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

Regulations are current to 2018-12-12 and last amended on 2018-11-23. Previous Versions

PART CDrugs (continued)

DIVISION 2Good Manufacturing Practices (continued)

Records (continued)

  •  (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler shall

    • (a) maintain records of the results of the self-inspection program required by section C.02.012 and of any action taken in connection with that program; and

    • (b) retain those records for a period of at least three years.

  • (2) Every person who fabricates or packages/labels a drug shall

    • (a) maintain records on the operation of the sanitation program required to be implemented under section C.02.007; and

    • (b) retain those records for a period of at least three years.

  • SOR/82-524, s. 3;
  • SOR/97-12, ss. 19, 53.

 Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every fabricator, packager/labeller, wholesaler and importer of an active ingredient shall add all of the following information to the documentation that accompanies the active ingredient, immediately after any like information that has been added by another person:

  • (a) their establishment licence number, or if there is none, their name, address, telephone number, fax number and email address;

  • (b) an indication whether they have fabricated, packaged/labelled, wholesaled, distributed or imported the active ingredient and the date on which that activity was carried out;

  • (c) the expiration date; and

  • (d) the lot number.

  • SOR/2013-74, s. 12.

Samples

  •  (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year after the expiration date of the drug unless their establishment licence specifies some other period.

  • (2) Subject to subsection (4), the fabricator of a drug in dosage form shall retain a sample of each lot or batch of raw materials used in the fabrication for two years after the materials were last used in the fabrication unless their establishment licence specifies some other period.

  • (3) Subject to subsection (4), the fabricator of an active ingredient shall retain a sample of each lot or batch of it for the following period unless their establishment licence specifies some other period:

    • (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or

    • (b) in any other case, one year after the expiration date of the lot or batch.

  • (4) If a fabricator is required to maintain samples in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 4(F);
  • SOR/92-654, s. 8;
  • SOR/97-12, s. 20;
  • SOR/2013-74, s. 13.

 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.

 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

  • SOR/97-12, s. 23.

 [Repealed, SOR/97-12, s. 24]

 [Repealed, SOR/97-12, s. 67]

 [Repealed, SOR/97-12, s. 26]

 On written request from the Minister, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations.

  • SOR/97-12, s. 27;
  • SOR/2018-69, s. 27.

 No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease.

  • SOR/97-12, s. 27.
  • SOR/79-236, s. 1;
  • SOR/93-202, s. 15;
  • SOR/97-12, s. 28.
  •  (1) Every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label.

  • (2) Subsection (1) does not apply to

    • (a) a drug sold to a drug fabricator;

    • (b) a drug sold under a prescription;

    • (c) a radiopharmaceutical as defined in section C.03.201; or

    • (d) a component or kit as defined in section C.03.205.

  • SOR/80-543, s. 9;
  • SOR/97-12, s. 61;
  • SOR/2001-181, s. 4;
  • SOR/2013-122, s. 16.
 
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