1. (1) Except for quantities that require a written directive under paragraph (2) of Rule 0400-20-07- .20, a licensee may use any unsealed radioactive material, prepared for medical use for uptake, dilution, or excretion that is:

   1. (a) Obtained from:

      1. 1. A manufacturer or preparer licensed under paragraph (10) of Rule 0400-20-10- .13 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or
      2. 2. A PET radioactive drug producer licensed under paragraph (8) of Rule 0400-20- 10-.11 or equivalent Agreement State requirements; or

   2. (b) Excluding production of PET radionuclides, prepared by:

      1. 1. An authorized nuclear pharmacist;
      2. 2. 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
      3. 3. An individual under the supervision, as specified in Rule 0400-20-07-.19, of the authorized nuclear pharmacist in part 1 of this subparagraph or the physician who is an authorized user in part 2 of this subparagraph; or
   3. (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
   4. (d) Prepared by the licensee in accordance with a Radioactive Drug Research Committee approved application or an Investigational New Drug (IND) protocol accepted by Food and Drug Administration (FDA) for use in research.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq. Administrative History: Original rule filed February 22, 2012; effective May 22, 2012.