10-144-220 Me. Code R. § G-D-204

Current through 2024-51, December 18, 2024
Section 144-220-G-D-204 - Permissible Molybdenum-99 Concentration
A. 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