ML19210E267
| ML19210E267 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/1979 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | David Brown NORTH CAROLINA, STATE OF |
| References | |
| NUDOCS 7912040205 | |
| Download: ML19210E267 (1) | |
Text
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NUCLEAR REGULATORY COMMISSION
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I" M Ref: SA/ECA Mr. Dayne 11. Brown, Chief Radiation Protection Section Division of Facility Service Box 12200 Raleigh, North Carolina 27605
Dear fir. Brown:
Identified below is a licensee in North Carolina who was confirmed to have received Xe-133 shipments from Oak Ridge Ilational Laboratory (0 Rill) during fiscal year 1978. ORill 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. This State licensee was mentioned by Nuclear Pharmacy, Inc's. (NPI) response to an NRC Notice of Violation.
Duke University Durham, North Carolina 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,
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t G. Wayne V,crr, ssistant Director For State Agreements Program Office of State Programs 1468 321 205 7912040 i