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Food and Drug Regulations

Version of section C.03.208 from 2018-04-04 to 2018-06-12:


 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  • (p) [Repealed, SOR/2001-203, s. 3]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
  • SOR/2018-69, s. 36(F)
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