ML19325D131

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Responds to Re Use of non-FDA Approved Radiopharms for Diagnostic or Therapeutic Purposes by State of CA Licensees
ML19325D131
Person / Time
Issue date: 10/11/1988
From: Lubenau J
NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To: Wong G
SACRAMENTO, CA
Shared Package
ML19325D099 List:
References
RULE-PRM-35-9 NUDOCS 8910190038
Download: ML19325D131 (2)


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Gerard C. Wong, Ph.D.

Supervising Health Physicist Radiological Health Branch Department of Health Services 0

l 714 P Street Sacramento, California 95814

Dear Mr. Wong:

r We have reviewed your letter dated September 27, 1988 regarding the use of non-FDA approved radiopharmaceuticals for diagnostic or therapeutic i

purposes by California licensees.

i While we have no problems with the wording or overall theme of your i

advisory, we feel that you should write directly to FDA for an official interpretation of that agency's regulations. Whether or not you receive guidance from the FDA, you should at least issue your advisory in order i

to inform hospitals that they may be operating in a grey area.

I We appreciate the opportunity to review this matter.

Sincerely, t

c bWC[4 Joel 0. Lubenau Acting Assistant rector for State Agreements Program State Local and Indian Tribe Programs

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