[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: 10CFR35.315]

[Page 570]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
               Subpart F--Radiopharmaceuticals for Therapy
 
Sec. 35.315  Safety precautions.

    (a) For each patient or human research subject receiving 
radiopharmaceutical therapy and hospitalized for compliance with 
Sec. 35.75 of this chapter, a licensee shall:
    (1) Provide a private room with a private sanitary facility;
    (2) Post the patient's or the human research subject's door with a 
``Radioactive Materials'' sign and note on the door or in the patient's 
or human research subject's chart where and how long visitors may stay 
in the patient's or the human research subject's room;
    (3) Authorize visits by individuals under age 18 only on a case-by-
case basis with the approval of the authorized user after consultation 
with the Radiation Safety Officer;
    (4) Promptly after administration of the dosage, measure the dose 
rates in contiguous restricted and unrestricted areas with a radiation 
measurement survey instrument to demonstrate compliance with the 
requirements of part 20 of this chapter, and retain for three years a 
record of each survey that includes the time and date of the survey, a 
plan of the area or list of points surveyed, the measured dose rate at 
several points expressed in millirem per hour, the instrument used to 
make the survey, and the initials of the individual who made the survey.
    (5) Either monitor material and items removed from the patient's or 
the human research subject's room to determine that their radioactivity 
cannot be distinguished from the natural background radiation level with 
a radiation detection survey instrument set on its most sensitive scale 
and with no interposed shielding, or handle them as radioactive waste.
    (6) [Reserved]
    (7) Survey the patient's or the human research subject's room and 
private sanitary facility for removable contamination with a radiation 
detection survey instrument before assigning another patient or human 
research subject to the room. The room must not be reassigned until 
removable contamination is less than 200 disintegrations per minute per 
100 square centimeters; and
    (8) Measure the thyroid burden of each individual who helped prepare 
or administer a dosage of iodine-131 within three days after 
administering the dosage, and retain for the period required by 
Sec. 20.1206(a) of this chapter a record of each thyroid burden 
measurement, its date, the name of the individual whose thyroid burden 
was measured, and the initials of the individual who made the 
measurements.
    (b) A licensee shall notify the Radiation Safety Officer immediately 
if the patient or the human research subject dies or has a medical 
emergency.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 
FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 59 FR 61784, Dec. 2, 
1994; 62 FR 4133, Jan. 29, 1997]