Section R12-1-703. License for Medical Use of Radioactive Material

A.      In addition to the requirements set forth in R12-1-309, the Agency shall issue a specific license for medical use of radio- active material if:

1.        The applicant has appointed a radiation safety committee, meeting the requirements in R12-1-705, that will oversee the use of licensed material throughout the licensee’s facility and associated radiation safety program;

2.        The applicant possesses facilities for the clinical care of patients or human research subjects; and

3.        The individual designated on the application as an autho- rized user has met the training and experience require- ments in R12-1-719, R12-1-721, R12-1-723, R12-1-727, R12-1-728, or R12-1-744.

B.       Specific licenses to individual authorized users for medical use of radioactive material:

1.        The Agency shall approve an application by a prospective individual authorized user or prospective group of autho- rized users for a specific license governing the medical use of radioactive material if:

a.         The applicant satisfies the general requirements in R12-1-309;

b.        The application is for use in the applicant’s practice at an office outside of a medical institution;

c.         The applicant meets the training and experience requirements in subsection (A)(3); and

d.        The applicant has a radiation safety committee, if the criteria in R12-1-705 are applicable and a RDRC, if the use is basic research involving humans.

2.        The Agency shall not approve an application by a pro- spective authorized user or group of prospective autho- rized users for a specific license to receive, possess, or use radioactive material on the premises of a medical institution unless:

a.         The use of radioactive material is limited to:

i.         The administration of radiopharmaceuticals for diagnostic or therapeutic purposes;

ii.        The performance of diagnostic studies on patients or human research subjects to whom a radiopharmaceutical has been administered;

iii.      The performance of in vitro diagnostic studies; or

iv.       The calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation, or diagnostic instru- mentation;

b.        The authorized user brings the radioactive material and removes the radioactive material upon depar- ture; and

c.         The medical institution does not hold a radioactive materials license under subsection (A).

C.      Specific licenses for certain groups of medical uses of radioac- tive material:

1.        The Agency shall approve an application for a specific license under subsections (A) or (B), for any medical use or uses of radioactive material specified in Groups 100 through 1,000, in Exhibit A of this Article, for all of the materials within each group requested in the application if:

a.         The applicant satisfies the requirements of subsec- tions (A) and (B);

b.        Each person involved in the preparation and use of the radioactive material is an authorized user, an authorized nuclear pharmacist, or certified as a nuclear medicine technologist by the Medical Radiologic Technology Board of Examiners (MRTBE);

c.         The applicant’s radiation detection and measuring instrumentation is adequate for conducting the pro- cedures involved in the authorized uses selected from Group 100 through Group 1,000; and

d.        The applicant’s radiation safety operating proce- dures are adequate for handling and disposal of the radioactive material involved in the authorized uses selected from Group 100 through Group 1,000.

2.        Any licensee who is authorized to use radioactive mate- rial:

a.         In unsealed form under Groups 100, 200, 300 or 1,000 listed in Exhibit A of this Article, shall do so using radiopharmaceuticals prepared in accordance with R12-1-311(I); or

b.        In sealed source form under Groups 400, 500, 600, or 1,000 listed in Exhibit A of this Article, shall do so using sealed sources that have been manufactured and distributed in accordance with R12-1-311(K);

c.         In any form under group 1,000 listed in Exhibit A of this Article, shall do so using sealed and unsealed sources that have been manufactured and distributed in accordance with the specific license issued by the Agency.

3.        Any licensee who is licensed according to subsection (C)(1), for one or more of the medical use groups in Exhibit A also is authorized to use radioactive material under the general license in R12-1-306(F) for the speci- fied in vitro uses without filing Form ARRA-9 as required by R12-1-306(F)(2); provided, that the licensee is subject to the other provisions of R12-1-306(F).

D.      In addition to the other license application requirements in this Section, each applicant shall include in the radiation safety program required under subsection (A)(1) a system for ensur- ing that each syringe and vial that contains unsealed radioac- tive material is labeled in accordance with R12-1-431(D).

Historical Note

Former Rule Section G.3; Former Section R12-1-703 repealed, new Section R12-1-703 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-703

renumbered and amended as Section R12-1-704, former Section R12-1-702 renumbered and amended as Section R12-1-703 effective December 20, 1985 (Supp. 85-6).

Section repealed and new Section adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Amended by

final rulemaking at 10 A.A.R. 2122, effective July 3,

2004 (Supp. 04-2). Amended 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).