Current through Register Vol. 49, No. 13, September 23, 2024
Subpart
1.
Applicable regulation.
A license issued under this chapter is subject to all rules
and orders of the commissioner.
Subp.
2.
Transfer prohibited.
A. No license issued or granted under this
chapter nor any right under a license must be transferred, assigned, or in any
manner disposed of, either voluntarily or involuntarily, directly or
indirectly, through transfer of control of a license to any person, unless the
commissioner, after securing full information, finds that the transfer is in
accordance with this chapter and gives consent in writing.
B. An application for transfer of license
must include:
(1) the identity, technical,
and financial qualifications of the proposed transferee; and
(2) financial assurance for decommissioning
information required by part 4731.3080.
Subp. 3.
Scope of license.
A person licensed by the commissioner under this chapter must
confine the licensees possession and use of radioactive material to the
locations and purposes authorized in the license. Except as otherwise provided
in the license, a license issued under parts 4731.3000 to 4731.7280 carries
with it the right to receive, acquire, own, and possess radioactive material.
Preparation for shipment and transport of radioactive material must be
according to parts 4731.0400 to 4731.0424.
Subp. 4.
Bankruptcy.
A. A general licensee required to register
under part 4731.3215, subpart 3a, and a specific licensee issued a license
under this chapter must notify the commissioner, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy
under any chapter of
United States Code, title 11, by or
against:
(2) an entity, as defined under United States
Code, title 11, section 101, paragraph (15), that controls the licensee or
lists the license or licensee as property; or
(3) an affiliate of the licensee, as defined
under United States Code, title 11, section 101, paragraph (2).
B. The bankruptcy notification
must indicate the bankruptcy court in which the petition for bankruptcy was
filed and the date of the filing of the petition.
Subp. 5.
Additional conditions.
A. The commissioner may incorporate in any
license, at the time of issuance or thereafter by appropriate rule or order,
such additional conditions and requirements with respect to the licensee's
receipt, possession, use, and transfer of radioactive material as the
commissioner deems appropriate or necessary to protect health or to minimize
danger to life or property.
B. The
commissioner may require reports, record keeping, and inspections of activities
under the license as may be necessary or appropriate to effectuate the purposes
of this chapter.
Subp.
6.
Emergency plan.
A licensee that is required to submit an emergency plan under
part 4731.3065, subpart 4, item A, must follow the emergency plan approved by
the commissioner. The licensee:
A. may
change the plan without commissioner approval only if the changes do not
decrease the effectiveness of the plan;
B. must furnish the change to the
commissioner and to affected off-site response organizations within six months
after the change is made; and
C.
may not implement proposed changes that decrease, or potentially decrease, the
effectiveness of the approved emergency plan without prior application to and
prior approval by the commissioner.
Subp. 7.
Generator testing.
A licensee preparing technetium-99m radiopharmaceuticals from
molybdenum-99 / technetium-99m generators or rubidium-82 from
strontium-82/rubidium-82 generators must test the generator eluates for
molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination,
respectively, according to part 4731.4435. The licensee must record the results
of each test and retain each record for three years after the record is made.
The licensee must report the results of any test that exceeds the permissible
concentration listed in part 4731.4435, item A, at the time of generator
elution, in accordance with part 4731.4528.
Subp. 8.
Security requirements for
portable gauges.
A portable gauge licensee must 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.
Subp. 9.
Authorization to produce
PET.
Authorization under part 4731.3065, subpart 7, 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 requirements or other federal and state
requirements governing radioactive drugs.
A. Each licensee authorized under part
4731.3065, subpart 7, to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium must:
(1) satisfy the labeling requirements in part
4731.3395, subpart 1, 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;
and
(2) 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 part 4731.3395, subpart 3.
B. A licensee that is a pharmacy
authorized under part 4731.3065, subpart 7, to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium must
require that any individual that prepares PET radioactive drugs must be:
(1) an authorized nuclear pharmacist that
meets the requirements in part 4731.3395, subpart 2; or
(2) an individual under the supervision of an
authorized nuclear pharmacist specified in part 4731.4407.
C. A pharmacy, authorized under part
4731.3065, subpart 7, 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, must meet the requirements of part
4731.3395, subpart 2.
Statutory Authority: MS s
144.1202;
144.1203