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

Regulations are current to 2014-10-15 and last amended on 2014-08-21. 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“licence”[Repealed, SOR/2004-238, s. 31]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.