Ohio Admin. Code 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, or NARM licensing state for NARM requirements; or

(b) An United States nuclear regulatory commission, or agreement state, or NARM licensing state for NARM 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 manufacturer or preparer licensed under rule 3701:1-46-43oftheAdministrativeCode or equivalent United States nuclear regulatory commission, agreement state, or NARM licensing state for NARM requirements.

(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 , or NARM licensing state for NARM 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 percent 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.

Notes

Ohio Admin. Code 3701:1-58-25

Five Year Review (FYR) Dates: 4/7/2022 and 04/07/2027
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 10/04/2010

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