Section 0400-20-07-.40 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED(1) A licensee may use, for imaging and localization studies, any radioactive material prepared for medical use, in quantities that do not require a written directive as described in paragraph (2) of Rule 0400-20-07-.20 that is: (a) Obtained from: 1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10-.13 or equivalent regulations of another Agreement State or U.S. Nuclear Regulatory Commission requirements; or2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400-20-10-.11 or equivalent Agreement State requirements; or(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, or Rule 0400-20-07-.47 and item (1)(c)1(ii)(VII) of Rule 0400-20-07-.43, or an individual under the supervision of either as specified in Rule 0400-20-07-.19; or(c) Obtained from and prepared by an Agreement State or U.S. Nuclear Regulatory Commission licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA); or(d) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug (IND) protocol accepted by Food and Drug Administration (FDA).Tenn. Comp. R. & Regs. 0400-20-07-.40
Original rule filed February 22, 2012; effective May 22, 2012.Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.