CFR /  Title 10  /  Part 35: Medical Use Of Byproduct Material

Section No.	Description
Section 35.1	Definitions
Section 35.2	Maintenance of records
Section 35.5	Provisions for the protection of human research subjects
Section 35.6	FDA, other Federal, and State requirements
Section 35.7	Information collection requirements: OMB approval
Section 35.8	Implementation
Section 35.10	License required
Section 35.11	Application for license, amendment, or renewal
Section 35.12	License amendments
Section 35.13	Notifications
Section 35.14	Exemptions regarding Type A specific licenses of broad scope
Section 35.15	License issuance
Section 35.18	Specific exemptions
Section 35.19	Authority and responsibilities for the radiation protection program
Section 35.24	Radiation protection program changes
Section 35.26	Supervision
Section 35.27	Written directives
Section 35.40	Procedures for administrations requiring a written directive
Section 35.41	Suppliers for sealed sources or devices for medical use
Section 35.49	Training for Radiation Safety Officer
Section 35.50	Training for an authorized medical physicist
Section 35.51	Training for an authorized nuclear pharmacist
Section 35.55	Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist,
Section 35.57	Recentness of training
Section 35.59	Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material
Section 35.60	Calibration of survey instruments
Section 35.61	Determination of dosages of unsealed byproduct material for medical use
Section 35.63	Authorization for calibration, transmission, and reference sources
Section 35.65	Requirements for possession of sealed sources and brachytherapy sources
Section 35.67	Labeling of vials and syringes
Section 35.69	Surveys of ambient radiation exposure rate
Section 35.70	Release of individuals containing unsealed byproduct material or implants containing byproduct material
Section 35.75	Provision of mobile medical service
Section 35.80	Decay-in-storage
Section 35.92	Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required
Section 35.100	Training for uptake, dilution, and excretion studies
Section 35.190	Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required
Section 35.200	Permissible molybdenum-99, strontium-82, and strontium-85 concentrations
Section 35.204	Training for imaging and localization studies
Section 35.290	Use of unsealed byproduct material for which a written directive is required
Section 35.300	Safety instruction
Section 35.310	Safety precautions
Section 35.315	Training for use of unsealed byproduct material for which a written directive is required
Section 35.390	Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal
Section 35.392	Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than
Section 35.394	Training for the parenteral administration of unsealed byproduct material requiring a written directive
Section 35.396	Use of sources for manual brachytherapy
Section 35.400	Surveys after source implant and removal
Section 35.404	Brachytherapy sources accountability
Section 35.406	Safety instruction
Section 35.410	Safety precautions
Section 35.415	Calibration measurements of brachytherapy sources
Section 35.432	Decay of strontium-90 sources for ophthalmic treatments
Section 35.433	Therapy-related computer systems
Section 35.457	Training for use of manual brachytherapy sources
Section 35.490	Training for ophthalmic use of strontium-90
Section 35.491	Use of sealed sources for diagnosis
Section 35.500	Training for use of sealed sources for diagnosis
Section 35.590	Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit
Section 35.600	Surveys of patients and human research subjects treated with a remote afterloader unit
Section 35.604	Installation, maintenance, adjustment, and repair
Section 35.605	Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
Section 35.610	Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
Section 35.615	Dosimetry equipment
Section 35.630	Full calibration measurements on teletherapy units
Section 35.632	Full calibration measurements on remote afterloader units
Section 35.633	Full calibration measurements on gamma stereotactic radiosurgery units
Section 35.635	Periodic spot-checks for teletherapy units
Section 35.642	Periodic spot-checks for remote afterloader units
Section 35.643	Periodic spot-checks for gamma stereotactic radiosurgery units
Section 35.645	Additional technical requirements for mobile remote afterloader units
Section 35.647	Radiation surveys
Section 35.652	Five-year inspection for teletherapy and gamma stereotactic radiosurgery units
Section 35.655	Therapy-related computer systems
Section 35.657	Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
Section 35.690	Other medical uses of byproduct material or radiation from byproduct material
Section 35.1000	Records of authority and responsibilities for radiation protection programs
Section 35.2024	Records of radiation protection program changes
Section 35.2026	Records of written directives
Section 35.2040	Records for procedures for administrations requiring a written directive
Section 35.2041	Records of calibrations of instruments used to measure the activity of unsealed byproduct material
Section 35.2060	Records of radiation survey instrument calibrations
Section 35.2061	Records of dosages of unsealed byproduct material for medical use
Section 35.2063	Records of leaks tests and inventory of sealed sources and brachytherapy sources
Section 35.2067	Records of surveys for ambient radiation exposure rate
Section 35.2070	Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material
Section 35.2075	Records of mobile medical services
Section 35.2080	Records of decay-in-storage
Section 35.2092	Records of molybdenum-99, strontium-82, and strontium-85 concentrations
Section 35.2204	Records of safety instruction
Section 35.2310	Records of surveys after source implant and removal
Section 35.2404	Records of brachytherapy source accountability
Section 35.2406	Records of calibration measurements of brachytherapy sources
Section 35.2432	Records of decay of strontium-90 sources for ophthalmic treatments
Section 35.2433	Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma
Section 35.2605	Records of safety procedures
Section 35.2610	Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic
Section 35.2630	Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations
Section 35.2632	Records of periodic spot-checks for teletherapy units
Section 35.2642	Records of periodic spot-checks for remote afterloader units
Section 35.2643	Records of periodic spot-checks for gamma stereotactic radiosurgery units
Section 35.2645	Records of additional technical requirements for mobile remote afterloader units
Section 35.2647	Records of surveys of therapeutic treatment units
Section 35.2652	Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units
Section 35.2655	Report and notification of a medical event
Section 35.3045	Report and notification of a dose to an embryo/fetus or a nursing child
Section 35.3047	Report of a leaking source
Section 35.3067	Violations
Section 35.4001	Criminal penalties
Section 35.4002	Purpose and scope