ML19225C563
| ML19225C563 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1979 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | PHARMATOPES, INC. |
| References | |
| NUDOCS 7908010115 | |
| Download: ML19225C563 (1) | |
Text
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[ga arcyq'o, NUCLEAR REGUL ATORY COMMISSION UNITED ST ATES s
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ATL ANT A, L L OHGI A 30303 o,
g, % - g JUL 131979 PHARMATOPES INC.
413 HEST GRACE STREET RICHMOND VA 2322' If The enclosed IE Circular 79-14 is forwarded to you f or inf ormation.
suggested there are any questions related to your understanding of 'o=
actions, please contact this office.
Sincerely, hw~/
g Jmes P. O'Reilly Director
Enclosures:
1.
IE Circular No. 79-14 2.
List of IE Circulars Issued in 7979 ff } ;o!
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b UNITED STATES NUCI. EAR REGUI.ATORY C0tf1SSION OFFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C.
20555 July 13,1979 II Circular No. 79-14 UNALTTHORizED PROCUREMENT AND DISTRIBUTION OF Description of Circumstances:
f Texas Recently the U.S. Nuclear Regulatory Coccissio d bulk itioned the material into unit doses, relabeled and packaged th ial and distributed
' /.,e bulk snipeents of it as a prepared radiopharmaceutical for human use.
d to medical Xenon-133 were procured by the nuclear pharwaey and transferre institutions not authorized to receive the material.
NRC and the The above actions by the nuclear pharmacy are contrary to both The nuclear Food and Drug Administration (FDA) regulatorj requirements.
d t was not phamacy procured the Xenon-133 gas f rom a supplier whose l tion, NRC license which requires that " radioactive gases as free ga intended for bucan use.
lier who distributes to be administered to humans, shall be procured f rom a suppi h the Federa the product indicated for buman use in accordance w tAlso, con For Bunan Use" to medical institutions who were only aut and Cosmetic Act."
Xenon-133 in a form suitable for busan use.
drugs that The NRC only licenses nuclear pharascies to distribute radioact have been approved or accepted by E A. Drug Application" (NDA) or (b) for which for a New (a) subject to an R A-approved "Neo FDA has accepted a " Notice of Claimed Investigational Exemption The nuclear pharmacy in this case violated FDA Drug" (IND).
drugs. As part it did not possess an NDA or IND whic U.e., total radioactive material into "pbarmaceutical grade" radioactive of W approvsl of NDAs and IhDs, FDA requires that certain testr h
terial radionuclide purity, etc.) be performed to ensure that t e f Xenon-133 at
,nd eifective for busan use.
. test either the unit doses or the bulk shipments o is ticals:
dic r.otice to Licensees Vbo Procure, Distribute, and Use Radiopharma l for All licensees who procure, process, and distribute radiopha of husan use or who adcinister radiopharmaceuticals to hu nd brochures IrkC's and RA's regulations, pharmaceuticals for human us 7130135 4iO 54i 790
July 13, 1979 IE Circular No. 79-14 Page 2 of 2 h
dioactive enclosed in radiopharmaceutical packages to verify that t e ra Cbecical grade a radiopharmaceutical intended f or human use." Caution: For Manu-radioactive materials are typically labeled as follows: Pharmaceutically Unrefined.
asterial 12 Not Tested facturin't, Processing or Repacking.
Not for Humso Use in Present Form."
for Sterality or Freedom Froe Pyrogens.
human use Most NRC licensees who distribute and use radio t
of this Circular, which requi es that indicated for human cured only from a supplier who distributes the product Act. Distributors use in accordance with the Federal Food, Drug and C nsure against the use of unauthorized radioactive esterial.
to the attention of all The contents of this Circular should be brought diopharmaceu-personnel in your orgsnization who procure, prepare, and use r.'
included in your ticals for human use. Appropriate instructions should bereceipt, prep procedures for procurement, ticals.
If you require additional No written response to this Circular is required.informati f the appropriate NRC Regional Office.
410 342
Enclosure Page 1 of 3 7c '
IE Circular No.
July 13, 1979 LISTING OF 3E CIRCULARS ISSUED IN
- _ASI T='ELVE MONTHS Issued To Date Circu!af Subject of Issue No.
~.
All Holders of BW7 7/12/78 HPCI Turbine P.everring OLs or cps for 78-14 Chamber Hold Down Bolting plants with a EPCI Terry Turbine excepting Duane Arnold and Monticello All Holders of 7/20/78 Checkvalves Fail to Reactor OLs or CFs 78-15 Close In Vertical Position All Holders of 7/26/78 Limitorque Valve Reactor OLs or 73-16 cps Actuators All Holders of 10/13/78 Inadequate Guard Training /
and applicants 78-17 Qu.slification and Falsified for Reactor OLs Tretning Records All Bolders of 11/6/78 Reactor OLs or cps UL Fire Test 78-18 All Rolders of 12/28/78 Manual Dverride (Bypass) cps 78-39 of Safety Actuation Signals e
o3
u Enclosure Fage 2 of 3 IE Circular No. '9-14 July 13, 1979 LISTING OF IE CIRCULARS ISSUED IN LAST TWILVE MONTHS Date of Issued to Circular,
Subject Issue No.
All Holders of 1/12/79 Administration of Licensees except
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79-01 Unautborized Byproduct Teletberapy Medical Material to Ham:ns Licensees and each Ra dion'.-as cer'.ical Suppl.:r All Holders of 2/16/79 Failure of 120 Volt Vital Se*ctor OLs 79-02 AC Power Supplies am. cps All Holders of 2/23/79 loadequate Guard Training-mod applicants 79-03 Qualification and Falsified for Special Nuclear Training Records Material Licenses in Safeguards Group I All Holders of 3/16/79 J, case Locking Nut On Reactor OLs or cps 79-04 Limitorque Valve Operators All Holders of 3/20/79 Moisture Leakage In Reactor OLs or cps 79-05 Strac!ed Wire Conductors All Bolders of 4/19/79 Failure to Use Syringe Medical Licensees 79-06 and Battle Shields in except teletberapy Nuclear Medicine licensees All Bolders of 5/2/79 Unexpected Speed Incre.se BW7 OL's or CP's 79-07 of Reactor Recirculatson MC Set Resulted in Reactor Power Increase All Fuel Facilities 5/18/79 Attempted Extortion - Low Licensed by NRC 79-08 Enriched Uranium 6/22/79 All Naterials Occurrences of Split or Pilority 1, Fuel
~
79-09 Punctured Regulator Diaphrages Cycle end Operating In Certain Self Contained Reactor Licensees Breathing Appsratus 410 344
Enclosure IE Circular No. 79-14 Page 3 cf 3 July 13, 1979 LISTING OT IE CIECULARS ISSUED IN LAST 7WILVE MONTHS Issued to Date of
~
Circular-Sutiect Issued No.
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All Power Reactor 6/26/79 Pipefittings Manufactured Licensees with a 79-10 from Unacceptable Material CP and/or OL All Applicants 6/27/79 Design /Constructica for, and Holders 79-11 Interface Problee of Power Reactor cps All Power Reactors 6/28/79 Potential Disel Generator Operating Facilities 79-12 Turbocharger Problee and all Utilities having a CF All Power Reactor 7/10/79 Replacement of Diesel Operating Facilities 79-23 Fire Pump Starting and all Utilities Contactors having a CP
.