[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: 10CFR35.41]

[Page 573]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35_MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
              Subpart B_General Administrative Requirements
 
Sec. 35.41  Procedures for administrations requiring a written directive.

    (a) For any administration requiring a written directive, the 
licensee shall develop, implement, and maintain written procedures to 
provide high confidence that:
    (1) The patient's or human research subject's identity is verified 
before each administration; and
    (2) Each administration is in accordance with the written directive.
    (b) At a minimum, the procedures required by paragraph (a) of this 
section must address the following items that are applicable to the 
licensee's use of byproduct material--
    (1) Verifying the identity of the patient or human research subject;
    (2) Verifying that the administration is in accordance with the 
treatment plan, if applicable, and the written directive;
    (3) Checking both manual and computer-generated dose calculations; 
and
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical units 
authorized by Sec. 35.600.
    (c) A licensee shall retain a copy of the procedures required under 
paragraph (a) in accordance with Sec. 35.2041.