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

Regulations are current to 2016-09-18 and last amended on 2016-08-26. Previous Versions

PART JRestricted Drugs

DIVISION 1

General

 In this Part,

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 restricted drugs into or from the country; (autorité compétente)

institution

institution means any institution engaged in research on drugs and includes a hospital that is licensed by a province, a university, a department or agency of the Government of Canada or of a province or any part thereof; (établissement)

international obligation

international obligation means an obligation in respect of a restricted 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licence[Repealed, SOR/2004-238, s. 31]

licensed dealer

licensed dealer means the holder of a licence issued under section J.01.007.2; (distributeur autorisé)

permit

permit means a permit issued under section J.01.005; (permis)

pharmacist

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

practitioner

practitioner means a person who is registered and entitled under the laws of a province to practise the profession of medicine; (praticien)

prescription

prescription means an authorization given by a practitioner, as defined in subsection 2(1) of the Act, that a stated amount of a drug be dispensed for the person named in the authorization; (ordonnance)

qualified investigator

qualified investigator means, in respect to a restricted drug, a person who

  • (a) is employed by or is connected with an institution, or

  • (b) is engaged in research in an institution in respect of that drug,

and whose use and possession of that drug is authorized by the Minister pursuant to section J.01.018; (chercheur compétent)

qualified person in charge

qualified person in charge means the individual with the qualifications specified in subsection J.01.003.2(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)

restricted drug

restricted drug means

  • (a) any substance that is set out in the schedule to this Part or anything that contains the substance; and

  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, except a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and except cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, that is to be or that has been compounded by a pharmacist in accordance with or in anticipation of a prescription; (drogue d’usage restreint)

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)

  • SOR/97-228, s. 22;
  • SOR/2004-238, s. 31;
  • SOR/2013-172, s. 1.

Possession

  •  (1) The following persons are authorized to have a restricted drug other than a restricted drug listed in Part II of the schedule to this Part in their possession:

    • (a) a licensed dealer;

    • (b) a qualified investigator if he has possession for the purpose of and in connection with research in an institution;

    • (c) an analyst, inspector, member of the Royal Canadian Mounted Police, constable, peace officer, member of the staff of the Department of Health or officer of a court, if such person has possession for the purpose of and in connection with his employment; and

    • (d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that restricted drug.

  • (2) A person is authorized to have a restricted drug other than a restricted drug listed in Part II of the schedule to this Part in their possession if the person is acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b) or (d).

  • (2.1) A person is authorized to have a restricted drug other than a restricted drug listed in Part II of the schedule to this Part in their possession if

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

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

  • SOR/97-228, s. 23;
  • SOR/99-125, s. 7;
  • SOR/2010-222, s. 23;
  • SOR/2015-210, s. 2.

Licences, Permits and Licensed Dealers

 Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a restricted drug.

  • SOR/2004-238, s. 32.

 To be eligible for a dealer’s licence, a person must be

  • (a) an individual who ordinarily resides in Canada;

  • (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

  • (c) the holder of a position that includes responsibility for restricted drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

  • SOR/2004-238, s. 32.
  •  (1) A licensed dealer

    • (a) shall designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to restricted drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and

    • (b) may designate an alternate qualified person in charge who must work at the premises set out in the licence and have authority to replace the qualified person in charge when that person is absent.

  • (2) The qualified person in charge and, if applicable, the alternate qualified person in charge

    • (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

    • (b) shall be a pharmacist or a practitioner registered with a provincial professional licensing authority or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

    • (c) shall not have been convicted, as an adult, within the previous 10 years, of

      • (i) a designated drug offence,

      • (ii) a designated criminal offence, or

      • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

  • SOR/2004-238, s. 32;
  • SOR/2010-222, ss. 24(E), 34;
  • SOR/2014-260, s. 14(F).

 No licensed dealer shall import or export a restricted drug without a permit.

 
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