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: a. a manufacturer or preparer licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State requirements; orb. 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:a. An authorized nuclear pharmacist who meets the requirements in R9-7-712;b. a physician who is an authorized user and who meets the requirements specified in R9-7-721 or both R9-7-721(3)(a)(ii)(7) and R9-7-723; orc. An individual under the supervision, as specified in R9-7-706, of the authorized nuclear pharmacist in subsection (2)(a) or the physician who is an authorized user in subsection (2)(b); or3. If a research protocol:a. Obtained from and prepared by a Department, NRC, or another Agreement State 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; or b. 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.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: a. a manufacturer or preparer licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State requirements; orb. 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:a. An authorized nuclear pharmacist who meets the requirements in R9-7-712;b. a physician who is an authorized user and who meets the requirements specified in R9-7-721 or both R9-7-721(3)(a)(ii)(7) and R9-7-723; orc. An individual under the supervision, as specified in R9-7-706, of the authorized nuclear pharmacist in subsection (2)(a) or the physician who is an authorized user in subsection (2)(b); or3. If a research protocol:a. Obtained from and prepared by a Department, NRC, or another Agreement State 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; orb. 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.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: a. a manufacturer or preparer licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State requirements; orb. 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:a. An authorized nuclear pharmacist who meets the requirements in R9-7-712;b. a physician who is an authorized user and who meets the requirements specified in R9-7-721 or R9-7-723; orc. An individual under the supervision, as specified in R9-7-706, of the authorized nuclear pharmacist in subsection (2)(a) or the physician who is an authorized user in subsection (2)(b); or 3. If a research protocol: a. Obtained from and prepared by a Department, NRC, or another Agreement State 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; orb. 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. 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; or2. 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.
A. A licensee must only use sealed sources:1. Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses: or2. In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units 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.B. A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units: 1. Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or2. In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of R9-7-709(1) are met. 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; and2. 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. Ariz. Admin. Code tit. 9, ch. 7, art. 7, exh. A
New Article 7, Exhibit A recodified from 12 A A.C. 1., Article 7, Exhibit A at 24 AA.R. 813, effective March 22, 2018 (Supp. 18-1). Exhibit A, Group 100, Group 200, and Group 1000 amended by final exempt rulemaking at 24 A.A.R. 2151, effective July 12, 2018 (Supp. 18-3). Amended by final expedited rulemaking at 30 A.A.R. 2681, effective 8/7/2024.