Section 180-7-045 - RADIONUCLIDE CONTAMINANTS045.01LIMITS. 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).045.02CONCENTRATION 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.045.03STRONTIUM-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 7-045.01.045.04RECORDS. A licensee who must measure radionuclide concentration must retain a record of each measurement according to 180 NAC 7-099.045.05REPORTING REQUIREMENT. A licensee must report according to 180 NAC 7-120 each occurrence of a concentration exceeding the limits specified in 180 NAC 7-045.01.180 Neb. Admin. Code, ch. 7, § 045
Amended effective 11/3/2020Amended effective 6/14/2023