ML19210E259
| ML19210E259 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/1979 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Lacker D TEXAS, STATE OF |
| References | |
| NUDOCS 7912040185 | |
| Download: ML19210E259 (2) | |
Text
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UNITED sT ATEs 8 ')
'j NUCLEAR REGULATORY COMMISSION n C WASHINGTON, D. C. 20555 Os
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nov mm Ref:
SA/ECA Mr. David K. Lacker, Director Division of Occupational Health and Radiation Control Texas Department of Health 1100 W. 49th Street Austin, Texas 78756
Dear Mr. Lacker:
Identified below are licensees in Texas 'who were confirmed to have received Xe-133 shipments from Oak Ridge National Laboratory (0 Rill) 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-123. These State licensees were mentioned by Nuclear Pharmacy, Inc's. (NPI) response to an NRC Notice of Violation.
Methodist Hospital Houston, Texas Texatope Pharmacy San Antonio, Texas 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 vho 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 330 7
912040
Mr. David K. Lacker Based on your review of the licenses you may want to initiate enforcement action against the licensees.
Sincerely, esa -
(G). Wayne Kerr, Assistant Director b for State Agreements Program Office of State Programs 1,468 31