Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE NOT REQUIRED
Section 120.548 - Radionuclide Contaminants

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.548

Current through Register 1531, September 27, 2024

(A) A licensee shall not administer to humans a radiopharmaceutical containing:

(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 µCi of Mo-99 per mCi of Tc-99m); or

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 µCi of Sr-82 per mCi of Rb-82 chloride); or

(3) More than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi of Sr-85 per mCi of Rb-82).

(B) A licensee that uses molybdenum-99/ technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with 105 CMR 120.548(A).

(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 105 CMR 120.548(A).

(D) A licensee who must measure radionuclide contaminant concentration shall retain a record of each measurement in accordance with 105 CMR 120.590(N).

(E) The licensee shall report any measurement that exceeds the limits in 105 CMR 120.548(A) at the time of generator elution, in accordance with 105 CMR 120.594(F).

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