ML19210E265
| ML19210E265 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/1979 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Deboer T NEW YORK, STATE OF |
| References | |
| NUDOCS 7912040199 | |
| Download: ML19210E265 (1) | |
Text
g k
UNITED STAT Es p,
NUCLEAft REGULATORY COMMISSION O'.
- j WASHINGTON, D. O. 20555
,o NOV 151979 Ref:
SA/ECA Mr. T. K. DeBoer Director Technical Development Programs New York State Energy Office Agency Building 2 2 Rockefeller Plaza Albany, New York 12223
Dear 1r. DeBoer:
Identified below is a licensee in New York who was confirmed to have received Xe-133 shipments from Oak Ridge National Laboratory (0RNL) during fiscal year 1978. ORNL is, among others, a non-FDA, approved Xe-133 suppliar; i.e., it does not hold an FDA-issued IND or NDA for supplying Xe-133. This State licensee was mentioned by Nuclear Pharmacy, Inc's. (NPI) response to an NRC Notice of Violation.
Sloan-Kettering Institute New York, New York It was noted during 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 license to determine if the above License Condition in the same wording, or similar wording, is used, and notify us of the results of your findings.
Based on your review of the license you may want to initiate enforcement action against the licensee.
Sincerely,
/ L
. aayne Kerr, Assistant Director for State Agreements Program Office of State Programs i A6B A2 99 i
4 7912040