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Enabling statute: Food and Drugs Act
    Food and Drug Regulations
Disclaimer: These documents are not the official versions (more).
Source: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/238344.html
Regulation current to September 15, 2006

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PART G

CONTROLLED DRUGS

Division 1

General

G.01.001. (1) In this Part,

“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” 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” 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” means a drug set out in the schedule to this Part and includes a preparation; (drogue contrôlée)

“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” 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”[SOR/2004-238, s. 1]

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

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

“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)

“practitioner”[Repealed, SOR/97-228, s. 7]

“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” 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” 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” 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” 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” means an order given orally. (commande verbale)

“written order”[Repealed, SOR/85-550, s. 1]

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

“Act” means the Controlled Drugs and Substances Act (Loi)

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

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

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

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

“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.

G.01.002. (1) A person is authorized to have a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 or 17 of Part I of the schedule to this Part in his or her possession where the person has obtained the controlled drug under these Regulations, in the course of activities performed in connection with the enforcement or administration of an Act or regulation, or from a person who is exempt under section 56 of the Controlled Drugs and Substances Act from the application of subsection 5(1) of that Act with respect to that controlled drug, and the person

(a) requires the controlled drug for his 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 he has such possession;

(b) is a practitioner who is registered and entitled to practise in a province other than the province in which he has such possession and such possession is for emergency medical purposes only;

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

(d) has obtained the controlled drug for his own use from a practitioner or pursuant to a prescription that is not issued or obtained in contravention of these Regulations;

(e) is a practitioner of medicine who received the controlled drug under subsection G.06.001(3) or (4) and whose possession is for a purpose referred to in subsection G.06.001(5);

(f) is an agent of a practitioner of medicine who received the controlled drug under subsection G.06.001(3) and whose possession is for the purpose of complying with subsection G.06.001(4);

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

(h) is a person other than a person referred to in paragraph (e) or (f), is exempted under section 56 of the Controlled Drugs and Substances Act with respect to possession of that controlled drug and whose possession is for a purpose set out in the exemption; or

(i) is a person referred to in paragraph G.06.001(5)(b).

(2) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where the person is acting as the agent for any person referred to in paragraph (1)(a) to (e), (h) or (i).

(3) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where

(a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(g); and

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

SOR/97-515, s. 3; SOR/99-125, s. 1; SOR/2003-34, s. 1; SOR/2003-413, s. 1.

G.01.002.1. Section C.01.004 does not apply to a test kit that contains a controlled drug where a registration number has been issued for the test kit pursuant to section G.06.002.3 and has not been cancelled pursuant to section G.06.002.4.

SOR/80-543, s. 11.

G.01.003. In the case of a controlled drug that is dispensed by a pharmacist pursuant to a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained shall carry the following:

(a) the name and address of the pharmacy or pharmacist;

(b) the date and number of the prescription;

(c) the name of the person for whom the controlled drug is dispensed;

(d) the name of the practitioner;

(e) directions for use; and

(f) any other information that the prescription requires be shown on the label.

SOR/80-543, s. 11; SOR/2004-238, s. 2(F).

G.01.004. The Controlled Drugs and Substances 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.

SOR/92-386, s. 2; SOR/97-228, s. 8.

G.01.005. [Repealed, SOR/80-543, s. 12]

G.01.006. Except as otherwise provided in this Part, no person shall sell a controlled drug or preparation that does not comply with all provisions of Parts C and D applicable to it.

G.01.007. No person shall

(a) advertise a controlled drug to the general public; or

(b) issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol C in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement.

G.01.008. [Repealed, SOR/80-543, s. 12]

Prescribed Manner of Notice of Application for an Order of Restoration

G.01.010. (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.

(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application for an order of restoration is to be made to the magistrate and shall specify

(a) the magistrate to whom the application is to be made;

(b) the time and place where the application is to be heard;

(c) the controlled drug or other thing in respect of which the application is to be made; and

(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the controlled drug or other thing referred to in paragraph (c).

SOR/97-228, s. 9.


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