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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

Samples

  • C.02.025. (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the distributor’s or importer’s establishment licence.

  • (2) The fabricator shall retain a sample of each lot or batch of raw materials used in the fabrication of a drug for a period of at least two years after the materials were last used in the fabrication of the drug, unless otherwise specified in the fabricator’s establishment licence.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 4(F);
  • SOR/92-654, s. 8;
  • SOR/97-12, s. 20.

C.02.026. 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

C.02.027. Every distributor referred to in paragraph C.01A.003(b) and importer shall establish the period of time during which each drug in the package in which it is sold will comply with the specifications.

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

C.02.028. Every distributor referred to in paragraph C.01A.003(b) and importer 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.

Sterile Products

C.02.029. 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

C.02.030. 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

C.03.001. In this Division,

“drug”

“drug” means a drug listed in Schedule C to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act that is of biological origin; (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“licence” or “Canadian licence”[Repealed, SOR/97-12, s. 22]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.