ML20041C136

EM-79-009A:on 820224,order Issued Imposing Civil Penalty of $2,000 Re Improper Procurement of Nonradiopharmaceutical Grade Xe-133.Penalty Mitigated Following NRC Consideration of Licensee Response

ML20041C136
Person / Time
Issue date:	02/24/1982
From:	Flack E, Lieberman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:
References
EN-79-009A, EN-79-9A, NUDOCS 8202260246
Download: ML20041C136 (2)

Text

February 24, 1982 EN 79-09A 3

0FFICE OF INSPECTION AND ENFORCEMENT NOTIFICATION OF SIGNIFICANT ENFORCEMERT KCTION c)

RECEIVED

1. 3 FE02519825 h Licensee: Nuclear Pharmacy, Incorporated, Milwaukee, WI License No. 48-17466-01MD

" 8them emser lac

//

Subject:

Imposition of Civil Penalties - $2,000

'u By EN 79-09, dated August 15, 1979, the Commission was notified of the intent of IE to issue a Notice of Violation and Proposed Imposition of Civil Penalties in the amount of Twenty Four Thousand Dollars to Nuclear Pharmacy, Incorporated (NPI). The proposed penalties were based on alleged items of noncompliance with NRC regulations and license conditions.

The first item of noncompliance was related to, (1) the improper procurement of non-radiopharmaceutical grade xenon-133, (2) the improper repackaging and relabeling of the product, and (3) the subsequent distribution of the material. The second item of noncompliance concerned bulk quentities of xenon-133, that were transferred to licensed medical institutions not authorized to receive such material.

Following an NRC inspection on January 13, 1979, Nuclear Pharmacy, Inc., immediately stopped this practice. There has been no report of any patient reaction as the result of the human use of the material. The case was also referred to the Department of Justice (DGJ) for review of alleged criminality implications.

The licensee responded to-the Notice in a letter dated October 22, 1979, in which the two items of noncompliance were denied. The Director of Inspection and Enforcement informed the licensee in a letter dated March 3,1980, that NRC had postponed further action on the proposed civil penalties at the request of D0J.

In a letter dated November 20, 1981, to Mr. Vakerics, attorney for the licensee, 00J stated that it had decided to defer prosecution ?f alleged criminal violations.

This decision was based on NPI's representation that _it had rectified the activities in question and will continue to comply with NRC's rules and regulations.

After consideration of the licem ee's response, IE has concluded that one violation should be withdrawn (the transfer of bulk quantities of xenon-133 to medical institutions that were later found to be authorized to receive the material).

In addition IE has concluded that, although the first item of noncompliance did occur, consideration should be given to the licensee's arguments-in favor of mitigation. Mitigation is considered appropriate in view of absence of harm to the public health and safety, NPI's enforcement history in the three years since the violations occurred, and consideration of circumstances surround-i_ng the case. _ Accordingly, the civil penalty for the first item of noncompliance-has been mitigated to Two Thousand Dollars and an Order Imposing a Civil Monetary Penalty has been issued today. The letter transmitting the civil penalty Order will inform the licensee that similar violations in the future may result in license suspension or revocation. The licensee and the State of Wisconsin are being informed by telephone.

Since this matter involves mitigation of one item and withdrawal of another, a press release has been prepared and will be mailed five days following mailing of the Order.

Page 1 of 2 pages

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p 6h r2o226o246 s2o224 PDR I&E EN-79-OO9A PDR j

February. 24,=1982-

.; Pag 2 '-2 EN 79-09A I nder the terms.of the' Order, the licensee may, within 30 days of the date of U

the. Order,. pay the civil. penalty or. request a hearing.

Contacts:

E. Flack, IE 24900

-J..Lieberman, IE 24909

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