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

(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.

Five Year Review (FYR) Dates: 06/12/2015 and 06/01/2020
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005, 10/4/10

Prior History: (Effective: 10/04/2010
R.C. 119.032 review dates: 06/28/2010 and 07/12/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005 )