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

C.03.203. (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 establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;

• (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.

C.03.204. (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.