FDA, NRC Pave Way for the first Domestic Supply of Medical Isotope

PUBLISHED: Feb 9, 2018
Relevant to: Clinical Lab, Critical Access Hospitals, Hospitals, Pharmacy

The U.S. Food and Drug Administration (FDA) and the Nuclear Regulatory Commission (NRC) have announced steps they are taking to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases. The FDA approved the RadioGenix System, a unique system for producing Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. The NRC is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for its medical purpose.

Tc-99m has been in use as a medical imaging diagnostic agent for decades and is used in more than 80 percent of nuclear medicine imaging procedures in the U.S. Before now, Molybdenum-99, or Mo-99, the parent of Tc-99m, could only be produced from enriched uranium by several facilities outside of the U.S. This required a complicated supply chain that involved shipping enriched uranium from the U.S. This left the U.S. vulnerable to possible shortages and/or supply chain issues.

To address these challenges, Congress enacted the American Medical Isotopes Production Act of 2012, which contained provisions to eliminate the use of highly enriched uranium for medical isotope production and encouraged the development of U.S. domestic supplies of Mo-99 and associated isotopes. As such, multiple federal agencies – including the FDA, NRC, as well as the Department of Energy’s National Nuclear Security Administration and National Laboratories, among others – have been working together with industry for several years to develop a technology that helps to minimize the industry’s dependence on highly enriched uranium and brings the supply chain within the U.S. As a result of this collaboration, the U.S. medical community will now have a domestic source of Tc-99m through the use of the RadioGenix System, which marks the first non-uranium process for the production of Mo-99 to prepare the Tc-99m.

As the regulatory authority responsible for overseeing the production, distribution, possession and use of radioactive materials and products containing radioactive materials, NRC is issuing guidance that will advise medical and commercial nuclear pharmacy users on the license amendments they will need to possess and use the RadioGenix System. StayAlert! is monitoring this topic and will publish additional information when the NRC guidance is available.

Want to read the full alert and receive alert emails?

Browse Additional Alerts