Section R12-1-720. Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

A.      A licensee may not administer to humans a radiopharmaceuti-

cal that contains more than 0.15 kilobecquerel of molybde- num-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium- 99m) or, more than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 micro- curie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabec- querel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

B.       A licensee that uses molybdenum-99/technetium-99m genera- tors for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with subsection (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 radio- nuclides strontium-82 and strontium-85 to demonstrate com- pliance with subsection (A).

D.      A licensee shall maintain a record of each molybdenum-99 concentration measurement or strontium-82 and strontium-85 concentrations measurements for three years following com- pletion of the measurement.

Historical Note

New Section made by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Section repealed; new Section made by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1). Amended by

final rulemaking at 20 A.A.R. 324, effective March 8,

2014 (Supp. 14-1).