Section 1930. Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

A. 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); or

2. 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. To demonstrate compliance with subsection A of this section, the licensee preparing the radioactive drug from the radionuclide generator shall:

1. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m generator;

2. Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems, not to exceed before the first patient use of the day for a strontium/rubidium-82 generator.

Historical Notes

Derived from 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.

Statutory Authority

§ 32.1-229 of the Code of Virginia.