[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: 10CFR35.190]

[Page 579]
 
                            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. 35.190  Training for uptake, dilution, and excretion 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. 35.100 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. Sec. 35.290, 35.390, or, 
before October 24, 2005, Sec. Sec. 35.910, 35.920, or 35.930, or 
equivalent Agreement State requirements; or
    (c)(1) Has completed 60 hours of training and experience in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for uptake, dilution, and excretion studies. 
The training and experience must include--
    (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; and
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec. 35.190, 35.290, 35.390, or, 
before October 24, 2005, Sec. Sec. 35.910, 35.920, or 35.930, 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 contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (F) Administering dosages of radioactive drugs to patients or human 
research subjects; and
    (2) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec. 35.190, 35.290, 
35.390, or, before October 24, 2005, Sec. Sec. 35.910, 35.920, or 
35.930, 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. 35.100.

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