South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS
Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED
Section 61-63.IV.D.RHA 4.38 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

Current through Register Vol. 48, No. 9, September 27, 2024

4.38.1 A licensee may not administer to humans a radiopharmaceutical that contains:

4.38.1.1 More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or

4.38.1.2 More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

4.38.2 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 RHA 4.38.1.

4.38.3 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 RHA 4.38.1.

4.38.4 If a licensee is required to measure the molybdenum-99 concentration, the licensee shall retain a record of each measurement in accordance with RHA 4.101.

4.38.5 The licensee shall report any measurement that exceeds the limits in RHA 4.38.1 of this section at the time of generator elution, in accordance with RHA 4.120.

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