Section 11-45-156 - Specific requirements for the use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies(a) A licensee may use any radioactive material in a non-gaseous or non-aerosol diagnostic radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a non-gaseous or non-aerosol radiopharmaceutical containing radioactive material: (1) Which has been granted acceptance or approval by the U.S. Department of Health and Human Services; or(2) Which has been prepared and compounded in accordance with chapter 16-95.(3) A licensee shall elute generators.(b) Radionuclide contaminants. (1) A licensee shall not administer a radiopharmaceutical containing: (B) More than 0.02 microcurie (0.02 kilobecquerel) of strontium-82 per millicurie (megabecquerel) of rubidium-82 chloride injection;(C) More than 0.2 microcurie (0.2 kilobecquerel) of strontium-85 per millicurie (megabecquerel) of rubidium-82 chloride injection.(2) A licensee preparing radiopharmaceuticals from radionuclide generators shall measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for the generator system, to determine compliance with the limits specified in paragraph (1).(3) A licensee who shall measure radionuclide contaminant concentration shall retain a record of each measurement. The record shall include, for each elution or extraction tested, the measured activity of the radiopharmaceutical expressed in millicuries (megabecquerels), the measured activity of contaminant expressed in microcuries (kilobecquerels), the ratio of the measures expressed in microcuries (kilobecquerels) of contaminant per millicurie (megabecquerel), the date of the test, and the initials of the individual who performed the test.(4) A licensee shall report immediately to the department each occurrence of radionuclide contaminant concentration exceeding the limits specified in paragraph (1).(c) Control of aerosols and gases. (1) A licensee who administers radioactive aerosols or gases shall do so with a system that shall keep airborne concentrations within the limits prescribed in subchapter 4.(2) The system shall provide collection and decay or disposal of the aerosol or gas in a shielded container.(3) A licensee shall only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.(4) Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit in subchapter 4. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.(5) A licensee shall post the time calculated in paragraph (4) at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.(6) A licensee shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six months. Records of these checks and measurements shall be maintained.(7) A copy of the calculations required in paragraph (4) shall be recorded and retained for the duration of the license.(d) A licensee authorized to use radioactive material for imaging and localization studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 0.1 millirem (one microsievert) per hour to fifty millirems (five hundred microsieverts) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range one millirem (ten microsieverts) per hour to one thousand millirems (ten millisieverts) per hour. The instruments shall be operable and calibrated in accordance with section 11-45-141.[Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)