| in this paragraph,
qualifies as an authorized user for those materials and uses performed
before these dates, for the purposes of this chapter.
(6) Individuals who need not comply with training requirements
in this subsection may serve as preceptors for, and supervisors of,
applicants seeking authorization on an agency, NRC, or agreement state
license for the same uses for which these individuals are authorized.
(m) Recentness of training. The training and experience
specified in subsections (h), (j), and (gg) - (ttt) of this section
for medical and veterinary use shall have been obtained within the
seven years preceding the date of application or the individual shall
have had related continuing education and experience since the required
training and experience was completed.
(n) Licenses for medical and veterinarian uses of radioactive
material without broad scope authorization. In addition to the requirements
of subsection (f) of this section, a license for medical and veterinarian
use of radioactive material as described in the applicable subsections
(ff), (hh), (kk), (rr), (bbb) and (ddd) of this section will be issued
if the department approves the following documentation submitted by
the applicant:
(1) that the physician(s) or veterinarian(s) designated
on the application as the authorized user(s) is qualified in accordance
with subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc) and (ttt)
of this section, as applicable;
(2) that the radiation detection and measuring instrumentation
is appropriate for performing surveys and procedures for the uses
involved;
(3) that the radiation safety operating procedures
are adequate for the handling and disposal of the radioactive material
involved in the uses; and
(4) that an RSC has been established in accordance
with subsection (i)(2) of this section, if applicable.
(o) License for medical and veterinary uses of radioactive
material with broad scope authorization. In addition to the requirements
of subsection (f) of this section, a license for medical use of radioactive
material with broad scope authorization will be issued if the department
approves the following documentation submitted by the applicant:
(1) that the review of authorized user qualifications
by the RSC is in accordance with subsections (gg), (jj), (nn) - (qq),
(zz), (aaa), (ccc) and (ttt) of this section, as applicable;
(2) that the application is for a license authorizing
unspecified forms and/or multiple types of radioactive material for
medical research, diagnosis, and therapy;
(3) that the radiation detection and measuring instrumentation
is appropriate for performing surveys and procedures for the uses
involved;
(4) that the radiation safety operating procedures
are adequate for the handling and disposal of the radioactive material
involved in the uses;
(5) that staff has substantial experience in the use
of a variety of radioactive material for a variety of human and animal
uses;
(6) that the full-time RSO meets the requirements of
subsection (h) of this section; and
(7) that an RSC has been established in accordance
with subsection (i)(1) of this section.
(p) License for the use of remote afterloader units,
teletherapy units, or gamma stereotactic radiosurgery units. In addition
to the requirements of subsection (f) of this section, a license for
the use of remote afterloader units, teletherapy units, or gamma stereotactic
radiosurgery units will be issued if the department approves the following
documentation submitted by the applicant:
(1) that the physician(s) designated on the application
as the authorized user(s) is qualified in accordance with subsection
(ttt) of this section;
(2) that the radiation detection and measuring instrumentation
is appropriate for performing surveys and procedures for the uses
involved;
(3) that the radiation safety operating procedures
are adequate for the handling and disposal of the radioactive material
involved in the uses;
(4) of the radioactive isotopes to be possessed;
(5) of the sealed source manufacturer(s) name(s) and
the model number(s) of the sealed source(s) to be installed;
(6) of the maximum number of sealed sources of each
isotope to be possessed, including the activity of each sealed source;
(7) of the manufacturer and model name and/or number
of the following units, as applicable:
(A) remote afterloader unit;
(B) teletherapy unit; or
(C) gamma stereotactic radiosurgery unit;
(8) that the authorized medical physicist designated
on the application is qualified in accordance with subsection (j)
of this section;
(9) of the safety procedures and instructions as required
by subsection (ggg) of this section;
(10) of the spot check procedures as required by subsections
(mmm) - (ooo) of this section, as applicable; and
(11) that an RSC has been established in accordance
with subsection (i)(1) or (2) of this section if applicable.
(q) License for other medical or veterinary uses of
radioactive material or a radiation source approved for medical or
veterinary use that is not specifically addressed in this section.
In addition to the requirements of subsection (f) of this section,
a licensee may use radioactive material or a radiation source approved
for medical use which is not specifically addressed in this section
if:
(1) the department approves the following documentation
submitted by the applicant:
(A) any additional aspects of the medical use of the
material that are applicable to radiation safety that are not addressed
in, or differ from, requirements in this section;
(B) identification of and commitment to follow the
applicable radiation safety program requirements in this section that
are appropriate for the specific medical use;
(C) any additional specific information on:
(i) radiation safety precautions and instructions;
(ii) methodology for measurement of dosages or doses
to be administered to patients or human research subjects; and
(iii) calibration, maintenance, and repair of instruments
and equipment necessary for radiation safety; and
(D) any other information requested by the department
in its review of the application; and
(2) the applicant or licensee has received written
approval from the department in a license or license amendment and
the licensee uses the material in accordance with the regulations
and specific conditions the department considers necessary for the
medical use of the material.
(r) License amendments and notifications.
(1) Requests for amendment of a license or deletion
of an authorized use site shall be filed in accordance with §289.252(aa)
of this title.
(2) A licensee shall apply for and shall receive a
license amendment before the following:
(A) receiving or using radioactive material for a type
of use that is authorized in accordance with this section, but is
not authorized on their current license issued in accordance with
this section;
(B) permitting anyone to work as an authorized user,
authorized nuclear pharmacist, authorized medical physicist, or ophthalmic
physicist, under the license except an individual who is identified
as an authorized user, an authorized nuclear pharmacist, authorized
medical physicist, or an ophthalmic physicist:
(i) on an agency, NRC or agreement state license or
other equivalent permit or license recognized by the department that
authorizes the use of radioactive material in medical use or in the
practice of nuclear pharmacy;
(ii) on a permit issued by an agency, NRC or agreement
state specific license of broad scope that is authorized to permit
the use of radioactive material in medical use or in the practice
of nuclear pharmacy;
(iii) on a permit issued by an NRC master material
licensee that is authorized to permit the use of radioactive material
in medical use or in the practice of nuclear pharmacy; or
(iv) by a commercial nuclear pharmacy that has been
authorized to identify authorized nuclear pharmacists.
(C) changing RSOs, except as provided in subsection
(g)(7) of this section;
(D) receiving radioactive material in excess of the
amount or in a different form, or receiving a different radionuclide
than is authorized on the license;
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