120.131 - Specific Terms and Conditions of Licenses

120.131. Specific Terms and Conditions of Licenses

(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.

(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).

(Amended by Mass Register Issue 1307, eff. 2/26/2016. Amended by Mass Register Issue 1373, eff. 9/7/2018.)

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