Statutes, codes, and regulations
South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROLSubchapter 61-63 - Radioactive Materials (Title A)Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS
Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED
Section 61-63.IV.D.RHA 4.37 - Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive is not Required

S.C. Code Regs. § § 61-63.IV.D.RHA 4.37

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Current through Register Vol. 48, 12, December 27, 2024
Section 61-63.IV.D.RHA 4.37 - Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive is not Required

Except for quantities that require a written directive under RHA 4.17.2, a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is--

4.37.1 Obtained from:
4.37.1.1 A manufacturer or preparer licensed under RHA 2.7.5 or equivalent Agreement State requirements; or
4.37.1.2 A PET radioactive drug producer licensed under Part 2 of this Regulation or equivalent Agreement State requirements; or
4.37.2 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 and 4.39.3.2.7, or an individual under the supervision of either as specified in RHA 4.15;
4.37.3 Obtained from and prepared by an NRC 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
4.37.4 Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

S.C. Code Regs. § 61-63.IV.D.RHA 4.37