OAR 333-116-0180: Determination of Dosages of Unsealed Radioactive Material for Medical Use

A licensee must: (1) Assay, within 30 minutes before medical use, the activity of each radiopharmaceutical dosage that contains more than 370 kilobecquerels (10 uCi) of an alpha-, beta-, or photon-emitting radionuclide; (2) For a dosage of an alpha- or beta-emitting radionuclide prepared by the licensee, this determination must be made by direct measurement or by a combination of measurements and calculations. (3) A licensee must not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent, unless authorized in writing by an authorized user. (4) Retain a record of the assays required by this rule in accordance with OAR 333-100-0057. The record must contain the: (a) Generic name, trade name or abbreviation of the radiopharmaceutical, its lot number and expiration dates and the radionuclide; (b) Patient's name and identification number if one has been assigned; (c) Prescribed dosage and activity of the dosage at the time of assay or a notation that the total activity is less than 370 kilobecquerels (10 uCi); (d) Date and time of the assay; (e) Date and time of administration; and (f) Initials of the individual who performed the assay.