3701:1-58-34. Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required

Except for quantities that require a written directive under paragraph (B) of rule 3701:1-58-15 of the Administrative Code, a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

(A) Obtained from:

(1) 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

(2) A PET radioactive drug producer licensed in accordance with paragraph (I) of rule 3701:1-40-14 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirement; or

(B) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in rule 3701:1-58-36 or 3701:1-58-40 and paragraph (C)(1)(b)(vii) of rule 3701:1-58-36 of the Administrative Code; or

(3) An individual under the supervision, as specified in rule 3701:1-58-14 of the Administrative Code, of the authorized nuclear pharmacist in paragraph (B)(1) of this rule or the physician who is an authorized user in paragraph (B)(2) of this rule;

(C) Obtained from and prepared by 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

(D) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug protocol accepted by United States food and drug administration.

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: 8/15/05, 12/22/08, 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, 12/22/08 )