Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions
Drugs, other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals
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)
- SOR/79-236, s. 4.
C.03.206. Sections C.01.005 and C.04.019 do not apply to a component or kit.
- SOR/79-236, s. 4.
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.
- SOR/79-236, s. 4;
- SOR/97-12, s. 58.
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]
- SOR/79-236, s. 4;
- SOR/93-202, s. 18;
- SOR/97-12, ss. 58, 62;
- SOR/2001-203, s. 3.
- Date modified: