[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: 10CFR35.63]

[Page 578]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                Subpart C--General Technical Requirements
 
Sec. 35.63  Determination of dosages of unsealed byproduct material 
for medical use.

    (a) A licensee shall determine and record the activity of each 
dosage before medical use.
    (b) For a unit dosage, this determination must be made by--
    (1) Direct measurement of radioactivity; or
    (2) A decay correction, based on the activity or activity 
concentration determined by--
    (i) A manufacturer or preparer licensed under Sec. 32.72 of this 
chapter or equivalent Agreement State requirements; or
    (ii) An NRC or Agreement State licensee for use in research in 
accordance with a Radioactive Drug Research Committee-approved protocol 
or an Investigational New Drug (IND) protocol accepted by FDA.
    (c) For other than unit dosages, this determination must be made by-
-
    (1) Direct measurement of radioactivity;
    (2) Combination of measurement of radioactivity and mathematical 
calculations; or
    (3) Combination of volumetric measurements and mathematical 
calculations, based on the measurement made by a manufacturer or 
preparer licensed under Sec. 32.72 of this chapter or equivalent 
Agreement State requirements.
    (d) Unless otherwise directed by the authorized user, a licensee may 
not use a dosage if the dosage does not fall within the prescribed 
dosage range or if the dosage differs from the prescribed dosage by more 
than 20 percent.
    (e) A licensee shall retain a record of the dosage determination 
required by this section in accordance with Sec. 35.2063.