reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.504 - Provisions for Research Involving Human Subjects

Current through Register 1525, July 5, 2024
A licensee may conduct research involving human subjects
				  using radioactive material provided:
(A) That the research is conducted, funded,
				supported, or regulated by a Federal agency which has implemented the Federal
				Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply
				for and receive approval of a specific amendment to its Agency license before
				conducting such research. Both types of licensees shall, at a minimum, obtain
				prior informed consent from the human subjects and obtain prior review and
				approval of the research activities by an "Institutional Review Board" in
				accordance with the meaning of these terms as defined and described in the
				Federal Policy for the Protection of Human Subjects;
(B) The research involving human subjects
				authorized in 105 CMR 120.504(A) shall be conducted using radioactive material
				authorized for medical use in the license; and
(C) Nothing in 105 CMR 120.504 relieves
				licensees from complying with the other requirements in
				105 CMR
				120.500.
(D)
FDA, Other Federal, and State
				Requirements
. Nothing in
				105 CMR
				120.500 relieves the licensee from complying
				with applicable U.S. Food and Drug Administration, other Federal, and State
				requirements governing radioactive drugs or devices.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.505 - Implementation

Current through Register 1525, July 5, 2024
(A) A licensee shall implement the provisions
				in
				105 CMR
				120.500 on October 6, 2006.
(B) When a requirement in
				105 CMR
				120.500 differs from the requirement in an
				existing license condition, the requirement in
				105 CMR
				120.500 shall govern.
(C) Any existing license condition that is
				not affected by a requirement in
				105 CMR
				120.500 remains in effect until there is a
				license amendment or license renewal.
(D) If a license condition exempted a
				licensee from a provision of
				105 CMR
				120.500 on October 6, 2006, it will continue
				to exempt a licensee from the corresponding provision in
				105 CMR
				120.500.
(E) If a license condition cites provisions
				in
				105 CMR
				120.500 that will be deleted on October 6,
				2006, then the license condition remains in effect until there is a license
				amendment or license renewal that modifies or removes this condition.
(F) Licensees shall continue to comply with
				any license condition that requires it to implement procedures required by
				105
				CMR 120.573,
				120.579,
				120.580
				and
				120.581
				until there is a license amendment or renewal that modifies the license
				condition.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.506 - License Required

Current through Register 1525, July 5, 2024
(A) A person shall
				only manufacture, produce, prepare, compound, acquire, receive, possess, use,
				or transfer radioactive material for medical use in accordance with a specific
				license issued by the Agency, the Nuclear Regulatory Commission or an Agreement
				State, or as allowed in 105 CMR 120.506(B)(1) or (2)
(B)
(1)
				Unless prohibited by license condition, an individual may receive, possess,
				use, or transfer radioactive material in accordance with
				105 CMR
				120.500 under the supervision of an
				authorized user as provided in
				105 CMR
				120.519.
(2) Unless prohibited by license condition,
				an individual may prepare unsealed radioactive material for medical use in
				accordance with
				105 CMR
				120.500 under the supervision of an
				authorized nuclear pharmacist or an authorized user as provided in
				105 CMR
				120.519.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.507 - Application for License, Amendments, or Renewal

Current through Register 1525, July 5, 2024
(A) An application must be signed by the
				applicant's or licensee's management.
(B) An application for a license for medical
				use of radioactive material as described in
				105
				CMR 120.544,
				120.547,
				120.552,
				120.559,
				120.568,
				120.570
				or
				120.589
				must be made by:
(1) Filing an original and
				one copy of Agency application form MRCP 120.100- 4 that includes the facility
				diagram, equipment, and training, experience and qualifications of the
				Radiation safety Officer, Associate Radiation Safety Officer(s), authorized
				user(s), authorized medical physicist(s), ophthalmic physicist(s), and
				authorized nuclear pharmacist(s); and
(2) Submitting procedures required by
				105
				CMR 120.573,
				120.579,
				120.580
				and
				120.581,
				as applicable.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.508 - License Amendments

Current through Register 1525, July 5, 2024
A licensee shall apply for and must receive a license
				  amendment:
(A) Before it receives,
				prepares or uses radioactive material for a type of use that is permitted under
				105 CMR
				120.500, but that is not authorized on the
				licensee's current license issued pursuant to
				105 CMR
				120.500;
(B) Before it permits anyone to work as an
				authorized user, a visiting authorized medical physicist, a visiting ophthalmic
				physicist, or visiting authorized nuclear pharmacist to work under the license
				except:
(1) for an authorized user, an
				individual who meets the requirements in
				105 CMR
				120.529 and
				120.546(A),
				120.551(A),
				120.556(A),
				120.557(A),
				120.558(A),
				120.566(A),
				120.569(A),
				and
				120.587(A);
(2) for an authorized nuclear pharmacist, an
				individual who meets the requirements in
				105 CMR
				120.526(A)  and
				120.529;
(3) for an authorized medical physicist, an
				individual who meets the requirements in
				105 CMR
				120.525(A)  and
				120.529;
(4) An individual who is identified as an
				authorized user or an authorized nuclear pharmacist or authorized medical
				physicist or ophthalmic physicist on an Agency, or the U.S. Nuclear Regulatory
				Commission or Agreement State license that authorizes the use of radioactive
				material in medical use or in the practice of nuclear pharmacy, respectively;
				or
(5) An individual who is
				identified as an authorized user or an authorized nuclear pharmacist or
				authorized medical physicist or ophthalmic physicist on a permit issued by the
				Agency, or the U.S. Nuclear Regulatory Commission or Agreement State specific
				licensee of broad scope that is authorized to permit the use of radioactive
				material in medical use or the practice of nuclear pharmacy,
				respectively.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.509 - Notifications

Current through Register 1525, July 5, 2024
(A) A licensee shall provide to the Agency no
				later than 30 days after the date that the licensee permits an individual to
				work as an authorized user, authorized medical physicist, ophthalmic physicist
				or an authorized nuclear pharmacist pursuant to
				105 CMR
				120.508(B):
(1) A copy of the board certification and, as
				appropriate, verification of completion of:
(a) Training for the authorized medical
				physicist under
				105 CMR
				120.525(C);
(b) Any additional case experience required
				in
				105
				CMR 120.556(B)(1)(b)6. for
				an authorized user under
				105
				CMR 120.552; or
(c) Device specific training in
				105
				CMR 120.587(C)  for the
				authorized user under
				105
				CMR 120.570; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.510 - Exemptions Regarding Type A Specific Licenses of Broad Scope

Current through Register 1525, July 5, 2024
A licensee possessing a Type A specific license of broad
				  scope for medical use is exempt from:
(A) The provisions of
				105 CMR
				120.507(D)  regarding the
				need to file an amendment to the license for medical use of radioactive
				material as described in
				105
				CMR 120.589;
(B) The provisions of
				105 CMR
				120.508(B);
(C) The provisions of
				105 CMR 120.508(F)
				 regarding additions to or changes in the
				areas of use at the addresses specified in the license;
(D) The provisions of
				105 CMR
				120.509(A);
(E) The provisions of
				105 CMR 120.509(B)(1)
				 for an authorized user, an authorized
				nuclear pharmacist, an ophthalmic physicist or an authorized medical
				physicist;
(F) The provisions of
				105 CMR
				120.509(B)(5); and
(G) The provisions of
				105
				CMR 120.523(A)  regarding
				suppliers for sealed sources.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.511 - License Issuance

Current through Register 1525, July 5, 2024
(A) The Agency shall
				issue a license for the medical use of radioactive material if:
(1) The applicant has filed Agency
				application form MRCP 120.100- 4 in accordance with the instructions in
				105 CMR
				120.507;
(2) The applicant has paid any applicable
				fee;
(3) The applicant meets the
				requirements of
				105 CMR
				120.100; and
(4) The Agency finds the applicant equipped
				and committed to observe the safety standards established by the Agency in
				these regulations for the protection of the public health and safety.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.513 - Specific Exemptions

Current through Register 1525, July 5, 2024
The Agency may, upon application of any interested person or
				  upon its own initiative, grant such exemptions from the regulations in
				  105 CMR
				  120.500 as it determines are authorized by
				  law and will not endanger life or property or the common defense and security
				  and are otherwise in the public interest.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.515 - Authority and Responsibilities for the Radiation Protection Program

Current through Register 1525, July 5, 2024
(A) In addition to the radiation protection
				program requirements of
				105 CMR
				120.210, a licensee's management must approve
				in writing:
(1) Requests for license
				application, renewal, or amendments before submittal to the Agency;
(2) Any individual before allowing that
				individual to work as an authorized user, authorized nuclear pharmacist or
				authorized medical physicist; and
(3) Radiation protection program changes that
				do not require a license amendment and are permitted under
				105 CMR
				120.517.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.517 - Radiation Protection Program Changes

Current through Register 1525, July 5, 2024
(A) A
				licensee may revise its radiation protection program without Agency approval
				if:
(1) The revision does not require an
				amendment under
				105 CMR
				120.508;
(2) The revision is in compliance with the
				regulations and the license;
(3)
				The revision has been reviewed and approved by the Radiation Safety Officer,
				licensee management and licensee's Radiation Safety Committee (if applicable);
				and
(4) The affected individuals
				are instructed on the revised program before the changes are
				implemented.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.519 - Supervision

Current through Register 1525, July 5, 2024
(A) A licensee that permits the receipt,
				possession, use, or transfer of radioactive material by an individual under the
				supervision of an authorized user as allowed by
				105 CMR 120.506(B)(1)
				 shall:
(1)
				In addition to the requirements in
				105 CMR
				120.753, instruct the supervised individual
				in the licensee's written radiation protection procedures, written directive
				procedures in
				105 CMR
				120.500, and license conditions with respect
				to the use of radioactive material;
(2) Require the supervised individual to
				follow the instructions of the supervising authorized user for medical uses of
				radioactive material, written radiation protection procedures, written
				directive procedures, regulations of
				105 CMR
				120.500, and license conditions with respect
				to the medical use of radioactive material; and
(3) Require that only those individuals
				permitted under state and local regulations and specifically trained, and
				designated by the authorized user, be permitted to administer radionuclides or
				radiation to patients or human research subjects.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.520 - Visiting Authorized User, Visiting Authorized Nuclear Pharmacist, Visiting Ophthalmic Physicist or Visiting Medical Physicist

Current through Register 1525, July 5, 2024
(A) A licensee may permit any visiting
				authorized user, visiting authorized nuclear pharmacist, visiting ophthalmic
				physicist or visiting authorized medical physicist to work as an authorized
				user, authorized nuclear pharmacist, ophthalmic physicist or medical physicist,
				respectively, under the terms of the licensee's license for 60 days each year
				if:
(1) The visiting authorized user, the
				visiting authorized nuclear pharmacist, the visiting ophthalmic physicist or
				the visiting authorized medical physicist has the prior written permission of
				the licensee's management and, if the work is performed on behalf of an
				institution, the institution's Radiation Safety Committee;
(2) The licensee has a copy of an Agency,
				Agreement State, or U.S. Nuclear Regulatory Commission license that identifies
				the visiting authorized user, the visiting authorized nuclear pharmacist, the
				visiting ophthalmic physicist or the visiting authorized medical physicist by
				name as an authorized user for medical use, as an authorized nuclear
				pharmacist, as an ophthalmic physicist, or as an authorized medical physicist
				respectively; and
(3) Only those
				procedures for which the visiting authorized user is specifically authorized by
				an Agency, Agreement State, or U.S. Nuclear Regulatory Commission license are
				performed by that individual.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.521 - Written Directives

Current through Register 1525, July 5, 2024
(A) A written
				directive must be dated and signed by an authorized user prior to
				administration of I-131 sodium iodide greater than 1.11 megabecquerel (30
				µCi), any therapeutic dosage of radioactive material or any therapeutic
				dose of radiation from radioactive material.
If, because of the emergent nature of the patient's
				  condition, a delay in order to provide a written directive would jeopardize the
				  patient's health, an oral directive will be acceptable, provided that the
				  information contained in the oral directive is documented as soon as possible
				  in writing in the patient's record and a written directive is prepared within
				  48 hours of the oral directive.
(B) The written directive must contain the
				patient or human research subject's name and the following:
(1) For an administration of a dosage of
				radioactive drug containing radioactive material, the radioactive drug
				containing radioactive material, dosage, and route of administration;
(2) For gamma stereotactic radiosurgery, the
				total dose, treatment site, and number of target coordinate settings per
				treatment for each anatomically distinct treatment site;
(3) For teletherapy, the total dose, dose per
				fraction, number of fractions, and treatment site;
(4) For high dose rate remote afterloading
				brachytherapy, the radionuclide, treatment site, dose per fraction, number of
				fractions, and total dose;
(5) For
				permanent implant brachytherapy:
(a) Before
				implantation: The treatment site, the radionuclide, and the total source
				strength; and
(b) After
				implantation but before the patient leaves the post-treatment recovery area:
				The treatment site, the number of sources implanted, the total source strength
				implanted, and the date; or
(6) For all other brachytherapy including
				LDR, MDR, and PDR:
(a) Prior to implantation:
				treatment site, the radionuclide, and dose; and,
(b) After implantation but prior to
				completion of the procedure: the radioisotope, treatment site, number of
				sources, and total source strength and exposure time (or, the total dose) and
				date.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.522 - Procedures for Administrations Requiring a Written Directive

Current through Register 1525, July 5, 2024
(A) For any administration requiring a
				written directive, the licensee shall develop, implement, and maintain written
				procedures to provide high confidence that:
(1) The patient's or human research subject's
				identity is verified before each administration; and
(2) Each administration is in accordance with
				the written directive.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.523 - Suppliers for Sealed Sources or Devices Containing Sealed Sources for Medical Use

Current through Register 1525, July 5, 2024
For medical use, a licensee may only use:
(A) Sealed sources or devices initially
				manufactured, labeled, packaged, and distributed in accordance with a license
				issued pursuant to
				105 CMR
				120.100 and
				120.128(L)
				 or the equivalent requirements of the
				Nuclear Regulatory Commission or an Agreement State; or
(B) Sealed sources or devices
				non-commercially transferred from a 10 CFR Part 35 licensee or an Agreement
				State medical use licensee.
(C)
				Teletherapy sources manufactured and distributed in accordance with a license
				issued pursuant to
				105 CMR
				120.100 or the equivalent requirements of the
				Nuclear Regulatory Commission, an Agreement State or a Licensing
				State.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.524 - Training for Radiation Safety Officer and Associate Radiation Safety Officer

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  individual fulfilling the responsibilities of the Radiation Safety Officer
				  (RSO) or an individual assigned duties and tasks as an Associate Radiation
				  Safety Officer as provided in
				  105
				  CMR 120.515 to be an individual who:
(A) Is certified by a speciality board whose
				certification process has been recognized by the Agency, Nuclear Regulatory
				Commission or an Agreement State and who meets the requirements in 105 CMR
				120.524(D). The names of board certifications that have been recognized by the
				Agency, Nuclear Regulatory Commission or an Agreement State are posted on the
				NRC's Medical Uses Licensee Toolkit Web page. To have its certification process
				recognized, a specialty board shall require all candidates for certification
				to:
(1)
(a)
				Hold a bachelor's or graduate degree from an accredited college or university
				in physical science or engineering or biological science with a minimum of 20
				college credits in physical science;
(b) Have five or more years of professional
				experience in health physics (graduate training may be substituted for no more
				than two years of the required experience) including at least three years in
				applied health physics; and
(c)
				Pass an examination administered by diplomates of the specialty board, which
				evaluates knowledge and competence in radiation physics and instrumentation,
				radiation protection, mathematics pertaining to the use and measurement of
				radioactivity, radiation biology, and radiation dosimetry; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.525 - Training for Authorized Medical Physicist

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require the
				  authorized medical physicist to be an individual who:
(A) Is certified by a speciality board whose
				certification process has been recognized by the Agency, Nuclear Regulatory
				Commission or an Agreement State and who meets the requirements in 105 CMR
				120.525(C). The names of board certifications that have been recognized by the
				Agency, Nuclear Regulatory Commission or an Agreement State are posted on the
				NRC's Medical Uses Licensee Toolkit Web page. To have its certification process
				recognized, a specialty board shall require all candidates for certification
				to:
(1) Hold a master's or doctor's degree in
				physics, medical physics, other physical science, engineering, or applied
				mathematics from an accredited college or university;
(2) Have two years of full-time practical
				training and/or supervised experience in medical physics;
(a) Under the supervision of a medical
				physicist who is certified in medical physics by a specialty board whose
				certification process has been recognized by the Agency, Nuclear Regulatory
				Commission or an Agreement State; or
(b) In clinical radiation facilities
				providing high-energy, external beam therapy (photons and electrons with
				energies greater than or equal to one million electron volts) and brachytherapy
				services under the direction of physicians who meet the requirements for
				authorized users in
				105
				CMR 120.528,
				120.566
				or
				120.587;
				and
(3) Pass an
				examination, administered by diplomates of the specialty board, that assesses
				knowledge and competence in clinical radiation therapy, radiation safety,
				calibration, quality assurance, and treatment planning for external beam
				therapy, brachytherapy, and stereotactic radiosurgery; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.526 - Training for an Authorized Nuclear Pharmacist

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require the
				  authorized nuclear pharmacist to be a pharmacist who:
(A) Is certified by a specialty board whose
				certification process has been recognized by the Agency, Nuclear Regulatory
				Commission or an Agreement State. The names of board certifications that have
				been recognized by the Agency, Nuclear Regulatory Commission or an Agreement
				State are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have
				its certification process recognized, a specialty board shall require all
				candidates for certification to:
(1) Have
				graduated from a pharmacy program accredited by the American Council on
				Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate
				Examination Committee (FPGEC) examination;
(2) Hold a current, active license to
				practice pharmacy;
(3) Provide
				evidence of having acquired at least 4000 hours of training/experience in
				nuclear pharmacy practice. Academic training may be substituted for no more
				than 2000 hours of the required training and experience; and
(4) Pass an examination in nuclear pharmacy
				administered by diplomates of the specialty board, that assesses knowledge and
				competency in procurement, compounding, quality assurance, dispensing,
				distribution, health and safety, radiation safety, provision of information and
				consultation, monitoring patient outcomes, research and development;
				or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 120.529 - Recentness of Training

Current through Register 1525, July 5, 2024
The training and experience specified in
				  105 CMR
				  120.500 must have been obtained within the
				  seven years preceding the date of application or the individual must have had
				  related continuing education and experience since the required training and
				  experience was completed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.531 - Quality Control of Diagnostic Equipment

Current through Register 1525, July 5, 2024
Each licensee shall establish written quality control
				  procedures for all diagnostic equipment used for radionuclide studies. As a
				  minimum, quality control procedures and frequencies shall be those recommended
				  by equipment manufacturers or procedures which have been approved by the
				  Agency. The licensee shall conduct quality control procedures in accordance
				  with written procedures.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.532 - Possession, Use, and Calibration of Instruments Used to Measure the Activity of Unsealed Radioactive Material

Current through Register 1525, July 5, 2024
(A) For
				direct measurements performed in accordance with
				105
				CMR 120.534, a licensee shall possess and use
				instrumentation to measure the activity of unsealed radioactive materials prior
				to administration to each patient or human research subject.
(B) A licensee shall calibrate the
				instrumentation required in 105 CMR 120.532(A) in accordance with nationally
				recognized standards or the manufacturer's instructions.
(C) A licensee shall retain a record of each
				instrument calibration required by 105 CMR 120.532 in accordance with
				105 CMR
				120.590(F).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.533 - Calibration of Survey Instruments

Current through Register 1525, July 5, 2024
(A) A licensee
				shall ensure that the survey instruments used to show compliance with
				105 CMR
				120.200 and
				120.500
				have been calibrated before first use, annually, and following
				repair.
(B) To satisfy the
				requirements of 105 CMR 120.533(A), the licensee shall:
(1) Calibrate all required scale readings up
				to ten millisieverts (1000 mrem) per hour with a radiation source;
(2) Have each radiation survey instrument
				calibrated:
(a) At energies appropriate for
				use and at intervals not to exceed 12 months or after instrument servicing,
				except for battery changes;
(b) For
				linear scale instruments, at two points located approximately A and % of
				fullscale on each scale; for logarithmic scale instruments, at mid-range of
				each decade, and at two points of at least one decade; and for digital
				instruments, at three points between 0.02 and ten millisieverts (two and 1000
				mrem) per hour; and
(c) For dose
				rate instruments, so that an accuracy within plus or minus 20% of the true
				radiation dose rate can be demonstrated at each point checked.
(3) Conspicuously note on the
				instrument the date of calibration.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.534 - Determination of Dosages of Unsealed Radioactive Material for Medical Use

Current through Register 1525, July 5, 2024
(A) A licensee shall determine and record the
				activity of each dosage prior to medical use.
(B) For a unit dosage, this determination
				must be made either by direct measurement or by a decay correction, based on
				the measurement made by a manufacturer or preparer licensed pursuant to
				105
				CMR 120.128(J)  or
				equivalent provisions of the Nuclear Regulatory Commission, or an Agreement
				State.
(C) For other than unit
				dosages, this determination must be made by direct measurement of radioactivity
				or by a combination of measurements of radioactivity and mathematical
				calculations or combination of volumetric measurements and mathematical
				calculations, based on the measurement made by a manufacturer or preparer
				licensed pursuant to
				105
				CMR 120.128(J)  or
				equivalent provisions of the Nuclear Regulatory Commission, or an Agreement
				State.
(D) Unless otherwise
				directed by the authorized user, a licensee shall not use a dosage if the
				dosage differs from the prescribed dosage by more than 20%.
(E) A licensee shall retain a record of the
				dosage determination required by 105 CMR 120.534 in accordance with
				105 CMR
				120.590(H).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.535 - Authorization for Calibration, Transmission and Reference Sources

Current through Register 1525, July 5, 2024
(A) Any person authorized by
				105 CMR 120.506
				for medical use of byproduct material may receive, possess, and use any of the
				following byproduct material for check, calibration, transmission, and
				reference use:
(1) Sealed sources, not
				exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person
				licensed under
				105
				CMR 120.128(L)  or
				equivalent Nuclear Regulatory Commission or Agreement State
				regulations;
(2) Sealed sources,
				not exceeding 1.11 Gbq (30 mCi) each, redistributed by a licensee authorized to
				redistribute the sealed sources manufactured and distributed by a person
				licensed under
				105
				CMR 120.128(L)  or
				equivalent Nuclear Regulatory Commission or Agreement State regulations,
				providing the redistributed sealed sources are in the original packaging and
				shielding and are accompanied by the manufacturer's approved
				instructions;
(3) Any byproduct
				material with a half-life not longer than 120 days in individual amounts not to
				exceed 0.56 GBq (15 mCi);
(4) Any
				byproduct material with a half-life longer than 120 days in individual amounts
				not to exceed the smaller of 7.4 MBq (200 µCi) or 1000 times the
				quantities in
				105
				CMR 120.297:
Appendix C
;
				or
(5) Technetium-99m in amounts as
				needed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.536 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

Current through Register 1525, July 5, 2024
(A) A licensee in possession of any sealed
				source or brachytherapy source shall follow the radiation safety and handling
				instructions supplied by the manufacturer or equivalent instructions approved
				by the Agency.
(B) A licensee in
				possession of a sealed source shall:
(1) Test
				the source for leakage before its first use, unless the licensee has a
				certificate from the supplier indicating that the source was tested within six
				months before transfer to the licensee; and
(2) Test the source for leakage at intervals
				not to exceed six months or at intervals approved by the Agency, another
				Agreement State, a Licensing State or the U.S. Nuclear Regulatory Commission in
				the Sealed Source and Device Registry.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.537 - Labeling of Vials and Syringes

Current through Register 1525, July 5, 2024
Each syringe and vial that contains a radioactive drug shall
				  be labeled to identify the radioactive drug. Each syringe shield and vial
				  shield shall also be labeled, unless the label on the syringe or vial is
				  visible when shielded.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.539 - Surveys for Ambient Radiation Dose Rate and Contamination

Current through Register 1525, July 5, 2024
(A) In addition to the surveys required by
				105 CMR
				120.200, a licensee shall survey with a
				radiation detection survey instrument at the end of each day of use all areas
				where unsealed radioactive material requiring a written directive was prepared
				for use or administered.
(B) A
				licensee does not need to perform the surveys required in 105 CMR 120.539(A) in
				area(s) where patients or human research subjects are confined when they can
				not be released pursuant to
				105
				CMR 120.540.
(C) A licensee shall retain a record of each
				survey in accordance with
				105 CMR
				120.590(J).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.540 - Release of Individuals Containing Unsealed Radioactive Material or Implants Containing Radioactive Material

Current through Register 1525, July 5, 2024
(A) A
				licensee may authorize the release from its control of any individual who has
				been administered unsealed radioactive material or implants containing
				radioactive material if the total effective dose equivalent to any other
				individual from exposure to the released individual is not likely to exceed
				five millisievert (0.5 rem). [NOTE: NRC Regulatory Guide, NUREG-1566, Vol. 9,
Consolidated Guidance About Materials Licenses: Program-Specific
				Guidance About Medical Licenses
, describes methods for calculating
				doses to other individuals and contains tables of activities not likely to
				cause doses exceeding five millisieverts (0.5 rem).]
(B) For patients administered radioactive
				material for which a written directive is required, a licensee shall provide
				the released individual, or the individual's parent or guardian, with oral and
				written instructions on actions recommended to maintain doses to other
				individuals as low as is reasonably achievable if the total effective dose
				equivalent to any other individual is likely to exceed one millisievert (0.1
				rem). If the total effective dose equivalent to a breast-feeding infant or
				child could exceed one millisievert (0.1 rem) assuming there were no
				interruption of breastfeeding, the instructions shall also include:
(1) Guidance on the interruption or
				discontinuation of breast-feeding; and
(2) Information on the potential
				consequences, if any, of failure to follow the guidance.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.541 - Provision of Mobile Medical Service

Current through Register 1525, July 5, 2024
The Agency may license mobile medical services and/or clients
				  of such services. The mobile medical service shall be licensed if the service
				  receives, uses or possesses radioactive material. The client of the mobile
				  medical service shall be licensed if the client receives or possesses
				  radioactive material to be used by a mobile medical service.
(A) A licensee providing mobile medical
				service shall:
(1) Obtain a letter signed by
				the management of each location where services are rendered that authorizes use
				of radioactive material at the client's address of use and clearly delineates
				the authority and responsibility of the licensee and the client. If the client
				is licensed, the letter shall document procedures for notification, receipt,
				storage and documentation of transfer of radioactive material delivered to the
				client's location for use by the mobile medical service;
(2) Check instruments used to measure the
				activity of unsealed radioactive material for proper function before medical
				use at each client's address or on each day of use, whichever is more frequent.
				At a minimum, the check for proper function required by 105 CMR 120.541(A)(2)
				must include a constancy check;
(3)
				Check survey instruments for proper operation with a dedicated check source
				before use at each client's address; and
(4) Before leaving a client's address, survey
				all areas of use to ensure compliance with the requirements in
				105 CMR
				120.200.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.542 - Storage of Volatiles and Gases

Current through Register 1525, July 5, 2024
(A) A licensee
				shall store volatile radiopharmaceuticals and radioactive gases in a radiation
				shield and container.
(B) A
				licensee shall store and use a multidose container in a properly functioning
				fume hood.
(C) A licensee who
				administers radioactive aerosols or gases shall do so with a system that will
				keep airborne concentrations within the limits prescribed in
				105 CMR
				120.200.
(D) The system shall either be directly
				vented to the atmosphere through an air exhaust or provide for collection and
				decay or disposal of the aerosol or gas in a shielded container.
(E) A licensee shall check the operation of
				collection systems monthly. Records of these checks shall be maintained for
				three years.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL TECHNICAL REQUIREMENTS › Section 120.543 - Decay-in-storage

Current through Register 1525, July 5, 2024
(A) A licensee may hold radioactive material
				with a physical half-life of less than 120 days (or longer, if the Agency has
				approved it) for decay-in-storage before disposal without regard to its
				radioactivity if the licensee:
(1) Monitors
				radioactive material at the surface and determines that its radioactivity
				cannot be distinguished from the background radiation level with an appropriate
				radiation detection survey instrument set on its most sensitive scale and with
				no interposed shielding;
(2)
				Removes or obliterates all radiation labels except for radiation labels on
				materials that are within containers and that will be managed as biomedical
				waste after they have been released from the licensee; and
(3) Separates and monitors each generator
				column individually with all radiation shielding removed to ensure that its
				contents have decayed to background radiation level before disposal.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, OR EXCRETION STUDIES › Section 120.544 - Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for Which a Written Directive Is Not Required

Current through Register 1525, July 5, 2024
A licensee may use any unsealed radioactive material, in
				  quantities that do not require a written directive, for a diagnostic use
				  involving measurements of uptake, dilution, or excretion:
(A)
(1)
				Obtained from a manufacturer or preparer licensed pursuant to 105 CMR 120
				128(J) or equivalent regulations of another Agreement State, or the Nuclear
				Regulatory Commission; or
(2) A PET
				radioactive drug producer licensed under
				105 CMR
				120.100 or equivalent regulations of the
				Nuclear Regulatory Commission or equivalent Agreement State requirements;
				or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, OR EXCRETION STUDIES › Section 120.545 - Possession of Survey Instrument

Current through Register 1525, July 5, 2024
A licensee authorized to use radioactive material for uptake,
				  dilution, and excretion studies shall possess a portable radiation detection
				  survey instrument capable of detecting dose rates over the range one
				  microsievert (0.1 mrem) per hour to 1000 microsieverts (100 mrems) per hour.
				  The instrument shall be operable and calibrated in accordance with
				  105 CMR
				  120.533.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, OR EXCRETION STUDIES › Section 120.546 - Training for Uptake, Dilution, and Excretion Studies

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of an unsealed radioactive material for the uses authorized
				  under
				  105
				  CMR 120.544 to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process has been recognized by the Agency, Nuclear
				Regulatory Commission or an Agreement State. The names of board certifications
				that have been recognized by the Agency, Nuclear Regulatory Commission or an
				Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.
				To have its certification process recognized, a specialty board shall require
				all candidates for certification to:
(1)
				Complete 60 hours of training and experience in basic radionuclide handling
				techniques and radiation safety applicable to the medical use of unsealed
				byproduct material for uptake, dilution, and excretion studies as described in
				105 CMR 120.546(C)(1)(a) through (b)6.; and
(2) Pass an examination, administered by
				diplomates of the specialty board, that assesses knowledge and competence in
				radiation safety, radionuclide handling, and quality control; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 120.547 - Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive Is Not Required

Current through Register 1525, July 5, 2024
A licensee may use, for imaging and localization studies, any
				  radioactive material prepared for medical use, in quantities that do not
				  require a written directive as described in
				  105 CMR
				  120.521 that is:
(A) Obtained from:
(1) A manufacturer or preparer licensed
				pursuant to
				105
				CMR 120.128(J)  or
				equivalent regulations of another Agreement State, or the Nuclear Regulatory
				Commission;
(2) A PET radioactive
				drug producer licensed under
				105 CMR
				120.100 or equivalent regulations of the
				Nuclear Regulatory Commission or equivalent Agreement State requirements;
				or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 120.548 - Radionuclide Contaminants

Current through Register 1525, July 5, 2024
(A) A licensee shall
				not administer to humans a radiopharmaceutical containing
:
(1) More than 0.15 kilobecquerel of
				molybdenum-99 per megabecquerel of technetium-99m (0.15 µCi of Mo-99 per
				mCi of Tc-99m); or
(2) More than
				0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride
				injection (0.02 µCi of Sr-82 per mCi of Rb-82 chloride); or
(3) More than 0.2 kilobecquerel of
				strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi
				of Sr-85 per mCi of Rb-82).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 120.551 - Training for Imaging and Localization Studies

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of unsealed radioactive material for the uses authorized under
				  105
				  CMR 120.547 to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process has been recognized by the Agency, Nuclear
				Regulatory Commission or an Agreement State. The names of board certifications
				that have been recognized by the Agency, Nuclear Regulatory Commission or an
				Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.
				To have its certification process recognized, a specialty board shall require
				all candidates for certification to:
(1)
				Complete 700 hours of training and experience in basic radionuclide handling
				techniques and radiation safety applicable to the medical use of unsealed
				byproduct material for imaging and localization studies as described in105 CMR
				120.551(C)(1)(a) through (b)7.; and
(2) Pass an examination, administered by
				diplomates of the specialty board, which assesses knowledge and competence in
				radiation safety, radionuclide handling, and quality control; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.552 - Use of Unsealed Byproduct Material for Which a Written Directive Is Required

Current through Register 1525, July 5, 2024
A licensee may use any unsealed radioactive material
				  identified in
				  105
				  CMR 120.556(B)(1)(b)6.
				  prepared for medical use and for which a written directive is required that
				  is:
(A) Obtained from a manufacturer
				or preparer licensed in accordance with
				105
				CMR 120.128(J)  or a PET
				radioactive drug producer licensed in accordance with
				105
				CMR 120.128(A), or
				equivalent Nuclear Regulatory Commission or Agreement State requirements;
				or
(B) Excluding production of PET
				radionuclides, prepared by an authorized nuclear pharmacist, or a physician who
				is an authorized user and who meets the requirements specified in
				105 CMR
				120.551 or
				120.556,
				or an individual under the supervision of either as specified in
				105 CMR 120.519;
				or
(C) Obtained from and prepared
				by an Agency, Nuclear Regulatory Commission, or Agreement State licensee in
				accordance with a Radioactive Drug Research Committee-approved protocol or an
				Investigational New Drug (IND) protocol accepted by the FDA for use in
				research; or
(D) Prepared by the
				licensee in accordance with a Radioactive Drug Research Committee-approved
				application or an IND protocol accepted by FDA for use in research.