[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: 10CFR35.204]

[Page 582]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
 Subpart D--Unsealed Byproduct Material--Written Directive Not Required
 
Sec. 35.204  Permissible molybdenum-99 concentration.

    (a) A licensee may not administer to humans a radiopharmaceutical 
that contains more than 0.15 kilobecquerel of molybdenum-99 per 
megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per 
millicurie of technetium-99m).
    (b) A licensee that uses molybdenum-99/technetium-99m generators for 
preparing a technetium-99m radiopharmaceutical shall measure the 
molybdenum-99 concentration of the first eluate after receipt of a 
generator to demonstrate compliance with paragraph (a) of this section.
    (c) If a licensee is required to measure the molybdenum-99 
concentration, the licensee shall retain a record of each measurement in 
accordance with Sec. 35.2204.