Food and Drug Regulations

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.