Effective Date: 01/08/97
Title: Section 16.120 - Specific licenses for human use of radioactive material in institutions

HUMAN USES OF RADIOACTIVE MATERIALS

16.120 Specific licenses for human use of radioactive material in institutions. An application by an institution for a specific license for human use of radioactive material will be approved if:

(a) The applicant satisfies the general requirements specified in section 16.103 of this Part.

(b) Reserved.

(c) The applicant possesses adequate facilities for the clinical care of patients.

(d) The physician designated on the application as the individual user has substantial experience in the proposed use, handling and administration of radionuclides and the clinical management of radioactive patients. (See section 16.2(a)(134) of this Part). The physician shall furnish suitable evidence of such experience with his application. A statement from his preceptor at the institution where he acquired his experience, indicating its extent and nature, may be submitted as evidence of such experience.

(e) The applicant shall have had previous experience operating under a specific institutional license and have been engaged in the use of radionuclides in medical research as well as routine diagnosis and therapy, if the application is for a license to use unspecified quantities or multiple types of radioactive material with atomic numbers 3 through 83.

(f) The license application is signed by the chairman of the radioactive materials committee and an authorized representative, normally the administrator, of the institution.




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