Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 7 - MEDICAL USE OF RADIOACTIVE MATERIAL
Section 180-7-045 - RADIONUCLIDE CONTAMINANTS

Universal Citation: 180 NE Admin Rules and Regs ch 7 ยง 045

Current through September 17, 2024

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.

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