Section 3701:1-58-37 - Use of unsealed radioactive material for which a written directive is requiredA licensee may use any unsealed radioactive material identified in paragraph (B)(1)(b)(vi) of rule 3701:1-58-40the Administrative Code prepared for medical use and for which a written directive is required 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) Prepared by, excluding production of PET radionuclides: (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 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; or (C) Obtained from and prepared by an United States nuclear regulatory commission or agreement state licensee for use in research in accordance with 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 an investigational new drug protocol accepted by United States food and drug administration.Ohio Admin. Code 3701:1-58-37
Effective: 8/15/2021
Five Year Review (FYR) Dates: 11/13/2020 and 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008, 10/04/2010