NRC medical-use licensing (10 CFR Part 35)

In the United States, a person or institution may manufacture, produce, acquire, receive, possess, prepare, use or transfer byproduct material for medical use only under a specific license issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State, under 10 CFR Part 35, "Medical Use of Byproduct Material." Part 35 divides medical use into distinct categories with their own subparts: uptake, dilution and excretion studies not requiring a written directive (35.100); imaging and localisation studies not requiring a written directive, i.e. most diagnostic PET and SPECT tracers (35.200); uses requiring a written directive, i.e. most therapeutic radiopharmaceuticals (35.300); manual brachytherapy (35.400); sealed sources for diagnostic use (35.500); sealed sources in remote afterloaders, teletherapy and gamma stereotactic units (35.600); and any other medical use not specifically addressed elsewhere (35.1000).

Agreement States are US states that have entered into an agreement with the NRC under section 274b of the Atomic Energy Act, giving the state authority to license and inspect byproduct, source, and certain special nuclear materials within its borders; the large majority of US states are Agreement States, so most medical-use licenses are issued and inspected by state radiation control programmes rather than the NRC directly, applying regulations that must be compatible with, though not always textually identical to, Part 35. Non-Agreement States and federal enclaves remain under direct NRC jurisdiction.

The NRC issues two broad types of specific license for medical use: a specific license of limited scope, tailored to the particular radionuclides, forms and medical uses named on the license, and a specific license of broad scope (issued under 10 CFR Part 33), which authorises a wider range of quantities and uses, typically for large academic medical centres, and carries additional internal radiation safety committee obligations in exchange for more flexibility. An applicant applies using NRC Form 313, must demonstrate through named, individually qualified staff (Authorized Users, Radiation Safety Officer, Authorized Medical Physicists, Authorized Nuclear Pharmacists as applicable) that it is equipped and committed to meet Part 35's safety standards, and must amend its license before adding new radionuclides, new uses, or new addresses of use.