10 CFR 35 — Medical Use of Byproduct Material

Nuclear-medicine rules behind AFI 48-148 and MTF radiation safety. 111 sections, full current text (eCFR edition 2026-07-15), each cross-linked to the AF pubs that cite it.

SectionTitleAF citations
35.1Purpose and scope.
35.2Definitions.3 × 1 pubs
35.5Maintenance of records.
35.6Provisions for the protection of human research subjects.
35.7FDA, other Federal, and State requirements.
35.8Information collection requirements: OMB approval.
35.10Implementation.
35.11License required.
35.12Application for license, amendment, or renewal.
35.13License amendments.
35.14Notifications.
35.15Exemptions regarding Type A specific licenses of broad scope.
35.18License issuance.
35.19Specific exemptions.
35.24Authority and responsibilities for the radiation protection program.1 × 1 pubs
35.26Radiation protection program changes.3 × 1 pubs
35.27Supervision.
35.40Written directives.4 × 1 pubs
35.41Procedures for administrations requiring a written directive.
35.49Suppliers for sealed sources or devices for medical use.
35.50Training for Radiation Safety Officer and Associate Radiation Safety Officer.
35.51Training for an authorized medical physicist.3 × 1 pubs
35.55Training for an authorized nuclear pharmacist.
35.57Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
35.59Recentness of training.3 × 1 pubs
35.60Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.
35.61Calibration of survey instruments.
35.63Determination of dosages of unsealed byproduct material for medical use.
35.65Authorization for calibration, transmission, and reference sources.
35.67Requirements for possession of sealed sources and brachytherapy sources.
35.69Labeling of vials and syringes.
35.70Surveys of ambient radiation exposure rate.
35.75Release of individuals containing unsealed byproduct material or implants containing byproduct material.3 × 1 pubs
35.80Provision of mobile medical service.
35.92Decay-in-storage.7 × 1 pubs
35.100Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
35.190Training for uptake, dilution, and excretion studies.
35.200Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
35.204Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
35.290Training for imaging and localization studies.
35.300Use of unsealed byproduct material for which a written directive is required.
35.310Safety instruction.
35.315Safety precautions.
35.390Training for use of unsealed byproduct material for which a written directive is required.
35.392Training 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).
35.394Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).
35.396Training for the parenteral administration of unsealed byproduct material requiring a written directive.
35.400Use of sources for manual brachytherapy.
35.404Surveys after source implant and removal.
35.406Brachytherapy sources accountability.
35.410Safety instruction.
35.415Safety precautions.
35.432Calibration measurements of brachytherapy sources.
35.433Strontium-90 sources for ophthalmic treatments.
35.457Therapy-related computer systems.
35.490Training for use of manual brachytherapy sources.
35.491Training for ophthalmic use of strontium-90.
35.500Use of sealed sources and medical devices for diagnosis.
35.590Training for use of sealed sources and medical devices for diagnosis.
35.600Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
35.604Surveys of patients and human research subjects treated with a remote afterloader unit.
35.605Installation, maintenance, adjustment, and repair.
35.610Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
35.615Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
35.630Dosimetry equipment.
35.632Full calibration measurements on teletherapy units.
35.633Full calibration measurements on remote afterloader units.
35.635Full calibration measurements on gamma stereotactic radiosurgery units.
35.642Periodic spot-checks for teletherapy units.
35.643Periodic spot-checks for remote afterloader units.
35.645Periodic spot-checks for gamma stereotactic radiosurgery units.
35.647Additional technical requirements for mobile remote afterloader units.
35.652Radiation surveys.
35.655Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
35.657Therapy-related computer systems.
35.690Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
35.1000Other medical uses of byproduct material or radiation from byproduct material.
35.2024Records of authority and responsibilities for radiation protection programs.2 × 1 pubs
35.2026Records of radiation protection program changes.2 × 1 pubs
35.2040Records of written directives.2 × 1 pubs
35.2041Records for procedures for administrations requiring a written directive2 × 1 pubs
35.2060Records of calibrations of instruments used to measure the activity of unsealed byproduct material.2 × 1 pubs
35.2061Records of radiation survey instrument calibrations.2 × 1 pubs
35.2063Records of dosages of unsealed byproduct material for medical use.2 × 1 pubs
35.2067Records of leaks tests and inventory of sealed sources and brachytherapy sources.3 × 1 pubs
35.2070Records of surveys for ambient radiation exposure rate.2 × 1 pubs
35.2075Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.6 × 1 pubs
35.2080Records of mobile medical services.4 × 1 pubs
35.2092Records of decay-in-storage.3 × 1 pubs
35.2204Records of molybdenum-99, strontium-82, and strontium-85 concentrations.2 × 1 pubs
35.2310Records of safety instruction.2 × 1 pubs
35.2404Records of surveys after source implant and removal.2 × 1 pubs
35.2406Records of brachytherapy source accountability.2 × 1 pubs
35.2432Records of calibration measurements of brachytherapy sources.2 × 1 pubs
35.2433Records of decay of strontium-90 sources for ophthalmic treatments.
35.2605Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
35.2610Records of safety procedures.
35.2630Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
35.2632Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.
35.2642Records of periodic spot-checks for teletherapy units.
35.2643Records of periodic spot-checks for remote afterloader units.
35.2645Records of periodic spot-checks for gamma stereotactic radiosurgery units.
35.2647Records of additional technical requirements for mobile remote afterloader units.
35.2652Records of surveys of therapeutic treatment units.
35.2655Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
35.3045Report and notification of a medical event.5 × 2 pubs
35.3047Report and notification of a dose to an embryo/fetus or a nursing child.
35.3067Report of a leaking source.
35.3204Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
35.4001Violations.
35.4002Criminal penalties.
Unofficial reference aid. Confirm against the current eCFR edition before citing in a finding.
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