ML19207C345
| ML19207C345 | |
| Person / Time | |
|---|---|
| Issue date: | 08/17/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML19207C343 | List: |
| References | |
| FOIA-79-362, FOIA-80-341 NUDOCS 7909110328 | |
| Download: ML19207C345 (5) | |
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Appendix A NOTICE OF VIOLATION Nuclear Pharmacy, Inc.
License No. 48-17466-01MD This refers to the inspection conducted by a representative of the Rcgion III (Glen Ellyn, Illinois) Office at Nuclear Pharmacy, Inc., Milwaukee, WI, of activities authorized by NRC License No. 48-17466-01MD.
Based on the inspection conducted on January 16 and 17, 1979, it appears that certain of your activities were in noncompliance with NRC requirements, as noted below.
1.
License Condition 15 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 Federal Food, Drug, and Cosmetic Act.
License Condition 9D restricts the use of xenon-133 to " processing, mixing or compounding, and distribution of pre-pared radiopharmaceuticals to authorized recipients."
Contrary to the above, Nuclear Pharmacy, Inc. routinely procured bulk quan-tities of xenon-133 gas from a supplier whose product was not indicated for human use in accordance with the Federal Food Drug and Cosmetic Act and which was labeled "not for human use;" routinely processed, mixed or compounded such bu quantities of xenon-133 into unit dose containers, relabeled the unit dose containers indicating them to be for human use; and distributed these con-tainers to medical licensees, representing falsely that the product was a prepared radiopharmaceutical for administration to humans.
Each bulk pro-curement processed in this manner is indicated in Attachment 1 and con-stitutes a separate violation which had a potential for causing or contri-buting to an occurrence related to health and safety.
Civil Penalty - $2,000 x 8 occurrences = $16,000 2.
10 CFR 30.41 (b)(5) and 10 CFR 30.41(c) restrict the transfer of byproduct material to persons authorized under terms of a specific license to possess the material in the type, form, and quantity te be transferred.
Contrary to the above, Nuclear Pharmacy, Inc., transferred bulk quantities of xenon-133 gas labeled "not for human use" to medical institutions, a form which those institutions were not authorized to receive.
Each of the transferees was authorized to receive xenon-133 only from a supplier who is authorized to distribute xenon-133 in a form suitable for human use in accordance with the Federal Food, Drug, and Cosmetic Act.
Each bulk ship-ment is indicated in Attachment 1 and is a separate infraction.
Civil Penalty - $1,000 x 8 shipments = $8,000 This Notice of Violation is sent to Nuclear Pharmacy, Inc., pursuant to the pro-visions of Section 2.201 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations.
Nuclear Pharmacy, Inc., is hereby required to submit to this office, within twenty-five (25) days of this notice, a written statement or explanation in reply, including for each item of noncompliance, (1) admission or denial of the alleged item of noncompliance; (2) the reasons for the item of non-compliar.ce if admitted; (3) the corrective steps which have been tak.en and the results achieved; (4) corrective steps which will be taken to avoid further non-compliance; and (5) the date when full compliance will be achieved.
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SHIPMENTS RECEIVED FROM UNION CARBIDE CORPORATION AND PROCESSED INTO UNIT DOSES Date Processed Nuclear Pharmacy
- Date Received Lot No.
Amount (mci) or Distributed Log No.
Rx No.
1/11/79 B-2747 1527 1845 10.0 1/16/79 32388 11.2 1/16/79 32379 11.5 1/16/79 32373 11.7 1/16/79 32273 1/4/79 110809 1884 1809 16.5 1/8/79 31665 19.0 1/8/79 31697 23.7 1/8/79 31698 18.0 1/9/79 31702 21.3 1/9/79 31802 10.7 1/9/79 31808 17.5 1/11/79 32040 21.2 1/11/79 32041 16.8 1/11/79 32042 11.2 1/12/79 32045 16.5 1/12/79 32046 20.6 1/12/79 32121 18.9 1/12/79 32122 13.2 1/15/79 32214 20.2 1/15/79 32221 15.6 1/15/79 32222 13.9 1/15/79 32267 12/28/78 110808 1804 1776 23.0 12/30/78 31056 16.7 12/30/78 31057 15.8 1/1/79 31070 11.4 1/1/79 31074 13.2 1/1/79 31075 11.9 1/2/79 31159 16.0 1/2/79 31196 18.4 1/3/79 31285 18.0 1/3/79 31288 20.02 1/3/79 31289 9.30 1/3/79 31309 19.00 1/3/79 31271 19.00 1/3/79 31272 Similar amounts 1/4/79 31513 1/5/79 31525 1/5/79 31526 1/5/79 31527 1/5/79 31529 1/5/79 31530 1/5/79 31531 ATTACHMENT 1 to APPENDIX A S.
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SHIPMENTS RECEIVED FROM UNION CARBIDE CORPORATION AND PROCESSED INTO UNIT DOSES (CONTINUED)
Date Processed Nuclear Phcrmacy
- Date Received Lot No.
Amount (mci) or Distributed Log Nc.
Rx No.
Similar Amounts 1/5/79 31532 1/5/79 31545 1/5/79 31565 1/5/79 31566 1/5/79 31567 12/21/78 110587 2042 1746 12/23/78 - One unit dose 12/16/78 - Four unit doses 12/27/78 - Seven unit doses 12/28/78 - Three unit doses 12/29/78 - three unit doses 12/14/78 110540 1866 1713 12/16/78 - Two unit doses 12/17/78 - One unit dose 12/18/78 - Four unit doses 12/19/78 - Nine unit doses 12/20/78 - Four unit doses 12/21/78 - Six unit doses 12/22/78 - Four unit doses 12/26/78 - Two unit doses 12/7/78 110476 1621 1674 12/9/78 - One unit dose 12/11/78 - Ten unit doses 12/12/78 - Four unit doses 12/13/78 - Three unit doses 11/30/78 110180 1950 1634 12/1/78 - Two unit doses 12/5/78 - Three unit doses 12/7/78 - Four unit doses 12/8/78 - Four unit doses 12/9/78 - Two unit doses ATTACHMENT 1 to APPENDIX A O 1 ",
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SHIPMENTS RECEIVED FROM UNION CARBIDE CORPORATION AND PROCESSED INTO UNIT DOSES (CONTINUED)
Date Processed Nuclear Pharmacy
- Date Received Lot No.
Amount (mci) or Distributed Log No.
Rx No.
11/22/78 110218 2024 1595 11/27/78 - Three unit doses 11/28/79 - Six unit doses 11/29/78 - Two unit doses 11/30/78 - Three unit doses 12/1/78 - One unit dose 12/2/78 - One unit dose 12/3/78 - Two unit doses
^Date received is recorded as the calibration date shown on the Union Carbide label. In many cases, Nuclear Pharmacy Inc. physically received the material the day after or the day before the calibration date shown on the Union Carbide label.
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ATTACHMENT 1 to APPENDIX A
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SHIPMENTS RECEIVED FROM UNION CARBIDE CORPORATION AND DISTRIBUTED IN BULK Nuclear Pharmacy
- Date Received Lot No.
Amount (mci)
Date Distributed Loc No.
Rx No.
1/11/79 E-2745 1675 1/12/79 1844 32161 1/10/79 111049 1343 1/11/79 1836 32030 12/28/78 110808 1717 12/29/78 1775 31034 12/28/78 110808 1804 12/29/78 1774 31032 12/19/78 110645 1549 12/20/78 1736 30398 12/14/78 110540 1779 12/15/78 1712 30018 12/S/78 110337 1707 12/12/78 1690 29681 11/30/78 110180 1720 12/1/78 1833 28730 12/1/78 1833 28731
- Date received is recorded as the calibration date snown on tne Union Carbide label. In many cases. Nuclear Pharmacy Inc. physically received the material the day after or t'a cay before the calibration date shown on the Union Carbide label.
ATTACHMENT 1 TO APPENDIX A t,
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