Food and Drug Regulations

Version of section C.03.209 from 2006-03-22 to 2018-04-03:


 A package insert shall be included in every kit and shall show

  • (a) the proper name and the brand name, if any, of the kit and a description of its use;

  • (b) a list of the contents of the kit;

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

  • (d) identification of the radionuclides that can be used to prepare the radiopharmaceutical;

  • (e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

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

  • (g) a description of the biological actions of the prepared radiopharmaceutical;

  • (h) indications and contraindications in respect of the prepared radiopharmaceutical;

  • (i) warnings and precautions in respect of the components and the prepared radiopharmaceutical;

  • (j) the adverse reactions, if any, associated with the prepared radiopharmaceutical;

  • (k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request;

  • (l) the radiation dosimetry in respect of the prepared radiopharmaceutical;

  • (m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use;

  • (n) a statement of the route of administration of the prepared radiopharmaceutical; and

  • (o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration.

  • SOR/79-236, s. 4;
  • SOR/93-202, s. 19;
  • SOR/97-12, s. 58.
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