Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
(1) A licensee may not administer to humans a radiopharmaceutical that contains more than:
(a) 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or
(b) 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
(c) 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).
(2) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each elute from a generator to demonstrate compliance with subsection (1) of this section.
(3) 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 strontium-82 and strontium-85 to demonstrate compliance with subsection (1) of this section.
(4) 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 WAC
246-240-587.
(5) The licensee shall report any measurement that exceeds the limits in subsection (1) of this section at the time of generator elution, in accordance with WAC
246-240-660.
[Statutory Authority: RCW
70A.388.040 and
70A.388.110. WSR 22-19-084, § 246-240-160, filed 9/20/22, effective 10/21/22. Statutory Authority: RCW
70.98.050 and
70.98.080. WSR 09-06-003, § 246-240-160, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW
70.98.050. WSR 06-05-019, § 246-240-160, filed 2/6/06, effective 3/9/06.]