Current through Register 1531, September 27, 2024
(A)
Each license issued pursuant to
105
CMR 120.000 shall be subject to all the provisions of
M.G.L. c. 111, §§ 3, 5M through 5P, and to all rules, regulations,
orders of the Agency and license conditions as provided for in
105 CMR
120.130(B).
(B)
(1) No
license issued or granted under
105
CMR 120.000 and no right to possess or utilize
radioactive material granted by any license issued pursuant to 105 CMR 120.131
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
M.G.L. c. 111, §§ 3, 5M through 5P, and to all valid rules,
regulations, and orders of the Agency, and shall give its consent in
writing.
(2) 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
105 CMR
120.125(C), as
applicable.
(C)
Each person licensed by the Agency pursuant to
105 CMR
120.100 shall confine use and possession of
the material licensed to the locations and purposes authorized in the license.
Preparation for shipment and transport of byproduct material shall be in
accordance with the provisions of 10 CFR Part 71 and
105 CMR
120.770.
(D) Each licensee shall notify the Agency in
writing when the licensee decides to permanently discontinue all activities
involving materials authorized under the license.
(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.
(F) The
notification specified in 105 CMR 120.131(E) shall indicate the bankruptcy
court in which the petition for bankruptcy was filed and the date of the filing
of the petition.
(G) 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.
(H) 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
105 CMR
120.548. 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
105 CMR 120.548(A)
at the time of generator elution, in
accordance with
105 CMR
120.594(F).
(I)
(1)
Authorization under
105
CMR 120.128(A) 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
105
CMR 120.128(A) to produce
PET radioactive drugs for noncommercial transfer to medical use licensees in
its consortium shall:
1. Satisfy the labeling
requirements in
105
CMR 120.128(J)(1)(d) 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.
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
105
CMR 120.128(J)(3).
(3) A licensee that is a pharmacy
authorized under
105
CMR 120.128(A) 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:
1. an authorized nuclear
pharmacist that meets the requirements in
105
CMR 120.128(J)(2)(b);
or
2. an individual under the
supervision of an authorized nuclear pharmacist as specified in
105 CMR
120.519.
(4) A pharmacy, authorized under
105
CMR 120.128(A) 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
105
CMR
120.128(J)(2)(e).
