ML19108A155
| ML19108A155 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/2019 |
| From: | Andrea Kock NRC/NMSS/DMSST |
| To: | Linda Howell, David Pelton, James Trapp NRC Region 1, NRC/RGN-III, NRC Region 4 |
| Daibes Said, NMSS/MSEB, 415-6863 | |
| Shared Package | |
| ML19108A145 | List: |
| References | |
| Download: ML19108A155 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 25, 2019 MEMORANDUM TO: James M. Trapp, Director Division of Nuclear Materials Safety Region I David L. Pelton Director Division of Nuclear Materials Safety Region III Linda Howell, Acting Director Division of Nuclear Materials Safety Region IV FROM: Andrea L. Kock, Director Division of Materials Safety, Security, State, /RA/
and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
ISSUANCE OF GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS LICENSING GUIDANCE This memorandum is to inform you that on July 25, 2019, the U.S. Nuclear Regulatory Commission (NRC) issued the enclosed revised licensing guidance entitled, Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance.
The current NRC licensing guidance under Title 10 Code of Federal Regulations (CFR) 35.1000 for Germanium-68/Gallium-68 generators [Ge-68/Ga-68 generators] (Revision 1) was issued on July 13, 2017 and can be found in NRCs Agencywide Documents Access Management System (ADAMS) (Accession No. ML17075A488). At that time, the only Ge-68/Ga-68 generator approved by the U.S. Food and Drug Administration (FDA) and available on the market was the Eckert and Ziegler GalliaPharm generator. Now that additional Ge-68/Ga-68 generators (IREs [Institute of Radio Elements] Galli Eo' generator and others) are becoming commercially available, the Ge-68/Ga-68 generator licensing guidance has been revised to eliminate reference to any specific generator manufacturer or product.
CONTACT: Said Daibes Figueroa, NMSS/MSEB 301-415-6863
J. Trapp, et al. 2 All sections of this guidance apply to both medical licensee and commercial nuclear pharmacy licensee use of these generators unless otherwise specified. This guidance does not apply to licensees or applicants that will receive unit or bulk doses of Gallium-68 (Ga-68) radiopharmaceuticals.
This guidance provides applicants with an acceptable means of satisfying the requirements for a license for the use of Ge-68/Ga-68 generators to prepare Ga-68 radiopharmaceuticals. It is not intended to be the only means of satisfying the requirements for a license.
This licensing guidance may be found on the NRC Medical Uses Licensee Toolkit at:
http://www.nrc.gov/materials/miau/med-use-toolkit.html.
Enclosure:
April 2019, Germanium-68/
Gallium-68-Pharmaceutical Grade Generators Licensing Guidance
J. Trapp, et al. 3
SUBJECT:
ISSUANCE OF GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS LICENSING GUIDANCE DISTRIBUTION Kevin Williams, NMSS Donna Janda, RI Jeff Griffis, TTC Joseph Nick, RI Patty Pelke, RIII Christian Einberg, NMSS Christine Lipa, RIII Michael Hay, RIV Lisa Dimmick, NMSS Vincent Gaddy, RIV ADAMS Accession Package No. ML19108A145 Memo ML19108A155 OFFICE NMSS/MSEB NMSS/MSEB NMSS/MSEB NMSS/MSST NAME SDaibes LDimmick CEinberg AKock DATE 04/24/19 04/26/19 05/02/19 07/25/19 OFFICIAL RECORD COPY