Food and Drug Regulations

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.