Society News Archive

4 September 2014
Changes in DOE Isotope Program

The Department of Energy (DOE) Isotope Program, within the Office of Science, currently produces and distributes the radioisotope germanium-68 (68Ge). There are two primary uses of the 68Ge: (1) in the manufacture of calibration sources for positron emission tomography (PET) scanners used for diagnostic medical imaging and (2) in the manufacture of germanium-68/gallium-68 (68Ge/68Ga) generators, which provide 68Ga as a positron source in radiopharmaceuticals used in PET imaging.

The DOE published a Notice of Inquiry and Request for comment in the Federal Register on 8 March 2013 concerning its consideration of withdrawal from commercial production of 68Ge. The DOE received numerous comments in response to this Notice of Inquiry, evaluated substantial information provided by one private domestic company seeking the DOE's withdrawal, and assessed other available information. The DOE determined that 68Ge is reasonably available from the commercial sector for use in the manufacture of calibration sources but not for use in 68Ge/68Ga generators.

To serve the nation's interests in the advancement of health care, the DOE will continue to produce and distribute 68Ge for use in the manufacture of 68Ge/68Ga generators until such time as firm data exists establishing that there are multiple domestic suppliers capable of fully satisfying the needs of the United States market without the participation of DOE in that market.

More information can be found in the Federal Register notice.