ML20040B922
| ML20040B922 | |
| Person / Time | |
|---|---|
| Issue date: | 10/12/1979 |
| From: | Jamarl Cummings NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | Lippe L JUSTICE, DEPT. OF |
| Shared Package | |
| ML20040B919 | List: |
| References | |
| FOIA-81-349 NUDOCS 8201260594 | |
| Download: ML20040B922 (4) | |
Text
OCT 121979 ffr. Lawrence Lippe, Chief, General Litigation and Legal
- Advice' Section Crininal Division
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U. S. Department of Justice h'ashington, D. C.
20530 Dear !!r.
ppe:
Submitted for your consideration and appropriate action is an inspection report, Report flunber 79-1 (Attachment A.), prepared by a member of the Region III (Glen Ellyn,. Illinois) staff of the flucicar Regulatory Conmission '(NRC), Office of Inspection and Enforcement. The report identifies possible violations by Nuclear Phamacy, Incorporated, ftilwaukee, Pisconsin, and its nanapenent; of Section 223 of the Atonic Energy Act, 42 USC 52273, and '10 CFR 530.34(c), 530.41(b)(5), and 530.41(c).
These possible violations arise from the sale of chemical grade Xenon-133 (Xe-133) which had been misrepresented and sold for use as a radiopharmaceutical The same acts which led to violations of Section 223 for hunan use; also appear. to have resul,ted in violations of.18 USC 51001 and 18 USC 371. Rationale. for our opinion is as.follows:
Nuclear Phamacy. Incorporated, is a New I'exico based corporation with approxinately 15 branch phamacies located throughout the United States.
Each branch is individually licensed by the NP.C or by an Agreenent State.
On Novenber' 30,'1978, the State of Texas' determined 'that a f.'uclear Phamacy branch loca'ted in the State had been. distributing Xe-133..obtained in bulk quantities from the Union Carbide Corporation. Union Carbide is not approved by the Food and Drug Adninistration (FDA) as a nanufacturer of Xe-133 for human use (see Attachment 4 of Attachment Al.As a result of that iaspection, the State of Texas issued a Cease and Desist Order l
to all Nuclear Pharmacy branches in Texas and advised NRC 6f 'their The flPC Office of State Prbarars findings and enforcement action.
l renuested that the Office of Inspection and Enforcement conduct special-inspections of each NRC licensed Nuclear Phamacy branch to ascertain
. the existence of similar practices by NRC licensed branches of the -
.Uuclear Pha,macy Corporation.
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007 1 2 1979 As a result oT this special inspection, it was detemined, as shown in Attachnent A, that the l'iltaukee lluclear Pharmacy had, fron its establishment in 1977 and continuing through January 16, 1979, the date of the inspection, procured Xe-133 from Union, Carbide on a routine basis lind had distributed the Union Carbide product both in bulk and in unit dose containers to nedical institutions for human use.
The liihtaukee Nuclear Phamacy currently holds License !!unber 48-17466-OIf;D (Attachment B), whict, was issued, in part, pursuant to the Atonic Energy Act of 1954, as amended; the Energy Reorganization Act 'of 1974 (Public Law 93-438); and 10 CFR, Part 30.
Its mos,t recent amendment is dated April 27, 1978.
Among other things it allows !!ilwaukee fluclear Phamacy to receive, acquire, possess and transfer the by-product Xe-133 in either a pas and/or saline fom.
Ten CFR 530.34(c) advises that, "Except as otherwise provided in the license," licenses issued pursuant to the regulations in Parts 30-35 "shall carry with it the right to receive, acquire, own, and possess by-product material." Licens.e Condition Nunber 15 of l'ilwaukee Nuclear Phantacy's' license states, " Radioactive gases as free gas or in solution, to be administered to humans, shall be procured fron a supplier who distributes the product indicated for hunan use in accordance with the.
Federal Food, Drug, and Cosmetic Act."
By acquiring Xe-133 from Union Carbide Ccrporation, a fim which only produces a chenical. grade product and which Union Carbide states is not f.or human use, !!ilwaukee. Nuclear Phamacy, Incorporated, is in violation of License Condition Number' 15, and.with 10 CFR 930.34(c).
A violation of.10 CFR E30.34(c), which was-issued under the authhrity of Section 161..of the.Act. 42 USC 52201, is a crime under Section 223. 42 c
USC E2273, if connitted willfully.' '
TenCFR630.41(b)h)restrictsthetransferofby-productmaterfalto persons authorized to receive such. material under terms of a license issued by the Commission. Ten CFR 530.41(c) requires that the transferce's license cust authcrize receipt of the type, fom, and cuantity of'by-product material to be transferred. License Condition Number 90 of.the Mihtaukee Nuclear Pham::cy. Incorporated, license limits the " distribution of prepared radiophamactuticals to authorized recipients." itisrepresenting
.chenical grade Xe-133 qs being e radiopharmaceutical suitable for human use, and dispensing chemical grade Xe-133 to medical' licensees authorized only human use of such. material,is a-violation of f.icense Condition-.
Nurber 90..and.,with 10'C[R 830.41(b)(5) an_d.530.41P.L
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Violations;of 10 CFR. 530.41(b)(5) ahd-30.41(ch whict'ere issued under,'.
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OCT 121979 According to the' data in Attachment A, fillwaukee Nuclear Phamacy regularly sold and. transferred chemical grade Xe-133 to medical licensees who wre only licensed by the NRC to receive radiophamaceuticals for human use.
All transfers of Xe-133 were accompanied by an invoice (Attachnent 5 of Attachment A), described as a " prescription blank." which contained the following text,- in part:
" CAUTION:
To be used under the direct supervision of a physician" and
" Spec instructions:
Inhalation Adninistration only" "lfa rning:
This radiophamaceutical is licensed by the U. S. Nuclear P.cgulat.,
Commission. distribution to persons licensed pursuant to 34.14 and
- 35.100 Group I, Group II, Group IV or Group V of 10 CFR Part 35.
Syringe containing drug should be kept in this container or within heavier shield."
By labeling chemical grade Xe-133 in a manner that clearly represented it to be a radiophamaceutical suitable for human use, fillwaukee Nuclear Pharmacy caused all of its medical licensee customers to be in violation of their NRC license conditions, thereby subverting an NRC regulatory program intended for the protection of public. health.
It should also be noted that NRC licensees are. subject to NP,C ' inspection, to assure compliance with license conditions and regulations.
To demonstrate compliance with the conditforf that they only acquire radiophamaceuticals-indicated for human use, customers af t'llwaukee Nuclear Phamacy would no doubt provide NRC inspectors with !!ilwaukee Nuclear's above quoted invoice " prescription h1ank."
Hisrep.resentipgIthe quality and suitability of a relevant product to both licensees of the NRC and to the NRC, would~ be a crime under 18 USC 1001, if_ cenitted knowingly and willfully.
As evidence of knowledge and willfullness. regarding all of the violative acts previously cited, reference is nade to Attachment A, page 6, paragraph 1; page ll, last paragraph; and to Attachment C.
These references refer _ to the acknowledgement by the licensee.and corporate management -
that, due to's highly competitive industry and perceived contradictions t
I between the regulations of various agencies they knowingly engaged in, a continuing practice which was in noncompl.iance with FDA requirenents.
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NRC requirements, and the conditions of their.11 cense
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In detemining what action to'take on this referral,"you may wish to, consider tha't Xe-133 gas when.used as 'a radiophamaceutical.(by-product)
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is admiriistered to h.umans for variousjtes.ts. relating to he' art and ' lung" w
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DCT 121979 1 r. Laurence Lippe a
',4isorders. 'The distribution of this product not intended for hunan use, but nisrepresented as such, indicates a serious disregard for public health and safety.
The !!RC's Office of Inspection and Enforcenent, independent of any criminal action which might be undertaken by the Departnent of Justice, has proposed the impositi.on of civil penalties against the firm, itilwaukee fluclear Phamacy, pursuant to Section 234 of the Atomic Energy Act, as anended, 42 USC 2282 and 10 CFR 2.205.
Please advise what further asr,istance you ray reqdire in this natter.
Sincerely, Janes J. Cumings, Director '
Office of Inspector and Auditor Attachnents:
As stated t
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Subject:
79-54 OIA Reading Fortuna Reading Strickler
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'1.iniversity'of Oklahoma at Oklahoma City' Health Sciences Center Conege of ?t*macy March 6,
1981 Chairman Nuclear Regulatory Commission FREEDOM OF INFORMATION Fsshington, DC 20555 ACT REQUEST f02~A-2/-/00 h,ggIg g,a g
Dear Mr. Chairman:
Under the provisions of the Freedom of Information Act, 5-USC-552, I am requesting access to the following:
1.
Inspection reports of nuclear pharmacies under license catagory 02500 for the years 1979 and 1980.
2.
Copies of any PNO (Preliminary Notification Reports) involving any incidences occurring with licensees licensed under 02500 for the years 1979 and 1980.
I am requesting this information so that I might technically analyze the rate of noncompliance by nuclear pharmacies from a statistical consideration and to develop a paper that, with time, will identify the parameters that effect the incidence noncompli-ance rate.
As you know the act permits you to reduce or waive fees when the use of the information is considered as "primarily benefiting the public."
I believe that this request fits that catagory and therefore ask you to waive any fees.
If all or any part of this request is denied, please site the specific exemptions which you think justify your refusal to release the information and inform me of the appeal procedures available to me under the law.
I would appreciate your handling this request as quickly as possible and I'll look forward to hearing from you within 10 days as the law stipulates.
Sincerely,
/
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Rodney D.
Ice, Ph.D.
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Certified llealth Physicist RDI/smg Post Office Box 26901 C44 N.E.14th Street Ok fahoma City, Oklahoma 73190 AC 405 2716484
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June 10, 1981 Dr. Rodney D. Ice Certified Health Physicist i.
The University of Oklahoma at Oklahoma City IN RESPONSE REFER Oklahoma City, OK 73190 TO F01A-81-100
Dear Dr. Ice:
This is in further response to your letter of March 6,1981 in which you requested, pursuant to the Freedom of Information Act, two categories of documents pertaining to inspection reports and preliminary notification reports (PN0s) for licenses under the 02500 category.
Please find enclosed the seven documents listed on Appendix A.
We have been informed that Pharmatopes, Inc., License No. 35-19583-OlMD, has not as yet been inspected.
This completes NRC action on your request.
Sin,cerely, f
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[fJ.M.Felton, Director Division of Rules and Records Office of Administration
Enclosures:
As stated p
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RE:({)0lA-81-100 APPENDIX A 1.
April 16,1981 Letter to Pharmatopes, Inc. (Vincent M. Immerso) from John D. Kinneman, re:
Inspection No. 81-01 2.
February 12, 1981 Letter to Diagnostic Management, Inc. (Dennis R.
Hoogland) from W. L. Fisher, re:
Notice of Violation and Inspection Report, with attachments (26 pages) 3.
June 27, 1980 Letter to RAD /lRID (Krishnan Suthanthiran) from John D. Kinneman, re: Notice of Violation, with attachment (3 pages) 4.
October 24, 1979 Letter.to University of Pittsburgh (Dr. Neil Wald) from Robert 0. McClintock, re:
tiotice of Violation, with attachment (3 pages) 5.
February 8,1978 Letter to E. R. Squibb & Sons, Inc. (Dr. Charles L.
Kroll) from Robert 0. McClintock, re:
Inspection 78-01 6.
December 19, 1977 Letter to CIS Radiopharmaceutical, Inc. (Daniel Nachter) from Robert 0. McClintock, re: Notice of Violation and Inspection Report, with attachments (11 pages) 7.
July 14,1976 USNRC Inspection Findings and Licensee Acknowledgment for Cambridge Nuclear Radiopharmaceutical Corp.
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June 2, 1981 Dr. Rodney D. Ice Certified Health Physicist
!!ealth Sciences Center The University of Oklahoma at Oklahoma City P. O. Box 26901 IN RESPONSE REFER Oklahoma City, OK 73190 TO F0lA-81-100
Dear Dr. Ice:
This is in further response to your letter of March 6,1981, in which you requested, pursuant to the Freedom of Information Act, two categories of documents pertaining to inspection reports and preliminary notification reports (PN0s) for licenses issued under category 02500 for 1979 and 1980.
On April 30, 1981 you agreed, in a telephone convirsation with Ms. Sarah N.
Wigginton of iay staff, to limit your request for inspection reports for the year 1980 for the present time, with the understanding that you might also need the reports for 1979 in the event your statistical sample is not large enough.
Please find enclosed the 3S documents listed on Appendix A.
The dates on the reports reflect the latest date of inspection; in some cases, you will see that the inspections.were not conducted in 1980.
This is due to the fact that inspections are carried out on a cyclical, rather than annual, basis.
liowever, we have included them in the event they may be of use to you in your research.
One licensee, Western Diagnostics Services, has not as yet been inspected.
In addition, 14 inspection reports have been requested from the NRC regional offices. As soon as we receive those reports, we will forward them to you.
Sincerely,
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Fel on, Director Division of Rules and Records
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Office of Administration
Enclosures:
As stated
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F0l A-81-100 APPENDIX A 1.
April 13,1981 Letter to Mallinckrodt, Inc., from James G. Keppler, re:
IE Report No. 81-01 (11 pages) 2.
March 13,1981 Letter to Norland Instruments from D. G. Wiedeman, Notice of Violation (3 pages) re:
3.
February 12, 1981 Letter to Diagnostic Management, Inc., from W. L.
Fisher, re: Notice of Violation and Inspection Report (26 pages) 4.
February 4,1981 Letter to Bio-Dynamics /bmc from W. L. Fisher, re:
Notice of Violation (4 pages) 5.
December 18, 1980 Letter to Phannatopes, Inc., from Boyce H. Grier, re: Report No. 30-14826/80-01 (17 pages) 6 November 20, 1980 Letter to Pacific Radiopharmacy, Ltd., from H. E.
Book, re:
Notice of Violation and Notice of Deviation (5 pages)
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November 7,1980 Letter to University of Utah from Glen D. Brown, re:
Inspection Report (3 pages) 8.
August 14, 1980 Letter to New England Nuclear Corporation from John D. Kinneman, re:
Inspection Report Numbers 30-4579/80-01 ;
30-4581/80-02 and 30-4704/80-01 (12 pages) 9.
August 11, 1980 Letter to Diagnostic Isotopes, Inc.,
from Boyce H.
Grier, re: Notice of Violation and Inspection Report (18 pages)
- 10. August 7,1980 USNRC Inspection Findings and Licensee Acknowledgment
.for Virginia Commonwealth University
- 11. August 7, 1980 Letter to Minnesota Mining and Manufacturing Company from A. B. Davis, re: Inspection Report (23 pages) 12.
July 10,1980 Letter to Pharmaco Nuclear, Inc., from John D.
Kinneman, re: Routine inspection 13.
June 27, 1980 Letter to RAD / IRID, Inc., from John D. Kinneman, re: Notice of Violation (3 pages) 14.
June 26,1980 Letter to University of Minnesota from James G.
Keppler, re: Notice of Violation and Inspection Reports (28 pages)
- 15. April 25,1980 Letter to William Beaumont Hospital from James G.
Keppler, re: Notice o,f Violation (8 pages)
- 16. April 21, 1980 Letter to Nuclear Pharmacy, Inc., from A. B. Davis,
Inspection Report (12 pages) re:
O RLOr0I^-81-iOO 2
- 17. April 2,1980 Letter to Gamma Diagnostic Laboratories from George H. Smith, re:
Notice of Violation (4 pages) 18.
February 20, 1980 Letter to Nuclear Pharmacy, Inc., (Elfreth Alley Apothecary) from Boyce H. Grier, re:
Inspection Report (8 pages) 19.
January 18, 1980 Letter to Pharmatopes. Inc., from J. Philip Stohr, re: Notice of Violation (3 pages) 20 January 2, 1980 Letter to Pharmaco Nuclear from A. B. Davis, re:
Notice of Violation (2 pages) 21.
December 17, 1979 Letter to Amersham Corporation from A. B. Davis, re:
Notice of Violation and Inspection Reports (13 pages)
- 22. September 24, 1979 Letter to Minnesota Mining and Manufacturing Co.
from A. B. Davis, re:
Notice cf Violation and Inspection Reports (21 pages) 23.
September 18, 1979 Letter to Capintec Instruments, Inc., from Robert
- 0. McClintock, re:
Notice of Violation (4 pages)
- 24. August 17, 1979 Letter to Nuclear Pharmacy, Inc., from James G.
Keppler, re:
Inspection Report (22 pages)
- 25. August 16, 1979 USNRC Inspection findings and Licensee Acknowledgment for Pharmaco Nuclear
- 26. June 29,1979 Letter to Medi+ Physics, Inc., from James G. Keppler, re:
Notice of Violation (4 pages) 27.
February 1,1979 Letter to Abbott Laboratories from A. B. Davis, re:
Notice of Violation (3 pages) 1 28.
December 5,1978 USNRC Inspection Findings and Licensee Acknowledgment for The Proctor & Gamble Company 29.
November 15, 1978 USNRC Inspection Findings and Licensee Acknowledgment l
for Pharmatopes Inc.
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31.
October 27, 1978 USNRC Inspection Finding: and Licensee Acknowledgment for The University of Oklahoma Health Sciences Center
- 32. August 23, 1978 Letter to Pharmatopes. Inc., from A. B. Davis, re:
- 33. May 11, 1978 letter to The Regents of the University of Michigan from A. B. Davis, re:
Notice of Violation (3 pages-)
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- 34. April ll,1978 Letter to Pharmatopes, Inc., from W. L. Fisher, re:
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roia-81-ioo 3
35.
January 26, 1977 Letter to leahy Nuclear Corporation from James M.
Allan, re:
Item of Noncompliance (3 pages)
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April 10, 1981 Dr. Rodney D. Ice, Dean Health Sciences Center The University of Oklahoma at
-Oklahoma City P. O. Box 26901 IN RESPONSE REFER Oklahoma City, OK 73190 TO F01A-81-100
Dear Dr. Ice:
.This is in partial response to your letter of March 6,1981 in which you requested, pursuant to the Freedom of Information Act, two categories of documents pertaining to inspection reports and preliminary notification reports (PN0s) for nuclear pharmacies under license category 02500.
Please find enclosed the documents listed on Appendix A, which represent the PH0s pertaining to nuclear pharmacies during 1979 and 1980.
With regard to the inspection reports, we have been advised that there are 57 licensees under the 02500 category, some of whom hold multiple licenses.
If you do not want to have specific reports and want instead to have access to all inspection reports, there may be additional search time involved.
Our best estimate' is that it would require approximately-one week to complete the scarch and reproduce the records.
We will not take any further action on this portion of your request until we hear from you.
If you have any questions, please feel free to call Ms.
Sarah N. Wigginton of my staff on (301) 492-8133.
Sin ly, J. M. Felton, Director Division of Rules and Records Office of Administration
Enclosures:
As stated I-
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- 15. October 25. 1979 puo.ggg.79 22. Nx1 car Pharmacy. Tnc. r APPENDIX A Transportation Acctdent - No toss of t tal Pre 11minary Notifications of Event or tinusual Occurrences
- 16. July 23.1979 pNo.79-279. M411tnckrodt. Inc.. re: Lost shipment of Licensed Byproduct mter a 1.
Decedier 16. 1980 PNO-III-80 231 11tnckrodt. Inc.. re: Lost 17 July 23.1979 PNO-79-275. N111nchrodt.11.c.. re: Lost shipment of Radioactive Material (2 pages)
Shipment of Licensed Byproduct mter a 2.
Noventer 12, 1980 Co. (3H). re:PNO-III-80-212. Minnesota Minin
- 18. June 8.1979 PNO-79-143. E. R. Squibb Co.. re: Release Report on Ceslum-137 Scaled Sourc/
of Wterial to the Pubile Domin A
PParently tos t (2 pages) 3 Noverder 12, 1980
- 19. April 11.1979 PNO-79-79. Abbott Laboratories. re: t source of 1;ominal 0.992 Millicurles of M ne PNO-ill-80-211 h111ncLrodt. Inc., re:
tost Shipment (2 pages)
Package Containing 8 Mil 11 curies I-131 (2 pag 4 August 7.1980 PHO-III-80-146. Abbott Laboratories. re:
20 July 23.1980 PNO-1-80 07 Eng e
e Con in ng d oa tive leaking RIA Kit at Purolator Terminal 5.
July 29,1980 te t out Proper D.O.T. Label PNO-III-80-141. Pharmatopes '. re: tost 100
.Hillicurle Technetf um-99m Source (2 pages) 6 July 23.1980 PNO-III-80-136. Nuclear Pharmacy. Inc., re:
Abandoned Radioactive mterial (2 pages) 7 July 16,1980 PHO-III-80-133, Pharmatopes inc., re:
Report on Possible Theft of Byprodxt Nterfal from a flapital (2 pages) 8 July 16, 1980 PNG-III-80-132. P!'arma topes. Inc., re:
on 7ccident of Vahtcle Carrying ByproductReport L terial (2 pages) 9.
July 8,1980 PNO-III-80-129. Mallinckrodt. Inc. re:
Two Cases A rked Radfoactive h terial Purchased at an Estaic Sale (2 pages) 10 June 30.1980*
PNO-III-80-121. M411tockrodt. Inc., re:
Trans-portation Accident involving Radioactive hterial 11. June 5,1980 PHO-III-80-110. Abbott laboratories. re:
Package Containing One Microcurfe of Iodine-125 Crushed at O'Itare Airport 12 April 17,1980 PNO-III-80-71. N111nck'rodt. Inc.. re: tost Container with 250 Microcuries of Cr-51 (2 pages)
- 13. April 10,1980 PNO-It!-80 67. Abbott laboratories. re:
Intera Transit (2 pages)ruption of Nuclear Medicine
' 14 t*, arch 7,1980 PNO-III-80-43. Minnesota. HinIng and l'anu.
facturing, re: Vehicle Contamination from teaking Po-210 Static Eliminator d