reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-06 - License required

Current through all regulations passed and filed through July 1, 2024
(A) A person may manufacture, produce,
			 acquire, receive, possess, prepare, use, or transfer radioactive material for
			 medical use only in accordance with a specific license issued by the director,
			 United States nuclear regulatory commission, an agreement state,
			  or as
			 allowed in paragraph (B)(1) or (B)(2) of this rule.
(B) A specific license is not needed for an
			 individual who:
(1) Receives, possesses,
			 uses, or transfers radioactive material in accordance with the regulations in
			 this chapter under the supervision of an authorized user as provided in rule
			 3701:1-58-14 of the
			 Administrative Code, unless prohibited by license condition; or
(2) Prepares unsealed radioactive material
			 for medical use in accordance with the regulations in this chapter under the
			 supervision of an authorized nuclear pharmacist or authorized user as provided
			 in rule
			 3701:1-58-14 of the
			 Administrative Code, unless prohibited by license condition.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-07 - Application for license, amendment or renewal

Current through all regulations passed and filed through July 1, 2024
(A)
								An application
			 must be signed by the applicant's or licensee's "management," as defined in
			 rule
			 3701:1-38-01 of the
			 Administrative Code.
(B)
								An application for a license for medical use of
			 radioactive material, as described in rules
			 3701:1-58-32,
			 3701:1-58-34,
			 3701:1-58-37,
			 3701:1-58-43,
			 3701:1-58-53,
			 3701:1-58-55,
			 and
			 3701:1-58-72
			 of the Administrative Code, must be made by:
(1)
									Submitting
			 documentation in accordance with rule
			 3701:1-40-14
			 of the Administrative Code, and including the facility diagram; equipment; and
			 training and experience 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);
(2)
									Submitting the appropriate license fees listed in rule
			 3701:1-38-02
			 of the Administrative Code after receiving an invoice from the department;
			 and
(3)
									Submitting procedures required by rules
			 3701:1-58-58
			 and
			 3701:1-58-64
			 to
			 3701:1-58-66
			 of the Administrative Code, as applicable.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-08 - License amendments

Current through all regulations passed and filed through July 1, 2024
A licensee shall apply for and must receive a license amendment
				and pay the invoiced amendment fee specified in rule
				3701:1-38-02
				of the Administrative Code:
(A) Before
			 it receives, prepares, or uses radioactive material for a type of use that is
			 permitted under this chapter, but that is not authorized on the licensee's
			 current license issued under this chapter, and Chapter 3701:1-40 of the
			 Administrative Code;
(B) Before it
			 permits anyone to work as an authorized user, authorized nuclear pharmacist,
			 ophthalmic physicist, or authorized medical
			 physicist under the license, except:
(1) For
			 an authorized user, an individual who meets the requirements in rule
			 3701:1-58-22,
			 and paragraph (A) of rule
			 3701:1-58-33,
			 paragraph (A) of rule
			 3701:1-58-36,
			 paragraph (A) of rule
			 3701:1-58-40,
			 paragraph (A) of rule
			 3701:1-58-41,
			 paragraph (A) of rule
			 3701:1-58-42,
			 paragraph (A) of rule
			 3701:1-58-51,
			 paragraph (A) of rule
			 3701:1-58-54,
			 and paragraph (A) of rule
			 3701:1-58-71
			 of the Administrative Code.
(2) For
			 an authorized nuclear pharmacist, an individual who meets the requirements in
			 paragraph (A) of rule
			 3701:1-58-20
			 and rule
			 3701:1-58-22
			 of the Administrative Code.
(3) For
			 an authorized medical physicist, an individual who meets the requirements in
			 paragraph (A) of rule
			 3701:1-58-19
			 and rule
			 3701:1-58-22
			 of the Administrative Code.
(4) An
			 individual who is identified as an authorized user, an authorized nuclear
			 pharmacist, ophthalmic physicist, or authorized
			 medical physicist:
(a) On a United States
			 nuclear regulatory commission or agreement state license or other equivalent
			 permit or license recognized by the director that authorizes the use of
			 radioactive material in medical use or in the practice of nuclear
			 pharmacy;
(b) On a permit issued by
			 a United States nuclear regulatory commission or agreement state specific
			 license of broad scope that is authorized to permit the use of radioactive
			 material in medical use or in the practice of nuclear pharmacy;
(c) On a permit issued by a United States
			 nuclear regulatory commission master material licensee that is authorized to
			 permit the use of radioactive material in medical use or in the practice of
			 nuclear pharmacy; or
(d) By a
			 commercial nuclear pharmacy that has been authorized to identify authorized
			 nuclear pharmacists;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-09 - Notifications

Current through all regulations passed and filed through July 1, 2024
(A) A licensee
			 shall provide the director a copy of the board certification and the written
			 attestation(s), signed by a preceptor, the United States nuclear regulatory
			 commission or agreement state license, the permit issued by a United States
			 nuclear regulatory commission master material licensee, the permit issued by a
			 United States nuclear regulatory commission or agreement state licensee of
			 broad scope, or the permit issued by a United States nuclear regulatory
			 commission master material license broad scope permittee for each individual no
			 later than thirty days after the date that the licensee permits the individual
			 to work as an authorized user, an authorized nuclear pharmacist,
			 ophthalmic physicist, or an authorized medical
			 physicist, under paragraph (B) of rule
			 3701:1-58-08
			 of the Administrative Code. For individuals permitted to work under paragraph
			 (B)(4) of rule
			 3701:1-58-08
			 of the Administrative Code, within the same thirty day time frame, the licensee
			 shall also provide, as appropriate, verification of completion of;
(1) Any additional case experience required
			 in paragraph (B)(1)(b)(vi) of rule
			 3701:1-58-40
			 of the Administrative Code for an authorized user under rule
			 3701:1-58-37
			 of the Administrative Code;
(2) Any
			 additional training required in paragraph (C) of rule
			 3701:1-58-71
			 of the Administrative Code for an authorized user under rule
			 3701:1-58-55
			 of the Administrative Code; and
(3) Any additional training required in
			 paragraph (C) of rule
			 3701:1-58-19
			 of the Administrative Code for an authorized medical physicist.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-10 - Exemptions regarding type A specific licenses of broad scope

Current through all regulations passed and filed through July 1, 2024
A licensee possessing a type A specific license of broad scope
				for medical use, issued under rules
				3701:1-40-22
				and
				3701:1-40-23
				of the Administrative Code, is exempt from:
(A) The provisions of paragraph (D) of rule
			 3701:1-58-07
			 of the Administrative Code regarding the need to file an amendment to the
			 license for medical use of radioactive material, as described in rule
			 3701:1-58-72
			 of the Administrative Code;
(B) The
			 provisions of paragraph (B) of rule
			 3701:1-58-08
			 of the Administrative Code;
(C) The
			 provisions of paragraph (F) of rule
			 3701:1-58-08
			 of the Administrative Code regarding additions to or changes in the areas of
			 use at the addresses identified in the application or on the license;
(D) The provisions of paragraph (A) of rule
			 3701:1-58-09 of the
			 Administrative Code;
(E) The
			 provisions of paragraph (B)(1) of rule
			 3701:1-58-09 of the
			 Administrative Code for an authorized user, an authorized nuclear pharmacist,
			 ophthalmic physicist, or an authorized medical
			 physicist;
(F) The provisions of
			 paragraph (B)(5) of rule
			 3701:1-58-09 of the
			 Administrative Code regarding additions to or changes in the areas of use
			 identified in the application or on the license where radioactive material is
			 used in accordance with either rule
			 3701:1-58-32
			 or
			 3701:1-58-34
			 of the Administrative Code; and
(G)
			 The provisions of paragraph (A) of rule
			 3701:1-58-17
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-11 - License issuance

Current through all regulations passed and filed through July 1, 2024
(A) The director shall issue a license for
			 the medical use of radioactive material if:
(1) The applicant has filed
			 
									documentation in accordance with
			  rule
			 3701:1-58-07
			 of the Administrative Code;
(2)
			 The applicant has paid any applicable fee as provided in rule
			 3701:1-38-02
			 of the Administrative Code;
(3)
			 The director finds the applicant equipped and committed to observe the safety
			 standards established by the director for the protection of the public health
			 and safety; and
(4) The applicant
			 meets the requirements of Chapter 3701:1-40 and rule
			 3701:1-38-02
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-12 - Authority and responsibilities for the radiation protection program

Current through all regulations passed and filed through July 1, 2024
(A) In addition to
			 the radiation protection program requirements of rule
			 3701:1-38-11
			 of the Administrative Code, a licensee's management shall approve in writing:
(1) Requests for a license application,
			 renewal, or amendment before submittal to the director;
(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 rule
			 3701:1-58-13
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-13 - Radiation protection program changes

Current through all regulations passed and filed through July 1, 2024
(A) A licensee may revise its radiation
			 protection program without the director's approval if:
(1) The revision does not require a license
			 amendment under rule
			 3701:1-58-08
			 of the Administrative Code;
(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 and licensee management; and
(4) The affected individuals are
			 instructed on the revised program before the changes are implemented.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-14 - Supervision

Current through all regulations passed and filed through July 1, 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 paragraph
			 (B)(1) of rule
			 3701:1-58-06 of
			 the Administrative Code, shall:
(1) In
			 addition to the requirements in rule
			 3701:1-38-10
			 of the Administrative Code, instruct the supervised individual in the
			 licensee's written radiation protection procedures, written directive
			 procedures, regulations of this chapter, and license conditions with respect to
			 the use of radioactive material; and
(2) Require the supervised individual to
			 follow the instructions of the supervising authorized user for medical uses of
			 radioactive material, written radiation protection procedures established by
			 the licensee, written directive procedures, regulations of this chapter, and
			 license conditions with respect to the medical use of radioactive material.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-15 - Written directives

Current through all regulations passed and filed through July 1, 2024
(A) A written directive must be dated and
			 signed by an authorized user before the administration of iodine-131 sodium
			 iodide greater than 1.11 megabecquerels (thirty
			 microcuries), any therapeutic dosage of unsealed 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 is
			 acceptable. The information contained in the oral directive must be documented
			 as soon as possible in writing in the patient's record. A written directive
			 must be prepared within forty-eight hours of the oral directive.
(B) The written directive must contain the
			 patient or human research subject's name and the following information:
(1) For any administration of quantities
			 greater than 1.11 megabecquerels (thirty
			 microcuries) of sodium iodide iodine-131: the dosage;
(2) For an administration of a therapeutic
			 dosage of unsealed radioactive material other than sodium iodide iodine-131:
			 the radioactive drug, dosage, and route of administration;
(3) For gamma stereotactic radiosurgery: the
			 total dose, treatment site, and values for the target coordinate settings per
			 treatment for each anatomically distinct treatment site;
(4) For teletherapy: the total dose, dose per
			 fraction, number of fractions, and treatment site;
(5) For high dose-rate remote afterloading
			 brachytherapy: the radionuclide, treatment site, dose per fraction, number of
			 fractions, and total dose;
(6) For permanent implant
			 brachytherapy:
(a) Before implantation:
			 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 when the
			 licensee assessed the patient's implantation; or
(7)
									For all other
			 brachytherapy, including low, medium, and pulsed dose rate remote
			 afterloaders:
(a)
										Before implantation: The treatment site, radionuclide,
			 and dose; and
(b)
										After implantation but before completion of the
			 procedure: The radionuclide; treatment site; number of sources; total source
			 strength and exposure time (or the total dose); and the date when the licensee
			 assessed the patient's implantation.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-16 - Procedures for administrations requiring a written directive

Current through all regulations passed and filed through July 1, 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.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-17 - Suppliers for sealed sources or devices for medical use

Current through all regulations passed and filed through July 1, 2024
For medical use, a licensee may only use:
(A) Sealed sources or devices manufactured,
			 labeled, packaged, and distributed in accordance with a license issued under
			 Chapter 3701:1-40 and rules
			 3701:1-38-02
			 and
			 3701:1-46-44
			 of the Administrative Code or equivalent requirements of the United States
			 nuclear regulatory commission or an agreement state;
(B) Sealed sources or devices noncommercially
			 transferred from an individual licensed in accordance with rule
			 3701:1-58-06 of
			 the Administrative Code or a United States nuclear regulatory commission or
			 agreement state medical use licensee; or
(C) Teletherapy sources manufactured and
			 distributed in accordance with a license issued under Chapter 3701:1-40 of the
			 Administrative Code or the equivalent requirements of the United States nuclear
			 regulatory commission or an agreement state.
Five Year Review (FYR) Dates:
				03/09/2017 and
				03/01/2022
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005, 12/22/08
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-18 - Training for radiation safety officer and associate radiation safety officer

Current through all regulations passed and filed through July 1, 2024
Except as provided in rule
				3701:1-58-21 of the
				Administrative Code, the licensee shall require an individual fulfilling the
				responsibilities of the radiation safety officer or an individual assigned
				duties and tasks as an associate radiation safety officer as provided in rule
				3701:1-58-12 of the
				Administrative Code to be an individual who:
(A) Is certified by a specialty board whose
			 certification process has been recognized by the director, the United States
			 nuclear regulatory commission, or an agreement state and who meets the
			 requirements in paragraph (D) of this rule. The names of board certifications
			 which have been recognized by the director, the United States nuclear
			 regulatory commission, or an agreement state will be posted on the United
			 States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page
			 at
www.nrc.gov
. 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 twenty college credits in physical
			 science;
(b) Have five or more
			 years of professional experience in health physics, for which graduate training
			 may be substituted for no more than two years of the required experience, with
			 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
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-19 - Training for an authorized medical physicist

Current through all regulations passed and filed through July 1, 2024
Except as provided in rule
				3701:1-58-21
				of the Administrative Code, the licensee shall require the authorized medical
				physicist to be an individual who:
(A)
			 Is certified by a specialty board whose certification process has been
			 recognized by the director, the United States
			 nuclear regulatory commission, or an agreement state and who meets the
			 requirements in 
								paragraph (C) of this rule. The names of board
			 certifications which have been recognized by the director,
			 the United States nuclear regulatory commission,
			 or an agreement state will be posted on the United States nuclear regulatory
			 commission's "Medical Uses Licensee Toolkit" web
			 page at
www.nrc.gov
. 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
			 under this rule by the director,
			 the United States nuclear regulatory commission,
			 or an agreement state; or
(b) In
			 clinical radiation facilities providing high-energy, external beam therapy with
			 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 rule
			 3701:1-58-21,
			 3701:1-58-51,
			 or
			 3701:1-58-71
			 of the Administrative Code; 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
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-20 - Training for an authorized nuclear pharmacist

Current through all regulations passed and filed through July 1, 2024
Except as provided in rule
				3701:1-58-21 of the
				Administrative Code, 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 director, United States nuclear regulatory commission, or an
			 agreement state. The names of board certifications which have been recognized
			 by the director, United States nuclear regulatory commission, or an agreement
			 state will be posted on the United States nuclear regulatory commission's
			 "Medical Uses Licensee Toolkit" web page at
www.nrc.gov
. 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 "
									Accreditation Council on Pharmaceutical
			 Education" (ACPE) (previously named the "American
			 Council on Pharmaceutical Education") 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 four thousand hours of training/experience
			 in nuclear pharmacy practice. Academic training may be substituted for no more
			 than two thousand 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
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-22 - Recentness of training

Current through all regulations passed and filed through July 1, 2024
The training and experience specified in rules
				3701:1-58-12
				to
				3701:1-58-21,
				3701:1-58-32
				to
				3701:1-58-71,
				and
				3701:1-58-104
				of the Administrative Code 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.
Replaces: 3701:1-58-22
Five Year Review (FYR) Dates:
				03/09/2017 and
				03/01/2022
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005, 12/22/08
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-23 - Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material

Current through all regulations passed and filed through July 1, 2024
(A) For direct measurements performed in
			 accordance with rule
			 3701:1-58-25
			 of the Administrative Code, a licensee shall possess and use instrumentation to
			 measure the activity of unsealed radioactive material before it is administered
			 to each patient or human research subject.
(B) A licensee shall calibrate the
			 instrumentation required in paragraph (A) of this rule in accordance with
			 nationally recognized standards or the manufacturer's instructions.
(C) A licensee shall retain a record of each
			 instrument calibration required by this rule in accordance with rule
			 3701:1-58-77
			 of the Administrative Code.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-24 - Calibration of survey instruments

Current through all regulations passed and filed through July 1, 2024
(A) A licensee shall calibrate the survey
			 instruments used to show compliance with this chapter and Chapter 3701:1-38 of
			 the Administrative Code before first use, annually, and following a repair that
			 affects the calibration. A licensee shall:
(1) Calibrate all scales with readings up to
			 ten millisievert
									(one thousand millirem) per hour with a radiation source;
(2) Calibrate two separate
			 readings on each scale or decade that will be used to show compliance; and
(3) Conspicuously note on the
			 instrument the date of calibration.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-25 - Determination of dosages of unsealed radioactive material for medical use

Current through all regulations passed and filed through July 1, 2024
(A) A licensee
			 shall determine and record the activity of each dosage before medical use.
(B) For a unit dosage, this
			 determination must be made by:
(1) Direct
			 measurement of radioactivity; or
(2) A decay correction, based on the activity
			 or activity concentration determined by:
(a)
			 A manufacturer or preparer licensed under rule
			 3701:1-46-43
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission, or agreement staterequirements;
(b)
			 An United States nuclear regulatory commission, or agreement state
										
			 licensee for use in research in accordance with a radioactive drug research
			 committee-approved protocol or an investigational new drug protocol accepted by
			 United States food and drug administration; or
(c)
										 A PET
			 radioactive drug producer licensed under paragraph (I) of rule
			 3701:1-40-14
			 of the Administrative Code, or equivalent United States nuclear regulatory
			 commission or agreement state requirements.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-26 - Authorization for calibration, transmission, and reference sources

Current through all regulations passed and filed through July 1, 2024
(A) Any person
			 authorized by rule
			 3701:1-58-06 of
			 the Administrative Code for medical use of radioactive material may receive,
			 possess, and use any of the following radioactive material for check,
			 calibration, transmission, and reference use:
(1) Sealed sources, not exceeding
			 1.11
			 gigabecquerels (thirty millicuries) each, manufactured and distributed by a
			 person licensed under rule
			 3701:1-46-44
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission, or agreement state regulations.
(2) Sealed sources, not exceeding
			 1.11
			 gigabecquerels (thirty millicuries) each, redistributed by a licensee
			 authorized to redistribute the sealed sources manufactured and distributed by a
			 person licensed under rule
			 3701:1-46-44
			 of the Administrative Code or equivalent United States 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 radioactive material with a half-life
			 not longer than one hundred twenty days in individual amounts not to exceed
			 0.56 gigabecquerels (fifteen millicuries).
(4) Any radioactive material with a half-life
			 longer than one hundred twenty days in individual amounts not to exceed the
			 smaller of 7.4 megabecquerels (two hundred microcuries) or one thousand times
			 the quantities in appendix A to rule
			 3701:1-40-17
			 of the Administrative Code.
(5)
			 Technetium-99m in amounts as needed.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-27 - Requirements for possession of sealed sources and brachytherapy sources

Current through all regulations passed and filed through July 1, 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.
(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 other
			 intervals approved by the director, United States nuclear regulatory
			 commission, or an agreement state.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-28 - Labeling of vials and syringes

Current through all regulations passed and filed through July 1, 2024
Each syringe and vial that contains unsealed radioactive
				material must be labeled to identify the radioactive drug. Each syringe shield
				and vial shield must also be labeled unless the label on the syringe or vial is
				visible when shielded.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-29 - Surveys of ambient radiation exposure rate

Current through all regulations passed and filed through July 1, 2024
(A) In addition to the surveys required by
			 Chapter 3701:1-38 of the Administrative Code, a licensee shall survey, with a
			 radiation detection survey instrument at the end of each day of use, the
			 following:
(1) All areas where unsealed
			 radioactive material requiring a written directive was prepared for use or
			 administered. This includes all unsealed radiopharmaceuticals prepared for use
			 or administered under rule
			 3701:1-58-37
			 of this chapter.
(2) All areas
			 where unsealed radioactive material not requiring a written directive was
			 routinely prepared for use or routinely administered. This includes all
			 unsealed radiopharmaceuticals prepared for use or administered under rule
			 3701:1-58-32
			 or rule
			 3701:1-58-34
			 of this chapter.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-30 - Release of individuals containing unsealed radioactive material or implants containing radioactive material

Current through all regulations passed and filed through July 1, 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 millisieverts (0.5 rem).
(B) A licensee shall provide the released
			 individual, or the individual's parent or guardian, with instructions,
			 including 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 nursing infant or child
			 could exceed one millisievert (0.1 rem) assuming there were no interruption of
			 breast-feeding, the instructions must 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.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-31 - Provision of mobile medical service

Current through all regulations passed and filed through July 1, 2024
(A) A licensee providing mobile medical
			 service shall:
(1) Obtain a letter signed by
			 the management of each client for which services are rendered that permits the
			 use of radioactive material at the client's address and clearly delineates the
			 authority and responsibility of the licensee and the client;
(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 this paragraph 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 Chapter
			 3701:1-38 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-32 - Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required

Current through all regulations passed and filed through July 1, 2024
Except for quantities that require a written directive under
				paragraph (B) of rule
				3701:1-58-15
				of the Administrative Code, a licensee may use any unsealed radioactive
				material prepared for medical use for uptake, dilution, or excretion studies
				that is:
(A) Obtained from:
(1)
									 A manufacturer
			 or preparer licensed under rule
			 3701:1-46-43
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(2)
									 A PET
			 radioactive drug producer licensed in accordance with paragraph (I) of rule
			 3701:1-40-14
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirement; or
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-33 - Training for uptake, dilution, and excretion studies

Current through all regulations passed and filed through July 1, 2024
Except as provided in rule
				3701:1-58-21
				of the Administrative Code, the licensee shall require an authorized user of
				unsealed radioactive material for the uses authorized under rule
				3701:1-58-32
				of the Administrative Code to be a physician who:
(A) Is certified by a medical specialty board
			 whose certification process has been recognized by the director, United States
			 nuclear regulatory commission, or an agreement state . The names of board certifications which have been recognized by
			 the director, United States nuclear regulatory commission, or an agreement
			 state will be posted on the United States nuclear regulatory commission's
			 "Medical Uses Licensee Toolkit" web page at
www.nrc.gov
. To have its certification
			 process recognized, a specialty board shall require all candidates for
			 certification to:
(1) Complete sixty hours of
			 training and experience in basic radionuclide handling techniques and radiation
			 safety applicable to the medical use of unsealed radioactive material for
			 uptake, dilution, and excretion studies that includes the topics listed in
			 paragraphs (C)(1)(a) and (C)(1)(b) of this rule; 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
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-34 - Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required

Current through all regulations passed and filed through July 1, 2024
Except for quantities that require a written directive under
				paragraph (B) of rule
				3701:1-58-15
				of the Administrative Code, a licensee may use any unsealed radioactive
				material prepared for medical use for imaging and localization studies that is:
(A) Obtained from:
(1)
									 A manufacturer
			 or preparer licensed under rule
			 3701:1-46-43
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(2)
									 A PET
			 radioactive drug producer licensed in accordance with paragraph (I) of rule
			 3701:1-40-14
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirement; or
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-35 - Permissible molybdenum-99, strontium-82, and strontium-85 concentrations

Current through all regulations passed and filed through July 1, 2024
(A) A licensee may
			 not administer to humans a radiopharmaceutical that contains:
(1) More than 0.15 kilobecquerel of
			 molybdenum-99 per megabecquerel of technetium-99m ( 0.15 microcurie of
			 molybdenum-99 per millicurie of technetium-99m); or
(2) More than 0.02 kilobecquerel of
			 strontium-82 per megabecquerel of rubidium-82 chloride injection ( 0.02
			 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more
			 than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82
			 chloride injection ( 0.2 microcurie of strontium-85 per millicurie of
			 rubidium-82).
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-36 - Training for imaging and localization studies

Current through all regulations passed and filed through July 1, 2024
Except as provided in rule
				3701:1-58-21
				of the Administrative Code, the licensee shall require an authorized user of
				unsealed radioactive material for the uses authorized in rule
				3701:1-58-34
				of the Administrative Code to be a physician who:
(A) Is certified by a medical specialty board
			 whose certification process has been recognized by the director, United States
			 nuclear regulatory commission, or an agreement state . The names of board certifications which have been recognized by
			 the director, the United States nuclear
			 regulatory commission, or an agreement state will be posted on the United
			 States nuclear regulatory commission's "Medical Uses
			 Licensee Toolkit" web page at
www.nrc.gov
. To have its certification process
			 recognized, a specialty board shall require all candidates for certification
			 to:
(1) Complete seven hundred hours of
			 training and experience in basic radionuclide handling techniques and radiation
			 safety applicable to the medical use of unsealed radioactive material for
			 imaging and localization studies that includes the topics listed in paragraphs
			 (C)(1)(a) and (C)(1)(b) of this rule; 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
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-37 - Use of unsealed radioactive material for which a written directive is required

Current through all regulations passed and filed through July 1, 2024
A licensee may use any unsealed radioactive material
				identified in paragraph (B)(1)(b)(vi) of rule
				3701:1-58-40the
				Administrative Code prepared for medical use and for which a written
				directive is required that is:
(A)
			 Obtained from:
(1) A manufacturer or preparer
			 licensed under rule
			 3701:1-46-43
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(2) A PET radioactive drug producer licensed
			 in accordance with paragraph (I) of rule
			 3701:1-40-14
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirement; or
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-38 - Safety instruction for unsealed radioactive material

Current through all regulations passed and filed through July 1, 2024
In addition to the requirements of rule
				3701:1-38-10
				of the Administrative Code,
(A) A
			 licensee shall provide radiation safety instruction, initially and at least
			 annually, to personnel caring for patients or human research subjects who
			 cannot be released under rule
			 3701:1-58-30
			 of the Administrative Code. To satisfy this requirement, the instruction must
			 be commensurate with the duties of the personnel and include:
(1) Patient or human research subject
			 control;
(2) Visitor control,
			 including:
(a) Routine visitation to
			 hospitalized individuals in accordance with paragraph (A)(1) of rule
			 3701:1-38-13
			 of the Administrative Code, and
(b)
			 Visitation authorized in accordance with paragraph (C) of rule
			 3701:1-38-13
			 of the Administrative Code;
(3) Contamination control;
(4) Waste control; and
(5) Notification of the radiation safety
			 officer, or his or her designee, and an authorized user if the patient or the
			 human research subject has a medical emergency or dies.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-39 - Safety precautions for unsealed radioactive material

Current through all regulations passed and filed through July 1, 2024
(A) For each
			 patient or human research subject who cannot be released under rule
			 3701:1-58-30
			 of the Administrative Code, a licensee shall:
(1) Quarter the patient or the human research
			 subject either in:
(a) A private room with a
			 private sanitary facility; or
(b) A
			 room, with a private sanitary facility, with another individual who also has
			 received therapy with unsealed radioactive material and who also cannot be
			 released under rule
			 3701:1-58-30
			 of the Administrative Code;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-40 - Training for use of unsealed radioactive material for which a written directive is required

Current through all regulations passed and filed through July 1, 2024
Except as provided in rule
				3701:1-58-21
				of the Administrative Code, the licensee shall require an authorized user of
				unsealed radioactive material for the uses authorized under rule
				3701:1-58-37
				of the Administrative Code to be a physician who:
(A) Is certified by a medical specialty board
			 whose certification process has been recognized by the director, United States
			 nuclear regulatory commission, or an agreement state and who meets the
			 requirements in paragraph (B)(1)(b)(vi) of this rule. Specialty boards whose
			 certification processes have been recognized by the director, the United States
			 nuclear regulatory commission, or an agreement state will be posted on the
			 United States nuclear regulatory commission's "Medical Uses Licensee Toolkit"
			 web page at
www.nrc.gov
. To be recognized, a
			 specialty board shall require all candidates for certification to:
(1) Successfully complete residency training
			 in a radiation therapy or nuclear medicine training program or a program in a
			 related medical specialty. These residency training programs must include seven
			 hundred hours of training and experience as described in paragraphs (B)(1)(a)
			 to (B)(1)(b)(v) of this rule. Eligible training programs must be approved by
			 the "Residency Review Committee of the Accreditation Council for Graduate
			 Medical Education," the "Royal College of Physicians and Surgeons of Canada,"
			 or the "
									Council on Postdoctoral Training of the American
			 Osteopathic Association;" and
(2)
			 Pass an examination, administered by diplomats of the specialty board, which
			 tests knowledge and competence in radiation safety, radionuclide handling,
			 quality assurance, and clinical use of unsealed radioactive material for which
			 a written directive is required; or