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 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 in each
eluate from 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 at
least three years following completion of the measurement.
E. A licensee shall notify by telephone the
Department 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
Department 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.
F. A licensee shall submit a written report,
according to
R9-7-1907(1) through
(3), to the Department within 30 calendar
days after discovery of an eluate exceeding the permissible concentration at
the time of generator elution. The written report must include the action taken
by the licensee; the patient dose assessment; the methodology used to make this
dose assessment if the eluate was administered to patients or human research
subjects; and the probable cause and an assessment of failure in the licensee's
equipment, procedures, or training that contributed to the excessive readings
if an error occurred in the licensee's breakthrough determination; and the
information in the telephone report required by subsection (E).
Notes
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