Chapter 3701:1-58 | Medical Use of Radioactive Materials

(A) A licensee may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.(B) If the research is conducted, funded, supported, or regulated by a federal agency that has implement…

Nothing in this chapter relieves the licensee from complying with applicable United States food and drug administration, other federal, and state requirements governing radioactive drugs or devices. Last updated November 18, 2022 at 8:28 AM Authorized By: 3748.02, 3748.04 Amplifi…

(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 pa…

(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, 37…

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 …

(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…

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 fi…

(A) A licensee shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by rule 3701:1-58-69 of the Administrative Code for the duration of use of the unit.(B) The record must contain:(1) The inspector's radioacti…

(A) A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which:(1) The administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:(a) A dose that…

(A) A licensee shall report any dose to an embryo/fetus that is greater than fifty millisievert (five rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/f…

A licensee shall file a report within five days if a leak test required by rule 3701:1-58-27 of the Administrative Code reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report must be filed with the address list…

(A) Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive, to be a physician who:(1) Is an authorized user under rule 3701:…

(A) The licensee shall notify by telephone the department at 614-644-2727 and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in paragraph (A) of rule 3701:1-58-35 of the Administrative Code …

(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 Ad…

(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 bef…

(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 re…

(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…

(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 ra…

(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 administrati…

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…

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 370…

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…

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 reg…

(A) (1) An individual identified as a radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on a United States nuclear regulatory commission or agreement state license or a permit is…

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 continu…

(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) 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 reading…

(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) 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…

(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…

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. Last updated November 18, 2022 at 8:32 AM…

(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 direct…

(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 …

(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 li…

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 man…

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 specia…

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 manufactu…

(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 stronti…

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…

A licensee may use any unsealed radioactive material identified in paragraph (B)(1)(b)(vi) of rule 3701:1-58-40 the 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 r…

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 o…

(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 pri…

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 specia…

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (thirty-three millicurie…

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (thirty-three millicuries) to be …

A licensee shall use only brachytherapy sources:(A) As approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the sealed source and device…

(A) The licensee shall make a survey to locate and account for all sources that have not been implanted immediately after implanting sources in a patient or a human research subject.(B) The licensee shall make a survey of the patient or the human research subject with a radiation…