[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: 10CFR35.53]

[Page 564]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                Subpart C--General Technical Requirements
 
Sec. 35.53  Measurement of dosages of unsealed byproduct material for medical use.

    A licensee shall:
    (a) Measure the activity of each dosage of a photon-emitting 
radionuclide prior to medical use.
    (b) Measure, by direct measurement or by combination of measurements 
and calculations, the activity of each dosage of an alpha- or a beta-
emitting radionuclide prior to medical use, except for unit dosages 
obtained from a manufacturer or preparer licensed pursuant to 10 CFR 
32.72 or equivalent Agreement State requirements;
    (c) Retain a record of the measurements required by this section for 
three years. To satisfy this requirement, the record must contain the:
    (1) Generic name, trade name, or abbreviation of the 
radiopharmaceutical, its lot number, and expiration dates and the 
radionuclide;
    (2) Patient's or human research subject's name, and identification 
number if one has been assigned;
    (3) Prescribed dosage and activity of the dosage at the time of 
measurement, or a notation that the total activity is less than 1.1 
megabecquerels (30 microcuries);
    (4) Date and time of the measurement; and
    (5) Initials of the individual who made the record.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 
FR 61784, Dec. 2, 1994]

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