Tenn. Comp. R. & Regs. 0400-20-10-.16 - SPECIFIC TERMS AND CONDITIONS OF LICENSES

(1) Each license issued pursuant to this Chapter shall be subject to all provisions of T.C.A. §§ 68-202-201 et seq., now or hereafter in effect, and to all rules, regulations, and orders of the Division.

(2) Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of T.C.A. Title 68, Chapter 202, Part 2. Rule 0400-20-10-.21 shall apply to the license and any right under the license.

(3) Each person licensed by the Division pursuant to this Chapter shall confine his or her use and possession of the material licensed to the locations and purposes authorized in the license.

(4) Each licensee authorized under paragraph (5) of Rule 0400-20-10-.13 to distribute certain devices to generally licensed persons shall:

(a) Report to the Division within 30 days after the end of each calendar quarter all transfers of such devices to persons generally licensed under paragraph (2) of Rule 0400-20-10.10 or, if no transfers have been made during the reporting period, the report shall so indicate. For all transfers the report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Division and the general licensee, the type and model number of device transferred and the quantity and type of radioactive material contained in the device; and

(b) Furnish to each general licensee in this State to whom he transfers such device a copy of the general license contained in paragraph (2) of Rule 0400-20-10-.10.

(5) Each specific licensee shall notify the Division in writing when the licensee decides to permanently discontinue all activities involving radioactive materials authorized under the license.

(6) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with Rule 0400-20-07-.41. The licensee shall record the results of each test and retain each record for 3 years after the record is made.

(7) Each specific licensee and each general licensee meeting the criteria of part (2)(c)14 of Rule 0400-20-10-.10 shall:

(a) Provide the Division written notification, at the address in Rule 0400-20-04-.07, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code (U.S.C.):

1. By or against the licensee;

2. By or against an entity (as that term is defined in 11 U.S.C. 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

3. By or against an affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee;

(b) Include in the notification required in subparagraph (a) of this paragraph the bankruptcy court in which the petition for bankruptcy was filed; and

(c) Include in the notification required in subparagraph (a) of this paragraph the date of the filing of the petition.

(8) When temporary job-sites are authorized on a specific license, radioactive material may be used at temporary job-sites, in areas not under exclusive federal jurisdiction, throughout the State of Tennessee.

(9) Each portable gauge licensee shall use a minimum of 2 independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(10)

(a) Authorization under paragraph (8) of Rule 0400-20-10-.11 to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and Agreement State requirements governing radioactive drugs.

(b) Each licensee authorized under paragraph (8) of Rule 0400-20-10-.11 to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

1. Satisfy the labeling requirements in part (10)(a)4 of Rule 0400-20-10-.13 for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium; and

2. Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in subparagraph (10)(c) of Rule 0400-20-10-.13.

(c) A licensee that is a pharmacy authorized under paragraph (8) of Rule 0400-20-10 -. 11 to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

1. An authorized nuclear pharmacist that meets the requirements in part (10)(b)2 of Rule 0400-20-10-.13, or

2. An individual under the supervision of an authorized nuclear pharmacist as specified in Rule 0400-20-07-.19.

(d) A pharmacy, authorized under paragraph (8) of Rule 0400-20-10-.11 to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of part (10)(b)5 of Rule 0400-20-10-.13.

(11) Each person licensed under paragraph (3) of Rule 0400-20-10-.13 shall:

(a) Label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."

(b) Ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.

(c) Provide the information specified in this subparagraph to each person to whom source material is transferred for use under Rule 0400-20-10-.09. This information must be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

1. A copy of Rule 0400-20-10-.09 and Rule 0400-20-10-.22.

2. Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.

(d) Report transfers as follows:

1. File a report with the Director, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The report shall include the following information:

(i) The name, address, and license number of the person who transferred the source material;

(ii) For each general licensee under Rule 0400-20-10-.09 or provisions equivalent to Rule 0400-20-10-.09 to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

(iii) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

2. File a report with the Director, Division of Radiological Health, to the address given in subparagraph (1)(c) of Rule 0400-20-04-.07, in addition to each responsible Agreement State Agency, that identifies all persons, operating under Rule 0400-20-10-.09 or provisions equivalent to 0400-20-10-.09, to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information (limited, for reports to other Agreement State Agencies, to information specific to those transfers made to the Agreement State being reported to):

(i) The name, address, and license number of the person who transferred the source material;

(ii) For each general licensee under Rule 0400-20-10-.09 or provisions equivalent to Rule 0400-20-10-.09 to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

(iii) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

3. Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under Rule 0400-20-10-.09 or provisions equivalent to Rule 0400-20-10-.09, during the current period, a report shall be submitted to the NRC, Division, and, upon request, the appropriate Agreement State Agency indicating so.

(e) Maintain all information that supports the reports required by this paragraph concerning each transfer to a general licensee for a period of one year after the event is included in a report.

Notes

Tenn. Comp. R. & Regs. 0400-20-10-.16

Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed March 3, 2015; effective June 1, 2015. Amendments filed September 1, 2021; effective 11/30/2021.

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