[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.204]

[Page 569]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                   Subpart E--Imaging and Localization
 
Sec. 35.204  Permissible molybdenum-99 concentration.

    (a) A licensee may not administer to humans a radiopharmaceutical 
containing more than 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 in each eluate or extract.
    (c) A licensee that must measure molybdenum concentration shall 
retain a record of each measurement for three years. The record must 
include, for each elution or extraction of technetium-99m, the measured 
activity of the technetium expressed in millicuries, the measured 
activity of the molybdenum expressed in microcuries, the ratio of the 
measures expressed as microcuries of molybdenum per millicurie of 
technetium, the time and date of the measurement, and the initials of 
the individual who made the measurement.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]