Ariz. Admin. Code § R9-7-720 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations
A. A licensee may
not administer to humans a radiopharmaceutical that contains 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, more than
0.02 kilo-becquerel 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 a generator to demonstrate compliance with subsection
(A).
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 subsection (A).
D.
A licensee shall maintain a record of each molybdenum-99 concentration
measurement or strontium-82 and strontium-85 concentrations measurements for
three years following completion of the measurement.
E. A licensee shall notify by telephone the
NRC Operations Center and the distributor of the generator within seven
calendar days after discovery that an eluate exceeded the permissible
concentration listed in subsection (A) at the time of generator elution. The
telephone report to the NRC must include the manufacturer, model number, and
serial number (or lot number) of the generator; the results of the measurement;
the date of the measurement; whether dosages were administered to patients or
human research subjects; when the distributor was notified; and the action
taken.
Notes
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