ML20050C577
| ML20050C577 | |
| Person / Time | |
|---|---|
| Issue date: | 02/24/1982 |
| From: | Deyoung R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Sanchez R NUCLEAR PHARMACY, INC. |
| Shared Package | |
| ML20050C578 | List: |
| References | |
| NUDOCS 8204090108 | |
| Download: ML20050C577 (3) | |
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IEEQ FILE COPY FEB 2 41982
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License No. 48-17466 01MD p
s-NC Nuclear Pharmacy, Inc.
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'N.
ATTN:
Robert Sanchez, President d
P. O. Box 25141 V
Albuquerque, NM 87215
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Gentlemen:
This is in reference to your letter of October 22, 1979, in response to the Notice of Violation and Notice of Proposed Imposition of Civil Penalties sent to you with our letter dated August 17, 1979.
The notices concerned items of noncompliance found during an NRC inspection conducted on January 16 and 17, 1979, of activities under NRC License No. 48-17466-01MD at your facility in Milwaukee, Wisconsin.
Your counsel, Mr. Vakerics, was informed formally by Mr. Stello's letter dated March 3, 1980, that the NRC had postponed further action on the proposed civil penalty at the request of the U. S. Department of Justice.
The Justice Department recently informed us that we could resume our consideration of civil administrative action against NPI.
In a letter dated November 20, 1981, to Mr. Vakerics, the Justice Department stated that it had decided to defer prosecution of alleged criminal violations of NPI's license conditions.
This decision was, "...substantially based upon NPI's representation that it has rectified the activities in question and will continue to comply with NRC rules and regulations."
In your letter of October 22, 1979, you denied the two alleged items of noncompliance and protested the proposed imposition of civil penalties.
With regard to the first item of noncompliance, License Condition 15 does require in ou'r view that NPI procure all radioactive gases intended for human use from a supplier that has an FDA approved "New Drug Application" (NDA) or an "Investigatiohal Exemption for a New Drug" (IND) for the isotope involved.
Our view is based on the fact that the FDA has generally defined radioactive drugs as new drugs.
See 40 FR 31298 (July 25, 1975).
Moreover, the FDA specifically identified xenon-133 as a new drug on November 3, 1971.
See 36 FR 2106; 21 CFR 310.503(c).
The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of any new drug unless an approval of an NDA is effective with respect to the drug or an acceptable IND which permits the investigational use of the drug is on file with the FDA.
See 21 U.S.C. 355(a), (b), and (1).
Although we have sustained the first item of noncompliance, we recategorized this item as an infraction in accordance with the Criteria for Determining Enforcement Action and Categories of Noncompliance with AEC Regulatory Require-ments, dated December 31, 1974, and we have determined to mitigate the civil 8204090108 820224 NMS LIC30
.48-17466-01MD PDR
_ - =. - -
FEB 2 4 E2 Nuclear Pharmacy, Inc. penalty to Two Thousand Dollars for the occurrences cited in Item 1.
This l
mitigation is appropriate in view of the absence of harm to public health and safety associated with these particular violations, NPI's enforcement history in the three years since the violations occurred, and our. consideration of the circumstances surrounding the violations. While we have mitigated the civil penalty, we intend to closely monitor your activities in the future.
Future i
violations similar to that described in Item 1 may result in license suspension or revocation.
i With respect to the second iten of noncompliance, you averred that the i
transferees were authorized to receive xenon-133 of the type, form, and quantity that was transferred to them by NPI and, therefore, NPI did not make unauthorized transfers of radioactive material. Upon further review, we agree that NPI was only required to verify the type, form, and quantity of xenon-133 that was listed in the licenses of the hospitals for which the transfers were made. This apparently was done. Therefore, we are withdrawing the item of noncompliance and its proposed civil penalty.
Accordingly, after careful consideration of your response to the Notice of Violation and Notice of Proposed Imposition of Civil Penalties, we have determined to impose a civil penalty in the amount of $2000 for the first item of noncompliance set forth in the Notice of Violation. We hereby serve the enclosed Order Imposing a Civil Monetary Penalty.
f Sincerely, Richard C. DeYoung, Director Office of Inspection and Enforcement
Enclosure:
Order cc: Thomas V. Vakerics, Esquire Suite 800 1
1919 Pennsylvania Avenue, N. W.
Washington, D. C.
20006 T
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Nuclear Pharmacy, Inc. Distribution PDR NSIC TIC SECY VStello,DED/ROGR RCDeYoung, IE JHSr.iezek, IE LCobb, IE CA APuglise, CON L-316 Fingram, PA DNussbaumer, OSP El Reading File E00 Reading File VMiller, NMSS JCrooks, AE0D JCummings, 0IA JMurray ELD (3)
JLieberman, ES:IE TWBrockett, IE Enforcement Dirctors RI, RII, RIII, RIV, RV IE Files Central File CP Book Department of Health & Social Services ATTN: Lawrence T. McDonnell, Chief Radiation Protection Section Division of Health P. O. Box 309 Madison, WI 53701 Department of Health and Environment ATTN:
T. Wolff, Environmental Manager Radiation Portection Bureau P. O. 968 Santa Fe, N!! 87503