ML18267A365
| ML18267A365 | |
| Person / Time | |
|---|---|
| Issue date: | 10/12/2018 |
| From: | Dan Collins NRC/NMSS/DMSST |
| To: | Jack Giessner, Troy Pruett, James Trapp Division of Nuclear Materials Safety I, Division of Nuclear Materials Safety III, Division of Nuclear Materials Safety IV |
| Said Daibes-Figueroa | |
| Shared Package | |
| ML18267A357 | List: |
| References | |
| Download: ML18267A365 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 October 12, 2018 MEMORANDUM TO: James M. Trapp, Director Division of Nuclear Materials Safety Region I John B. Giessner, Director Division of Nuclear Materials Safety Region III Troy W. Pruett, Director Division of Nuclear Materials Safety Region IV FROM: Daniel S. Collins, Director Division of Materials Safety, Security, State, /RA/
and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
OPPORTUNITY TO COMMENT ON DRAFT LICENSING GUIDANCE FOR GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS Enclosed for your review and comment is draft licensing guidance for Germanium-68 (Ge-68)/Gallium-68 (Ga-68) generators pharmaceutical grade generators. These generators are similiar to conventional molybdenum-99/technetium-99m (Mo-99/Tc-99m) and strontium-82/rubidium-82 (Sr-82/Rb-82) generators, which are regulated under Title 10 of the Code of Federal Regulations 35.200, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. Like Mo-99/Tc-99m and Sr-82/Rb-82 generators, potential breakthrough of the parent radionuclide is possible when eluting the generator. This could lead to Ge-68 contaminating the Ga-68 radiopharmaceutical and potentially causing an unnecessarily higher radiation exposure to patients that planned. 10 CFR 35.204 provides permissible concentration limits for parent radionuclides for Mo-99/Tc-99m and Sr-82/Rb-82 generators to limit such exposure, but no such limit is specified for Ge-68/Ga-68 generators. Therefore, the use of a Ge-68/Ga-68 generator to prepare Ga-68 radiopharmaceuticals for imaging and localization studies is regulated under 10 CFR 35.1000, "Other Medical Uses of Byproduct Material or Radiation from Byproduct Material."
CONTACT: Said Daibes Figueroa (301) 415-6863
J. Trapp et.al. The current NRC licensing guidance is specific to the GalliaPharmTM Ge-68/Ga-68 generator from the manufacturer Eckert and Ziegler.1 The NRC staff, in foreseeing the need to provide licensing guidance for Ge-68/Ga-68 generators made by additional manufacturers, has modified the existing guidance into a non-manufacturer-specific licensing guidance. In this guidance no changes have been implemented in license commitments, breakthrough limit, or radiation safety aspects of the guidance of the Ge-68/Ga-68 generator for generating Ga-68 radiopharmaceuticals.
Please provide any comments that you or your staff, have on this draft document to the point of contact listed below. We would appreciate receiving your comments within 45 calendar days from the issuance of this memorandum.
If you have any questions regarding this correspondence, please contact me at (301) 415-3340 or Said Daibes Figueroa of my staff at (301) 415-6863.
Enclosure:
Draft Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance 1
The licensing guidance for the Eckert and Ziegler GalliaPharmTM Germanium-68/Gallium-68 pharmacy grade generator was last published in July 2017 and can be found in the NRCs Agencywide Documents Access Management System (Accession No. ML1705A488).
J. Trapp et. al.
SUBJECT:
OPPORTUNITY TO COMMENT ON DRAFT LICENSING GUIDANCE FOR GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS DATE: October 12, 2018 Package: ML18267A357 OFC MSST/MSEB MSST/MSEB MSST NAME S. Daibes D. Bollock D.Collins Figueroa DATE 09/25/18 09/25/18 10/12/18 OFFICIAL RECORD COPY