(methylenedioxy)phenethyl]hydroxylamine)(18)3,4,5-trimethoxyamphetamine (3,4,5-trimethoxy-alpha-methylbenzeneethanamine)2 | Lysergic acid diethylamide (LSD) (N,N-diethyllysergamide) and its salts3 | N,N-Diethyltryptamine (DET) (3-[(2-diethylamino)ethyl]indole) and its salts4 | N,N-Dimethyltryptamine (DMT) (3-[(2-dimethylamino)ethyl]indole) and its salts5 | N-Methyl-3-piperidyl benzilate (LBJ) (3-[(hydroxydiphenylacetyl)oxy]-1-methylpiperidine) and its salts6 | Harmaline (4,9-dihydro-7-methoxy-1-methyl-3H-pyrido(3,4-b)indole) and its salts7 | Harmalol (4,9-dihydro-1-methyl-3H-pyrido(3,4-b)indol-7-ol) and its salts8 | Psilocin (3-[2-(dimethylamino)ethyl]-4-hydroxyindole) and its salts9 | Psilocybin (3-[2-(dimethylamino)ethyl]-4-phosphoryloxyindole) and its salts10 | N-(1-phenylcyclohexyl)ethylamine (PCE) and its salts11 | 1-[1-(2-Thienyl)cyclohexyl]piperidine (TCP) and its salts12 | 1-Phenyl-N-propylcyclohexanamine and its salts13 | Mescaline (3,4,5-trimethoxybenzeneethanamine) and its salts, but not peyote (lophophora)14 | 2-Methylamino-1-phenyl-1-propanone and its salts15 | 1-[1-(Phenylmethyl)cyclohexyl]piperidine and its salts16 | 1-[1-(4-Methylphenyl)cyclohexyl]piperidine and its salts17 | Etryptamine (3-(2-aminobutyl)indole) and its salts18 | Rolicyclidine (1-(1-phenylcyclohexyl)pyrrolidine) and its salts19 | Benzylpiperazine (BZP), namely 1-benzylpiperazine and its salts, isomers and salts of isomers20 | Trifluoromethylphenylpiperazine (TFMPP), namely 1-(3-trifluoromethylphenyl)piperazine and its salts, isomers and salts of isomers21 | Methylenedioxypyrovalerone (MDPV), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues22 | Cathinone ((-)-alpha-aminopropiophenone) and its salts23 | 2C-phenethylamines and their salts, derivatives, isomers and salts of derivatives and isomers that correspond to the following chemical description:any substance that has a 1-amino-2-phenylethane structure substituted at the 2’ and 5’ or 2’ and 6’ positions of the benzene ring by an alkoxy or haloalkoxy group, or substituted at two adjacent carbon atoms of the benzene ring which results in the formation of a furan, dihydrofuran, pyran, dihydropyran or methylenedioxy group — whether or not further substituted on the benzene ring to any extent, whether or not substituted at the amino group by one or two, or a combination of, methyl, ethyl, propyl, isopropyl, hydroxyl, benzyl (or benzyl substituted to any extent) or benzylene (or benzylene substituted to any extent) groups and whether or not substituted at the 2-ethyl (beta carbon) position by a hydroxyl, oxo or alkoxy group — and its salts and derivatives and salts of derivatives, including(1)4-bromo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25B-NBOMe)(2)4-chloro-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25C-NBOMe)(3)4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25I-NBOMe)(4)4-bromo-2,5-dimethoxybenzeneethanamine (2C-B)24 | AH-7921 (1-(3,4-dichlorobenzamidomethyl)cyclohexyldimethylamine), its salts, isomers and salts of isomers25 | MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including(1)Diphenidine (DEP) (1-(1,2-diphenylethyl)piperidine)(2)Methoxphenidine (2-MeO-Diphenidine, MXP) (1-[1-(2-methoxyphenyl)-2-phenylethyl]piperidine)(3)Ephenidine (NEDPA, EPE) (N-ethyl-1,2-diphenylethylamine)(4)Isophenidine (NPDPA) (N-isopropyl-1,2-diphenylethylamine)but not including(5)Lefetamine ((-)-N,N-dimethyl-alpha-phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers26 | W-18 (4-chloro-N-[1-[2-(4-nitrophenyl)ethyl]-2-piperidinylidene]benzenesulfonamide), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues27 | U-47700 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including(1)Bromadoline (4-bromo-N-(2-(dimethylamino)cyclohexyl)benzamide)(2)U-47109 (3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)benzamide)(3)U-48520 (4-chloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide)(4)U-50211 (N-(2-(dimethylamino)cyclohexyl)-4-hydroxy-N-methylbenzamide)(5)U-77891 (3,4-dibromo-N-methyl-N-(1-methyl-1-azaspiro[4.5]decan-6-yl)benzamide)Item | Name1 | Salvia divinorum (S. divinorum), its preparations and derivatives, including(1)Salvinorin A ((2S,4aR,6aR,7R,9S,10aS,10bR)-9-(acetyloxy)-2-(3-furanyl)dodecahydro-6a,10b-dimethyl-4,10-dioxo-2H-naphtho[2,1-c]pyran-7-carboxylic acid methyl ester)2 | Catha edulis Forsk, its preparations, derivatives, alkaloids and salts, including(1)Cathine (d-threo-2-amino-1-hydroxy-1-phenylpropane)but not including(2)Cathinone ((-)-alpha-aminopropiophenone) and its saltsItem | Column 1 | Column 2Substance | Period1 | Spirobrorphine (8-[1-(4-bromophenyl)ethyl]-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one) and its salts | October 1, 2026 to June 4, 20272 | Spirochlorphine (8-[1-(4-chlorophenyl)ethyl]-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one) and its salts | October 1, 2026 to June 4, 2027
Federal laws of Canada reproduced under the Reproduction of Federal Law Order (SI/97-5); not the official version. Source: Justice Laws Website.