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

Regulations are current to 2017-08-27 and last amended on 2017-06-20. Previous Versions

 Smallpox vaccine, when tested by acceptable methods,

  • (a) shall be free from extraneous micro-organisms, in the case of vaccine prepared for use by jet gun; and

  • (b) shall contain not more than 500 viable non-pathogenic bacteria per millilitre, in the case of vaccine prepared for use by the multiple pressure technique or by scarification.

 Smallpox vaccine must demonstrate evidence of disease prevention that is at least equivalent to that of a vaccine that

  • (a) is known to prevent human to human transmission of smallpox; and

  • (b) meets the potency of equal to or greater than 108 pockforming units per millilitre, as determined using chick embryo chorioallantoic membranes.

  • SOR/2006-2, s. 2.

 No person shall sell smallpox vaccine unless

  • (a) in the case of fluid vaccine, it has been stored at a temperature below -10°C;

  • (b) in the case of dried vaccine, it has been stored at a temperature below 10°C; and

  • (c) the outer label carries a statement that it shall be stored at a temperature of not more than 5°C.

  • SOR/97-12, s. 44.

 Notwithstanding the provisions of section C.04.003, the date of issue of smallpox vaccine shall be not later than

  • (a) in the case of fluid vaccine, nine months after the date of manufacture; and

  • (b) in the case of dried vaccine, 24 months after the date of manufacture.

 The expiration date of smallpox vaccine shall not exceed the following, unless supported by evidence of stability satisfactory to the Minister:

  • (a) in the case of fluid vaccine, 3 months after the date of issue; or

  • (b) in the case of dried vaccine, 12 months after the date of issue.

  • SOR/2006-2, s. 3.

 No inner label shall be required for smallpox vaccine in single-dose containers or when dispensed in capillary tubes.

 No person shall sell smallpox vaccine to which an antibiotic has been added.

Poliomyelitis Vaccine

 Poliomyelitis vaccine shall be an aqueous suspension of killed poliomyelitis viruses, Types I, II, and III.

 Poliomyelitis vaccine shall be prepared in acceptable tissue culture medium from strains of poliomyelitis virus proven capable of producing vaccine of acceptable potency.

 Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum.

 No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency.

 The outer label shall carry a statement of any antibiotic present in the vaccine.

 The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Director, is presented that a longer period is appropriate.

  • SOR/85-715, s. 6.

Poliovirus Vaccine, Live, Oral

 Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that

  • (a) have been obtained directly from a source acceptable to the Director;

  • (b) are shown to be genetically stable by an acceptable method;

  • (c) are shown to be non-pathogenic when given orally to humans;

  • (d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and

  • (e) have a history of successful use in the production of polio-virus vaccine, live, oral.

 Poliovirus vaccine, live, oral, shall be fabricated, packaged/labelled and tested in premises separated from buildings where other products are fabricated, packaged/labelled or tested, and from buildings where control tests involving the use of cell lines or virus strains not employed in the fabrication, packaging/labelling and testing of poliovirus vaccine, live, oral, are carried out.

  • SOR/97-12, s. 45.

 No fabricator shall permit the introduction of any bacterial or viral cultures other than those used in the manufacture of poliovirus vaccine, live, oral on any premises that are used for the manufacture of poliovirus vaccine, live, oral.

  • SOR/97-12, s. 61.

 Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, if

  • (a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Director; and

  • (b) the fabricator has received written permission from the Director to carry out such manufacture.

  • SOR/97-12, s. 61.

 Poliovirus vaccine, live, oral shall be prepared only

  • (a) in a tissue culture,

  • (b) in a medium, and

  • (c) by methods

acceptable to the Director.

 No fabricator shall sell poliovirus vaccine, live, oral, unless he has tested each lot for extraneous micro-organisms and the vaccine is free therefrom.

  • SOR/97-12, s. 61.

 A fabricator of poliovirus vaccine, live, oral shall test, by a method acceptable to the Director, each lot of vaccine for neurovirulence and for genetic markers and it shall meet the requirements established by the Director.

  • SOR/97-12, s. 61.

 No fabricator shall employ any person in the manufacture of poliovirus vaccine, live, oral unless such person

  • (a) is free from infectious disease;

  • (b) has been vaccinated successfully against poliomyelitis by poliovirus vaccine, live, oral; and

  • (c) has been proved by periodic tests to be a non-carrier of poliomyelitis virus.

  • SOR/97-12, s. 61.

 A fabricator of poliovirus vaccine, live, oral shall not permit the entry to a building in which the vaccine is manufactured of any person who

  • (a) is not directly concerned with the manufacturing processes; or

  • (b) has been working on the same day with experimental animals or with infectious agents.

  • SOR/97-12, s. 61.

Bacteriophage

 Bacteriophage shall be a virus preparation with specific lytic action against micro-organisms actually or potentially pathogenic.

 The expiration date of bacteriophage shall be not later than 12 months after the date of manufacture or the date of issue.

Toxins, Toxoids

Schick Test Reagents

 Schick test reagents for the diagnosis of susceptibility to diphtheria shall be

  • (a) diphtheria toxin for Schick test;

  • (b) Schick control; and

  • (c) diphtheria toxin for Schick test with control.

 Diphtheria toxin for Schick test shall be sterile diluted diphtheria toxin stabilized by an acceptable method.

 Schick control shall be suitably diluted

  • (a) diphtheria toxoid; or

  • (b) sterile diphtheria toxin heated at a temperature of 95°C for five minutes.

 The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by

  • (a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and

  • (b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.

 
Date modified: