Program, derives from the NRC's general responsibilities for protecting public health and safety in connection with nuclear reactors. All other sources and medical uses of ionizing radiation are regulated by other entities, such as the states or the FDA.4

Through the Medical Use Program, the NRC licenses facilities, authorizes physician users, develops radiation safety regulations, sets criteria for determining misadministration of byproduct materials in medical use, orders prompt reporting of misadministrations, conducts compliance inspections, applies a system of sanctions for infractions of its regulations, and assesses and collects fees and fines. The program is administered through two different systems. In 29 states ("Agreement States"), the NRC formally delegates authority to regulate byproduct material to the state government. In the remaining 21 states ("Non-Agreement States"), the NRC directly licenses, monitors, inspects, and enforces its regulations for approximately 2,000 licensed users and institutions.

Over the years, the NRC has intensified its regulation of radiation medicine. In 1967, its predecessor, the Atomic Energy Commission (AEC), codified its medical regulations into a new Part 35 of Title 10 of the Code of Federal Regulations (CFR); this covered both the medical use of radioactive drugs and the use of radiation devices. although medical licensees are required to comply with many other sections of Title 10, Part 35 (Medical Use of Byproduct Material) is the most important.

Part 35 contains provisions designed to protect workers from radiation devices, beams, and sources. For example, to protect patients scheduled for radiation procedures, Part 35 requires quality management (QM) procedures (35.32), a measurement of each dose prior to administration (35.53), a survey of the patient after removal of temporary implants (35.406), and safety checks of teletherapy machines and rooms (35.615). Finally, other sections pertain to protection of the public and of patients not scheduled for radiation procedures; these provisions include surveys before returning radiation areas to unrestricted use (35.315, 35.415), criteria for releasing patients who have received doses of radioactivity (35.75), and QM redundancy procedures for verifying patient identity (35.32).

The NRC oversees medical use licensees through its inspection, investigation, and enforcement programs. Inspections involve (a) unannounced visits by NRC personnel to each licensed facility on a periodic basis (ranging from once a year to once every four years, depending on the scope of the license), and (b) special inspections to follow up a particular incident. Inspections are intended to ensure that licensed programs are conducted in accordance with NRC requirements, with specific provisions of the license, and with the health and safety requirements

4  

Boron neutron capture therapy, which does not involve byproduct material but rather uses radiation directly from a nuclear reactor to treat patients, is also regulated by the NRC.



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