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

C.04.013 Every fabricator and packager/labeller shall safely segregate all work with spore-bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided.

C.04.014 No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs.

C.04.015 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 of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations.

C.04.016 All animals from which drugs are prepared and preserved shall be

• (a) under the direct supervision of competent medical or veterinary personnel;

• (b) kept in quarantine by the fabricator for at least seven days before use; and

• (c) healthy and free from infectious disease.

C.04.017 A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.

C.04.018 A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease.

C.04.019 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.”.

C.04.020 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.

Bacterial Vaccines, Products Analogous to Bacterial Vaccines

C.04.050 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.

C.04.051 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.

C.04.052 No fabricator shall use a substrate (culture medium), in the production of a bacterial vaccine, that contains any horse meat or horse serum.

C.04.053 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.

C.04.054 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.

C.04.055 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

C.04.060 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.-.

C.04.061 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

C.04.065 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.

C.04.066 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

C.04.070 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.

C.04.071 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.

C.04.072 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.

C.04.073 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.

C.04.074 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.

C.04.075 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.

C.04.076 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.

C.04.077 A fabricator of B.C.G. vaccine shall keep, at a temperature not exceeding 5.0°C, and for not less than six months,

• (a) the culture on glycerine-water potato medium from which the Sauton I and Sauton II subcultures were made, and

• (b) not less than six vials of the final product

from each lot thereof.

C.04.078 Every fabricator and packager/labeller of B.C.G. vaccine shall keep, in form satisfactory to the Minister, continuous clinical records of the use of B.C.G. vaccine in humans.

C.04.079 A fabricator of B.C.G. vaccine shall examine pathologically all test animals used and shall immediately report to the Minister any evidence of active, progressive tuberculosis in any such animals.

C.04.080 The expiration date for B.C.G. vaccine shall be not more than

• (a) 10 days after harvesting in the case of fluid vaccine;

• (b) 12 months after harvesting in the case of freeze dried vaccine stored at a temperature of 4°C or above; or

• (c) 20 months after harvesting in the case of freeze dried vaccine stored at a temperature below 4°C.

C.04.081 No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion.

C.04.082 No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.

C.04.083 The label of fluid B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of

• (a) the weight of bacteria per millilitre; and

• (b) the route of administration of the vaccine.

C.04.084 The label of freeze-dried B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of

• (a) the amount of bacteria per vial or per dose; and

• (b) the route of administration of the vaccine.

C.04.085 The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine.

Products Analogous to Bacterial Vaccines

C.04.090 A product analogous to a bacterial vaccine shall be

• (a) a bacterial antigen, other than a bacterial vaccine, such as a lysate, or

• (b) an extract prepared from a bacterial culture,

and shall conform to the requirements of these Regulations for bacterial vaccines except those of paragraphs (a) and (b) of C.04.054.

C.04.091 The expiration date of a product analogous to a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue, but for dried tuberculin and tuberculin containing at least 50 per cent glycerin the expiration date shall be not later than five years after the date of manufacture or the date of issue, and for all other tuberculins not more than 12 months after the date of manufacture or the date of issue.

Virus and Rickettsial Vaccines

C.04.100 A virus vaccine, rickettsial vaccine, shall be a suspension of, or prepared from, living or killed viruses or rickettsiae.

C.04.101 No person shall sell a virus or a rickettsial vaccine unless the fabricator has submitted to the Minister details of the source of the strains of viruses or rickettsiae used, the method of their propagation, the method of fabrication of the vaccine, the methods employed for determining sterility, safety, identity and potency and any other tests required by these Regulations.

C.04.102 Upon written request from the Minister every fabricator and packager/labeller shall submit with respect to each lot of virus or rickettsial vaccine, when ready for sale, detailed protocols of sterility, safety, identity, potency, and of any other tests required by these Regulations.

Smallpox Vaccine

C.04.110 Smallpox vaccine

• (a) shall be a virus vaccine;

• (b) shall be the living virus of vaccinia or its derivatives obtained from

  • (i) the vesicles produced in the skin of healthy calves by inoculation of vaccinia virus,

  • (ii) specifically infected membranes of chick embryos, or

  • (iii) suitable tissue culture infected with vaccinia virus or its derivatives; and

• (c) shall be in fluid or dried form.