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

Regulations are current to 2019-01-30 and last amended on 2019-01-15. Previous Versions

PART CDrugs (continued)

DIVISION 4 (continued)

Schedule D Drugs (continued)

 The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry

  • (a) on both the inner and the outer labels

    • (i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,

    • (ii) the name of the distributor referred to in paragraph C.01A.003(b),

    • (iii) the potency of the drug, where applicable,

    • (iv) the recommended dose of the drug,

    • (v) the lot number,

    • (vi) the expiration date except upon the inner label of a single-dose container, and

    • (vii) adequate direction for use; and

  • (b) on the outer label

    • (i) the address of the distributor referred to in paragraph C.01A.003(b),

    • (ii) [Repealed, SOR/2013-179, s. 3]

    • (iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug,

    • (iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required,

    • (v) a statement of the net contents in terms of weight, measure, or number, and

    • (vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:

      “HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.

      SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.

  • SOR/78-424, s. 7;
  • SOR/93-202, s. 21;
  • SOR/97-12, ss. 39, 54, 58;
  • SOR/2011-88, s. 6;
  • SOR/2013-179, s. 3.

 Except in the case of the following drugs, 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:

  • (a) a drug sold to a person who holds an establishment licence; and

  • (b) a drug sold under a prescription.

  • SOR/80-543, s. 10;
  • SOR/97-12, s. 40;
  • SOR/2001-181, s. 4;
  • SOR/2013-122, s. 17.

Bacterial Vaccines, Products Analogous to Bacterial Vaccines

 Except as provided in this Division, a bacterial vaccine shall be a sterile suspension of killed cultures of bacteria, with or without the addition of other medication, and shall not include an autogenous vaccine.

 No person shall sell a bacterial vaccine unless the culture that has been used in its preparation has been tested by an acceptable method for identity and purity and when so tested it shall be true to name and a pure strain, and a record of the culture shall be maintained which shall include a statement of its origin, properties and characteristics.

 No fabricator shall use a substrate (culture medium), in the production of a bacterial vaccine, that contains any horse meat or horse serum.

  • SOR/97-12, s. 61.

 A fabricator of a bacterial vaccine prepared from a bacterium that does not grow readily in ordinary culture media shall test its sterility in media which are specially favourable to the growth of such bacterium, and it shall be sterile.

  • SOR/97-12, s. 61.

 Except as provided in sections C.04.083, C.04.084 and C.04.090, both the inner and outer labels of every multiple-dose container and the outer label of every single-dose container of a bacterial vaccine shall carry a statement of

  • (a) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre,

  • (b) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre, of each species or immunogenic type for a vaccine that contains a number of different species or immunogenic types of bacteria,

  • (c) the exact nature and amount of any substance, other than a simple diluent, combined with such vaccine, and

  • (d) the recommended dose,

and the inner label of a single-dose container shall carry a statement that it contains only one dose.

 The expiration date of a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue.

Typhoid Vaccine

 Cultures of Salmonella typhosa used in the preparation of typhoid vaccine shall be smooth, motile, and in the Vi form, with the following antigenic structure IX,XII,Vi; d.-.

 No person shall sell any lot of typhoid vaccine unless such lot has been shown to meet a test for potency made by an acceptable method.

Pertussis Vaccine

 A fabricator shall, in the preparation of pertussis (whooping cough) vaccine, use only strains of Bordetella pertussis that meet the requirements of an antigenic test made by an acceptable method.

  • SOR/90-217, s. 1;
  • SOR/97-12, s. 61.

 No person shall sell any lot of pertussis (whooping cough) vaccine unless such lot has been shown to meet a test for potency made by an acceptable method.

B.C.G. (Bacille Calmette-Guerin) Vaccine

 B.C.G. vaccine shall be prepared from living B.C.G. organisms that

  • (a) have been obtained directly from a source approved by the Minister;

  • (b) are proved to be non-pathogenic by an acceptable method; and

  • (c) have a history of successful use in the production of B.C.G. vaccine.

  • SOR/2018-69, s. 27.

 No fabricator shall employ any person in the manufacture of B.C.G. vaccine unless such person

  • (a) has been and remains free from all forms of tuberculous infection,

  • (b) undergoes every six months a medical examination, that shall include an X-ray examination of the chest, for the presence of tuberculosis, such examination being made by a qualified, practising physician who shall sign a certificate of such person’s freedom from tuberculosis, and such certificate shall be kept on file and be available at all times, and

  • (c) resides in a household that is at all times free from active tuberculosis,

nor shall a fabricator employ such person in any other laboratory position.

  • SOR/97-12, s. 61.

 The preparation, preservation and packaging/labelling of B.C.G. vaccine shall be conducted under the direct supervision of an experienced bacteriologist who has

  • (a) not less than three years postgraduate training in bacteriology and immunology;

  • (b) specialized in the field of bacteriology; and

  • (c) at least one year of practical experience in the manufacture of B.C.G. vaccine.

  • SOR/97-12, s. 41.

 No fabricator shall permit any culture that is not a B.C.G. culture to be at any time on any premises that are used for the manufacture of B.C.G. vaccine.

  • SOR/97-12, s. 61.

 A packager/labeller shall test by an acceptable method, after filling of the final container, each lot of B.C.G. vaccine for the presence of contaminating micro-organisms and when so tested it shall be free therefrom.

  • SOR/97-12, s. 65.

 Notwithstanding section C.04.074, a fluid B.C.G. vaccine may be released for sale if no growth has appeared upon the test culture medium after an incubation of 24 hours, but if there is evidence of the presence of contaminating micro-organisms in any lot during the test period of 10 days the packager/labeller shall at once recall such lot.

  • SOR/97-12, s. 65.

 Every fabricator and packager/labeller shall determine the number of viable B.C.G. organisms in each lot of vaccine by an acceptable method and shall keep a record of the number.

  • SOR/97-12, s. 63.
 
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