La. Admin. Code tit. 33 § XV-729

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

Section XV-729 - Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies

A. A licensee may use the following prepared radiopharmaceuticals for diagnostic studies involving the measurement of uptake, dilution, or excretion:

1. iodine-131 as sodium iodide, iodinated human serum albumin (IHSA), labeled rose bengal, or sodium iodohippurate;

2. iodine-125 as sodium iodide or iodinated human serum albumin (IHSA);

3. cobalt-57 as labeled cyanocobalamin;

4. cobalt-58 as labeled cyanocobalamin;

5. chromium-51 as sodium chromate or labeled human serum albumin;

6. iron-59 as citrate; and

7. any radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion for which the Food and Drug Administration (FDA) has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA).

B. A licensee using a radiopharmaceutical specified in Subsection A of this Section for a clinical procedure other than one specified in the product label or package insert instructions shall comply with the product label or package insert instructions regarding physical form, route of administration, and dosage range.

C. The radiopharmaceuticals specified in Subsection A of this Section shall be:

1. obtained from a manufacturer or preparer, or a PET radioactive drug producer, licensed in accordance with LAC 33:XV.328.J, equivalent Nuclear Regulatory Commission requirements, or agreement state requirements;

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.D, or E.1 and D.3.a.ii.(f), or, before October 24, 2005, LAC 33:XV.763.D; or an individual under the supervision of either as specified in LAC 33:XV.709;

3. obtained from and prepared by a 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

4. prepared by the licensee, for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA.

La. Admin. Code tit. 33, § XV-729

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 30:1177 (June 2004), amended by the Office of the Secretary, Legal Affairs Division, LR 34:982 (June 2008), amended by the Office of the Secretary, Legal Division, LR 40:291 (February 2014).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.(1).