Arizona Administrative Code
Title 9 - HEALTH SERVICES
Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL
Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL
Exhibit A - Medical Use Groups
Current through Register Vol. 30, No. 38, September 20, 2024
Group 100
Included is the use of any unsealed radioactive material for use in uptake, dilution, or excretion studies and not requiring a written directive: Except for quantities that require a written directive under R9-7-707, a licensee may use unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is:
1. Obtained from:
b. a PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an Agreement State license;
2. Excluding production of PET radionuclides. prepared by:
3. If a research protocol:
Group 200
Included is the use of any unsealed radioactive material for use in imaging and localization not requiring a written directive. Except for quantities that require a written directive under R9-7-707, a licensee may use unsealed byproduct material prepared for medical use for imaging and localization studies that is:
1. Obtained from:
b. a PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an Agreement State license;
2. Excluding production of PET radionuclides. prepared by:
3. If a research protocol:
Group 300
Included is the use of any unsealed byproduct radioactive material, identified in R9-7-723(A)(2)(a)(ii)(6), prepared for use and for which a written directive is required that is:
1. Obtained from:
b. a PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an Agreement State license;
2. Excluding production of PET radionuclides. prepared by:
3. If a research protocol:
Group 400
Included is the use of sources for manual brachytherapy. A licensee must use only brachytherapy sources:
1. Approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or
2. In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA, provided that the requirements of R9-7-709 are met.
Group 500
Included is the use of sealed sources and medical devices for diagnosis.
1. A licensee may only use sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
2. A licensee may only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
3. Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of R9-7-709(1) are met.
Group 600
Included is the use of sealed sources in remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.
Group 1000
A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in this Article if:
1. The applicant or licensee has submitted the information required by this Article; and
2. The applicant or licensee has received written approval from the Department in a license or license amendment and uses the material in accordance with the rules and specific conditions the Department considers necessary for the medical use of the material.
