Tenn. Comp. R. & Regs. 0400-20-07-.38

Current through June 26, 2024

Section 0400-20-07-.38 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED

(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:

(a) Obtained from:

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. 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:

1. An authorized nuclear pharmacist;

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. 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

(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 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.

Tenn. Comp. R. & Regs. 0400-20-07-.38

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.