Tenn. Comp. R. & Regs. 0400-20-07-.13

Current through June 26, 2024
Section 0400-20-07-.13 - LICENSE AMENDMENTS
(1) A licensee shall apply for and must receive a license amendment:
(a) Before the licensee receives, prepares, or uses radioactive material for a type of use that is permitted under this rule, but that is not authorized on the licensee's current license issued pursuant to this rule;
(b) Before the licensee permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or an authorized medical physicist under the license, except:
1. For an authorized user, an individual who meets the requirements in Rule 0400-20-07-.27, subparagraph (1)(a) of Rule 0400-20-07-.39, subparagraph (1)(a) of Rule 0400-20-07-.43, subparagraph (1)(a) of Rule 0400-20-07-.47, subparagraph (1)(a) of Rule 0400-20-07-.48, subparagraph (1)(a) of Rule 0400-20-07-.49, subparagraph (1)(a) of Rule 0400-20-07-.59, subparagraph (1)(a) of Rule 0400-20-07-.62, and subparagraph (1)(a) of Rule 0400-20-07-.80;
2. For an authorized nuclear pharmacist, an individual who meets the requirements in paragraph (1) of Rule 0400-20-07-.25 and Rule 0400-20-07-.27;
3. For an authorized medical physicist, an individual who meets the requirements in paragraph (1) of Rule 0400-20-07-.24 and Rule 0400-20-07-.27;
4. An individual who is identified as an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist on a U.S. Nuclear Regulatory Commission or Agreement State license or Licensing State or other equivalent permit or license recognized by the Division that authorizes the use of radioactive material in medical use in the practice of nuclear pharmacy; or
5. An individual who is identified as an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist on a permit issued by a U.S. Nuclear Regulatory Commission or Agreement State or Licensing State specific licensee of broad scope that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy;
(c) Before the licensee changes radiation safety officers, except as provided in paragraph (3) of Rule 0400-20-07-.17;
(d) Before the licensee allows anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license;
(e) Before the licensee receives radioactive material in excess of the amount or in a different physical or chemical form than is authorized on the license;
(f) Before the licensee adds to or changes the areas of use identified in the application or on the license;
(g) Before the licensee changes the address(es) of use identified in the application or on the license;
(h) Before the licensee revises procedures required by Rule 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73, and 0400-20-07-.74, as applicable, where such revision reduces radiation safety;
(i) Before the licensee changes statements, representations, and procedures that are incorporated into the license;
(j) Before the licensee releases licensed facilities for unrestricted use; and
(k) Before the licensee receives a sealed source from a different manufacturer or of a different model number than authorized by its license, unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.
(2) Reserved.

Tenn. Comp. R. & Regs. 0400-20-07-.13

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.