Title 10

PART 35

Part 35 - Medical Use Of Byproduct Material

PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL Authority:Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); 44 U.S.C. 3504 note. Source:67 FR 20370, Apr. 24, 2002, unless otherwise noted. Editorial Note:Nomenclature changes to part 35 appear at 79 FR 75739, Dec. 19, 2014.

10:1.0.1.1.25.1SUBPART A
Subpart A - General Information
10:1.0.1.1.25.1.94.1SECTION 35.1
   35.1 Purpose and scope.
10:1.0.1.1.25.1.94.2SECTION 35.2
   35.2 Definitions.
10:1.0.1.1.25.1.94.3SECTION 35.5
   35.5 Maintenance of records.
10:1.0.1.1.25.1.94.4SECTION 35.6
   35.6 Provisions for the protection of human research subjects.
10:1.0.1.1.25.1.94.5SECTION 35.7
   35.7 FDA, other Federal, and State requirements.
10:1.0.1.1.25.1.94.6SECTION 35.8
   35.8 Information collection requirements: OMB approval.
10:1.0.1.1.25.1.94.7SECTION 35.10
   35.10 Implementation.
10:1.0.1.1.25.1.94.8SECTION 35.11
   35.11 License required.
10:1.0.1.1.25.1.94.9SECTION 35.12
   35.12 Application for license, amendment, or renewal.
10:1.0.1.1.25.1.94.10SECTION 35.13
   35.13 License amendments.
10:1.0.1.1.25.1.94.11SECTION 35.14
   35.14 Notifications.
10:1.0.1.1.25.1.94.12SECTION 35.15
   35.15 Exemptions regarding Type A specific licenses of broad scope.
10:1.0.1.1.25.1.94.13SECTION 35.18
   35.18 License issuance.
10:1.0.1.1.25.1.94.14SECTION 35.19
   35.19 Specific exemptions.
10:1.0.1.1.25.2SUBPART B
Subpart B - General Administrative Requirements
10:1.0.1.1.25.2.94.1SECTION 35.24
   35.24 Authority and responsibilities for the radiation protection program.
10:1.0.1.1.25.2.94.2SECTION 35.26
   35.26 Radiation protection program changes.
10:1.0.1.1.25.2.94.3SECTION 35.27
   35.27 Supervision.
10:1.0.1.1.25.2.94.4SECTION 35.40
   35.40 Written directives.
10:1.0.1.1.25.2.94.5SECTION 35.41
   35.41 Procedures for administrations requiring a written directive.
10:1.0.1.1.25.2.94.6SECTION 35.49
   35.49 Suppliers for sealed sources or devices for medical use.
10:1.0.1.1.25.2.94.7SECTION 35.50
   35.50 Training for Radiation Safety Officer and Associate Radiation Safety Officer.
10:1.0.1.1.25.2.94.8SECTION 35.51
   35.51 Training for an authorized medical physicist.
10:1.0.1.1.25.2.94.9SECTION 35.55
   35.55 Training for an authorized nuclear pharmacist.
10:1.0.1.1.25.2.94.10SECTION 35.57
   35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
10:1.0.1.1.25.2.94.11SECTION 35.59
   35.59 Recentness of training.
10:1.0.1.1.25.3SUBPART C
Subpart C - General Technical Requirements
10:1.0.1.1.25.3.94.1SECTION 35.60
   35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.
10:1.0.1.1.25.3.94.2SECTION 35.61
   35.61 Calibration of survey instruments.
10:1.0.1.1.25.3.94.3SECTION 35.63
   35.63 Determination of dosages of unsealed byproduct material for medical use.
10:1.0.1.1.25.3.94.4SECTION 35.65
   35.65 Authorization for calibration, transmission, and reference sources.
10:1.0.1.1.25.3.94.5SECTION 35.67
   35.67 Requirements for possession of sealed sources and brachytherapy sources.
10:1.0.1.1.25.3.94.6SECTION 35.69
   35.69 Labeling of vials and syringes.
10:1.0.1.1.25.3.94.7SECTION 35.70
   35.70 Surveys of ambient radiation exposure rate.
10:1.0.1.1.25.3.94.8SECTION 35.75
   35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material.
10:1.0.1.1.25.3.94.9SECTION 35.80
   35.80 Provision of mobile medical service.
10:1.0.1.1.25.3.94.10SECTION 35.92
   35.92 Decay-in-storage.
10:1.0.1.1.25.4SUBPART D
Subpart D - Unsealed Byproduct Material - Written Directive Not Required
10:1.0.1.1.25.4.94.1SECTION 35.100
   35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
10:1.0.1.1.25.4.94.2SECTION 35.190
   35.190 Training for uptake, dilution, and excretion studies.
10:1.0.1.1.25.4.94.3SECTION 35.200
   35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
10:1.0.1.1.25.4.94.4SECTION 35.204
   35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
10:1.0.1.1.25.4.94.5SECTION 35.290
   35.290 Training for imaging and localization studies.
10:1.0.1.1.25.5SUBPART E
Subpart E - Unsealed Byproduct Material - Written Directive Required
10:1.0.1.1.25.5.94.1SECTION 35.300
   35.300 Use of unsealed byproduct material for which a written directive is required.
10:1.0.1.1.25.5.94.2SECTION 35.310
   35.310 Safety instruction.
10:1.0.1.1.25.5.94.3SECTION 35.315
   35.315 Safety precautions.
10:1.0.1.1.25.5.94.4SECTION 35.390
   35.390 Training for use of unsealed byproduct material for which a written directive is required.
10:1.0.1.1.25.5.94.5SECTION 35.392
   35.392 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).
10:1.0.1.1.25.5.94.6SECTION 35.394
   35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).
10:1.0.1.1.25.5.94.7SECTION 35.396
   35.396 Training for the parenteral administration of unsealed byproduct material requiring a written directive.
10:1.0.1.1.25.6SUBPART F
Subpart F - Manual Brachytherapy
10:1.0.1.1.25.6.94.1SECTION 35.400
   35.400 Use of sources for manual brachytherapy.
10:1.0.1.1.25.6.94.2SECTION 35.404
   35.404 Surveys after source implant and removal.
10:1.0.1.1.25.6.94.3SECTION 35.406
   35.406 Brachytherapy sources accountability.
10:1.0.1.1.25.6.94.4SECTION 35.410
   35.410 Safety instruction.
10:1.0.1.1.25.6.94.5SECTION 35.415
   35.415 Safety precautions.
10:1.0.1.1.25.6.94.6SECTION 35.432
   35.432 Calibration measurements of brachytherapy sources.
10:1.0.1.1.25.6.94.7SECTION 35.433
   35.433 Strontium-90 sources for ophthalmic treatments.
10:1.0.1.1.25.6.94.8SECTION 35.457
   35.457 Therapy-related computer systems.
10:1.0.1.1.25.6.94.9SECTION 35.490
   35.490 Training for use of manual brachytherapy sources.
10:1.0.1.1.25.6.94.10SECTION 35.491
   35.491 Training for ophthalmic use of strontium-90.
10:1.0.1.1.25.7SUBPART G
Subpart G - Sealed Sources for Diagnosis
10:1.0.1.1.25.7.94.1SECTION 35.500
   35.500 Use of sealed sources and medical devices for diagnosis.
10:1.0.1.1.25.7.94.2SECTION 35.590
   35.590 Training for use of sealed sources and medical devices for diagnosis.
10:1.0.1.1.25.8SUBPART H
Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
10:1.0.1.1.25.8.94.1SECTION 35.600
   35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
10:1.0.1.1.25.8.94.2SECTION 35.604
   35.604 Surveys of patients and human research subjects treated with a remote afterloader unit.
10:1.0.1.1.25.8.94.3SECTION 35.605
   35.605 Installation, maintenance, adjustment, and repair.
10:1.0.1.1.25.8.94.4SECTION 35.610
   35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.8.94.5SECTION 35.615
   35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.8.94.6SECTION 35.630
   35.630 Dosimetry equipment.
10:1.0.1.1.25.8.94.7SECTION 35.632
   35.632 Full calibration measurements on teletherapy units.
10:1.0.1.1.25.8.94.8SECTION 35.633
   35.633 Full calibration measurements on remote afterloader units.
10:1.0.1.1.25.8.94.9SECTION 35.635
   35.635 Full calibration measurements on gamma stereotactic radiosurgery units.
10:1.0.1.1.25.8.94.10SECTION 35.642
   35.642 Periodic spot-checks for teletherapy units.
10:1.0.1.1.25.8.94.11SECTION 35.643
   35.643 Periodic spot-checks for remote afterloader units.
10:1.0.1.1.25.8.94.12SECTION 35.645
   35.645 Periodic spot-checks for gamma stereotactic radiosurgery units.
10:1.0.1.1.25.8.94.13SECTION 35.647
   35.647 Additional technical requirements for mobile remote afterloader units.
10:1.0.1.1.25.8.94.14SECTION 35.652
   35.652 Radiation surveys.
10:1.0.1.1.25.8.94.15SECTION 35.655
   35.655 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.8.94.16SECTION 35.657
   35.657 Therapy-related computer systems.
10:1.0.1.1.25.8.94.17SECTION 35.690
   35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.9SUBPART I
Subparts I-J [Reserved]
10:1.0.1.1.25.10SUBPART K
Subpart K - Other Medical Uses of Byproduct Material or Radiation From Byproduct Material
10:1.0.1.1.25.10.94.1SECTION 35.1000
   35.1000 Other medical uses of byproduct material or radiation from byproduct material.
10:1.0.1.1.25.11SUBPART L
Subpart L - Records
10:1.0.1.1.25.11.94.1SECTION 35.2024
   35.2024 Records of authority and responsibilities for radiation protection programs.
10:1.0.1.1.25.11.94.2SECTION 35.2026
   35.2026 Records of radiation protection program changes.
10:1.0.1.1.25.11.94.3SECTION 35.2040
   35.2040 Records of written directives.
10:1.0.1.1.25.11.94.4SECTION 35.2041
   35.2041 Records for procedures for administrations requiring a written directive
10:1.0.1.1.25.11.94.5SECTION 35.2060
   35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct material.
10:1.0.1.1.25.11.94.6SECTION 35.2061
   35.2061 Records of radiation survey instrument calibrations.
10:1.0.1.1.25.11.94.7SECTION 35.2063
   35.2063 Records of dosages of unsealed byproduct material for medical use.
10:1.0.1.1.25.11.94.8SECTION 35.2067
   35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources.
10:1.0.1.1.25.11.94.9SECTION 35.2070
   35.2070 Records of surveys for ambient radiation exposure rate.
10:1.0.1.1.25.11.94.10SECTION 35.2075
   35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.
10:1.0.1.1.25.11.94.11SECTION 35.2080
   35.2080 Records of mobile medical services.
10:1.0.1.1.25.11.94.12SECTION 35.2092
   35.2092 Records of decay-in-storage.
10:1.0.1.1.25.11.94.13SECTION 35.2204
   35.2204 Records of molybdenum-99, strontium-82, and strontium-85 concentrations.
10:1.0.1.1.25.11.94.14SECTION 35.2310
   35.2310 Records of safety instruction.
10:1.0.1.1.25.11.94.15SECTION 35.2404
   35.2404 Records of surveys after source implant and removal.
10:1.0.1.1.25.11.94.16SECTION 35.2406
   35.2406 Records of brachytherapy source accountability.
10:1.0.1.1.25.11.94.17SECTION 35.2432
   35.2432 Records of calibration measurements of brachytherapy sources.
10:1.0.1.1.25.11.94.18SECTION 35.2433
   35.2433 Records of decay of strontium-90 sources for ophthalmic treatments.
10:1.0.1.1.25.11.94.19SECTION 35.2605
   35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.11.94.20SECTION 35.2610
   35.2610 Records of safety procedures.
10:1.0.1.1.25.11.94.21SECTION 35.2630
   35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.11.94.22SECTION 35.2632
   35.2632 Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.
10:1.0.1.1.25.11.94.23SECTION 35.2642
   35.2642 Records of periodic spot-checks for teletherapy units.
10:1.0.1.1.25.11.94.24SECTION 35.2643
   35.2643 Records of periodic spot-checks for remote afterloader units.
10:1.0.1.1.25.11.94.25SECTION 35.2645
   35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units.
10:1.0.1.1.25.11.94.26SECTION 35.2647
   35.2647 Records of additional technical requirements for mobile remote afterloader units.
10:1.0.1.1.25.11.94.27SECTION 35.2652
   35.2652 Records of surveys of therapeutic treatment units.
10:1.0.1.1.25.11.94.28SECTION 35.2655
   35.2655 Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
10:1.0.1.1.25.12SUBPART M
Subpart M - Reports
10:1.0.1.1.25.12.94.1SECTION 35.3045
   35.3045 Report and notification of a medical event.
10:1.0.1.1.25.12.94.2SECTION 35.3047
   35.3047 Report and notification of a dose to an embryo/fetus or a nursing child.
10:1.0.1.1.25.12.94.3SECTION 35.3067
   35.3067 Report of a leaking source.
10:1.0.1.1.25.12.94.4SECTION 35.3204
   35.3204 Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
10:1.0.1.1.25.13SUBPART N
Subpart N - Enforcement
10:1.0.1.1.25.13.94.1SECTION 35.4001
   35.4001 Violations.
10:1.0.1.1.25.13.94.2SECTION 35.4002
   35.4002 Criminal penalties.