ML20023C845
| ML20023C845 | |
| Person / Time | |
|---|---|
| Issue date: | 12/19/1979 |
| From: | Gower G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Fortuna R NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180096 | |
| Download: ML20023C845 (3) | |
Text
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NUCLEAR REGULA10RY COMMISSION e
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MEMORAftDUM FOR:
Roger Fortuna, Assistant Director for investigations,01A FROM:
George C. Gower, Acting Executive Officer for Operations Support, IE
SUBJECT:
ALLEGATIONS OF IMPROPER ACTIVITIES BY liUCLEAR PHARMACY, IriC. (NPI)
Enclosed for your information and nw. as appropriate, is a copy of a letter received from a Mr.
,aEast Cleveland, Ohio.
1 letter indicates an awareness of the pending enforcement action M r. '
against tipi and includes a number of issues which appear to warrant further investigation.
In view of the nature of the allegations and their impact upon the current liPI case, if true, we would like to meet with you and discuss our planned followup on this matter.
L'e understand that you have made a preliminary contact with Mr.,
to l
acknowledge the Agencies' receipt of his letter and that further contacts i
with him are planned.
Lj l
l).
y'
,r~]l"1:~e u-George C. Gower l
Acting Executive Officer l
for Operations Supp. ort, IE
Enclosure:
--1 Letter to Sniezek l
dtd 12/1/7!T T
l cc w/ enclosure:
D. Thompson, IE P. Baci IE J. Murray, ELD B. Davis, Rlli cc w/o enclosure:
J. Sniezek I
i r
8305180096 830412
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, a registered phamacist, presently employed by Phamatopes, It c., a radiophamacy located in Oak Park, liichigan, having been sworn, do solemnly swear that I have been advised of the nature of this inquiry and provide the following infomation freely, voluntarily and with no threats or promises.
Ipresentlyresideat[
., East Cleveland, Ohio, 44112(216i~ 7 I am a graduate oT Ine University of Wisconsin, School of Phamacy, l'adison, Wisconsin (1967).
Prior to my employment with Phamatopes, Inc., I was employed by Phamaco fiuclear, Inc., in C.leveland, Ohio, f rom September-December 1979.
Previous to that I was employed by Pharmaco Nuclear, Inc., in Chicago, Illinois, from approxi-mately October 1977 to September 1979 and in Cleveland from January 1976 to October 1977.
I am the author of the attached letter directed to a lir. James Sniezek of NRC and dated December 1,1979.
I drafted this letter because of my knowledge of these isses and my professional concern as a registered phamacist.
I first heard of Nuclear Pharmacy, Inc. (NPI) and this issue in approxi-mately late 1976 while working in Cleveland with P.harmaco liuclear, Inc.
~
(during my first employgmentyith them) from:
Mr.i who resides on in Cleveland Heights, Ohio (216
. He was then (1976) a'fo5ier employee of HPI's El Paso, Texas, pharmacy.
is presently employed by Pharmaco Nuclear, Inc., Cleveland, Ohio.
.at that time told me that while working for NPI at El Paso that NPI was receiving non-NDA Union Carbide Xenon-133 in bulk and that he was repacking it into unit doses for sale to hospitals.
The hospitals used this material for patients for diagnostic inhalation studies. I fl ~ also advised that when repacking the bulk Xenon-133, it was repacked into spent (used) New England Nuclear (NEN) unit dose vials. The significance of this practice was that the hospitals then assumed they were giving patients NDA approved unit doses of Xenon-133 for inhalation studies.
This was the last I heard of this matter until early 1979 and more specifically in the summer of 1979 when I saw a copy of an NRC Region III. letter transmitting an NRC circular regarding NPI and Xenon-133.
.I then called an associate,f '
, St. Luke's Hospital,)
, Milwaukee, IWs'coniih"(414-l 1.
Ms.'
is a chief techriTcTa'n in the Nuclear Medicine Department.
Her sup'ervisor is a Dr.!
rof Nuclear liedicine.1 (phonetic)
~'
was thelTia~rfia'cissior the Nuclear Medicine Depai tnie'nt. ' Ms.'
_,_,/.
advised me the hospital was buying Xenon-133 in bulk from HPI" labeled' not for human use and had an NPI prescriptien on it.
Since it had a prescription she felt that it was suitable for humans.
I had called Ms.l about the NRC circular.
The hospital (St. Luke's) had bought in b'ulk from HPI up through about April 1979 or later.
Ms.!
continued and icld ne that she had talked with a pharmacist at NPI Mildaukee who told her that he was breaking the bulk Xenon-133 down and repacking it ful
4 L
2 y
r into unit dose vials, some of which were. spent lien vials.
The fief 4 gas originally in the vials had an NDA approval.
She had asked if the bulk was all.right.
The fiPI-pharmacist assured her it was since he was
' breaking it down into unit doses.
3 I am not sure who Ms.'
was_ referring to as the tipi phamacist but I
~
believe it was either[,
or[
[ ~~ }~ 3 A few months ago I spoke to Mr.!
aoain recarding this matter and he again told me that when he w'orked at liPI in El Paso he had been ordered by Robert Sanchez, President of liPI, in 1976-77 to refill spent NEfi until (sic) dose vials.
Iwouldthinkthatf~
,. Regional Director for NPI would be the person who. told the 11ilwaukee NPI pharmacist (s) to repackage bulk 2enon-133 (sic) in spent fiEN unit dose vials.
~
Shortly thereaf ter I spoke with f~
, a phamacist at NPI in Chicago.
I believe thatF ~~ presentif resides inl ~ ~~"", Illinois (312-~
. t-told me in that conversation and others during roughlf the same~ t'ime f rame that he was to tell his accounts per Zimmer's orders that bulk Zenon (sic) "not for human use" from Union Carbide was only shipped to industrial accounts not hospitals.
~ ~ ~~~
I spoke with, again later in the summer (1979) and she advised that sne nac a phone call with fiPI Milwaukee and was told that the bulk 7enon-133 (sic) cnly went to industrial accounts not hospitals.
- knew that was not true since she had seen her hospital receive bulk ship.ents of Union Carbide Xenon-133 from tiPl.
I spoke with lis.<
again in September of this year.
She said her boss Dr.l_
thad called the President of fiPI, Sanchez.
A little late: an attorney from the Washington, D. C., area representing NPI called. Ms.:
-said that the attorney advised that she and the hospital could be in' trouble for talking about this matter since it was all a mistake.
I have read the foregoing statement of 12 pages and it is true and correct.
/s/l a
Sworn and subscribed to me at Oak Park, Michigan, this 28th day of December 1979.
/s/ Roger A. Fortuna Roger A. fortuna
/s/ Edward M. Podolak, Jr.
Edward 11. Podolak, Jr.
.