justicedao/ipfs_state_laws huggingface dataset:
333-116-0300 Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required (1) A licensee may use any unsealed radioactive material for a diagnostic use involving measurements of uptake, dilution or excretion that: (a) The Food and Drug Administration (FDA) has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA); and (b) Is obtained from a manufacturer or preparer licensed under OAR 333-102-0285 or equivalent Nuclear Regulatory Commission or Agreement State requirements; or (c) Is prepared and compounded by an authorized nuclear pharmacist, a physician who is an authorized user, or an individual under the supervision of either as specified in OAR 333-116-0100, 333-116-0670 and 333-116-0670(3)(B); or (d) Is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA. (2) A licensee using a radiopharmaceutical specified in section (1) of this rule for a clinical procedure other than one specified in the product label or package insert instructions for use must comply with the product label or package insert instructions regarding physical form, route of administration and dosage range. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 18-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0310 Possession of Survey Instrument A licensee authorized to use radioactive material for uptake, dilution and excretion studies must have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range one Sv (0.1 mrem) per hour to one mSv (100 mrem) per hour. The instrument must be operable and calibrated in accordance with OAR 333-116-0170. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 19-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0320 Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required (1) A licensee may use any radioactive material in a diagnostic radiopharmaceutical, except aerosol or gaseous form, or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for: (a) Which the Food and Drug Administration has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA); or (b) Which is prepared and compounded by an authorized nuclear pharmacist, a physician who is an authorized user, or an individual under the supervision of either as specified in OAR 333-116-0100, 333-116-0670 or 333-116-0680; or (c) Obtained from a manufacturer or preparer licensed under divisions 333-102 and 333-116 or equivalent Nuclear Regulatory Commission or Agreement State requirements. (2) A licensee using radiopharmaceuticals specified in section (1) of this rule for clinical procedures other than one specified in the product label or package insert instructions must comply with the product label or package insert regarding physical form and dosage range. (3) A licensee must elute generators in compliance with OAR 333-116-0330 and prepare radiopharmaceuticals from kits in accordance with the manufacturer's instructions. (4) Technetium-99m pentetate as an aerosol for lung function studies is not subject to the restrictions in section (1) of this rule. Provided the conditions of OAR 333-116-0340 are met, a licensee must use radioactive aerosols or gases only if specific application is made to and approved by the Authority. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 20-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0330 Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration (1) A licensee must not administer to humans a radiopharmaceutical containing more than 0.15 kBq (0.15 uCi) of molybdenum-99 per MBq (mCi) 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). (3) A licensee that uses molybdenum-99/technetium-99 generators for preparing technetium-99m radiopharmaceuticals must measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with section (1) of this rule. (4) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with section (1) of this rule. (5) A licensee who must measure molybdenum concentration or strontium-82 and strontium-85 must retain a record of each measurement in accordance with OAR 333-100-0057. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in MBq (mCi), the measured activity of the molybdenum expressed in kBq (uCi), the ratio of the measures expressed as kBq (uCi) of molybdenum per MBq (mCi) of technetium, the date of the test and the initials of the individual who performed the test. (6) A licensee must report immediately to the Authority in accordance with OAR 333-116-1011 each occurrence of molybdenum-99 concentration exceeding the limits specified in section (1) of this rule. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 21-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0340 Control of Aerosols and Gases (1) A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed by OAR 333-120-0130 and 333-120-0180. (2) The system must 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. (3) A licensee must only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms. (4) Before receiving, using or storing a radioactive gas, the licensee must calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in 10 CFR Part 20 Appendix B to 20.1001 to 20.2401. The calculation must be based on the highest activity of gas handled in a single container and the measured available air exhaust rate. (5) A licensee must post the time calculated in accordance with section (4) of this rule at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed. (6) A licensee must check the operation of collection systems before each use and measure the ventilation rates in areas of use at intervals not to exceed six months. Records of these checks and measurements must be maintained for five years or until inspected by the Authority. (7) A copy of the calculations required in section (4) of this rule must be recorded and retained for the duration of the license. [Publications: Publications referenced are available from the agency.] Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 22-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0350 Possession of Survey Instruments A licensee authorized to use radioactive material for imaging and localization studies must have in its possession a portable, radiation detection survey instrument capable of detecting dose rates over the range of one Sv (0.1 mrem) per hour to one mSv (100 mrem) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten Sv (1 mrem) per hour to ten millisieverts (1000 mrem) per hour. The instruments must be operable and calibrated in accordance with OAR 333-116-0170. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 23-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0360 Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required A licensee may use any unsealed radioactive material identified in OAR 333-116-0680(2)(b)(F) prepared for medical use for which a written directive is required that is obtained from: (1) A manufacturer or preparer licensed under OAR 333-102-0285, U.S. Nuclear Regulatory Commission, or equivalent Agreement State requirements; or (2) A PET radiopharmaceutical producer licensed under OAR 333-102-0190(11) U.S. Nuclear Regulatory Commission or equivalent Agreement State requirements; or (3) Excluding production of PET radionuclides, prepared by: (a) An authorized nuclear pharmacist; (b) A physician who is an authorized user on a license from the Authority, other Agreement State, or the U.S. Nuclear Regulatory Commission and meets the specified requirements in OAR 333-116-0670 or 333-116-0680; or (c) An individual under the supervision, as specified in OAR 333-116-0100, of the authorized nuclear pharmacist in subsection (3)(a) of this rule or the physician who is an authorized user in subsection (3)(b) of this rule; or (4) Obtained from and prepared by an Authority, U.S. Nuclear Regulatory Commission, or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by the Food and Drug Administration; or (5) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 24-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 4-2010, f. & cert. ef. 2-16-10 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0370 Safety Instructions (1) A licensee must provide oral and written radiation safety instruction for all personnel caring for patients or human research subjects undergoing radiopharmaceutical therapy who cannot be released under OAR 333-116-0260. Refresher training must be provided at intervals not to exceed one year. (2) To satisfy section (1) of this rule, the instruction must describe the licensee's procedures for: (a) Patient or human research subject control; (b) Visitor control; including (A) Routine visitation to hospitalized individuals in accordance with OAR 333-120-0180(1)(a); and (B) Visitation authorized in accordance with OAR 333-120-0180(3). (c) Contamination control; (d) Waste control; and (e) Notification of the Radiation Safety Officer or authorized user in case of the patient's death or medical emergency. (3) A licensee must maintain, in accordance with OAR 333-100-0057, a list of individuals receiving instruction required by section (1) of this rule, a description of the instruction, the date of instruction and the name of the individual who gave the instruction. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 114-2024, minor correction filed 12/10/2024, effective 12/10/2024 PH 25-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0390 Possession of Survey Instruments A licensee authorized to use radioactive material for radiopharmaceutical therapy must have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 1 uSv (0.1 mrem) per hour to 1 mSv (100 mRem) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 uSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The instruments must be operable and calibrated in accordance with OAR 333-116-0170. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 27-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0400 Use of Sealed Sources for Diagnosis (1) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry. (2) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry. (3) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of OAR 333-116-0140(6) are met. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 28-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0410 Availability of Survey Instrument A licensee authorized to use radioactive material as a sealed source for diagnostic purposes must have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to 100 mrem (one mSv) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (1 mrem) per hour to ten mSv (1000 mrem) per hour. The instrument must be operable and calibrated in accordance with OAR 333-116-0170. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 29-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0420 Use of Sources for Manual Brachytherapy A licensee must use only brachytherapy sources for therapeutic medical uses: (1) 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 Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (2) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the Food and Drug Administration and are manufactured, labeled, packaged and distributed under a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State provided that the requirements of OAR 333-116-0140 are met. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 30-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0425 Surveys After Source Implant and Removal (1) Immediately after implanting sources in a patient or a human research subject, the licensee must make a survey to locate and account for all sources that have not been implanted. (2) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee must make a survey of the room and the patient or the human research subject with an appropriate radiation detection survey instrument to confirm that all sources have been removed. (3) A licensee must retain a record of the surveys required by sections (1) and (2) of this rule in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 31-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06
333-116-0430 Safety Instructions (1) The licensee must provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training must be provided at intervals not to exceed one year. (2) To satisfy section (1) of this rule, the instruction must describe: (a) Size and appearance of the brachytherapy sources; (b) Safe handling and shielding instructions in case of a dislodged source; (c) Procedures for patient control; (d) Procedures for visitor control including both: (A) Routine visitation to hospitalized individuals in accordance with OAR 333-120-0180(1)(a); and (B) Visitation authorized in accordance with OAR 333-120-0180(3); and (e) Procedures for notification of the Radiation Safety Officer or authorized user if the patient dies or has a medical emergency. (3) A licensee must retain a record of individuals receiving instruction required by section (1) of this rule in accordance with OAR 333-100-0057. The record must contain a description of the instruction, the date of instruction and the name of the individual who gave the instruction. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0440 Safety Precaution (1) A licensee must, for each patient or human research subject receiving implant therapy: (a) Not place the patient or human research subject in the same room with a patient or human research subject who is not receiving radiation therapy; (b) Post the patient's or human research subject's door with a "Caution: Radioactive Materials" sign and note on the door or in the patient's chart where and how long visitors may stay in the patient's room; (c) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer; (d) Promptly after implanting the sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with OAR 333-120-0180 of these rules. Retain a record of each survey in accordance with OAR 333-100-0057. Each record must include the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts (mrem) per hour, the instrument used to make the survey and the initials of the individual who made the survey; and (e) Instruct the patient or human research subject and, where appropriate, the patient's or human research subject's family, orally and in writing concerning radiation safety precautions that will help to keep the radiation dose to household members and the public as low as reasonably achievable before releasing the patient if the patient was administered a permanent implant. (2) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source: (a) Dislodged from the patient; and (b) Lodged within the patient following removal of the source applicators. (3) A licensee must notify the Radiation Safety Officer or authorized user immediately if the patient or human research subject dies or has a medical emergency. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 33-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91