Tenn. Comp. R. & Regs. 0400-20-07-.41 - RADIONUCLIDE CONTAMINANTS

(1) A licensee shall not administer to humans a radiopharmaceutical that contains:

(a) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 µCi of Mo-99 per mCi of Tc-99m); or

(b) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 µCi of Sr-82 per mCi of Rb-82 chloride), or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi of Sr-85 per mCi of Rb-82).

(2) To demonstrate compliance with paragraph (1) of this rule, a licensee preparing radioactive drugs from radionuclide generators shall:

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

(b) Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.

(3) A licensee who must measure radionuclide contaminant concentration shall retain a record of each measurement in accordance with Rule 0400-20-07-.95.

(4) A licensee shall report immediately to the Division each occurrence of radionuclide contaminant concentration exceeding the limits specified in paragraph (1) of this rule.

Notes

Tenn. Comp. R. & Regs. 0400-20-07-.41

Original rule filed February 22, 2012; effective May 22, 2012.

Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.