Section 335.4020  Permissible Molybdenum-99 Concentration

a)         A licensee may not administer to humans a radiopharmaceutical that contains more than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 µCi of molybdenum-99 per mCi of technetium-99m).

b)         A licensee that uses molybdenum-99/technetium-99m generators for preparing technetium-99m radiopharmaceuticals shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with subsection (a) of this Section.

c)         A licensee shall maintain a record of the molybdenum-99 concentration tests required by subsection (b) of this Section for 5 years. The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as kBq of molybdenum per MBa of technetium-99m (or µCi of molybdenum per mCi of technetium), the time and date of the measurement and the name of the individual who made the measurement.

d)         A licensee shall report immediately to the Agency each occurrence of molybdenum-99 concentration exceeding the limits specified in subsection (a) of this Section.

(Source:  Amended at 30 Ill. Reg. 9029, effective April 28, 2006)