[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: 10CFR35.390]

[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. 35.390  Training for use of unsealed byproduct material for which 
a written directive is required.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec. 35.300 to be a physician who--

[[Page 584]]

    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been recognized by the Commission or 
an Agreement State; or
    (b)(1) Has completed 700 hours of training and experience in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material requiring a written directive. 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. 35.390(a), 35.390(b), or, 
before October 24, 2004, Sec. 35.930, or equivalent Agreement State 
requirements. A supervising authorized user, who meets the requirements 
in Sec. 35.390(b) or, before October 24, 2004, Sec. 35.930(b), must 
also have experience in administering dosages in the same dosage 
category or categories (i.e., Sec. 35.390(b)(1)(ii)(G)(1), (2), (3), or 
(4)) as the individual requesting authorized user status. The work 
experience must involve--
    (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;
    (F) Eluting generator systems, measuring and testing the eluate for 
radionuclidic purity, and processing the eluate with reagent kits to 
prepare labeled radioactive drugs; and
    (G) Administering dosages of radioactive drugs to patients or human 
research subjects involving a minimum of three cases in each of the 
following categories for which the individual is requesting authorized 
user status--
    (1) Oral administration of less than or equal to 1.22 gigabecquerels 
(33 millicuries) of sodium iodide I-131;
    (2) Oral administration of greater than 1.22 gigabecquerels (33 
millicuries) of sodium iodide I-131 \2\;
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    \2\ Experience with at least 3 cases in Category (G)(2) also 
satisfies the requirement in Category (G)(1).
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    (3) Parenteral administration of any beta emitter or a photon-
emitting radionuclide with a photon energy less than 150 keV; and/or
    (4) Parenteral administration of any other radionuclide; and
    (2) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (b)(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. 35.300. The written certification must be signed by a 
preceptor authorized user who meets the requirements in Sec. Sec. 
35.390(a), 35.390(b), or, before October 24, 2004, Sec. 35.930, or 
equivalent Agreement State requirements. The preceptor authorized user, 
who meets the requirements in Sec. 35.390(b) or, before October 24, 
2004, Sec. 35.930(b), must also have experience in administering 
dosages in the same dosage category or categories (i.e., Sec. 
35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the individual requesting 
authorized user status.

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