Food and Drug Regulations

G.01.001 (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.