ML19210E256
| ML19210E256 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/1979 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Porter B LOUISIANA, STATE OF |
| References | |
| NUDOCS 7912040175 | |
| Download: ML19210E256 (2) | |
Text
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UNITED STATES y
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P f WASHINGTON, D. C. 20555 S
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NOV la 13/3 Ref:
SA/ECA Mr. B. Jim Porter Division of Radiation Control Natural Resources and Energy Department of Conservation P.O. Box 14690 Baton Rouge, Louisiana 70808
Dear Mr. Porter:
Identified below are licensees in Louisiana who were confirmed to have received Xe-133 shipments from Oak Ridge National Laboratory (ORNL) during fiscal year 1978. ORfil 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.
St. Patrick Hospital Lake Charles, Louisiana Texatope Pharmacy New Orleans, Louisiana 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 licenses 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.
1468 281 7912040l D
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Mr.'B. Jim Porter Based on your review of the licenses you may want to initiate enforcement action against the licensees.
Sincerely, (Hb
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G Wayne Kerr, Assistant Director for State Agreements Program Office of State Programs 1468 282 f
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