ML20133H805

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Refers to 780227 Telcon Discussing Distribution of Kits Approval for Use w/Tc-99m
ML20133H805
Person / Time
Issue date: 03/07/1978
From: Cooper J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Mcclellan J
MALLINCKRODT, INC.
Shared Package
ML20133G976 List: ... further results
References
FOIA-96-343 NUDOCS 9701170295
Download: ML20133H805 (1)


Text

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MAR 7 1978 Mallinckrode Nuclear ATTN Mr. Jim McClellan Order Department 2703 'Jegner Street St. Louis NO 63043 Gentlemen:

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This refers to our telephone conversation of February 27, 1978, during i

which we discussed distribution of kits approved for use with technitium-99m. These kits ars approved for distribution under your Approval No. 24-04206-04MA, and are not specifically licensad as such. Since they do not contain byproduct material they are not subject to the

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same distribution control measures as your radiopharmaceuticals, and may be distributed to sales personnel and other customers without your usual license verification procedures. They are subject to inspection at the actual place of use, i.e., the licensed medical institution or medical practioner.

Sincerely, b

John W. Cooper, Chief Radioisotopes Licensing Section 1

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9701170295 970114 POR FOIA FLOYD96-343 PDR

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