ML19225C564
| ML19225C564 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | R.H. ARMSTRONG, INC. |
| References | |
| NUDOCS 7908010117 | |
| Download: ML19225C564 (1) | |
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UNITED ST ATES
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RE GION 11 5 e i;JJJ' [E 6
101 M ARIE TT A ST., N W., SulT E 3100 o,
CQ ATLANT A, GEORal A 30303
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JUL 131979 R,
H, ARMSTRONG INC, BOX 428 PARSONS hy 26267 Il The enclosed IE Circular 79-14 is forwarded to you f or inf ormation.
there are any questions related to your understanding of the suggested actions, please contact this office.
Sincerely, NC, k.
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Jemes P. O'Reilly Lt Director
Enclosures:
1.
IE Circular No. 79-14 2.
List of IE Circulars Issued in 1979 n '- [\\
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UNITED STATES NUCLEAR REGULATORY Cot 1SS10N OFFICE OF INSPECTION AND EF/0RCEMENT WASHINGTON, D.C.
20555 July 13,1979 IE Circular No. 79-14
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UNAUTHORizID PROCUREMENT AND DIST'RIBUTION OF XENON-133 Description of Circumstances:
Recently the U.S. Nuclear Regulatory Coerission (NPC) shipments of Xenon-133 gas labeled "Not For Human Use"; partitioned the material into unit doses, relabeled sei packaged the material, and distributed Some bulk shipments of it as a prepared radiopbarzaceutical for bu=an use.
Xenon-133 were procured by the nuclear pharmacy and transferred to medical institutions not authorized to receive the asterial-The above actions by the nuclear pt.armacy are contrary to both NRC and the The nuclear Food and Drug Administration (FDA) regulatory requirements.
pharmacy procured the Xenon-133 gas froz a supplier whose produ NRC license which requires that " radioactive gases as intended for bucan use.
the product indicated for human use in accordance with the and Cosmetic Act."
Use" to medical institutions who were only authorized to in a form suitable for busan use.
The NRC only licenses nuclear pharmacies to distribute radioactive d have been approved or accepted by FDA.
(a) subject to an FDA-approved "New Drug Application" (NDA) or (b) for whic FDA has accepted a " Notice of Claimed Investigational F.xemption for a New The nuclear pbsrmacy in this case violated FDA regulations since it did not possers an NDA or IND which is required to g e ss " chemical gra Drug" (IND).
As part radioactive material into "pbarzaceutical grade" rodioactive S ugs.
of its approval of NDAs and INDs, TDA requires that certsin tests (i.e.. tot activity, radionuclide purity, etc.) be performed to ensure that the material The enclear pharmacy in this case also is safe and effective for huase use.
dai not test either the unit doses or the bulk shipments of Xenon-133 Notice to Licensees Vbo Fiocure, Distribute, and Use Radiophernaceuticals:
Alllice$seeswhoprocure, process,anddistributeradiopharmaceuticalsfor bwean use or who administer radiopharmaceuticals to busins should be aw Licensees who receive Xenon-133 and other radio-NRC's and TDA's regulations.
pharmaceuticals for human use should review the labels, fcaflets, med 410 3;S 790718013s
f"I{I 'gl' II Circular No 79-14 i
enclosed in radiopharmaceutical packages to verify that the rsf;onct ve Chemical grade caterial is a radiopharmaceutical intended f or human use." Caution: For Manu-radioactive materials are typically labeled as follows:Pha rmaceutically Unrefined.
Not Tested facturic1, Processing or Repacking.
Not for Human Use in Present Form."
for Sterility or Freedom From Pyrogens.
Most NRC licensees vbo distribute and use radioactive ma have a license condition, as stated in the De',cription of Circumst.nce of ints Circular, which requires that indicated for buman cured only from a supplier who distributes the product Distributors in accordance with the Federal Food, Drug and Cosmetic Act.
inst ano users should review their NEC licenses and procedures to ensure aga usa the use of unauthorized radioactive material.to the attention of all The contents of this Circular should be brought h
personnel in your organization vbo procure, prepare, and use radiop arm d d to your ticals for human use. Appropriate instructions should be inclu e procedures f or procurement, receipt, preparation and use of radiopha ticals.
required.
If you require additional No written response to this Circular it f the information regarding this subject, please contact Lbe Director o appropriate NRC Regional Office.
410 3:56
Enclosure Page 1 of 3 IE Circular No. 7e July 13,1979 LIST W,OF 1E CIRCULARS ISSUED IN
- >.5I T='LLVL NONTHS Issued To Date Circulaf Subject of lasue Ne.
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s All holders of BWT 7/12/78 EPCI Turbine Reve rr inF OLs or cps for Chamber Hold Down Bolttog plants with a HPCI 78-14 Terry Turbine excepting Duane Arnold and Monticello All Holders of 7/20/78 Checkva2ves Tail to Reactor OLs or cps 78-15 Close In Vertical Position All Bolders of 7/26/76 Limitorque Valve Reactor Ols or 78-16 cps Actuators All Holders of 10/13/78 Inadequate Guard Training /
and applicants 78-17 Qualification and Falsified for Reactor OLs Training Records All Holders of 11/6/78 UL Fire Test Reactor OLs or cps 78-18 All Holders of 12/28/78 Manual Override (Bypass) cps 78-19 of Safety Actuation Signals 4Id j3[
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Enclosure IE Circular No. 79-14 Page 2 of 3 July 13, 1979 LISTING OF IE CIRCUlAs 5 ISSUED IN LAST TVELVE MONTHS Date of Is22ed to Circular -
Subject Issue No.
1/12/79 All Holders of Adminirtration of Licensees except
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79-91 Unauthorized Byproduct Teletherapy M-dical Material to Humans Licensees and each Radiopharmaceuticsl Supplier All Holders of 2/16/79 Failure of 120 Volt Vital Reactor Ols 79-02 AC Power Supplies and cps 2/23/79 All Holders of Inadequate Guard Training-and applicants 79-03 Qualification and Falsified for Special Nuclear Training Records Material Licenses in Safeguards Group 1 3/16/79 All Bolders of Loose Locking Nut On Reactor OLs or cps 79-04 Limitorque Valve Operators 3/20/79 All Holders et Moisture Leakage In Reactor OLs or cps 79-05 Stranded Wire Conductors 4/19/79 All Rolders of 79-06 Failure to Use Syringe Nedical Licensees and Battle Shields in except teletherapy Nucleer Medicine licensees All Bolders of 5/2/79 79-07 Unexpected Speed Increase BV7 OL's or CP's of Reactor Recirculation HC Set Resulted in Reactor Power Increase 5/1E/79 All Fuel Facilities Attempted Extortion - Lov Licensed by NRC 79-08 Enriched Uranium 6/22/79 All unterials occurrences of Split or Priority I. Fuel
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79-09 Punctured Regulator Daaphrages Cycle and Ope rating In Certain Self Contained teactor Licensees Breathing Apparatus 410 338
Enclosure IE Circular No. 79-14 Page 3 of 3 July 13, 1979 LISTING OF IE CIRCULARS ISSUED IN LAST TVELVE MONTHS Issued to Date of Circular.
Subject lesued No.
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All Pcwer Reactor 6/26/79 Pipefittings Manufactured Licecsees with a 79-10 from Unacceptable Material CP and/or OL All Applicants 6/27/79 Design / Construction for, and Holders 79-11 Interface Problee of Power Reactor cps All Power Reactors 6/28/79 Potential Disel Generator Operating Fac21stres 79-12 Turbocharger Problee and all Utilities having a CP All Power Reactor 7/10/79 Replacement of Diesel Operating Pacilities 79-13 Fire Pump Starting and all Utilities Contactors having a CP 9
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