10-144-220 Me. Code R. § G-A-13

Current through 2024-51, December 18, 2024

Section 144-220-G-A-13 - License amendments

A licensee shall apply for and must receive a license amendment:

A. Before it receives, prepares, or uses radioactive material for a type of use that is permitted under this part, but is not authorized on the licensee's current license under this part;

B. Before it permits anyone to work as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist under the license, except:

(1) For an authorized user, an individual who meets the requirements in G.59, G.190.A, G.290.A, G.390.A, G.392.A, G.394.A, G.490.A, G.590.A, and G.690.A, G.690.B;

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in G.55.A and G.59;

(3) For an authorized medical physicist, an individual who meets the requirements in G.51.A and G.59;

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist, or ophthalmic physicist:

(a) On an Agency, Nuclear Regulatory Commission, or an Agreement State license or other equivalent permit or license recognized by the Agency that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy;

(b) On a permit issued by an Agency, Nuclear Regulatory Commission, or an 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 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 it changes Radiation Safety Officers, except as provided in G.24.C;

D. 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;

E. 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 G.100 or G.200;

F. Before it changes the address(es) of use identified in the application or on the license; and

G. Before it changes statements, representations, and procedures which are incorporated into the license; and

H. Before it releases licensed facilities for unrestricted use.

I. Before it revises procedures required by G.610, G.642, G.643, and G.645, as applicable, where such revision reduces radiation safety; and

J. 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;

K. 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.

10-144 C.M.R. ch. 220, § G-A-13