NRC announces its licensing decision in regards to Ra-223 Cl

February 1, 2013

NRC announces its licensing decision in regards to Ra-223 Cl

The U.S. Nuclear Regulatory Commission’s (NRC) staff has reviewed the radiation safety aspects of radium-223 dichloride (223RaCl2) and determined, based on available information, that licensing under Title 10 of the Code of Federal Regulations (10CFR) Part 35, Subpart E “Unsealed Byproduct Material – Written Directive Required” is appropriate. Under current regulations, physicians who are approved for the use of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV under 10 CFR 35.390 “Training for use of unsealed byproduct material for which a written directive is required” or 10 CFR 35.396 “Training for the parenteral administration of unsealed byproduct material requiring a written directive” can be authorized for the medical use of 223RaCl2.