10a ncac 15 .0320          SPECIFIC LICENSES: HUMAN USE BY INDIVIDUAL PHYSICIANS

(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.

 

History Note:        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.