Current through Register Vol. 30, No. 38, September 20, 2024
A. A
licensee shall determine and record the activity of each dosage before medical
use.
B. For a unit dosage, this
determination shall be made by:
1. Direct
measurement of radioactivity; or
2.
Decay correction, based on the activity or activity concentration determined
by:
a. A manufacturer or preparer licensed
under R9-7-311 or equivalent NRC or
Agreement State requirements; or
b.
A Department, a NRC, or an 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 or;
c. A PET radioactive drug producer licensed
under 1 R9-7-311 or equivalent NRC or
Agreement State requirements.
C. For other than unit dosages, this
determination shall 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
R9-7-311, or equivalent NRC or
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 for Department inspection for three years.
F. For direct measurements performed in
accordance with subsection (B)(1), a licensee shall possess and use
instrumentation to measure the activity of the dosage before it is administered
to each patient or human research subject.
G. A licensee shall calibrate the
instrumentation required in subsection (F) in accordance with nationally
recognized standards, the manufacturer's instructions, or the following
procedures.
1. The procedures that may be
followed are:
a. Check each dose calibrator
for constancy with a dedicated check source at the beginning of each day of
use;
b. Test each dose calibrator
for accuracy upon installation and at least annually thereafter by assaying at
least two sealed sources containing different radio-nuclides whose activity the
manufacturer has determined within 5 percent of its stated activity, whose
activity is at least 10 microcuries for radium-226 and 50 microcuries for any
other photon-emitting radio-nuclide, and at least one of which has a principal
photon energy between 100 keV and 500 keV;
c. Test each dose calibrator for linearity
upon installation and at least quarterly thereafter over a range from the
highest dosage that will be administered to a patient or human research subject
to 1.1 megabec-querels (30 microcuries);
d. Test each dose calibrator for geometry
dependence upon installation over the range of volumes and volume
configurations for which it will be used. The licensee shall keep a record of
this test for the duration of the use of the dose calibrator;
e. Perform appropriate checks and tests
required by this Section following adjustment or repair of the dose calibrator;
and
f. Mathematically correct
dosage readings for any geometry or linearity error that exceeds 10 percent if
the dosage is greater than 10 microcuries and shall repair or replace the dose
calibrator if the accuracy or constancy error exceeds 10 percent.
2. A licensee shall maintain the
dose calibrator in accordance with this subsection, even though the dose
calibrator is only used to "verify" a dosage prepared by a supplier authorized
in subsection (B)(2).
3. A licensee
shall maintain on file for Department review nationally recognized standards or
manufacturer's instructions used to maintain a dose calibrator and meet the
requirements of subsection (G).
H. A licensee shall calibrate the survey
instruments before first use, annually, and following a repair that affects the
calibration. A licensee shall:
1. Calibrate
all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation
source;
2. Calibrate two separated
readings on each scale or decade that will be used to show compliance;
and
3. Conspicuously note on the
instrument the date of calibration.
I. A licensee may not use survey instruments
if the difference between the indicated exposure rate and the calculated
exposure rate is more than 20 percent.
J. A licensee shall retain records of
instrument calibration for three years following the calibration.
