12VAC5-481-1930: Permissible molybdenum-99, strontium-82, and strontium-85 concentrations

A. Licensees may not administer to humans a radiopharmaceutical that contains:

1. More than 0.15 µCi of molybdenum-99 per mCi of technetium-99m (0.15 kBq of molybdenum-99 per MBq of technetium-99m); or

2. More than 0.02 µCi of strontium-82 per mCi of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection) or more than 0.2 µCi of strontium-85 per mCi of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection).

B. A licensee that uses molybdenum-99/technetium-99m for preparing a technetium-99m radiopharmaceautical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with subsection A of this section.

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 of this section.

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 12VAC5-481-2070 K.

E. The licensee shall report any measurement that exceeds the limits in subsection A of this section at the time of generator elution in accordance with 12VAC5-481-2080 D.