S.C. Code Regs. § § 61-63.IV.D.RHA 4.38

Current through Register Vol. 48, 12, December 27, 2024

Section 61-63.IV.D.RHA 4.38 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

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.

S.C. Code Regs. § 61-63.IV.D.RHA 4.38

Amended by State Register Volume 45, Issue No. 05, eff. 5/28/2021.