Current through 2024-51, December 18, 2024
Section 144-220-G-D-204 - Permissible Molybdenum-99 ConcentrationA. A licensee may not administer to humans a radioactive drug containing: (1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 µCi of molybdenum-99 per mCi of technetium-99m);(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 (0.02 µCi of Sr-82 per mCi of Rb-82 chloride); or(3) More than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi of Sr-85 per 1 mCi of Rb-82).B. To demonstrate compliance with G.204, the licensee preparing radioactive drugs from radionuclide generators shall: (1) Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m generator; or, as applicable.(2) Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.C. A licensee who must measure radionuclide contaminant concentration shall retain a record of each measurement in accordance with G.2204.D. A licensee shall report immediately to the Agency each occurrence of radionuclide contaminant concentration exceeding the limits specified in G.204.10-144 C.M.R. ch. 220, § G-D-204