ML19207C342
| ML19207C342 | |
| Person / Time | |
|---|---|
| Issue date: | 08/17/1979 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Reavis J NUCLEAR PHARMACY, INC. |
| Shared Package | |
| ML19207C343 | List: |
| References | |
| FOIA-79-362, FOIA-80-341 NUDOCS 7909110316 | |
| Download: ML19207C342 (2) | |
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UNITED STATES 8 " #' 3. - g y ',7, NUCLEAR REGULATORY COMMISSION WASHINGTON. D. C. 20555 gw f AUG 171979 Nuclear Pharmacy, Inc.
ATTN:
Mr. Jon M. Reavis License No.
48-17466-01MD Manager 1024 North 6th Street Milwaukee, WI 53203 Gentlemen:
An inspection conducted on January 16-17, 1979, at your facility showed that, contrary to regulatory requirements and license conditions, Nuclear Pharmacy, Inc.,
had routinely procured from Union Carbide Corporation non pharmaceutical grade xenon-133 gas, not intended for human use as indicated by package labeling.
Nuclear Pharmacy, Inc. repackaged and relabeled the product showing it to be for human use, and subsequently distributed the material for that purpose.
Bulk quantities of xenon-133 labeled "not for human use" were also transferred to licensed medical institutions not authorized to receive such material.
These actions occurred subsequent to a cease and desist order issued by the State of Texas to the Nuclear Pharmacy, Inc. locations in that State.
This order.put you on notice of your noncompliance with Nuclear Regulatory Commission regulations.
However, the shipments continued until the inspection mentioned above.
An immediate action letter dated January 18, 1979, f rom Mr. J. G.
Keppler, Director of the Nuclear Regulatory Commission's Region III Office (Glen Ellyn, Illinois), confirmed that you had ceased distribution of this material.
As discussed with you by Mr. J. G. Keppler during a meeting on March 23, 1979, we regard the improper distribution of xenon-133 by Nuclear Pharmacy, Inc., as a serious matter.
Because of the potential seriousness of these items and the fact that the products were relabeled to indicate they were approved for human use when they were not, we intend to prcpose civil penalties in the amount of Twenty-four Thousand Dollars ($24,000) as set forth in Appendix B for the items of noncompliance set forth in Appendix A.
You are required to respond to Appendix A, and in preparing your response, you should follow the instruc-tions in Appendix A.
Your written reply to this Notice of Violation in accord-ance with section 182 of the Atomic Energy Act of 1954, as amended, should be submitted under oath and will be considered in determining whether your license should be modified, suspended or revoked.
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CERTIFIED MAIL 7909110 ]g RETURN RECEIPT REQUESTED
Nuclear Pharmacy Inc. In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and the enclosures will be placed in the NRC's Public Document Room.
Sincerely,
<f Victor Stello, Jr.
Director Office of Inspection and Enforcement
Enclosures:
1.
Appendix A, Notice of Violation 2.
Appendix B, Notice of Proposed Imposition of Civil Penalties cc w/encls:
Nuclear Pharmacy, Inc.
Robert Sanchez, President Post Office Box 25141 Albuquerque, NM 87215 Nuclear Pharmacy, Inc.
Michael Zimmer, Ph.D.,
Regional Director 770 N. Church Road, Suite F Elmhurst, IL 60126 E
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