Rule 3701:1-58-25. Determination of dosages of unsealed radioactive material for medical use

119.03 (A) A licensee shall determine and record the activity of each dosage before medical use. (B) For a unit dosage, this determination must 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 rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission, or agreement state requirements; (b) An United States 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 protocol accepted by United States food and drug administration; or (c) A PET radioactive drug producer licensed under paragraph (I) of rule 3701:1-40-14 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements. (C) For other than unit dosages, this determination must be made by: (1) Direct measurement of radioactivity; (2) Combination of measurement of radioactivity and mathematical calculations; or (3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by: (a) A manufacturer or preparer licensed under rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or (b) A PET radioactive drug producer licensed under paragraph (I) of rule 3701:1-40-14 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state 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 twenty per cent. (E) A licensee shall retain a record of the dosage determination required by this rule in accordance with rule 3701:1-58-79 of the Administrative Code. Last updated November 18, 2022 at 8:32 AM Supplemental Information Authorized By: 3748.02 , 3748.04 Amplifies: 3748.04 4/7/2027 8/15/2005