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

Regulations are current to 2021-04-20 and last amended on 2021-04-14. Previous Versions

PART CDrugs (continued)

DIVISION 3 (continued)

Radiopharmaceuticals (continued)

  •  (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)
  •  (1) No person shall sell a drug that contains technetium-99m at any time during its useful life if it also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph.

  • (2) No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph.

  • SOR/97-12, s. 30
  • SOR/2012-129, s. 4

Drugs, Other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals

[
  • SOR/2017-259, s. 18(F)
]

 The following definitions apply in this section and in 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; or

  • (b) an empty vial or other accessory item in a kit. (constituant)

kit

kit means a package that is intended to be used in the preparation of radiopharmaceuticals and that

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

  • (b) may contain empty vials or other accessory items. (trousse)

  • SOR/79-236, s. 4
  • SOR/2017-259, s. 19

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

  • SOR/79-236, s. 4
  •  (1) 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.

  • (2) The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.

  • SOR/79-236, s. 4
  • SOR/97-12, s. 58
  • SOR/2017-259, s. 20
  • SOR/2018-69, s. 23(F)

 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 drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”;

  • (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/2017-259, s. 21
  • SOR/2018-69, s. 36(F)

 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
  • SOR/2018-69, s. 36(F)
 
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