[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: 10CFR35.40]

[Page 574-575]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
             Subpart B--General Administrative Requirements
 
Sec. 35.40  Written directives.

    (a) A written directive must be dated and signed by an authorized 
user before the administration of I-131 sodium iodide greater than 1.11 
megabecquerels (MBq) (30 microcuries ([mu]Ci)), any therapeutic dosage 
of unsealed byproduct material or any therapeutic dose of radiation from 
byproduct material.
    (1) If, because of the emergent nature of the patient's condition, a 
delay in order to provide a written directive would jeopardize the 
patient's health, an oral directive is acceptable. The information 
contained in the oral directive must be documented as soon as possible 
in writing in the patient's record. A written directive must be prepared 
within 48 hours of the oral directive.
    (b) The written directive must contain the patient or human research 
subject's name and the following information--
    (1) For any administration of quantities greater than 1.11 MBq (30 
[mu]Ci) of sodium iodide I-131: the dosage;
    (2) For an administration of a therapeutic dosage of unsealed 
byproduct material other than sodium iodide I-131: the radioactive drug, 
dosage, and route of administration;
    (3) For gamma stereotactic radiosurgery: the total dose, treatment 
site, and values for the target coordinate settings per treatment for 
each anatomically distinct treatment site;
    (4) For teletherapy: the total dose, dose per fraction, number of 
fractions, and treatment site;
    (5) For high dose-rate remote afterloading brachytherapy: the 
radionuclide, treatment site, dose per fraction, number of fractions, 
and total dose; or
    (6) For all other brachytherapy, including low, medium, and pulsed 
dose rate remote afterloaders:
    (i) Before implantation: treatment site, the radionuclide, and dose; 
and

[[Page 575]]

    (ii) After implantation but before completion of the procedure: the 
radionuclide, treatment site, number of sources, and total source 
strength and exposure time (or the total dose).
    (c) A written revision to an existing written directive may be made 
if the revision is dated and signed by an authorized user before the 
administration of the dosage of unsealed byproduct material, the 
brachytherapy dose, the gamma stereotactic radiosurgery dose, the 
teletherapy dose, or the next fractional dose.
    (1) If, because of the patient's condition, a delay in order to 
provide a written revision to an existing written directive would 
jeopardize the patient's health, an oral revision to an existing written 
directive is acceptable. The oral revision must be documented as soon as 
possible in the patient's record. A revised written directive must be 
signed by the authorized user within 48 hours of the oral revision.
    (d) The licensee shall retain a copy of the written directive in 
accordance with Sec. 35.2040.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 68 FR 75389, 
Dec. 31, 2003]