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

Regulations are current to 2017-11-06 and last amended on 2017-06-20. Previous Versions

 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DIVISION 4[Repealed, SOR/2003-196, s. 105]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 [Repealed, SOR/2003-196, s. 106]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 [Repealed, SOR/2003-196, s. 107]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 1

General

  •  (1) In this Part,

    agricultural implant

    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; (implant agricole)

    common name

    common name with reference to a controlled drug means the name in English or French by which the controlled drug is commonly known; (nom usuel)

    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)

    controlled drug

    controlled drug means

    • (a) a drug set out in the schedule to this Part, including a preparation; or

    • (b) in respect of a midwife, nurse practitioner or podiatrist, a drug set out in the schedule to this Part, including a preparation, 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)

    hospital

    hospital means a facility

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

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

    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)

    licence

    licence[SOR/2004-238, s. 1]

    licensed dealer

    licensed dealer means the holder of a licence issued under section G.02.003.2; (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)

    parenteral use

    parenteral use with reference to a controlled drug means administration by means of a hypodermic syringe, needle or other instrument through or into the skin of mucous membrane; (usage parentéral)

    permit

    permit means a permit issued under section G.02.008; (permis)

    pharmacist

    pharmacist

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

      • (i) to practise pharmacy, and

      • (ii) to operate a pharmacy or dispensary

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

    • (b) includes, for the purposes of sections G.01.002, G.01.003, G.03.002 to G.03.008, G.03.014, G.03.015 and G.03.017 and subsections G.05.003(3) and (4), a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province; (pharmacien)

    podiatrist

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

    practitioner

    practitioner[Repealed, SOR/97-228, s. 7]

    preparation

    preparation means a drug that contains a controlled drug and one or more active medicinal ingredients, in a recognized therapeutic dose, other than a controlled drug; (préparation)

    prescription

    prescription means a direction given by a practitioner that a stated amount of a specified controlled drug be dispensed for the person named therein; (ordonnance)

    proper name

    proper name with reference to a controlled drug means the name in English or French

    • (a) assigned to the drug in section C.01.002,

    • (b) that appears in bold face type for the drug in the Regulations and where the drug is dispensed in a form other than that described in Part C, the name of the dispensing form, or

    • (c) assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b) of this definition; (nom propre)

    qualified person in charge

    qualified person in charge means the individual with the qualifications specified in subsection G.02.001.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)

    test kit

    test kit means an apparatus

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

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

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

    verbal order

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

    written order

    written order[Repealed, SOR/85-550, s. 1]

  • (2) The definitions in this subsection apply in this Part and Part J.

    Act

    Act means the Controlled Drugs and Substances Act (Loi)

    advertisement

    advertisement has the same meaning as in section 2 of the Food and Drugs Act. (publicité ou annonce)

    Department

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

    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 paragraphs (a) to (d). (infraction désignée en matière criminelle)

    designated drug offence

    designated drug offence means

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

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

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

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

    label

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

    package

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

    Security Directive

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

  • (3) Unless otherwise provided, the definitions in subsection 2(1) of the Controlled Drugs and Substances Act apply in this Part and Part J.

  • 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.
 
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