ML19261A912
| ML19261A912 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | R.H. ARMSTRONG, INC. |
| References | |
| NUDOCS 7902090047 | |
| Download: ML19261A912 (1) | |
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60X c2s PAPSONS xv 26267 Gentlemen:
The enclosed IE Circular 79-01, is forwarded to you for information.
If there are any questions related to your understanding of the suggested actions, please contact this office, b
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Enclosures:
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IE Circular No. 79-01 2.
List of IE Circulars Issued in 1978 e
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UNITED STATES NUCLEAR REGULATORY C0Ff4ISSION OFFICE Or INSPECTION AND ENFORCEMENT WASHINGTON, D.C.
20555 IE Circular No. 79-01 January 12, 1979 Page 1 of 2 ADMINISTRATION OF UNAUTHORIZED BYPRODUCT MATERIAL TO HUMANS Description of Circumstances:-
Recently the U. S. Nuclear Regulatory Comission (NRC) has investigated two incidents in which reagent grade compounds containing byproduct material were administered as intravenous radiophamaceuticair to humans.
These compounds had neither been manufactured for use as radiophama-ceuticals nor undergone testing for human use.,
In these incidents the byproduct materials were in chemical foms other than the foms used in diagnostic studies and should not have been shipped by the supplier.
In one case Selenium-75 labeled selenious acid was shipped instead of Selenium-75 labeled selenomethionine.
In the other case Ytterbium-169 labeled chloride was shipped instead of Ytterbium-169. labeled diethylenetriaminepentaacetic acid (DTPA).
The hospitals which received these materials should not have accepted them since they were not authrized to possess them by their NRC license. In addition, the hospital personnel preparing the patient doses should not have prepared these materials for administration to a patient since the labels, leaflets, and brochures in each case identified the radicisotope and chemical fom and included a warning that the radioactive material was not for use in humans or clinical diagnosis.
Notice to Medical Licensees:
Medical licensees should have procedures to be followed by persons preparing radiophamaceuticals for administration to. humans. The procedures should include the following steps:
a.
confirmation that the compound is a radiopharmaceutical intend _ed for human us
' DUPIdCATE DOCUMENT Entire document previously entered into system under:
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