NRC
Nuclear Regulatory Commission
The US federal agency that regulates the civilian use of radioactive materials — licences, ALARA limits, training, security, transport, waste. Most radiopharma sites operate under an NRC (or Agreement-State) licence.
The NRC regulates civilian use of byproduct, source and special nuclear materials in the US — including medical use (10 CFR Part 35), radiation protection (10 CFR Part 20), packaging and transport (10 CFR Part 71), and security. In 39 Agreement States the State has assumed NRC's authority under §274.b of the Atomic Energy Act.
FDA regulates the drug aspects of radiopharmaceuticals (21 CFR 212, 21 CFR Part 11); NRC / Agreement State regulates the radioactive-material aspects. Most radiopharma sites must satisfy both. V5 stores NRC / Agreement-State licence data and ties material movements to authorised users (10 CFR 35.13).
- 10 CFR Part 20
- 10 CFR Part 35
- 10 CFR Part 71