[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: 10CFR35.394]

[Page 583-584]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35_MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
    Subpart E_Unsealed Byproduct Material_Written Directive Required
 
Sec. 35.394  Training for the oral administration of sodium iodide 

I-131 requiring a written directive in quantities greater than 1.22 
gigabecquerels (33 millicuries).

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries), 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. 35.390(a), 35.390(b) for 
uses listed in

[[Page 584]]

Sec. 35.390(b)(1)(ii)(G)(2), or, before October 24, 2005, Sec. Sec. 
35.930 or 35.934, or equivalent Agreement State requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide I-
131 for procedures requiring a written directive. The training must 
include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec. 35.390(a), 35.390(b), 35.394, 
or, before October 24, 2005, Sec. Sec. 35.930 or 35.934, or equivalent 
Agreement State requirements. A supervising authorized user, who meets 
the requirements in Sec. 35.390(b), must also have experience in 
administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(2). The 
work experience must involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation for survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that includes at least 3 cases involving the oral administration of 
greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-
131; and
    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section and has achieved a level of competency sufficient 
to function independently as an authorized user for medical uses 
authorized under Sec. 35.300. The written certification must be signed 
by a preceptor authorized user who meets the requirements in Sec. Sec. 
35.390(a), 35.390(b), 35.394, or, before October 24, 2005, Sec. Sec. 
35.930 or 35.934, or equivalent Agreement State requirements. A 
preceptor authorized user, who meets the requirements in Sec. 
35.390(b), must also have experience in administering dosages as 
specified in Sec. 35.390(b)(1)(ii)(G)(2).

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003; 
68 FR 75389, Dec. 31, 2003; 69 FR 55739, Sept. 16, 2004]