STC-19-048, Notification of Issuance of Germanium-68 Gallium-68 Pharmaceutical Grade Generators Licensing Guidance
| ML19106A412 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/2019 |
| From: | Paul Michalak Office of Nuclear Material Safety and Safeguards |
| To: | State of VT, State, Agreement States |
| Daibes Said, NMSS/MSEB, 415-6863 | |
| Shared Package | |
| ml19106a365 | List: |
| References | |
| STC-19-048 | |
| Download: ML19106A412 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 25, 2019 ALL AGREEMENT STATES, VERMONT NOTIFICATION OF ISSUANCE OF GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS LICENSING GUIDANCE (STC-19-048)
Purpose:
To inform the Agreement States that updated Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance was published in July 25, 2019.
Background:
The U.S. Nuclear Regulatory Commission (NRC) current 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.
Discussion: 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. All sections of this guidance apply to both medical licensee and commercial nuclear pharmacy licensee use of this generator 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 revision is available online at http://www.nrc.gov/materials/miau/med-use-toolkit.html.
If you have any questions regarding this correspondence, please contact me at 301-415-5804 or the individual named below:
POINT OF CONTACT: Said Daibes, PhD E-MAIL: Said.Daibes@nrc.gov TELEPHONE:
(301) 415-6863
/RA/
Paul Michalak, Chief State Agreement and Liaison Programs Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance
Letter ML19106A412 Package ML19106A365 OFFICE NMSS/MSEB NMSS/MSEB NMSS/MSEB NMSS/MSST NAME SDaibes LDimmick CEinberg PMichalak DATE 04/24/19 04/26/19 05/02/19 07/25/19