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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2022-01-12 and last amended on 2022-01-05. Previous Versions

PART DVitamins, Minerals and Amino Acids (continued)

DIVISION 3Addition of Vitamins, Mineral Nutrients or Amino Acids to Foods (continued)

 Section D.03.002 does not apply to a food when all of the following conditions are met:

  • (a) the food is

    • (i) a gluten-free food referred to in paragraph B.24.003(1)(g), or

    • (ii) represented for a special dietary use referred to in paragraph B.24.003(1)(h) or (i);

  • (b) no standard is prescribed in these Regulations for the food; and

  • (c) the food is not advertised.

  • SOR/78-64, s. 9
  • SOR/84-334, s. 2
  • SOR/90-830, s. 12
  • SOR/95-444, s. 3

DIVISION 4[Repealed, SOR/2003-196, s. 105]

DIVISION 5Minerals in Drugs

 [Repealed, SOR/2003-196, s. 106]

  •  (1) Subject to subsection (2), no person shall sell a drug containing fluorine if the largest recommended daily dosage of that drug as shown on the label thereof would, if consumed by a person, result in a daily intake by that person of more than one milligram of fluoride ion.

  • (2) Subsection (1) does not apply to a drug sold by prescription.

  • SOR/81-196, s. 2

 Where a drug contains fluorine, both the inner and outer labels of the drug shall carry a cautionary statement that, if the drug is used in an area where the drinking water has a natural fluorine content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, mottling of the tooth enamel of a user of the drug may result.

 [Repealed, SOR/2003-196, s. 107]

PART ECyclamate Sweeteners

[
  • SOR/2016-74, s. 11
]
  •  (1) In this Part, cyclamate sweetener means any of the following substances sold as a sweetener:

    • (a) cyclohexyl sulfamic acid or any of its salts; and

    • (b) any substance containing cyclohexyl sulfamic acid or any of its salts.

  • (2) Part B does not apply to any cyclamate sweetener.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 12

Sale

 No person shall sell a cyclamate sweetener that is not labelled as required by this Part.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 13

Advertising

 No person shall, in advertising a cyclamate sweetener to the general public, make any representation other than with respect to the name, price and quantity of the sweetener.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 14

Labelling

 Every cyclamate sweetener shall be labelled to state that it should be used only on the advice of a physician.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 15

 Every cyclamate sweetener shall be labelled to show

  • (a) its energy value expressed, in calories, per teaspoon, drop, tablet or other measure used in the directions for use and per 100 grams or 100 millilitres; and

  • (b) a list of all its ingredients and, in the case of cyclohexyl sulfamic acid or any of its salts or a carbohydrate, its quantity.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 16

PART GControlled Drugs

DIVISION 1General

Definitions

Marginal note:Definitions

 The following definitions apply in this Part.

Act

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

advertisement

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

competent authority

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

compound

compound includes a preparation. (composé)

controlled drug

controlled drug means

  • (a) a controlled substance set out in the schedule to this Part; or

  • (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in the schedule to this Part that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations. (drogue contrôlée)

designated criminal offence

designated criminal offence means

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

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

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

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

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

destroy

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

hospital

hospital means a facility that is

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

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

international obligation

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

label

label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)

licensed dealer

licensed dealer means the holder of a licence issued under section G.02.007. (distributeur autorisé)

midwife

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

nurse practitioner

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

package

package includes anything in which a controlled drug is wholly or partly contained, placed or packed. (emballage)

pharmacist

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

podiatrist

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

preparation

preparation means a drug that contains a controlled drug and an active medicinal ingredient in a recognized therapeutic dose, other than a controlled drug. (préparation)

prescription

prescription means an authorization given by a practitioner that a stated amount of a controlled drug be dispensed for the person named in it or the animal identified in it (ordonnance)

qualified person in charge

qualified person in charge means the individual designated under subsection G.02.004(1). (responsable qualifié)

Security Directive

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

senior person in charge

senior person in charge means the individual designated under section G.02.003. (responsable principal)

test kit

test kit means a kit

  • (a) that contains a controlled drug and a reagent system or buffering agent;

  • (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a controlled drug for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

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

  • SOR/78-220, s. 1
  • SOR/85-550, s. 1
  • SOR/86-91, s. 1
  • SOR/90-261, s. 1(F)
  • SOR/92-386, s. 1
  • SOR/97-228, s. 7
  • SOR/97-515, s. 2
  • SOR/2003-135, s. 2
  • SOR/2004-238, s. 1
  • SOR/2012-230, s. 6
  • SOR/2018-147, s. 29
  • SOR/2019-171, s. 1

Application

Marginal note:Agricultural implants

  •  (1) The Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant and set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C.

  • Marginal note:Definition of agricultural implant

    (2) In this section, agricultural implant means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency.

  • SOR/97-515, s. 3
  • SOR/99-125, s. 1
  • SOR/2003-34, s. 1
  • SOR/2003-413, s. 1
  • SOR/2018-69, ss. 67, 68
  • SOR/2019-171, s. 1

 [Repealed, SOR/2019-171, s. 1]

Marginal note:Member of police force

 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of this Part.

Marginal note:Application of Parts C and D

 Except as otherwise provided in this Part, it is prohibited to sell or provide a controlled drug or a preparation that does not comply with all provisions of Parts C and D that are applicable to it.

Possession

Marginal note:Authorized persons

  •  (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 and 17 of Part I of the schedule to this Part if the person has obtained the controlled drug in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that controlled drug, and the person

    • (a) requires the controlled drug for their business or profession and is

      • (i) a licensed dealer,

      • (ii) a pharmacist, or

      • (iii) a practitioner who is registered and entitled to practise in the province in which they possess that drug;

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

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

    • (d) has obtained the controlled drug for their own use

      • (i) from a practitioner, or

      • (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations;

    • (e) is a practitioner of medicine who received the controlled drug under subsection G.06.003(1) or (2) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(3);

    • (f) is an agent or mandatary of a practitioner of medicine who received the controlled drug under subsection G.06.003(1) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(2);

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

    • (h) is not a practitioner of medicine referred to in paragraph (e) or an agent or mandatary referred to in paragraph (f), is exempted under section 56 of the Act with respect to possession of that controlled drug and their possession is for a purpose set out in the exemption; or

    • (i) is the Minister.

  • Marginal note:Agent or mandatary

    (2) A person is authorized to possess a controlled drug referred to in subsection (1) if the person is acting as the agent or mandatary of any person who is authorized to possess it in accordance with any of paragraphs (1)(a) to (e), (h) and (i).

  • Marginal note:Agent or mandatary — person referred to in paragraph (1)(g)

    (3) A person is authorized to possess a controlled drug referred to in subsection (1) if they

    • (a) are acting as the agent or mandatary of a person who they have reasonable grounds to believe is a person referred to in paragraph (1)(g); and

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

 
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