Ohio Admin. Code 3701:1-58-32 - Use of unsealed radioactive material for uptake, dilution, and excretion 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 uptake, dilution, or excretion studies that is:
(A) Obtained from:
a manufacturer or
preparer licensed under rule 3701:1-46-43ofthe
Administrative Code or equivalent United States
nuclear regulatory commission or agreement state requirements;
(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,
prepared by:
(1) An authorized nuclear
pharmacist; or
(2) A physician who
is an authorized user and who meets the requirements specified in rule
3701:1-58-36,
or rule
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; or
(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
(IND) 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 (IND)
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
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005, 12/22/08, 10/4/10
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