12 Va. Admin. Code § 5-481-1930
Current through Register Vol. 41, No. 6, November 4, 2024
Section 12VAC5-481-1930 - Permissible molybdenum-99, strontium-82, and strontium-85 concentrationsA. Licensees may not administer to humans a radiopharmaceutical that contains: 1. More than 0.15 µCi of molybdenum-99 per mCi of technetium-99m (0.15 kBq of molybdenum-99 per MBq of technetium-99m); or2. More than 0.02 µCi of strontium-82 per mCi of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection) or more than 0.2 µCi of strontium-85 per mCi of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection).B. A licensee that uses molybdenum-99/technetium-99m for preparing a technetium-99m radiopharmaceautical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with subsection A of this section.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 subsection A of this section.D. If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with 12VAC5-481-2070 K.E. The licensee shall report any measurement that exceeds the limits in subsection A of this section at the time of generator elution in accordance with 12VAC5-481-2080 D.12 Va. Admin. Code § 5-481-1930
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; volume 32, Issue 24, eff. August 25, 2016; Amended, Virginia Register Volume 37, Issue 25, eff. 1/14/2022; Errata, 39:5 VA.R. 943 October 24, 2022.Statutory Authority: § 32.1-229 of the Code of Virginia.