Utah Admin. Code R313-19-34 - Terms and Conditions of Licenses
(1) Licenses issued pursuant to Rule R313-19
shall be subject to provisions of the Act, now or hereafter in effect, and to
all rules, and orders of the Director.
(2)
(a)
Licenses issued or granted under Rules R313-21 and R313-22 and rights to
possess or utilize radioactive material granted by a license issued pursuant to
Rules R313-21 and R313-22 shall not be transferred, assigned, or in any manner
disposed of, either voluntarily or involuntarily, directly or indirectly,
through transfer of control of a license to a person unless the Director shall,
after securing full information find that the transfer is in accordance with
the provisions of the Act now or hereafter in effect, and to all rules, and
orders of the Director, and shall give his consent in writing.
(b) An application for transfer of license
shall include:
(i) The identity, technical
and financial qualifications of the proposed transferee; and
(ii) Financial assurance for decommissioning
information required by
R313-22-35.
(3) Persons licensed by the Director pursuant
to Rules R313-21 and R313-22 shall confine use and possession of the material
licensed to the locations and purposes authorized in the license.
(4) Licensees shall notify the Director in
writing and request termination of the license when the licensee decides to
terminate activities involving materials authorized under the
license.
(5) Licensees shall notify
the Director in writing immediately following the filing of a voluntary or
involuntary petition for bankruptcy under any Chapter of Title 11, Bankruptcy,
of the United States Code by or against:
(a)
the licensee;
(b) an entity, as
that term is defined in
11
USC 101(15), controlling the
licensee or listing the license or licensee as property of the estate;
or
(c) an affiliate, as that term
is defined in
11
USC 101(2), of the
licensee.
(6) The
notification specified in Subsection R313-19-34(5) shall indicate:
(a) the bankruptcy court in which the
petition for bankruptcy was filed; and
(b) the date of the filing of the
petition.
(7) Licensees
required to submit emergency plans pursuant to Subsection
R313-22-32(8)
shall follow the emergency plan approved by the Director. The licensee may
change the approved plan without the Director's approval only if the changes do
not decrease the effectiveness of the plan. The licensee shall furnish the
change to the Director and to affected off-site response organizations within
six months after the change is made. Proposed changes that decrease, or
potentially decrease, the effectiveness of the approved emergency plan may not
be implemented without prior application to and prior approval by the
Director.
(8) Each licensee
preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m
generators or rubidium-82 from strontium-82/rubidium-82 generators shall test
the generator eluates for molybdenum-99 breakthrough or strontium-82 and
strontium-85 contamination, respectively, in accordance with Rule R313-32
(incorporating
10
CFR 35.204 by reference). The licensee shall
record the results of each test and retain each record for three years after
the record is made. The licensee shall report the results of each test that
exceeds the permissible concentration listed in R313-32 (incorporating
10
CFR 35.204(a) ) at the time
of generator elution, in accordance with R313-32 (incorporating 10 CFR 35.3204
).
(9) Each portable gauge licensee
shall use a minimum of two independent physical controls that form tangible
barriers to secure portable gauges from unauthorized removal, whenever portable
gauges are not under the control and constant surveillance of the
licensee.
(10)
(a) Authorization under Subsection
R313-22-32(9)
to produce Positron Emission Tomography (PET) radioactive drugs for
noncommercial transfer to medical use licensees in its consortium does not
relieve the licensee from complying with applicable FDA, other Federal, and
State requirements governing radioactive drugs.
(b) A licensee authorized under Subsection
R313-22-32(9)
to produce PET radioactive drugs for noncommercial transfer to medical use
licensees in its consortium shall:
(i)
Satisfy the labeling requirements in Subsection
R313-22-75(9)(a)(iv)
for each PET radioactive drug transport radiation shield and each syringe,
vial, or other container used to hold a PET radioactive drug intended for
noncommercial distribution to members of its consortium.
(ii) Possess and use instrumentation to
measure the radioactivity of the PET radioactive drugs intended for
noncommercial distribution to members of its consortium and meet the
procedural, radioactivity measurement, instrument test, instrument check, and
instrument adjustment requirements in Subsection
R313-22-75(9)(c).
(c) A licensee that is a pharmacy authorized
under Subsection
R313-22-32(9)
to produce PET radioactive drugs for noncommercial transfer to medical use
licensees in its consortium shall require that any individual that prepares PET
radioactive drugs shall be:
(i) an authorized
nuclear pharmacist that meets the requirements in Subsection
R313-22-75(9)(b)(ii);
or
(ii) an individual under the
supervision of an authorized nuclear pharmacist as specified in Rule R313-32
(incorporating
10
CFR 35.27 by reference).
(d) A pharmacy authorized under Subsection
R313-22-32(9)
to produce PET radioactive drugs for noncommercial transfer to medical use
licensees in its consortium that allows an individual to work as an authorized
nuclear pharmacist, shall meet the requirements of Subsection
R313-22-75(9)(b)(v).
Notes
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