North Carolina Administrative Code
Title 10A - HEALTH AND HUMAN SERVICES
Chapter 15 - RADIATION PROTECTION
Section .0300 - LICENSING OF RADIOACTIVE MATERIAL
Section 15 .0320 - SPECIFIC LICENSES: HUMAN USE BY INDIVIDUAL PHYSICIANS
Universal Citation: 10A NC Admin Code 15 .0320
Current through Register Vol. 38, No. 18, March 15, 2024
(a) An application by an individual physician or a group of physicians for a specific license for human use of radioactive material shall be approved if:
(1) the
applicant satisfies the general requirements in Rule.0318 of this
Section;
(2) The application is for
use in the applicant's practice in an office(s) outside a medical
institution;
(3) the applicant has
access to a hospital possessing adequate facilities to hospitalize and monitor
the applicant's radioactive patients whenever it is advisable;
(4) the applicant has experience, which meets
the requirements of the applicable sections of 10 CFR Part 35, in the proposed
use, the handling and administration of radioisotopes, and where applicable,
the clinical management of radioactive patients; and
(5) the physician(s) furnishes suitable
evidence of experience along with the application, except that a statement from
the medical isotope committee in the hospital where the applicant acquired
experience, indicating its amount and nature, may be submitted as evidence of
experience. 10 CFR Part 35 provides the requirements that meet the test for
suitable evidence of experience.
(b) The agency shall not approve an application by an individual physician or group of physicians for a specific license to receive, possess or use radioactive material on the premises of a hospital unless:
(1) The use of radioactive
material is limited to:
(A) the administration
of radiopharmaceuticals for diagnostic or therapeutic purposes;
(B) the performance of diagnostic studies on
patients to whom a radiopharmaceutical has been administered;
(C) the performance of IN VITRO diagnostic
studies; or
(D) the calibration and
quality control checks of radioactive assay instrumentation, radiation safety
instrumentation and diagnostic instrumentation;
(2) The physician brings the radioactive
material with him and removes the radioactive material when he
departs;
(3) No radioactive
material is received, possessed or stored in the hospital other than the amount
of material remaining in the patient; and
(4) The hospital does not hold a radioactive
material license under Rule.0319 of this Section.
Authority
G.S.
104E-7;
104E-10(b);
Eff. February 1, 1980;
Amended Eff. November 1, 2007; August 1,
2002; November 1, 1989;
Transferred and Recodified from
15A NCAC
11.0320 Eff. February 1,
2015.
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