Food and Drug Regulations

C.03.208 Every kit shall be labelled to show

• (a) its proper name;

• (b) its brand name, if any;

• (c) a list of its contents;

• (d) the name and address of the distributor referred to in paragraph C.01A.003(b);

• (e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;

• (f) the lot number;

• (g) a statement of any special storage requirements with respect to temperature and light;

• (h) the date after which the kit is not recommended for use, the name of the month being written in full or designated by letter abbreviation;

• (i) where the label of a component makes reference to the label of the kit that shows information as to the ingredients of the component, a quantitative list of the ingredients of that component;

• (j) a statement of the sterility and apyrogenicity of the components;

• (k) adequate directions for preparing the radiopharmaceutical or a reference to the accompanying package insert that shows such directions;

• (l) a statement of the duration of the useful life of the prepared radiopharmaceutical;

• (m) a statement of the storage requirements for the prepared radiopharmaceutical;

• (n) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use, or a reference to the accompanying package insert that shows such information; and

• (o) a statement of the route of administration of the prepared radiopharmaceutical.

• (p) [Repealed, SOR/2001-203, s. 3]