La. Admin. Code tit. 33 § XV-717

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-717 - Assay of Radiopharmaceutical Dosages

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.

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).