La. Admin. Code tit. 33, § XV-735 - Use of Radiopharmaceuticals for Therapy

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

A. A licensee may use the following prepared radiopharmaceuticals:
1. iodine-131 as iodide for treatment of hyperthyroidism, cardiac dysfunction, and thyroid carcinoma;
2. phosphorus-32 as soluble phosphate for treatment of polycythemia vera, leukemia, and bone metastases;
3. phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of malignant effusions;
4. any radioactive material in a radiopharmaceutical and for a therapeutic use for which the Food and Drug Administration has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND), or approved a "New Drug Application" (NDA). The licensee shall comply with the package insert instructions regarding indications and method of administration.
B. The radiopharmaceuticals specified in Subsection A of this Section shall be either:
1. obtained from a manufacturer, preparer, or a PET radioactive drug producer, licensed in accordance with LAC 33:XV.328.J or equivalent Nuclear Regulatory Commission or agreement state requirements; or
2. prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in LAC 33:XV.763.C, or an individual under the supervision of either as specified in LAC 33:XV.709.
C. A licensee may use any unsealed byproduct material identified in 763.E.1.b.i.(b).(vii) prepared for medical use and for which a written directive is required that is:
1. obtained from:
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 in accordance with LAC 33:XV.324.D.1 or equivalent NRC or agreement state requirements; or
2. excluding production of PET radionuclides, prepared by:
a. an authorized nuclear pharmacist;
b. a physician who is an authorized user and who meets the requirements specified in LAC 33:XV.763.D or E.1; or
c. an individual under the supervision, as specified in LAC 33:XV.709, of the authorized nuclear pharmacist in Subparagraph C.2.a of this Section or the physician who is an authorized user in Subparagraph C.2.b of this Section; or
3. obtained from and prepared by a NRC or agreement state licensee, for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or
4. ...

Notes

La. Admin. Code tit. 33, § XV-735
Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 24:2104 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 30:1178 (June 2004), amended by the Office of the Secretary, Legal Division, LR 40:292 (February 2014), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471857 (12/1/2021).
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.

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