Ohio Admin. Code 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 after receipt
of
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.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 10/04/2010
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