HUMAN USE OF RADIOPHARMACEUTICAL DRUG PRODUCTS APPROVED BY FDA FOR ROUTINE PROCEDURES

In order to use radioactive material not exempted by the State of Kentucky, an applicant must be licensed to practice medicine in the Commonwealth of Kentucky, and hold a faculty appointment with the University Of Louisville.

General and specific training and experience requirements for applicants adopted by the committee are those contained in Appendix Q of this manual.

Satisfactory completion of the University of Louisville course, Radiological Physics for Radiology Residents or its equivalent in practical training will serve as evidence of acceptable basic training.

Applicants should support their training and experience history with a preceptor statement from their training institution.  The preceptor statement should be signed by the chairman of the institution's radioisotope committee.  Certification by the American Board of Radiology or the American Board of Nuclear Medicine may be accepted by the Committee as sufficient evidence of satisfaction for all training and experience requirements.

GUIDELINES FOR THE HUMAN USE OF RADIONUCLIDES IN NON-ROUTINE OR INVESTIGATIONAL PROCEDURES

An applicant must already be authorized for Human use.  In addition, review and approval guidelines of applications for experimental and non-routine medical uses of radioactive material adopted by the Committee are those contained in Appendix R of this manual.  It should be emphasized that approval of the University Human Studies Committee is also mandatory prior to performing these procedures.

When non-routine or investigational medical use proposals fall under the authority of U.S. Food and Drug Administration (FDA) regulations, the investigator shall satisfy all FDA requirements, including the filing of an Investigative New Drug (IND) application or become approved as an investigator under a sponsor's IND.  The Committee will accept as adequate evidence for approval of the study, copies of the forms material, protocols and reports required to satisfy FDA requirements.

In general, non-routine or investigational medical procedures will be preceded by animal and/or in vitro data.  Animals may be used to document or determine:

1. Pharmacology (pharmacodynamics, endocrinology, metabolism, ect.).
2. Toxicity and Pathology (acute toxicity studies, sub-acute and chronic toxicity studies, reproduction and teratology studies, miscellaneous studies, ect.).
 
3. Dose range studies.

Animal studies will have been conducted in a manner to give proper consideration and attention to the condition of the use such as to whether the radioactive compound is for short or long term use, or whether for infants, children, pregnant women or fertile women