Canada Gazette, Part I, Volume 158, Number 22: Regulations Amending the Cannabis Regulations (Harmonization with Certain Provisions of the Controlled Substances Regulations)

June 1, 2024

Statutory authority
Cannabis Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Controlled Substances Regulations.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Regulations Amending the Cannabis Regulations (Harmonization with Certain Provisions of the Controlled Substances Regulations) under subsection 139(1) of the Cannabis Act footnote a.

Interested persons may make representations concerning the proposed Regulations within 60 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Regulatory, Legislative and Economic Affairs Division, Strategic Policy Directorate, Controlled Substances and Cannabis Branch, Department of Health, Address Locator: 0302I, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9 (email: cannabis.consultation@hc-sc.gc.ca).

Ottawa, May 23, 2024

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending the Cannabis Regulations (Harmonization with Certain Provisions of the Controlled Substances Regulations)

Amendments

1 (1) The definition nécessaire d’essai in subsection 1(2) of the French version of the Cannabis Regulations footnote 1 is repealed.

(2) The definition combination product in subsection 1(2) of the Regulations is replaced by the following:

combination product
means a product, consisting of a device and a prescription drug, that has a drug identification number. (produit mixte)

(3) The definition test kit in subsection 1(2) of the English version of the Regulations is replaced by the following:

test kit
means a kit
  • (a) that contains cannabis and an adulterating or denaturing agent;
  • (b) that is used to test for cannabis; and
  • (c) the contents of which are not intended or likely to be consumed or administered. (trousse d’essai ou nécessaire d’essai)

(4) Paragraph (c) of the definition prescription drug in subsection 1(2) of the Regulations is replaced by the following:

(5) Subsection 1(2) of the Regulations is amended by adding the following in alphabetical order:

brand name,
in relation to a prescription drug or a combination product, has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom commercial)
common name,
except in Part 7 and section 226.1, has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom usuel)
drug identification number
means the identification number assigned under paragraph C.01.014.2(1)(a) of the Food and Drug Regulations. (identification numérique)
former Narcotic Control Regulations
means the regulations made by Order in Council P.C. 1961-1133 of August 9, 1961 and registered as SOR/61-344. (ancien Règlement sur les stupéfiants)

(6) Subsection 1(2) of the French version of the Regulations is amended by adding the following in alphabetical order:

trousse d’essai ou nécessaire d’essai Trousse qui, à la fois :

2 Subparagraph 4(1)(c)(viii) of the Regulations is replaced by the following:

3 The Regulations are amended by adding the following after section 4:

Distribution to pharmacist for destruction

4.1 (1) For the purposes of subparagraph 9(1)(a)(i) and (iii) and paragraph 9(1)(b) of the Act, an individual who has cannabis in their possession is authorized to distribute the cannabis to a pharmacist, other than one who is practising in a hospital, for the purpose of its destruction if

Deeming — controlled substance

(2) Cannabis that is distributed to a pharmacist in accordance with subsection (1) is deemed, for the purpose of its destruction, to be a controlled substance within the meaning of subsection 1(2) of the Controlled Substances Regulations.

4 Subsection 12(2) of the Regulations is replaced by the following:

Responsibilities and knowledge

(2) The master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to those activities to properly carry out their duties.

5 Subsection 15(2) of the Regulations is replaced by the following:

Responsibilities and knowledge

(2) The master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to those activities to properly carry out their duties.

6 (1) Paragraph 23(2)(a) of the Regulations is replaced by the following:

(2) Paragraph 23(2)(b) of the English version of the Regulations is replaced by the following:

(3) Subparagraph 23(2)(c)(i) of the English version of the Regulations is replaced by the following:

(4) The portion of subparagraph 23(2)(c)(ii) of the Regulations before clause (A) is replaced by the following:

(5) Clauses 23(2)(c)(ii)(A) and (B) of the French version of the Regulations are replaced by the following:

7 Subsection 37(2) of the Regulations is replaced by the following:

Responsibilities and knowledge

(2) The responsible person is responsible for the activities conducted under the licence and must have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to those activities to properly carry out their duties.

8 (1) The definitions brand name and common name in section 139 of the Regulations are repealed.

(2) The definition licensed dealer in section 139 of the Regulations is replaced by the following:

licensed dealer
has the same meaning as in subsection 1(1) of the Controlled Substances Regulations. (distributeur autorisé)

(3) Section 139 of the Regulations is amended by adding the following in alphabetical order:

specialized in destruction
has the same meaning as in subsection 1(1) of the Controlled Substances Regulations. (spécialisé en destruction)

9 (1) Paragraph 143(1)(g) of the Regulations is replaced by the following:

(2) Paragraph 143(1)(i) of the Regulations is replaced by the following:

(3) Paragraphs 143(2)(a) and (b) of the Regulations are replaced by the following:

(4) Subsection 143(3) of the Regulations is replaced by the following:

Exception — pharmacist and practitioner

(3) It is prohibited for a holder of a cannabis drug licence to sell or distribute

10 (1) Subsections 146(4) and (5) of the Regulations are replaced by the following:

Witness — licensed dealer specialized in destruction

(4) The following individuals are qualified to witness the destruction of cannabis by a licensed dealer specialized in destruction:

Attestation by witnesses

(5) For each instance that they destroy cannabis, the holder of a cannabis drug licence or the licensed dealer specialized in destruction, as the case may be, must obtain an attestation signed and dated by two of the witnesses referred to in paragraph (1)(b) or (2)(b) stating that they witnessed the destruction and that the cannabis was destroyed in accordance with a method referred to in paragraph (1)(a) or (2)(a).

(2) Paragraph 146(6)(b) of the Regulations is replaced by the following:

(3) Subsection 146(7) of the Regulations is replaced by the following:

Retention period

(7) The holder of a cannabis drug licence and the licensed dealer specialized in destruction must retain the record and the attestation for at least two years after the day on which the cannabis is destroyed.

11 (1) The portion of subparagraph 150(3)(b)(iii) of the Regulations before clause (A) is replaced by the following:

(2) Clauses 150(3)(b)(iii)(A) and (B) of the French version of the Regulations are replaced by the following:

(3) Paragraph 150(3)(d) of the Regulations is replaced by the following:

(4) Paragraph 150(4)(c) of the English version of the Regulations is replaced by the following:

12 The French version of the Regulations is amended by replacing « visée à » with « prévue à » in paragraphs 151(2)(a) to (d).

13 (1) Subparagraph 152(2)(b)(i) of the Regulations is replaced by the following:

(2) Subparagraph 152(2)(c)(ii) of the Regulations is replaced by the following:

(3) The portion of subparagraph 152(2)(c)(iii) before clause (A) of the French version of the Regulations is replaced by the following:

14 The heading of Division 2 of Part 8 of the Regulations is replaced by the following:

Possession, Pharmacists, Practitioners, Hospitals and Licensed Dealers

15 (1) Paragraph 159(a) of the Regulations is replaced by the following:

(2) Paragraphs 159(c) to (f) of the Regulations are replaced by the following:

(3) Section 159 of the Regulations is renumbered as subsection 159(1) and is amended by adding the following:

Possession — prescription drug

(2) The following persons, if they have obtained a prescription drug either in accordance with these Regulations, or from a person that is exempt under section 140 of the Act from the application of subsections 9(1) and (2) and 10(1) and (2) of the Act with respect to that drug, are authorized to possess the drug:

16 Sections 160 and 161 of the Regulations are replaced by the following:

Possession — quantity allowed

160 Any quantity of drug containing cannabis that an individual is authorized to possess under paragraph 159(1)(c) or (d) is in addition to any other quantity of cannabis that the individual is authorized to possess under the Act.

17 Sections 163 and 164 of the Regulations are replaced by the following:

Exemption — section 21 of Act

163 A person is exempt from the application of section 21 of the Act if they display, refer to or otherwise use the brand name of a prescription drug, or the name of the holder of the drug identification number for a prescription drug, directly or indirectly in a promotion that is used in the sponsorship of a person, entity, event, activity or facility.

Exemption — section 22 of Act

164 A person is exempt from the application of section 22 of the Act if they display on a facility, as part of the name of the facility or otherwise, if the facility is used for a sports or cultural event or activity, the brand name of a prescription drug or the name of the holder of the drug identification number for a prescription drug.

18 Paragraph 170(a) of the Regulations is replaced by the following:

19 (1) The portion of section 171 of the Regulations before paragraph (a) is replaced by the following:

Sale, distribution and administration

171 Subject to section 174, a pharmacist is authorized to sell, distribute or administer a prescription drug to a person

(2) Paragraph 171(a) of the English version of the Regulations is replaced by the following:

(3) Subparagraph 171(b)(ii) of the French version of the Regulations is replaced by the following:

20 (1) The portion of subsection 172(1) of the Regulations before paragraph (a) is replaced by the following:

Return and destruction

172 (1) A pharmacist is authorized to sell or distribute a prescription drug, in accordance with a written order, to

(2) Paragraph 172(2)(a) of the Regulations is replaced by the following:

21 Section 173 of the Regulations is repealed.

22 The portion of subsection 174(1) of the Regulations before paragraph (a) is replaced by the following:

Prohibited activities

174 (1) It is prohibited for a pharmacist to

23 The portion of subsection 175(1) of the Regulations before paragraph (a) is replaced by the following:

Distribution — hospital

175 (1) Subject to section 174, a pharmacist may distribute a prescription drug to a hospital employee or a practitioner in a hospital in accordance with a written order signed and dated by

24 The portion of section 176 of the Regulations before paragraph (a) is replaced by the following:

Security obligations

176 A pharmacist must, with respect to a prescription drug on their premises or for which the pharmacist is responsible,

25 Section 177 of the Regulations is replaced by the following:

Record keeping

177 (1) A pharmacist who sells, distributes or administers a prescription drug must retain a record of the following information:

Non-application

(2) Subsection (1) does not apply to a pharmacist who sells or distributes a prescription drug under subsection 178(1) or 178.1(1).

26 Subsection 178(1) of the Regulations is replaced by the following:

Sale and distribution for emergency purposes

178 (1) Subject to section 174, a pharmacist may sell or distribute a prescription drug for emergency purposes to another pharmacist in accordance with a written order that is signed and dated by the other pharmacist.

27 The Regulations are amended by adding the following after section 178:

Sale and distribution — no emergency

178.1 (1) Subject to section 174, a pharmacist may, in circumstances other than an emergency, sell or distribute a prescription drug to another pharmacist, in accordance with a written order that is signed and dated by the other pharmacist, if

Signature

(2) Before selling or distributing the prescription drug, the pharmacist receiving the order must verify the signature, if it is unknown to them.

Record keeping

(3) The pharmacist who sells or distributes the prescription drug and the pharmacist to whom it is sold or distributed must each retain a record of the following information:

28 Paragraph 181(4)(a) of the Regulations is replaced by the following:

29 (1) The portion of subsection 184(1) of the French version of the Regulations before paragraph (a) is replaced by the following:

Retour et destruction

184 (1) Le praticien est autorisé à vendre ou à distribuer une drogue contenant du cannabis aux personnes ci-après conformément à une commande écrite :

(2) Paragraph 184(2)(a) of the Regulations is replaced by the following:

(3) Paragraph 184(3)(a) of the Regulations is replaced by the following:

30 The portion of section 186 of the Regulations before paragraph (a) is replaced by the following:

Record keeping

186 A practitioner who sells or distributes a drug containing cannabis to an individual for self-administration or for administration to an animal must, whether or not the practitioner charges for the drug, retain a record showing its proper name or common name — or, in the case of a prescription drug, its brand name — as well as the quantity of the drug sold or distributed, the name and address of the individual to whom and the date on which it was sold or distributed, if the quantity of the drug exceeds

31 (1) The portion of paragraph 189(1)(a) of the Regulations before subparagraph (i) is replaced by the following:

(2) Paragraphs 189(4)(b), (c) and (d) of the Regulations are replaced by the following:

(3) Subparagraph 189(5)(c)(iii) of the Regulations is replaced by the following:

32 (1) Subparagraph 191(a)(i) of the Regulations is replaced by the following:

(2) The portion of paragraph 191(b) of the Regulations before subparagraph (ii) is replaced by the following:

33 The portion of section 192 of the Regulations before paragraph (a) is replaced by the following:

Security obligations

192 An individual in charge of a hospital must, with respect to a prescription drug for which the hospital is responsible,

34 (1) Subparagraphs 193(3)(a)(i) and (ii) of the Regulations are replaced by the following:

(2) Subparagraphs 193(3)(b)(i) and (ii) of the Regulations are replaced by the following:

(3) Paragraph 193(3)(c) of the English version of the Regulations is replaced by the following:

35 (1) The portion of subsection 194(1) of the French version of the Regulations before paragraph (a) is replaced by the following:

Retour et destruction

194 (1) Malgré le paragraphe 193(2), la vente ou la distribution d’une drogue sur ordonnance aux personnes ci-après peut être autorisée par l’individu chargé de l’hôpital conformément à une commande écrite :

(2) Paragraph 194(2)(a) of the Regulations is replaced by the following:

(3) Paragraph 194(3)(b) of the English version of the Regulations is replaced by the following:

36 The Regulations are amended by adding the following after section 195:

Licensed Dealers

Record keeping — drug received

195.1 A licensed dealer who receives a drug containing cannabis must enter the following in a record retained for such purposes:

Sale or distribution for destruction

195.2 (1) A licensed dealer, other than a licensed dealer specialized in destruction, may sell or distribute a drug containing cannabis in accordance with a written order to a licensed dealer specialized in destruction, if the drug is sold or distributed for the purpose of its destruction.

Written order

(2) The written order must contain

Record keeping

(3) The licensed dealer referred to in subsection (1) that sells or distributes the drug must prepare a record that sets out

Retention period

195.3 The licensed dealer must retain the records referred to in section 195.1 and subsection 195.2(3) for at least two years after the day on which they are prepared.

DIVISION 3

Importation and Exportation by Travellers

Importation

195.4 On entering Canada, an individual may import a drug containing cannabis that is in their actual possession or that forms part of their baggage if

Exportation

195.5 On departing Canada, an individual may export a drug containing cannabis that is in their actual possession or that forms part of their baggage if

37 Section 196 of the Regulations is repealed.

38 Sections 198 and 199 of the Regulations are replaced by the following:

Exemption — section 21 of Act

198 A person is exempt from the application of section 21 of the Act if they display, refer to or otherwise use the brand name of a combination product, or the name of the holder of the drug identification number for the product, directly or indirectly in a promotion that is used in the sponsorship of a person, entity, event, activity or facility.

Exemption — section 22 of Act

199 A person is exempt from the application of section 22 of the Act if they display on a facility, as part of the name of the facility or otherwise, if the facility is used for a sports or cultural event or activity, the brand name of a combination product or the name of the holder of the drug identification number for the product.

39 Subparagraphs 205(c)(iv) and (v) of the Regulations are replaced by the following:

40 Subparagraphs 209(c)(iv) and (v) of the Regulations are replaced by the following:

41 Subparagraphs 214(c)(iv) and (v) of the Regulations are replaced by the following:

42 Subparagraphs 218(c)(iv) and (v) of the Regulations are replaced by the following:

43 Paragraph 224(2)(c) of the Regulations is replaced by the following:

44 Paragraph 225(2)(c) of the Regulations is replaced by the following:

45 Paragraph 226(1)(g) of the Regulations is replaced by the following:

46 Paragraph 227(1)(g) of the Regulations is replaced by the following:

47 Paragraph 229(1)(a) of the Regulations is replaced by the following:

48 (1) Subparagraphs 237(1)(a)(ii) to (iv) of the Regulations are replaced by the following:

(2) Subparagraph 237(1)(b)(i) of the Regulations is replaced by the following:

49 Paragraph 247(2)(a) of the Regulations is replaced by the following:

50 (1) Paragraph 255(a) of the Regulations is replaced by the following:

(2) Clause 255(b)(ii)(A) of the Regulations is replaced by the following:

(3) Paragraph 255(c) of the English version of the Regulations is replaced by the following:

51 Paragraph 256(b) of the English version of the Regulations is replaced by the following:

52 (1) Paragraphs 258(1)(b) and (c) of the Regulations are replaced by the following:

(2) Paragraph 258(1)(e) of the Regulations is replaced by the following:

(3) Subsection 258(2) of the Regulations is replaced by the following:

Signature and attestation

(2) The application must

53 Sections 260 and 261 of the Regulations are replaced by the following:

Issuance of a registration number

260 (1) Subject to section 260.1, the Minister must, after examining the information and documents required under sections 258 and 259, issue to the applicant a document that sets out a registration number for the test kit 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.

Alteration of documents

(2) A person must not alter or deface in any manner the document that sets out the registration number.

Refusal

260.1 The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that

Cancellation

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

Effect of cancellation

(2) The following rules apply when the registration number of a test kit is cancelled:

54 Section 263 of the Regulations is repealed.

55 The Regulations are amended by replacing “declaration” with “attestation”, with any necessary modifications, in the following provisions:

56 The Regulations are amended by replacing “licensed dealer” with “licensed dealer specialized in destruction” in the following provisions:

57 The Regulations are amended by replacing “a written statement that affirms” with “an attestation” in the following provisions:

58 The Regulations are amended by replacing “Narcotic Control Regulations” with “former Narcotic Control Regulations” in the following provisions:

59 The French version of the Regulations is amended by replacing « nécessaire », « nécessaire d’essai » and « nécessaires d’essai » respectively with « trousse », « trousse d’essai » and « trousses d’essai », with any necessary modifications, in the following provisions:

60 The French version of the Regulations is amended by replacing « imposer » with « infliger » in the following provisions:

61 The English version of the Regulations is amended by replacing “statement” with “attestation”, with any necessary modifications, in the following provisions:

Coming into Force

62 These Regulations come into force on the 365th day after the day on which they are published in the Canada Gazette, Part II.

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