333–116–0010
Purpose and Scope
333–116–0020
Definitions
333–116–0025
FDA, Other Federal, and State Requirements
333–116–0027
Implementation
333–116–0030
License Required
333–116–0035
Application for License, Amendment, or Renewal
333–116–0040
License Amendments
333–116–0045
Provisions for Research Involving Human Subjects.
333–116–0050
Notifications
333–116–0055
Exemptions Regarding Type a Specific Licenses of Broad Scope
333–116–0057
License Issuance
333–116–0059
Specific Exemptions
333–116–0090
Authority and Responsibilities for the Radiation Protection Program
333–116–0100
Supervision
333–116–0105
Written Directives
333–116–0107
Procedures for Administrations Requiring a Written Directive
333–116–0110
Visiting Authorized User
333–116–0120
Mobile Nuclear Medicine Service Administrative Requirements
333–116–0123
Radiation Safety Program Changes
333–116–0125
Quality Management Program
333–116–0140
Suppliers
333–116–0150
Quality Control of Imaging Equipment
333–116–0160
Possession, Use, Calibration and Check of Dose Calibrators
333–116–0165
Possession, Use Calibration, and Check of Instruments to Measure Dosages of Alpha- or Beta-emitting Radionuclides
333–116–0170
Calibration and Check of Survey Instrument
333–116–0180
Determination of Dosages of Unsealed Radioactive Material for Medical Use
333–116–0190
Authorization for Calibration and Reference Source
333–116–0200
Requirements for Possession of Sealed Sources and Brachytherapy Sources
333–116–0220
Labeling of Vials and Syringes
333–116–0250
Surveys for Contamination and Ambient Radiation Dose Rate
333–116–0255
Surveys Of Patients And Human Research Subjects Treated With A Remote Afterloader Unit
333–116–0260
Release of Patients Containing Therapeutic Quantities of Byproduct material or Permanent Implants
333–116–0280
Storage of Volatiles and Gases
333–116–0290
Decay-In-Storage
333–116–0300
Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required
333–116–0310
Possession of Survey Instrument
333–116–0320
Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required
333–116–0330
Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration
333–116–0340
Control of Aerosols and Gases
333–116–0350
Possession of Survey Instruments
333–116–0360
Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required
333–116–0370
Imaging and Localization: Safety Instruction
333–116–0380
Imaging and Localization: Safety Precautions
333–116–0390
Possession of Survey Instruments
333–116–0400
Use of Sealed Sources for Diagnosis
333–116–0410
Availability of Survey Instrument
333–116–0420
Use of Sources for Manual Brachytherapy
333–116–0425
Surveys After Source Implant and Removal
333–116–0430
Safety Instructions
333–116–0440
Safety Precaution
333–116–0445
Calibration Measurements of Brachytherapy Sources
333–116–0447
Decay of Strontium-90 Sources for Ophthalmic Treatments
333–116–0450
Brachytherapy Sources Inventory
333–116–0460
Release of Patients Treated with Temporary Implant
333–116–0470
Possession of Survey Instruments
333–116–0475
Therapy Related Computer Systems
333–116–0480
Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit
333–116–0485
Other Medical Uses of Byproduct Material or Radiation from Byproduct Material
333–116–0490
Installation, Maintenance, Adjustment and Repair
333–116–0495
Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
333–116–0500
Amendment
333–116–0525
Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
333–116–0530
Possession of Survey Instrument
333–116–0540
Radiation Monitoring Device
333–116–0550
Viewing System
333–116–0560
Dosimetry Equipment
333–116–0570
Full Calibration Measurement
333–116–0573
Full Calibration Measurements on Remote Afterloader Units
333–116–0577
Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units
333–116–0580
Periodic Spot-Checks for Teletherapy Units
333–116–0583
Periodic Spot-checks for Remote Afterloader Units
333–116–0585
Additional Technical Requirements for Mobile Remote Afterloader Units
333–116–0587
Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units
333–116–0590
Radiation Surveys Therapeutic Treatment Units
333–116–0600
Safety Checks and Five-year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units
333–116–0605
Therapy-Related Computer Systems
333–116–0610
Modification of Teletherapy Unit or Room Before Beginning a Treatment Program
333–116–0620
Reports of Teletherapy Surveys, Checks, Tests and Measurements
333–116–0640
Radiation Safety Officer Training and Experience Requirements
333–116–0650
Training for Experienced Radiation Safety Officer
333–116–0660
Training for Uptake, Dilution or Excretion Studies
333–116–0670
Training for Imaging and Localization Studies
333–116–0680
Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required
333–116–0683
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)
333–116–0687
Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than 1.22 Gigabecquerels (33 millicuries)
333–116–0690
Training for Therapeutic Use of Brachytherapy Source
333–116–0700
Training for Ophthalmic Use of Strontium-90
333–116–0710
Training for Use of Sealed Sources for Diagnosis
333–116–0715
Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive
333–116–0720
Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
333–116–0730
Training for Teletherapy or Brachytherapy Physicist
333–116–0740
Training for Experienced Authorized User, Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Nuclear Pharmacist or Authorized Nuclear Pharmacist
333–116–0750
Physician Training in a Three Month Program
333–116–0760
Recentness of Training
333–116–0800
Licensing and Registration of Positron Emission Tomography (PET) Facilities
333–116–0810
Supervision of PET Facilities
333–116–0820
Other Applicable Requirements
333–116–0830
Accelerator Facility Requirements
333–116–0840
Safety Considerations and Quality Management for PET Facilities
333–116–0850
Radiopharmacy and Radiochemical Production
333–116–0870
Rubidium-82 Generator
333–116–0880
Training and Experience for PET, PET/CT and SPECT/CT Personnel
333–116–0905
Training for Authorized Medical Physicist
333–116–0910
Training for an Authorized Nuclear Pharmacist
333–116–0915
Training for Experienced Nuclear Pharmacists
333–116–1000
Report and Notification of a Medical Event
333–116–1015
Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child
333–116–1030
Report Of A Leaking Source
Last Updated

Jun. 8, 2021

Rule 333-116-0400’s source at or​.us