Ohio Admin. Code 3701:1-58-37 - Use of unsealed radioactive material for which a written directive is required
A licensee may use any unsealed radioactive material
(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.
Notes
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
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