[Code of Federal Regulations] [Title 10, Volume 1] [Revised as of January 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 10CFR35.13] [Page 556-557] 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 or uses byproduct material for a clinical procedure permitted under this part but not permitted by the license issued pursuant to this part; (b) Before it permits anyone to work as an authorized user or authorized nuclear pharmacist under the license, except an individual who is: (1) An authorized user certified by the organizations specified in paragraph (a) of Sec. 35.910, Sec. 35.920, Sec. 35.930, Sec. 35.940, Sec. 35.950, or Sec. 35.960; (2) An authorized nuclear pharmacist certified by the organization specified in paragraph (a) of Sec. 35.980; (3) Identified as an authorized user or an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively; or (4) Identified as an authorized user or an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively. (c) Before it changes Radiation Safety Officers or Teletherapy Physicists; (d) Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license; and (e) Before it adds to or changes the areas of use or address or addresses of [[Page 557]] use identified in the application or on the license. [51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782, Dec. 2, 1994]