LAC 33:XV.717. Assay of Radiopharmaceutical Dosages

A. A licensee shall determine and record the activity of each dosage before medical use. B. For a unit dosage, this determination shall be made by: 1. direct measurement of radioactivity; or 2. a decay correction, based on the activity or activity concentration determined by: a. a manufacturer or preparer licensed under LAC 33:XV.328.J or equivalent agreement state requirements; or b. a U.S. Nuclear Regulatory Commission or agreement state licensee, for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or c. a PET radioactive drug producer license as specified in LAC 33:XV.324.D, equivalent agreement state requirements or equivalent Nuclear Regulatory Commission requirements. C. For other than unit dosages, this determination shall be made by: 1. direct measurement of radioactivity; 2. a combination of measurement of radioactivity and mathematical calculations; or 3. a combination of volumetric measurements and mathematical calculations, based on the measurement made by: a. a manufacturer or preparer licensed under LAC 33:XV.328.J or equivalent agreement state requirements; or b. a PET radioactive drug producer licensed under LAC 33:XV.324.D, equivalent agreement state requirements or Nuclear Regulatory Commission requirements. D. Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent. E. A licensee shall retain a record of the dosage determination required by this Section for three years. The record shall contain: 1. the radiopharmaceutical; 2. the patient's or human research subject's name or identification number, if one has been assigned; 3. the prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi); 4. the date and time of the dosage determination; and 5. the name of the individual who determined the dosage.