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: The radioactive material in this group shall be:

1.        Obtained from a manufacturer or preparer licensed under R12-1-703(C)(2)(a), or equivalent NRC or Agreement State requirements; or

2.        Obtained from a PET radioactive drug producer licensed under R12-1-703 or equivalent NRC or an Agreement State license excluding production of PET radionuclides prepared by an authorized nuclear pharmacist who meets the requirements in R12-1-712, a physician who is an authorized user and who meets the requirements specified in R12-1-721, or R12-1-723 and R12-1- 721(A)(3)(b)(vii), or an individual under the supervision of either as specified in R12-1-706; or

3.         If a research protocol:

a   Obtained from and prepared by an 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; or

b. Prepared by the licensee for use in research in accor- dance with a Radioactive Drug Research Commit- tee-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. PET radiopharmaceuticals may be used if the licensee meets the require- ments in R12-1-716. The radioactive material in this group shall be:

1.        Obtained from a manufacturer or preparer licensed under R12-1-703(C)(2)(a), or equivalent NRC or Agreement State requirements; or

2.        Obtained from a PET radioactive drug producer licensed under R12-1-703 or equivalent NRC or an Agreement State license excluding production of PET radionuclides prepared by an authorized nuclear pharmacist who meets the requirements in R12-1-712, a physician who is an authorized user and who meets the requirements specified in R12-1-721 or R12-1-723 and R12-1-721(A)(3)(b)(vii), or an individual under the supervision of either as speci- fied in R12-1-706; or

3.         If a research protocol:

a.         Obtained from and prepared by an Agreement State or NRC 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; or

b.        Prepared by the licensee for use in research in accor- dance with a Radioactive Drug Research Commit- tee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

Group 300

Included is the use of any unsealed radioactive material for medical use (radiopharmaceutical) for which a written directive is required. The radioactive material in this group shall be:

1.        Obtained from a manufacturer or preparer licensed under R12-1-703(C)(2)(a) or equivalent NRC or Agreement State requirements; or

2.        Obtained from a PET radioactive drug producer licensed under R12-1-703 or equivalent NRC or an Agreement State license excluding production of PET radionuclides prepared by an authorized nuclear pharmacist who meets the requirements in R12-1-712, a physician who is an

authorized user and who meets the requirements specified in R12-1-721 or R12-1-723, or an individual under the supervision of either as specified in R12-1-706; or

3.         If a research protocol:

a.         Obtained from and prepared by an Agreement State or NRC licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or

b.        Prepared by the licensee for use in research in accor- dance with an Investigational New Drug (IND) pro- tocol accepted by FDA.

Group 400

Included is the use of any brachytherapy source for therapeutic medical use that is manufactured in accordance with R12-1- 703(C)(2)(b) and:

1.        Approved for therapeutic use in the Sealed Source and Device Registry; or

2.        Part of a research protocol that is approved for therapeu- tic use under an active Investigational Device Exemption (IDE) application accepted by the FDA, and meets the requirements of R12-1-709.

Group 500

Included is the use of any sealed source that is manufactured in accordance with R12-1-703(C)(2)(b), and is approved for diagnos- tic use in the Sealed Source and Device Registry.

Group 600

Included is the use of sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosur- gery units that are manufactured in accordance with R12-1- 703(C)(2)(b) and:

1.        Approved for therapeutic use in the Sealed Source and Device Registry; or

2.        Part of a research protocol that is approved for therapeu- tic use under an active Investigational Device Exemption (IDE) application accepted by the FDA and meets the requirements of R12-1-709.

Group 1000

A licensee may use radioactive material or a radiation source approved for medical use which is not specifically addressed in R12-1-309(A)(4) 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 Agency in a license or license amendment and uses the material in accordance with the rules and specific conditions the Agency considers necessary for the medi- cal use of the material.

Historical Note

New Exhibit adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by

final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Section repealed; new Section made by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1). Amended by final rulemaking at 20

A.A.R. 324, effective March 8, 2014 (Supp. 14-1).