Section 0400-20-07-.41 - PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONS(1) A licensee shall not administer to humans a radiopharmaceutical that contains:(a) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium99m (0.15 µCi of Mo-99 per mCi of Tc-99m); or(b) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 µCi of Sr-82 per mCi of Rb-82 chloride), or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi of Sr-85 per mCi of Rb-82).(2) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with paragraph (1) of this rule.(3) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (1) of this rule.(4) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with Rule 0400-20-07-.95.(5) A licensee shall report immediately to the Division each occurrence of radionuclide contaminant concentration exceeding the limits specified in paragraph (1) of this rule at the time of generator elution, in accordance with Rule 0400-20-07-.114.Tenn. Comp. R. & Regs. 0400-20-07-.41
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.