Current through 2024-38, September 18, 2024
A. Each license issued pursuant to this Part
shall be subject to all provisions of the Act, now or hereafter in effect, and
to all rules, regulations, and orders of the Agency.
B. No license issued or granted pursuant to
this rule nor any right to possess or utilize radioactive material granted by
any license issued pursuant to this rule shall be transferred, assigned, or in
any manner disposed of, either voluntarily or involuntarily, directly or
indirectly, through transfer of control of any license to any person unless the
Agency 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 valid rules, regulations and orders of the Agency and shall give its
consent in writing.
(1) An application for
transfer of license must include:
(a) The
identity, technical and financial qualifications of the proposed transferee;
and
(b) Financial assurance for
decommissioning information required by C.8.F.
C. Each person licensed by the Agency
pursuant to this rule shall confine his/her use and possession of the
radioactive material licensed to the locations and purposes authorized in the
license. Except as otherwise provided in the license, a license issued pursuant
to this rule shall carry with it the right to receive, acquire, own, and
possess radioactive material. Preparation for shipment and transport shall be
in accordance with Part L.
D. 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 Part G. 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 any test that exceeds the permissible
concentration listed in Part G.204.A of these rules at the time of generator
elution, in accordance with Part G.3204 of these rules.
E. Each licensee shall notify the Agency, 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:
(1) The
licensee;
(2) An entity (as that
term is defined in 11 U.S.C.
101(15)) controlling the
licensee or listing the license or licensee as property of the estate;
or
(3) An affiliate (as that term
is defined in 11 U.S.C.
101(2)) of the
licensee.
(4) This notification
must indicate:
(a) The bankruptcy court in
which the petition for bankruptcy was filed; and
(b) The date of the filing of the
petition.
F.
Security requirements for portable gauges. Each portable gauge licensee or
registrant shall use a minimum of two independent physical controls that for
tangible barriers to secure portable gauges from unauthorized removal, whenever
portable gauges are not under the control and constant surveillance of the
licensee.
G. Positron emission
tomography (PET) production
(1) Authorization
under C.7.K 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.
(2) Each licensee authorized under C.7.K to
produce PET radioactive drugs for noncommercial transfer to medical use
licensees in its consortium shall:
(a) Satisfy
the labeling requirements in C.7.K 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.
(b) 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 C.7.K of this rule.
(3) A licensee that is a pharmacy
authorized under C.7.K 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:
(a) Authorized nuclear pharmacist that meets
the requirements in C.11.J., or
(b)
An individual under the supervision of an authorized nuclear pharmacist as
specified in Part G.
(4)
A pharmacy, authorized under C.7.K 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 C.11.J.
H. Conditions of licenses to initially
transfer source material for use under the 'small quantities of source
material' general license: Quality control, labeling, safety instructions, and
records and reports
(1) Each person licensed
under C.12 shall label the immediate container of each quantity of source
material with the type of source material and quantity of material and the
words, "radioactive material."
(2)
Each person licensed under C.12 shall ensure that the quantities and
concentrations of source material are as labeled and indicated in any transfer
records.
(3) Each person licensed
under C.12 shall provide the information specified in this paragraph to each
person to whom source material is transferred for use under C.5. or equivalent
provisions in Agreement State or NRC regulations if that State is regulated by
the NRC. This information must be transferred before the source material is
transferred for the first time in each calendar year to the particular
recipient. The required information includes:
(a) A copy of C.5 and C.21, or relevant
equivalent regulations of the Agreement State or NRC.
(b) Appropriate radiation safety precautions
and instructions relating to handling, use, storage, and disposal of the
material.
(4) Each person
licensed under C.12 shall report transfers as follows:
(a) File a report with this Agency. The
report shall include the following information:
(i) The name, address, and license number of
the person who transferred the source material;
(ii) For each general licensee under C.5 or
equivalent Agreement State or NRC provisions to whom greater than 50 grams
(0.11 lb) of source material has been transferred in a single calendar quarter,
the name and address of the general licensee to whom source material is
distributed; a responsible agent, by name and/or position and phone number, of
the general licensee to whom the material was sent; and the type, physical
form, and quantity of source material transferred; and
(iii) The total quantity of each type and
physical form of source material transferred in the reporting period to all
such generally licensed recipients.
(b) File a report with each responsible
Agreement State agency or NRC that identifies all persons, operating under
provisions equivalent to C.5, to whom greater than 50 grams (0.11 lb) of source
material has been transferred within a single calendar quarter. The report
shall include the following information specific to those transfers made to the
Agreement State or NRC being reported to:
(i)
The name, address, and license number of the person who transferred the source
material; and
(ii) The name and
address of the general licensee to whom source material was distributed; a
responsible agent, by name and/or position and phone number, of the general
licensee to whom the material was sent; and the type, physical form, and
quantity of source material transferred.
(iii) The total quantity of each type and
physical form of source material transferred in the reporting period to all
such generally licensed recipients within the Agreement State or NRC regulated
State.
(c) Submit each
report by January 31 of each year covering all transfers for the previous
calendar year. If no transfers were made to persons generally licensed under
C.5 during the current period, a report shall be submitted to the Agency or NRC
indicating so. If no transfers have been made to general licensees in a
particular Agreement or NRC State during the reporting period, this information
shall be reported to the responsible Agreement State agency or NRC upon request
of the agency.
(5) Each
person licensed under C.12 shall maintain all information that supports the
reports required by this section concerning each transfer to a general licensee
for a period of 1 year after the event is included in a report to the NRC or to
an Agreement State agency.
