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NRC Releases Updated Licensing Guidance for Ge-68/Ga-68 Generators

August 9, 2019

THE STORY

Recently, the Nuclear Regulatory Commission (NRC) updated licensing guidance of germanium-68/gallium-68 (Ge-68/Ga-68) pharmaceutical-grade generators. The new guidance is an update to the 2017 guidance.

All sections of the guidance apply to both medical licensee and commercial nuclear pharmacy licensees unless otherwise specified. This guidance does not apply to licensees or applicants that will receive unit or bulk doses of Ga-68 radiopharmaceuticals. These licensees and applicants will be regulated under Title 10 of the Code of Federal Regulations (10 CFR) 35.200.

WHY IT’S IMPORTANT

  • The guidance is an update to the 2017 guidance, which expressly named Eckert and Ziegler brand generators. The new guidance has been revised to eliminate reference to any specific generator manufacturer or product.

  • Reminder: Licensees must continue to provide financial assurance in amounts described in NRC’s July 2016 exemption memorandum pursuant to NRC DFP requirements.
    • Licensees possessing one or two Ge-68/Ga-68 generators (50 to 100 mCi of material) must provide for financial assurance for decommissioning in the amount of $225,000.
    • Licensees possessing more than 2 generators (>100 mCi) must provide financial assurance for decommissioning in the amount of $1,125,000.

  • The guidance includes revised breakthrough reporting requirements ("multiple" failures) in addition to other licensee commitments.

  • The guidance does not address the requirements for shipping an expired generator back to the manufacturer. In order to ship a generator by air transportation, the licensee must have documented function specific training and comply with International Air Transport Association (IATA) guidelines as well as Department of Transportation regulations (10 CFR Part 71).                      

WHAT SNMMI IS DOING

  • SNMMI is disseminating the new guidance to members and addressing any member concerns. If you have a concern, contact Caitlin Kubler, SNMMI Associate Director of Health Policy and Regulatory Affairs, at ckubler@snmmi.org

WHAT’S NEXT

  • SNMMI will continue to follow and inform members of updates from NRC related to this guidance