ML20050C580
| ML20050C580 | |
| Person / Time | |
|---|---|
| Issue date: | 02/24/1982 |
| From: | Deyoung R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | NUCLEAR PHARMACY, INC. |
| Shared Package | |
| ML20050C578 | List: |
| References | |
| NUDOCS 8204090111 | |
| Download: ML20050C580 (4) | |
Text
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of
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NUCLEAR PHARMACY, INC.
Byproduct Material License 1024 North 6th Street No. 48-17466-01 MD Milwaukee, Wisconsin 53203 ORDER IMPOSING A CIVIL MONETARY PENALTY I
Nuclear Phannacy, Incorporated,1024 North 6th Street, Milwaukee, Wisconsin (the " licensee") is the holder of Byproduct Material License No. 48-17466-01MD (the " license") issued by the Nuclear Regulatory Comission.
License Condition 90 authorizes the processing, mixing or compounding and distribution of prepared xenon-133 as a radiopharmaceutical to authorized recipients.
License Condition 15 requires the licensee to procure xenon-133 from a supplier who distributes the product indicated for human use in accordance with the Federal Food, Drug, and Cosmetic Act. The license was issued originally on May 25, 1977. This license was amended on June 17, 1977, to increase the maximum possession limit of xenon-133 from 500 millicuries to 2 curies.
II An inspection conducted on January 16-17, 1979, at the licensee's facility in Milwaukee, Wisconsin, showed that, contrary to regulatory requirements and license conditions, the licensee had procured xenon-133 gas (which was not approved for human use in accordance with the Federal Food, Drug, and Cosmetic Act) routinely from Union Carbide Corporation, had repackaged and relabeled the product showing it to be for human use, and subsequently had distributed the material for that purpose.
Bulk quantities of xenon-133 labeled "not for human use in present form" were also transferred to licensed medical institutions.
8204090111 820224 NMS LIC30 40-17466-01MD PDR
2-The specific items of noncompliance associated with the findings of the Commission inspection were described in accordance with 10 CFR 2.201 in a Notice of Violation which was served upon the licensee by letter dated August-17, 1979.
A Notice of Proposed Imposition of Civil Penalties dated August 17, 1979, was served concurrently upon the licensee in accordance with Section 234 of the Atomic Energy Act of 1954, as amended (42. U.S.C. 2282),
and 10 CFR 2.205. A letter dated October 22, 1979, with attachments, in response to the Notice of Violation and Notice of Proposed Imposition of Civil Penalties was received from the licensee.
Further action on this matter was suspended by the NRC at the request of the U.S. Department of Justice until November 1981.
III Upon consideration of the licensee's responce and the statements of fact, explanation and argument in denial or mitigation contained therein, the Director of the Office of Inspection and Enforcement has determined that the penalties designated in Item 1 of the Notice of Violation should be mitigated to Two Thousand Dollars and that Item 2 of the Notice of Violation should be withdrawn.
1 IV l
In view of the foregoing and pursuant't'd Section 234 of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2282, PL 96-295), and 10 CFR 2.205, i RAUC, d.i7-
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.. IT IS HEREBY ORDERED THAT:
The licensee pay civil penalties in the total amount of Two Thousand Dollars within thirty (30) days of the date of receipt of this Order, by check, draft, or money order payable to the Treasurer of the United States and mailed to the Director of the Office of Inspection and Enforcement.
V The licensee may request a hearing within thirty (30) days of the receipt of this Order. A request for a hearing shall be addressed to the Director, Office of Inspection and Enforcement, U.S.N.R.C., Washington, D. C.
20555. A copy of the hearing request shall also be sent to the Executive Legal Director, U.S.N.R.C., Washington, D. C.
20555.
If a hearing is requested, the Comission will issue an Order designating the time and place of hear ~ing.
Upon failure of the licensee to request a hearing within thirty
- days of the date of this Order, the provisions of this Order shall be effective without further proceedings and, if payment has not been made by that time, the matter may be referred to the Attorney General for collection.
VI In the event the licensee requests a hearing as provided above, the issues to be considered at such a hearing shall be:
.... (a) whether the licensee was. in compliance with the conditions of the license as set forth in Item 1 of the Notice of Violation issued on August 17, 1979, and (b) whether, on basis of the item of noncompliance, this Order Imposing a Civil Monetary Penalty should be sustained.
FOR THE NUCLEAR REGULARTORY COMMISSION Richard C./
- oung, rector Office of Inspection and Enforcement Dated at Bethesda. Maryland this 24th day of February, 1982 I
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