La. Admin. Code tit. 33, § XV-717 - Assay of Radiopharmaceutical Dosages

Current through Register Vol. 48, No. 3, March 20, 2022

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.

Notes

La. Admin. Code tit. 33, § XV-717
Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 24:2103 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 30:1176 (June 2004), amended by the Office of the Secretary, Legal Division, LR 40:290 (February 2014).
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.(1).

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