Title 10, Part 35 — Medical Use of Byproduct Material

Purpose and scope.

Definitions.

Maintenance of records.

Provisions for the protection of human research subjects.

FDA, other Federal, and State requirements.

Information collection requirements: OMB approval.

Implementation.

License required.

Application for license, amendment, or renewal.

License amendments.

Notifications.

Exemptions regarding Type A specific licenses of broad scope.

License issuance.

Specific exemptions.

Authority and responsibilities for the radiation protection program.

Radiation protection program changes.

Supervision.

Written directives.

Procedures for administrations requiring a written directive.

Suppliers for sealed sources or devices for medical use.

Training for Radiation Safety Officer and Associate Radiation Safety Officer.

Training for an authorized medical physicist.

Training for an authorized nuclear pharmacist.

Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

Recentness of training.

Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.

Calibration of survey instruments.

Determination of dosages of unsealed byproduct material for medical use.

Authorization for calibration, transmission, and reference sources.

Requirements for possession of sealed sources and brachytherapy sources.

Labeling of vials and syringes.

Surveys of ambient radiation exposure rate.

Release of individuals containing unsealed byproduct material or implants containing byproduct material.

Provision of mobile medical service.

Decay-in-storage.

Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

Training for uptake, dilution, and excretion studies.

Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

Training for imaging and localization studies.

Use of unsealed byproduct material for which a written directive is required.

Safety instruction.

Safety precautions.

Training for use of unsealed byproduct material for which a written directive is required.

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).

Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

Training for the parenteral administration of unsealed byproduct material requiring a written directive.

Use of sources for manual brachytherapy.

Surveys after source implant and removal.

Brachytherapy sources accountability.

Safety instruction.

Safety precautions.

Calibration measurements of brachytherapy sources.

Strontium-90 sources for ophthalmic treatments.

Therapy-related computer systems.

Training for use of manual brachytherapy sources.

Training for ophthalmic use of strontium-90.

Use of sealed sources and medical devices for diagnosis.

Training for use of sealed sources and medical devices for diagnosis.

Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

Surveys of patients and human research subjects treated with a remote afterloader unit.

Installation, maintenance, adjustment, and repair.

Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Dosimetry equipment.

Full calibration measurements on teletherapy units.

Full calibration measurements on remote afterloader units.

Full calibration measurements on gamma stereotactic radiosurgery units.

Periodic spot-checks for teletherapy units.

Periodic spot-checks for remote afterloader units.

Periodic spot-checks for gamma stereotactic radiosurgery units.

Additional technical requirements for mobile remote afterloader units.

Radiation surveys.

Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

Therapy-related computer systems.

Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Other medical uses of byproduct material or radiation from byproduct material.

Records of authority and responsibilities for radiation protection programs.

Records of radiation protection program changes.

Records of written directives.

Records for procedures for administrations requiring a written directive

Records of calibrations of instruments used to measure the activity of unsealed byproduct material.

Records of radiation survey instrument calibrations.

Records of dosages of unsealed byproduct material for medical use.

Records of leaks tests and inventory of sealed sources and brachytherapy sources.

Records of surveys for ambient radiation exposure rate.

Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.

Records of mobile medical services.

Records of decay-in-storage.

Records of molybdenum-99, strontium-82, and strontium-85 concentrations.

Records of safety instruction.

Records of surveys after source implant and removal.

Records of brachytherapy source accountability.

Records of calibration measurements of brachytherapy sources.

Records of decay of strontium-90 sources for ophthalmic treatments.

Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Records of safety procedures.

Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.

Records of periodic spot-checks for teletherapy units.

Records of periodic spot-checks for remote afterloader units.

Records of periodic spot-checks for gamma stereotactic radiosurgery units.

Records of additional technical requirements for mobile remote afterloader units.

Records of surveys of therapeutic treatment units.

Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

Report and notification of a medical event.

Report and notification of a dose to an embryo/fetus or a nursing child.

Report of a leaking source.

Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

Violations.

Criminal penalties.