[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.392]

[Page 584-585]
 
                            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. 35.392  Training for the oral administration of sodium iodide 

I-131 requiring a written directive in quantities less than or equal 
to 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 less than or equal to

[[Page 585]]

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 Sec. 35.390(b)(1)(ii)(G)(1) or (2), Sec. 35.394, or, 
before October 24, 2004, Sec. Sec. 35.930, 35.932, 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), 35.392, 
35.394, or, before October 24, 2004, Sec. Sec. 35.930, 35.932, 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)(1) or (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 less 
than or equal to 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), 35.392, 35.394, or, before October 24, 2004, 
Sec. Sec. 35.930, 35.932, or 35.934, or equivalent Agreement State 
requirements. A preceptor authorized user, who meets the requirement in 
Sec. 35.390(b), must also have experience in administering dosages as 
specified in Sec. 35.390(b)(1)(ii)(G)(1) or (2).

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