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Food and Drug Regulations

Version of section C.03.203 from 2018-06-13 to 2022-06-20:

  •  (1) Every radionuclide generator shall carry on the inner label

    • (a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name;

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

    • (c) the lot number;

    • (d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act;

    • (e) the drug identification number assigned for the radionuclide generator, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”;

    • (f) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”;

    • (g) a statement of the total parent radioactivity contained in the radionuclide generator;

    • (h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation;

    • (i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation;

    • (j) a statement of the recommended useful life of the drug after removal from the radionuclide generator;

    • (k) a statement of special storage requirements with reference to temperature or shielding;

    • (l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and

    • (m) a statement cautioning against the dismantling of the radionuclide generator.

  • (2) Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator.

  • (3) Section C.01.005 does not apply to a radionuclide generator.

  • SOR/79-236, s. 3
  • SOR/93-202, s. 17
  • SOR/97-12, ss. 54, 58, 62
  • SOR/2012-129, s. 3
  • SOR/2017-259, s. 17
  • SOR/2018-69, ss. 21(F), 22(F)
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