Rule 3701:1-58-08 | License amendments.
A licensee shall apply for and must receive a license amendment and pay the invoiced amendment fee specified in rule 3701:1-38-02 of the Administrative Code:
(A) Before it receives, prepares, or uses radioactive material for a type of use that is permitted under this chapter, but that is not authorized on the licensee's current license issued under this chapter, and Chapter 3701:1-40 of the Administrative Code;
(B) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist under the license, except:
(1) For an authorized user, an individual who meets the requirements in rule 3701:1-58-22, and paragraph (A) of rule 3701:1-58-33, paragraph (A) of rule 3701:1-58-36, paragraph (A) of rule 3701:1-58-40, paragraph (A) of rule 3701:1-58-41, paragraph (A) of rule 3701:1-58-42, paragraph (A) of rule 3701:1-58-51, paragraph (A) of rule 3701:1-58-54, and paragraph (A) of rule 3701:1-58-71 of the Administrative Code.
(2) For an authorized nuclear pharmacist, an individual who meets the requirements in paragraph (A) of rule 3701:1-58-20 and rule 3701:1-58-22 of the Administrative Code.
(3) For an authorized medical physicist, an individual who meets the requirements in paragraph (A) of rule 3701:1-58-19 and rule 3701:1-58-22 of the Administrative Code.
(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist:
(a) On a United States nuclear regulatory commission or agreement state license or other equivalent permit or license recognized by the director that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy;
(b) On a permit issued by a United States nuclear regulatory commission or agreement state specific license of broad scope that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy;
(c) On a permit issued by a United States nuclear regulatory commission master material licensee that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy; or
(d) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists;
(C) Before a radiation safety officer is changed, except as provided in rule 3701:1-58-12 of the Administrative Code;
(D) Before it permits anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license;
(E) Before it receives radioactive material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;
(F) Before it adds to or changes the areas of use identified in the application or on the license, except for areas of use where radioactive material is used only in accordance with either rule 3701:1-58-32 or 3701:1-58-34 of the Administrative Code;
(G) Before it changes the address(es) of use identified in the application or on the license;
(H) Before it revises procedures required by rules 3701:1-58-58 and 3701:1-58-64 to 3701:1-58-66 of the Administrative Code, as applicable, where such revision reduces radiation safety; and
(I) Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the sealed source and device registry, and is in a quantity and for an isotope authorized by the license.
Last updated November 18, 2022 at 8:28 AM
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