[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.13]

[Page 569-570]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35_MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                      Subpart A_General Information
 
Sec. 35.13  License amendments.

    A licensee shall apply for and must receive a license amendment--
    (a) Before it receives, prepares, or uses byproduct material for a 
type of use that is permitted under this part, but that is not 
authorized on the licensee's current license issued under this part;
    (b) Before it permits anyone to work as an authorized user, 
authorized nuclear pharmacist, or authorized medical physicist under the 
license, except--
    (1) For an authorized user, an individual who meets the requirements 
in Sec. Sec. 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 
35.490(a), 35.590(a), 35.690(a), 35.910(a), 35.920(a), 35.930(a), 
35.940(a), 35.950(a), or 35.960(a) and 35.59;
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Sec. Sec. 35.55(a) or 35.980(a) and 35.59;
    (3) For an authorized medical physicist, an individual who meets the 
requirements in Sec. Sec. 35.51(a) or 35.961(a) or (b) and 35.59;
    (4) An individual who is identified as an authorized user, an 
authorized nuclear pharmacist, or authorized medical physicist--
    (i) On a Commission or Agreement State license or other equivalent 
permit or license recognized by NRC that authorizes the use of byproduct 
material in medical use or in the practice of nuclear pharmacy;
    (ii) On a permit issued by a Commission or Agreement State specific 
license of broad scope that is authorized to permit the use of byproduct 
material in medical use or in the practice of nuclear pharmacy;
    (iii) On a permit issued by a Commission master material licensee 
that is authorized to permit the use of byproduct material in medical 
use or in the practice of nuclear pharmacy; or

[[Page 570]]

    (iv) 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 Sec. 35.24(c);
    (d) Before it receives byproduct 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 byproduct 
material is used only in accordance with either Sec. 35.100 or Sec. 
35.200;
    (f) Before it changes the address(es) of use identified in the 
application or on the license; and
    (g) Before it revises procedures required by Sec. Sec. 35.610, 
35.642, 35.643, and 35.645, as applicable, where such revision reduces 
radiation safety.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]