ML19256B535
| ML19256B535 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | MEDICAL COLLEGE OF HAMPTON ROADS, NORFOLK, VA (FORMER |
| References | |
| NUDOCS 7908010133 | |
| Download: ML19256B535 (1) | |
Text
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NUCLEAR REGUL ATORY COMMISSION 3. ' 'p/ '. $
REGION 11 101 MARILTT A ST., N W, SUITE 3100 y ((
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AT L ANT A, GEORGI A 30303
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'b' JUL 131979 EASTERN VIRGINIA MEDICAL-C AUTHORIT 655 NEST BRAMBLETON AVENUE NORFOLK VA 23510 The enclosed IE Circular 79-14 is forwarded to you for information.
If there are any questions related to your understanding of the suggested actions, please contact this of fice.
Sincerely, N
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vrn James P. O'Reilly At Director
Enclosures:
1.
IE Circular No. 79-14 2.
List of IE Circulars Issued in 1979 7 908010 G3
UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C.
20555 July 13, 1979 IE Circular No. 79-14 UNAUTHORIZED PROCUREMENT AND DISTRIBUTION OF XENON-133 Description of Circumstances:
Recently the U.S. Nuclear Regulatory Commission (NRC) and the State of Texas have investigated several incidents in which a nuclear pharmacy procured bulk shipments of Xenon-133 gas labeled "Not For Human Use"; partitioned the material into unit doses, relabeled and packaged the material, and distributed it as a prepared radiopharmaceutical for human use.
Some bulk shipments of Xenon-133 were procured by the nuclear pharmacy and transferred to medical institutions not outhorized to receive the material.
The above actions by the nuclear pharmacy are contrary to both NRC and the Food and Drug Administration (FDA) regulatory requirements.
The nuclear pharmacy procured the Xenon-133 gas from a supplier whose product was not intended for human use.
This was in noncompliance with the nuclear pharmacy's NRC license which requires that " 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 Federal Food, Drug and Cosmetic Act."
Also, contrary to NRC regulations (10 CFR 30.41 (b)(5) and 10 CFR 30.41(c)), the nuclear pharmacy transferred Xenon-133 "Not For Human Use" to medical institutions who were only authorized to receive Xenon-133 in a form suitable for human use.
The NRC only licenses nuclear pharmacies to distribute radioactive drugs that have be-n approved or accepted by FDA.
This includes those radioactive drugs:
(a) subject to an FDA-approved "New Drug Application" (NDA) or (b) for which FDA has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND).
The nuclear pharmacy in this case violated FDA regulations since it did not possess an NDA or IND which is required to process " chemical grade" radioactive material into " pharmaceutical grade" radioactive drugs. As part of its approval of NDAs and INDs, FDA requires that certain tests (i.e., total activity, radionuclide purity, etc.) be performed to ensure that the material is safe and effective for human use.
The nuclear pharmacy in this case also did not test either the unit doses or the bulk shipments of Xenon-133.
Notice to Licensees Who Procure, Distribute, and Use Radiopharmaceuticals:
All licensees who procure, process, a human use or who administer radiopharn NRC's and FDA's regulations.
License DUPLICATE DOCUMENT pharmaceuticals for human use should Entire document previously
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