LAC 33:XV.735. Use of Radiopharmaceuticals for Therapy

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. prepared by the licensee, for use in research in accordance with an IND protocol accepted by FDA.