ML19210E263
| ML19210E263 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/1979 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | WASHINGTON, STATE OF |
| References | |
| NUDOCS 7912040192 | |
| Download: ML19210E263 (2) | |
Text
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e UNITED STATES 8,
g NUCLEAR REGULATORY COMMISSION O..
- j WASHINGTON, D. C. 20555
/
NOV 151979 Ren SA M A Mr. Robert C. Will, Supervisor Radiation Control Program Department of Social and Health Services Mail Stop LD-ll Olympia, Washington 98504
Dear Mr. Will:
Identified below are licensees in Washington who were confirmed to have received Xe-133 shipments from Oak Ridge National Laboratory (ORNL) during fiscal year 1978. ORNL is, among others, a non-FDA-approved Xe-133 supplier; i.e., it does not hold an FDA-issued IND or NDA for supplying Xe-133. These State licensees were mentioned by Nuclear Pharmacy. Inc's. (NPI) response to an NRC Notice of Violation.
Holy Family Hospital Spokane, Washington University of Washington Seattle, Washington It was noted durinj NRC's investigation of the NPI violation case, that apparently some ambiguity exists in the NPI License Condition No.15 (Standard License Condition No. 55) which reads as follows:
Radioactive gases as free gas or in solution, to be administered to humans, shall be procured from a supplier who distributes the product indicated for human use in accordance with the Food, Drug and Cosmetic Act.
Further clarification or even replacement of this License Condition for involved licensees is expected soon.
This is a request for you to review the identified licenses to determine if the above License Condition in the same wording, or similar wording, is used, and notify us of the resul.ts of your findings.
1468 340 19 1 912040
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r Mr. Robert C. Will Based on your review of the licenses you may want to initiate enforcement action against the licensees.
Sincerely, B
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. Wayne Kerr, Assistant Director for State Agreements Program Office of State Programs 1468 Ai e
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