10-144-220 Me. Code R. § C-14

Current through 2024-51, December 18, 2024

Section 144-220-C-14 - Terms and conditions of a specific license

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.

10-144 C.M.R. ch. 220, § C-14