Tenn. Comp. R. & Regs. 0400-20-07-.44 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED

(1) A licensee may use any unsealed radioactive material identified in item (1)(b)1(ii)(VI) of Rule 0400-20-07-.47 prepared for medical use and for which a written directive is required that is:

(a) Obtained from:

1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-07-.10 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or

2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400-20-10-.11 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements;

(b) Excluding production of PET radionuclides prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Rule 0400-20-07-.43, Rule 0400-20-07-.47, or an individual under the supervision of either as specified in Rule 0400-20-07-.19;

(c) Obtained from and prepared by an Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA) for use in research; or

(d) Prepared by the licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA).

Notes

Tenn. Comp. R. & Regs. 0400-20-07-.44

Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.