6 Colo. Code Regs. § 1007-1-7-D
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-7-D - Unsealed Radioactive Material - Written Directive Not Required7.30Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required.7.30.1 Except for quantities that require a written directive under 7.11.2, a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is: 7.30.1.1 Obtained from: (1) A manufacturer or preparer licensed under Part 3, Section 3.12.10 or equivalent regulations of an Agreement State, or NRC; or;(2) A PET radioactive drug producer licensed under Part 3, Section 3.8.10 or equivalent regulations of an Agreement State or NRC; or7.30.1.2 Excluding production of PET radionuclides, prepared by:(1) An authorized nuclear pharmacist;(2) A physician who is an authorized user and who meets the requirements specified in Appendix 7E, or Appendix 7F and Section 7E3.1(2)(g) of Appendix 7E; or(3) An individual under the supervision, as specified in 7.10, of the authorized nuclear pharmacist in 7.30.1.2(1) or the physician who is an authorized user in 7.30.1.2(2); or7.30.1.3 Obtained from and prepared by a Department, Agreement State, or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or7.30.1.4 Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.7.30.2 Training For Uptake, Dilution, And Excretion Studies. The licensee shall require an authorized user of unsealed radioactive material for the uses authorized under 7.30 to meet the requirements of Appendix 7D.
7.32Use of unsealed radioactive material for imaging and localizations studies for which a written directive is not required.Except for quantities that require a written directive under 7.11, a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:
7.32.1 Obtained from: 7.32.1.1 A manufacturer or preparer licensed pursuant to Part 3, Section 3.12.10 or equivalent regulations of an Agreement State, or NRC; or7.32.1.2 A PET radioactive drug producer licensed under Part 3, Section 3.8.10; or7.32.2 Excluding production of PET radionuclides, prepared by:7.32.2.1 An authorized nuclear pharmacist;7.32.2.2 A physician who is an authorized user and who meets the requirements specified in Appendix 7E, or Appendix 7F and 7E3.1(2)(g); or7.32.2.3 An individual under the supervision, as specified in 7.10, of the authorized nuclear pharmacist in 7.32.2.1 or the physician who is an authorized user in 7.32.2.2;7.32.3 Obtained from and prepared by a Department, Agreement State, or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or7.32.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research.7.32.5 Authorized User Training for Imaging and Localization Studies for which a Written Directive is Not Required. The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.32 to meet the requirements of Appendix 7E.
7.33Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.7.33.1 A licensee may not administer to humans a radioactive drug that contains: 7.33.1.1 More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 µCi of 99Mo per mCi of 99mTc); or7.33.1.2 More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of 82Sr per mCi of 82Rb chloride); or more than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 µCi of 85Sr per mCi of 82Rb).7.33.2 A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radioactive drug shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with 7.33.1.7.33.3 A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radioactive drug shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with 7.33.1.7.33.4 If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement as follows:7.33.4.1 A licensee shall maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required by 7.33.2 and 7.33.3 for 3 years. The record must include:(1) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or(2) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerel of strontium-82 per megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium), kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or microcuries of strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.7.33.5 The licensee shall report any measurement that exceeds the limits in 7.33.1 at the time of generator elution, as follows: Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
7.33.5.1 The licensee shall notify by telephone the Department and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in 7.33.1 at the time of generator elution. The telephone report to the Department must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.7.33.5.2 The licensee shall submit a written report to the Department within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by 7.33.5.1.7.34Aerosols and gases.Provided the conditions of 7.28 are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Department.
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