Section 3701:1-58-35 - Permissible molybdenum-99, strontium-82, and strontium-85 concentrations(A) A licensee may not administer to humans a radiopharmaceutical that contains: (1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m ( 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection ( 0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection ( 0.2 microcurie of strontium-85 per millicurie of rubidium-82).(B) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate from a generator to demonstrate compliance with paragraph (A) of this rule.(C) 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 (A) of this rule.(D) 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 3701:1-58-85 of the Administrative Code.(E) The licensee shall report any measurement that exceeds the limits in paragraph (A) of this rule at the time of generator elution, in accordance with rule 3701:1-58-105 of the Administrative Code.Ohio Admin. Code 3701:1-58-35
Effective: 8/15/2021
Five Year Review (FYR) Dates: 11/13/2020 and 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 10/04/2010