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

C.03.205. For the purposes of sections C.03.206 to C.03.209,

“component”

“component” means

• (a) a unit of a drug, other than a radionuclide, separately packaged in a kit for use in the preparation of a radiopharmaceutical, or

• (b) an empty vial or other accessory item in a kit; (constituants)

“kit”

“kit” means a package

• (a) that contains one or more separately packaged units of a drug, other than a radionuclide, and

• (b) that may contain empty vials or other accessory items, for use in the preparation of radiopharmaceuticals. (trousse)

C.03.206. Sections C.01.005 and C.04.019 do not apply to a component or kit.

C.03.207. Every component shall be labelled to show

• (a) adequate identification of the component and an adequate description of its function;

• (b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;

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

• (d) the lot number;

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

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

• (g) adequate directions for use or a reference to the accompanying package insert that shows such directions.

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]