Ohio Administrative Code|Rule 3701:1-58-37 | Use of unsealed radioactive material for which a written directive is required.

                                                

A licensee may use any unsealed radioactive
material identified in paragraph (B)(1)(b)(vi) of rule 3701:1-58-40 the
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.



Last updated August 15, 2021 at 12:10 AM


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