1. A. A licensee shall report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

2. B. A licensee shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:

   1. 1. Is greater than 50 mSv (5 rem) total effective dose equivalent; or
   2. 2. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
3. C. The licensee shall notify the Department by telephone no later than the next calendar day after discovery of a dose to the embryo, fetus, or nursing child that requires a report in subsections (A) or (B).

4. D. The licensee shall submit a written report to the Department within 15 days after discovery of a dose to the embryo, fetus, or nursing child that requires a report in subsections (A) or (B). The written report shall include:

   1. 1. The licensee’s name;
   2. 2. The name of the prescribing physician;
   3. 3. A brief description of the event;
   4. 4. Why the event occurred;
   5. 5. The effect, if any, on the embryo/fetus or the nursing child;
   6. 6. What actions, if any, have been taken or are planned to prevent recurrence; and
   7. 7. Certification that the licensee notified the pregnant individual or mother (or the mother’s or child’s responsible relative or guardian), and if not, why not.
5. E. The report, required in subsection (D), shall not contain the individual’s or child’s name or any other information that could lead to identification of the individual or child.
6. F. The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both here-after referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under subsections (A) or (B), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee shall not delay any appropriate medical care for the embryo, fetus, or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subsection, the notification may be made to the mother’s or child’s responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother’s or child’s responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide the written description upon request.

7. G. A licensee shall:

   1. 1. Make a copy of the report provided to the Department and include with it the:

      1. a. Name of the pregnant individual or the nursing child who is the subject of the event; and
      2. b. Identification number or, if no other identification number is available, the Social Security number of the pregnant individual or the nursing child who is the subject of the event; and
   2. 2. Provide the copy of the information required in subsection (G)(1) to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

8. 1. Obtained from:

   1. a. A manufacturer or preparer licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State requirements; or
   2. b. A PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an Agreement State license;

9. 2. Excluding production of PET radionuclides, prepared by:

   1. a. An authorized nuclear pharmacist who meets the requirements in R9-7-712;
   2. 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; or
   3. c. 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

10. 3. If a research protocol:

    1. 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

    2. 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:

11. 1. Obtained from:

    1. a. A manufacturer or preparer licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State requirements; or
    2. b. A PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an Agreement State license;

12. 2. Excluding production of PET radionuclides, prepared by:

    1. a. An authorized nuclear pharmacist who meets the requirements in R9-7-712;
    2. 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; or
    3. c. 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

13. 3. If a research protocol:

    1. 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

    2. 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 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:

14. 1. Obtained from:

    1. a. A manufacturer or preparer licensed under R9-7-703(C)(2)(a), or equivalent NRC or Agreement State requirements; or
    2. b. A PET radioactive drug producer licensed under R9-7-703 or equivalent NRC or an Agreement State license;

15. 2. Excluding production of PET radionuclides, prepared by:

    1. a. An authorized nuclear pharmacist who meets the requirements in R9-7-712;
    2. b. A physician who is an authorized user and who meets the requirements specified in R9-7-721 or R9-7-723; or
    3. c. 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

16. 3. If a research protocol:

    1. 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

    2. 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 400

       Included is the use of sources for manual brachytherapy. A licensee must use only brachytherapy sources:

17. 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

18. 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.

19. 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.
20. 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.

21. 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.

22. A. A licensee must only use sealed sources:

    1. 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: or
    2. 2. 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.

23. B. A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

    1. 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; or

    2. 2. 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:

    3. 1. The applicant or licensee has submitted the information required by this Article; and
    4. 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.

Exhibit A. Medical Use Groups

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:

Historical Note

New Article 7, Exhibit A recodified from 12 A.A.C. 1., Article 7, Exhibit A at 24 A.A.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). Exhibit A, Groups 100 through 600 and Group 1000 amended by final expedited rulemaking at 30 A.A.R. 2681 (August 30, 2024), with an immediate effective date of August 7, 2024 (Supp. 24-3).

Historical Note

New Section R9-7-746 recodified from R12-1-746 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).

Amended by final expedited rulemaking at 28 A.A.R. 3533 (November 18, 2022), with an immediate effective date of November 2, 2022 (Supp. 22-4).