6 Colo. Code Regs. § 1007-1-3.15
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-3.15 - Specific Terms and Conditions of License3.15.1 Each license issued pursuant to this part shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the Department.3.15.2 Inalienability of Licenses. 3.15.2.1 No license issued or granted under this part and no right to possess or utilize radioactive material granted by any license issued pursuant to this part 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, now or hereafter in effect, and to all valid rules, regulations, and orders of the Department, and shall give its consent in writing.3.15.2.2 An application for transfer of license must include: (1) The identity, technical and financial qualifications of the proposed transferee;(2) Financial assurance for decommissioning information required by 3.9.6;(3) A description of the acquisition or proposed transfer including dates;(4) An updated organizational chart including the proposed transferee's management structure for the licensed activities;(5) Documentation of registration with the Colorado Secretary of State for the proposed transferee;(6) A statement from the proposed transferee's management that they will conduct business in accord with all of the commitments previously submitted by the current licensee;(7) A statement from the proposed transferee's management accepting liability for all licensed materials that are and have been possessed under the license; and(8) A copy of the appropriate radioactive materials license application signed by the RSO and the proposed transferee's management.3.15.3 Each person licensed by the Department pursuant to this part shall confine use and possession of the material licensed to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to Part 3 shall carry with it the right to receive, possess, and use source or byproduct material. Preparation for shipment and transport of source or radioactive material shall be in accordance with the provisions of Part 17.3.15.4 Notice and Disposition of Records Prior to License Termination.3.15.4.1 Each licensee shall notify the Department in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.3.15.4.2 Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the Department.(1) Records of disposal required by 4.48; and(2) Records of surveys required by 4.42.3.15.4.3 If licensed activities are transferred or assigned in accordance with 3.15.2, each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the records required in 3.15.4.2 to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated.3.15.4.4 Prior to license termination, each licensee shall forward the records required by 3.16.5 to the Department.3.15.5 Bankruptcy.3.15.5.1 Each specific licensee and each general license that is required to register by 3.6.4.3 of this part 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) 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) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.3.15.5.2 The notification specified in 3.15.5.1 shall include the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.3.15.6 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 Part 7. 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 Part 7, Section 7.33.1 at the time of generator elution, in accordance with Part 7, Section 7.33.5.3.15.7 Authorization under 3.8.10 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.3.15.7.1 Each licensee authorized under 3.8.10 to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall: (1) Satisfy the labeling requirements in 3.12.10.1(4) 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) 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 3.12.10.3.3.15.7.2 A licensee that is a pharmacy authorized under 3.8.10 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 3.12.10.2(2), or(2) An individual under the supervision of an authorized nuclear pharmacist as specified in Part 7, Section 7.10.3.15.7.3 A pharmacy, authorized under 3.8.10 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 3.12.10.2(5).Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/201438 CR 02, January 25, 2015, effective 2/14/201538 CR 05, March 10, 2015, effective 3/30/201538 CR 12, June 25, 2015, effective 7/15/201538 CR 14, July 25, 2015, effective 8/14/201539 CR 02, January 25, 2016, effective 2/14/201639 CR 16, August 25, 2016, effective 9/14/201639 CR 22, November 25, 2016, effective 12/15/201640 CR 11, June 10, 2017, effective 6/30/201740 CR 20, October 25, 2017, effective 11/14/201742 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202043 CR 18, September 25, 2020, effective 10/15/202044 CR 11, June 10, 2021, effective 7/15/202144 CR 14, July 25, 2021, effective 8/14/202145 CR 22, November 25, 2022, effective 12/15/2022