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

Regulations are current to 2014-10-27 and last amended on 2014-10-23. Previous Versions

 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material.

  • SOR/82-524, s. 3.

Stability

  •  (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

  • (2) Every fabricator and importer of an active ingredient shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 58;
  • SOR/2013-74, s. 14.
  •  (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

  • (2) Every fabricator and importer of an active ingredient shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 58;
  • SOR/2013-74, s. 14.

Sterile Products

 In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled

  • (a) in separate and enclosed areas;

  • (b) under the supervision of personnel trained in microbiology; and

  • (c) by a method scientifically proven to ensure sterility.

  • SOR/82-524, s. 3;
  • SOR/97-12, s. 21.

Medical Gases

 The provisions of sections C.02.025, C.02.027 and C.02.028 do not apply to medical gases.

  • SOR/85-754, s. 3.

Division 3

Schedule C Drugs

 In this Division,

“drug”

“drug” means a drug that is listed in Schedule C to the Act that is in dosage form or a drug that is an active ingredient of biological origin that can be used in the preparation of a drug listed in that Schedule; (drogue)

“licence”

“licence” or “Canadian licence”[Repealed, SOR/97-12, s. 22]

“manufacturer”

“manufacturer”[Repealed, SOR/97-12, s. 22]

“master lot”

“master lot” means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; (maître-lot)

“radionuclide generator”

“radionuclide generator” means a radioactive parent and daughter

  • (a) contained in an ion-exchange column, or

  • (b) dissolved in a suitable solvent in a liquid-liquid extraction system

where the radioactive daughter is separated from its parent by

  • (c) elution from the ion exchange column, or

  • (d) a solvent extraction procedure. (générateur de radionucléide)

  • SOR/97-12, s. 22;
  • SOR/2013-74, s. 15.