S.C. Code Regs. § § 61-63.IV.E.RHA 4.40
Current through Register Vol. 48, 12, December 27, 2024
Section 61-63.IV.E.RHA 4.40 - Use of Unsealed Radioactive Material for Which a Written Directive is RequiredA licensee may use any unsealed radioactive material identified in RHA 4.43.2.2.7 prepared for medical use and for which a written directive is required that is-
4.40.1 Obtained from: 4.40.1.1 A manufacturer or preparer licensed under RHA 2.7.5 or equivalent Agreement State requirements; or4.40.1.2 A PET radioactive drug producer licensed under Part 2 of this Regulation or equivalent Agreement State requirements; or4.40.2 Excluding production of PET radionuclides, prepared by: an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in RHA 4.39 or 4.43; or an individual under the supervision of either as specified in RHA 4.15; or4.40.3 Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or4.40.4 Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.S.C. Code Regs. § 61-63.IV.E.RHA 4.40
Amended by State Register Volume 45, Issue No. 05, eff. 5/28/2021.