South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part II - LICENSING OF RADIOACTIVE MATERIAL
Section 61-63.II.RHA 2.10 - Specific Terms and Conditions of Licenses

Universal Citation: SC Code Regs 61-63.II.RHA 2.10

Current through Register Vol. 48, No. 9, September 27, 2024

2.10.1 Each license issued pursuant to these regulations shall be subject to all the provisions of the Act, and to all rules, regulations, and orders of the Department, now or hereafter in effect.

2.10.2 Specific license transfer requirements.

2.10.2.1 No license issued or granted pursuant to the regulations in Parts II, VII, and XI nor any right under a license shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Department shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing.

2.10.2.2 An application for transfer of license must include:
2.10.2.2.1 The identity, technical and financial qualifications of the proposed transferee; and

2.10.2.2.2 Financial assurance for decommissioning information required by RHA 1.15.

2.10.3 Each person licensed by the Department pursuant to these regulations shall confine his use and possession of the material licensed to the locations and purposes authorized in the license.

2.10.4 Each specific licensee authorized under 2.7.5 to distribute certain devices to generally licensed persons.

2.10.5 Each licensee shall notify the Department in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.

2.10.6 Each general licensee that is required to register by RHA 2.4.2.3.11 of this Part and each specific licensee shall notify the Department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

2.10.6.1 The licensee:

2.10.6.2 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

2.10.6.3 An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.

2.10.7 Security requirements for portable gauges.

2.10.7.1 Each portable gauge licensee shall use a minimum of two 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.

2.10.8 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 RHA 4.38. The licensee shall record the results of each test and retain each record for 3 years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in 4.38.1 of this chapter at the time of generator elution, in accordance with RHA 4.120 of this chapter.

2.10.9.1 Authorization under Part 2 of this Regulation 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 State requirements governing radioactive drugs.

2.10.9.2 Each licensee authorized under Part 2 of this Regulation to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

2.10.9.2.1 Satisfy the labeling requirements in Part 2 of this Regulation 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.

2.10.9.2.2 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 Part 2 of this Regulation.

2.10.9.3 A licensee that is a pharmacy authorized under Part 2 of this Regulation 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:

2.10.9.3.1 an authorized nuclear pharmacist that meets the requirements in Part 2 of this Regulation; or

2.10.9.3.2 an individual under the supervision of an authorized nuclear pharmacist as specified in Part 2 of this Regulation.

2.10.9.4 A pharmacy, authorized under Part 2 of this Regulation 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 2 of this Regulation.

2.10.10 Conditions of licenses.

2.10.10.1 Each license shall contain and be subject to the following conditions:
2.10.10.1.1 [Reserved]

2.10.10.1.2 No right to the special nuclear material shall be conferred by the license except as defined by the license;

2.10.10.1.3 Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of the Act;

2.10.10.1.4 [Reserved]

2.10.10.1.5 [Reserved]

2.10.10.1.6 [Reserved]

2.10.10.1.7 [Reserved]

2.10.10.1.8 The license shall be subject to and the licensee shall observe, all applicable rules, regulations, and orders of the Department.

2.10.10.1.9 Notification of Bankruptcy.
2.10.10.1.9.1 Each licensee shall notify the Department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:
2.10.10.1.9.1.1 The licensee;

2.10.10.1.9.1.2 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

2.10.10.1.9.1.3 An affiliate (as that term is defined in 11 U.S.C 101(2)) of the licensee.

2.10.10.1.9.2 The notification required in 2.10.10.1.9.1 must indicate:
2.10.10.1.9.2.1 The bankruptcy court in which the petition for bankruptcy was filed; and

2.10.10.1.9.2.2 The date of the filing of the petition.

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