Current through November, 2024
Section 11-45-142 - Assay of radiopharmaceutical dosages(a) An assay shall be conducted, before medical use, of the activity of each radiopharmaceutical dosage that contains more than ten microcuries (three hundred seventy kilobecquerels) of a photon-emitting radionuclide;(b) Radiopharmaceuticals emitting alpha and/or beta radiations as the radiation of principal interest shall be obtained: (1) In unit dose form, calibrated by the supplier for individual patients; and(2) From a supplier which participates in a measurement quality assurance program with the National Institute of Standards and Technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard.(c) The licensee shall retain a record of the assays or calibrations required by subsections (a) and (b). To satisfy this requirement, the record shall contain the: (1) Radiopharmaceutical, or the radionuclide administered;(2) Patient's name, and identification number if one has been assigned;(3) Prescribed dosage and measured activity of the dosage at the time of assay, or a notation that the total activity was determined by a calibration traceable to a national standard;(4) Date and time of the assay or calibration and the date and time of the administration; and(5) Initials of the individual who performed the assay or documentation of the supplier's participation in the measurement quality assurance program.[Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)