Current through Register Vol. 50, No. 9, 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. a decay
correction, based on the activity or activity concentration determined by:
a. a manufacturer or preparer licensed under
LAC 33:XV.328.J or equivalent agreement state requirements; or
b. a U.S. Nuclear Regulatory Commission or
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 license as specified in LAC 33:XV.324.D,
equivalent agreement state requirements or equivalent Nuclear Regulatory
Commission requirements.
C. For other than unit dosages, this
determination shall be made by:
1. direct
measurement of radioactivity;
2. a
combination of measurement of radioactivity and mathematical calculations;
or
3. a combination of volumetric
measurements and mathematical calculations, based on the measurement made by:
a. a manufacturer or preparer licensed under
LAC 33:XV.328.J or equivalent agreement state requirements; or
b. a PET radioactive drug producer licensed
under LAC 33:XV.324.D, equivalent agreement state requirements or Nuclear
Regulatory Commission 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 three years. The record shall contain:
1. the radiopharmaceutical;
2. the patient's or human research subject's
name or identification number, if one has been assigned;
3. the prescribed dosage, the determined
dosage, or a notation that the total activity is less than 1.1 MBq (30
[MICRO]Ci);
4. the date and time of
the dosage determination; and
5.
the name of the individual who determined the dosage.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et seq. and
2104.B.(1).
