A licensee shall maintain a record of the radionuclide contaminant concentration tests required by Rule 0400-20-07-.41 for 3 years. The record must include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as kilobecquerel of contaminant per megabecquerel of desired radionuclide (microcuries/millicurie), or microgram of contaminant per megabecquerel of desired radionuclide (microgram/millicurie), the time and date of the measurement, and the name of the individual who made the measurement.
Tenn. Comp. R. & Regs. 0400-20-07-.95
Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.