ML19225C560
| ML19225C560 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | CORNELL UNIV., ITHACA, NY |
| References | |
| NUDOCS 7908010111 | |
| Download: ML19225C560 (1) | |
Text
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UNITED STATES y
2 NUCLEAR REGULATORY COMM!SSION
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JUL 131979 CORNELL UNIVERSITY RADIATION SAFETY OFFICC 512 E. STATE STREET ITHACA NY 14850 The enclosed IE Circular 79-14 is forwarded to you f or inf ormation.
If there are any questions related to your understanding of the suagested actions, please contact this of Sincerely, w %M
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James P. O'Reilly At Director
Enclosures:
1.
IE Circular No. 79-14 2.
List of IE Circulars Issued in 1979 4l0
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UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEHENT WASHINGTON, D.C.
20555 July 13, 1979 IE Circular No. 79-14 UNAUTHORIZED PROCUREMENT AND DISTRIBUTION OF XENON-133 Description of Circum tances:
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 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 Fede ral 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 " hot 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) 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 humor 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, and distribute radiopharmaceuticals for human use or who administer radiopharmaceuticals to humans should be aware of NRC's and FDA's regulations.
Licensees who receive Xenon-133 and other radio-pharmaceuticals for human use should review the labels, leaflets, and brochures 410 3D9 7 9 0718 013 E
IE Circular No. 79-14 July 13, 1979 Page 2 of 2 enclosed in radiopharmaceutical packages to verify that the radioactive material is a radiopharmaceutical intended for human use.
Chemical grade radioactive materials are typically labeled as follows: " Caution: For Manu-facturing, Processing or Repacking.
Pharmaceutically Unrefined.
Not Tested for Sterility or Freedom From Pyrogens.
Not for Human Use in Present Form."
Most NRC-licensees who distribute and use radioactive materials for human use have a license condition, as stated in the Description of Circumstances part of this Circular, which requires that radioactive gases for human use be pro-cured only from a supplier who distributes the product indicated for human use in accordance with the Federal Food, Drug and Cosmetic Act.
Distributors and users should review their NRC licenses and procedures to ensure against the use of unauthorized radioactive material.
The contents of this Circular should be brought to the attentic all personnel in your organization who procure, prepare, and use raai,.ha rmaceu-ticals for human use. Appropriat e instructions should be included in your procedures for procurement, receipt, preparation and use of radiopharmaceu-ticals.
No written response to this Circular is required.
If you require additional information regarding this subject, please contact the Director of the appropriate NRC Regional Office.
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IE Circular No. 79-14 Enclosure July 13, 1979 Page 1 of 3 LISTING OF IE CIRCULARS ISSUT9 IN LAST TWELVE MONTHS Circular Subject Date Issued To No.
of Issue 78-14 HPCI Turbine Reversing 7/12/78 All Holders of BWR Chamber Hold Down Bolting OLs or cps for plants with a HPCI Terry Turbine excepting Duane Arnold and Monticello 78-15 Checkvalves Fail to 7/20/78 All Holders of Close In Vertical Reactor OLs or cps Position 78-16 Limitorque Valve 7/26/78 All Holders of Actuators Reactor OLs or CPr 78-17 Inadequate Guard Training /
10/13/78 All Holders of Qualification and Falsified and applicants Training Records for Reactor OLs 78-18 UL Fire Test 11/6/78 All Holders af Reactor OLs or cps 78-19 Manual Override (Bypass) 12/28/78 All Holders of of Safety Actuation Signals cps kl0 7-JO/
IE Circular No. 79-14 Enciosure July 13, 1979 Page 2 of 3 LISTING OF IE CIRCULARS ISSUED IN LAST TkELVE MONTHS Circular Subiect Date of Issued to No.
Issue 79-01 Administration of 1/12/79 All Holders of Unauthorized Byproduct Licensees except Material to Ilumans Teletherapy Medical Licensees and each Radiopha rmaceutical Supplier 79-02 Failure of 120 Volt Vital 2/16/79 All Holders of AC Power Supplies Reactor OLs and cps 79-03 Inadequate Guard Training-2/23/79 All Holders of Qualification and Falsified and applicants Training Records for Special Nuclear Material Licenses in Safeguards Group I 79-04 Loose Locking Nut On 3/16/79 All Holders of Limitorque Valve Reactor OLs or cps Operators 79-05 Moisture Leakage In 3/20/79 All Holders of Stranded Wire Conductors Reactor OLs or cps 79-06 Failure to Use Syringe 4/19/79 All Holders of and Battle Shields in Medical Licensees Nuclear Medicine except teletherapy licensees 79-07 Unexpected Speed Increase 5/2/79 All Holcers cf of Reactor Recirculation BWR OL' or CP.
MG Set Resulted in Reactor Power Increase 79-08 Attempted Extortion - Low 5/18/70 All Fuel Facilities Enriched Uranium Licensed by NRC 79-09 Occurrences of Split or 6/22/79 All Materials Punctured Regulator Diaphragms Priority I, Fuel In Certain Self Contained Cycle and Operating Breathing Apparatus Reactor Licensees b0}
IE Circular No. 79-14 Enclosure July 13, 1979 Page 3 of 3 LISTING OF IE CIRCULARS ISSULD IN LAST TWELVE MONTHS Circular Subject Date of Issued to No.
issued 79-10 Pipefittings Manufactured 6/26/79 All Power Reactor frca Unacceptable Material Licensees with a CP and/or OL 79-11 Design / Construct. a 6/27/79 All Applicants Interface Problem for, and Holders of Power Reactor cps 79-12 Potential Disel Generator 6/28/79 All Power Reactors Turbocharger Problem Operating Facilities and all Utilities having a CP 79-13 Replacement of Diesel 7/10/79 All Powcr Reactor Fire Pump Starting Operating Facilities Contactors and all Utilities having a CP 410 so3