S.C. Code Regs. § § 61-63.IV.A.RHA 4.7

Current through Register Vol. 48, 12, December 27, 2024

Section 61-63.IV.A.RHA 4.7 - Application for License, Amendment, or Renewal

4.7.1 An application must be signed by the applicant's or licensee's management.

4.7.2 An application for a license for medical use of radioactive material as described in RHA 4.35, 4.37, 4.40, 4.46, 4.56, 4.58 and 4.88 must be made by--

4.7.2.1 Filing an original of DHEC Form 0813, "Application for Radioactive Material License," that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); and

4.7.2.2 Submitting procedures required by RHA 4.61, 4.67, 4.68 and 4.69, as applicable.

4.7.3 A request for a license amendment or renewal must be made by--

4.7.3.1 Submitting an original of either--

4.7.3.1.1 DHEC Form 0813, "Application for Radioactive Material License"; or

4.7.3.1.2 A letter containing all information required by DHEC Form 0813; and

4.7.3.2 Submitting procedures required by RHA 4.61, 4.67, 4.68 and 4.69, as applicable.

4.7.4 In addition to the requirements in RHA 4.7.2 and 4.7.3 of this section an application for a license or amendment for medical use of radioactive material as described in RHA 4.88 must also include:

4.7.4.1 Any additional aspects of the medical use of the material that are applicable to radiation safety that are not addressed in, or differ from, subparts A through C, L, and M of this part;

4.7.4.2 Identification of and commitment to follow the applicable radiation safety program requirements in subparts D through H of this part that are appropriate for the specific RHA 4.88 medical use;

4.7.4.3 Any additional specific information on -

4.7.4.3.1 Radiation safety precautions and instructions;

4.7.4.3.2 Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

4.7.4.3.3 Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and

4.7.4.4 Any other information requested by the Department in its review of the application.

4.7.5 An applicant that satisfies the requirements specified in RHA 2.8.2 of this chapter may apply for a Type A specific license of broad scope.

S.C. Code Regs. § 61-63.IV.A.RHA 4.7

Amended by State Register Volume 45, Issue No. 05, eff. 5/28/2021.