Current through Register Vol. 48, No. 12, March 22, 2024
a) A licensee shall
not administer to humans a radiopharmaceutical that contains more than:
1)0.15 kBq of molybdenum-99 per MBq of
technetium-99m (0.15µCi of molybdenum-99 per mCi of
technetium-99m);
2)0.02 kBq of
strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of
strontium-82 per mCi of rubidium-82); or
3)0.2 kBq of strontium-85 per MBq of
rubidium-82 chloride injection (0.2 µCi of strontium-85 per mCi of
rubidium-82.
b) To
demonstrate compliance with subsection (a), a licensee shall measure:
1) The concentration of molybdenum-99 in each
eluate from a molybdenum-99/technetium-99m generator; and
2) The concentration of strontium-82 and
strontium-85 before the first patient use of the day on each day that a
strontium-82/rubidium-82 generator is used.
c) A licensee shall maintain a record of the
concentration tests required by subsection (b) for 5 years. The record shall
include for each measurement, the time and date of the measurement, the name of
the individual who made the measurement and, for the corresponding measurement
in subsection (b):
1) The ratio of the measure
expressed as kBq of molybdenum per MBq of technetium-99m (or µCi of
molybdenum per mCi of technetium); or
2) The ratios of the measures expressed as
kBq of strontium-82 per MBq of rubidium-82 and kBq of strontium-85 per MBq of
rubidium-82 (or µCi of strontium per mCi of rubidium).
d) A licensee shall notify the
Agency and the distributor of the generator for each occurrence of a
concentration exceeding the limits specified in subsection (a) as follows:
1) Notification by telephone within 7 days
after the discovery that an eluate exceeded the permissible concentration. The
notification shall 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.
2) By an appropriate method
listed in 32 Ill. Adm. Code
310.110, the
licensee shall submit a written report to the Agency within 30 days after
discovery that an eluate exceeded the permissible concentration at the time of
generator elution. The written report shall 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 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 as required by subsection (d)(1).