180 NAC 7-045. RADIONUCLIDE CONTAMINANTS

045. RADIONUCLIDE CONTAMINANTS. 045.01 LIMITS. A licensee must not administer to humans a radioactive drug containing: (A) More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 μCi of molybdenum-99 per mCi of technetium-99m);(B) More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 μCi of strontium-82 per mCi of rubidium-82 chloride injection); or(C) More than 0.02 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.02 μCi of strontium-85 per mCi of rubidium-82 chloride injection). 045.02 CONCENTRATION MEASUREMENT IN RADIOACTIVE DRUG PREPARATION. To demonstrate compliance with 180 NAC 7-045, the licensee preparing radioactive drugs from radionuclide generators must: (A) Measure the concentration of radionuclide contaminant in each eluate after receipt of a molybdenum-99/technetium-99m generator; or(B) Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems. 045.03 STRONTIUM-82/RUBIDIUM-82 GENERATORS. A licensee that uses strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical must, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with 180 NAC 7-045.01. 045.04 RECORDS. A licensee who must measure radionuclide concentration must retain a record of each measurement according to 180 NAC 7-099. 045.05 REPORTING REQUIREMENT. A licensee must report according to 180 NAC 7-120 each occurrence of a concentration exceeding the limits specified in 180 NAC 7-045.01.