ML19256B533
| ML19256B533 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | DIAGNOSTIC ISOTOPES, INC. |
| References | |
| NUDOCS 7908010107 | |
| Download: ML19256B533 (1) | |
Text
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/p* ** cuq'o UNITED ST ATES
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NUCLEAR REGULATORY COMMISSION i
'*/' E REGION 11 101 M A RIE T T A ST., N W., SUIT E 3100 h ((
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O JUL 131979
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DIAGNO8 TIC PHOTON CORPORATION PRIDC0 INDUSTRIAL PARK PO Box 526 CARR 992 KH 03=RLG5 LUQUILLO PR 00673 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 office.
Sincerely, L
Q James P, O'Reilly Director
Enclosures:
1.
IE Circular No. 79-14 2.
List of IE Circulars Issued in 1979 7908010\\ 07
UNITED STATES NUCLEAR REGt'LATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C.
20555 July 13, 1979 IE Circular No. 79-14 UNAUT110RIZED 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 procurm d by the nuclear pharmacy and transferred to medical institutions not authorized 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 been approved or accepted by FDA. This includes those radioactive drugs:
(a) subject to an FDA-approved "New Drug Application" (NDA) or (b) f.:.
which FDA has accepted a " Notice of Claimed Investigational Exemption for a Sew 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 INus, 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 usa.
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, an human use or who administer radiopharm NRC's and FDA's regulations.
Licensee pharmaceuticals.ar human use should r DUPLICATE DOCUMENT Entire document previously entered into system under:
ANO No. of pages:
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