[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: 10CFR35.290]

[Page 580]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35_MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
  Subpart D_Unsealed Byproduct Material_Written Directive Not Required
 
Sec. 35.290  Training for imaging and localization studies.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec. 35.200 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (c) of this 
section and whose certification has been recognized by the Commission or 
an Agreement State; or
    (b) Is an authorized user under Sec. 35.390, or, before October 24, 
2005, Sec. 35.920, or equivalent Agreement State requirements; or
    (c)(1) Has completed 700 hours of training and experience in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for imaging and localization studies. The 
training and experience must include, at a minimum,--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use;
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user, 
who meets the requirements in Sec. Sec. 35.290, 35.390, or, before 
October 24, 2005, Sec. 35.920, or equivalent Agreement State 
requirements, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to safely contain spilled radioactive material 
and using proper decontamination procedures;
    (F) Administering dosages of radioactive drugs to patients or human 
research subjects; and
    (G) Eluting generator systems appropriate for preparation of 
radioactive drugs for imaging and localization studies, measuring and 
testing the eluate for radionuclidic purity, and processing the eluate 
with reagent kits to prepare labeled radioactive drugs; and
    (2) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec. 35.290, 35.390, 
or, before October 24, 2005, Sec. 35.920, or equivalent Agreement State 
requirements, that the individual has satisfactorily completed the 
requirements in paragraph (c)(1) of this section and has achieved a 
level of competency sufficient to function independently as an 
authorized user for the medical uses authorized under Sec. Sec. 35.100 
and 35.200.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 
69 FR 55738, Sept. 16, 2004]

[[Page 581]]