Food and Drug Regulations

C.01.011 (1) A drug referred to in subsection 10(2) of the Act shall be exempt from the standard for any drug contained in any publication mentioned in Schedule B to the Act to the extent that such drug differs from that standard with respect to colour, flavour, shape and size, if such difference does not interfere with any method of assay prescribed in any such publication.

(2) [Repealed, SOR/93-243, s. 2]

(3) Where a manufacturer’s standard is used for a drug, the manufacturer shall make available to the Director, on request, details of that standard and of a method of analysis for the drug acceptable to the Director.

(4) No person shall use a manufacturer’s standard for a drug that provides

• (a) a lesser degree of purity than the highest degree of purity, or

• (b) a greater variation in potency than the least variation in potency,

provided for that drug in any publication mentioned in Schedule B to the Act.