0400-20-10-.16 - SPECIFIC TERMS AND CONDITIONS OF LICENSES

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. §§ 68-202-201 et seq.

(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.

(Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed March 3, 2015; effective June 1, 2015.)

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

The following state regulations pages link to this page.