ML20062J101

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Discusses Commenting on Recent Commission Action Re Rule on Pharms
ML20062J101
Person / Time
Issue date: 11/14/1990
From: Shon F
Atomic Safety and Licensing Board Panel
To: Catizone C
NATIONAL ASSOCIATION OF BOARDS OF PHARMACY
Shared Package
ML20062J096 List:
References
FRN-55FR34513, RULE-PR-30 NUDOCS 9012110321
Download: ML20062J101 (1)


Text

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NUCLEAR REGULATORY COMMISSION a,

ATOMIC SAFETY AND LICENSING BOARD PANEL WASHINGTON, D.C 20566 November 14, 1990 Mr.

C.

A. Catizone, M.S.,

R.Ph.,

Executive Director National Association of Boards of Pharsacy O' Hare Corporate Center 1300 Higgins Road, Suite 103 Park Ridge, IL 60068

Dear Mr. Catizone:

Thank you for your letter of November 8 commenting on a recent Commission action.

In my present position I have no role in that particular rulemaking, and, indeed, I think it unlikely that the Commission will opt to involve the Licensing Board Panel in the development of a rule concerning pharmaceuticals (although that course of action would probably be open to the Commission if it so chose).

Accordingly, I have treated your letter as a comment in response to the Federal Reaister Notice of August 23, 1990 (55 Fed. Reg. 34513), and forwarded it to the Secretary of the Commission, Mr. Samuel Chilk.

The Federal Reaister Notice responded ta two of many points made in a Petition for Rulemaking submitted by the American College of Nuclear Physicians and the Society of Nuclear Medicine in June of 1989.

The notice announced an

" interim final rule"

(" interim" in that-it is effective for a limited period, " final" in that it is effective from the date of publication).

of the matters mentioned in your letter, the rule focusses chiefly on permission to depart from the manufacturer's package insert in accord with a valid prescription.

Other aspects of the petition concerning compounding and dispensing are still pending, I understand.

I have been in contact with our Dr. Anthony Tse, whom I believe you know, and he tells me that progress is being made on the other aspects of the ACNP/SNM atition, and that further responses te the matters containea as that petition should be forthcoming shortly.

Your

ruly, n

L c Fre[erick J.

S n

cc: A. Tse S. Chilk V 1

9012110321 901108 l

PDR PR 30 55FR34513 PDR.

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