ML20045B152
| ML20045B152 | |
| Person / Time | |
|---|---|
| Issue date: | 04/06/1993 |
| From: | Selin I, The Chairman NRC COMMISSION (OCM) |
| To: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| NUDOCS 9306160350 | |
| Download: ML20045B152 (3) | |
Text
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i;ELEffED TO THE PDR RESPONSE SHEET 4//W/9.3 N-w T0:
SAMUEL J. CHILK, SECRETARY OF THE C0f4 MISSION FROM:
THE CHAIRMAN
SUBJECT:
SECY-93-050 - PROPOSED AMENDMENTS ON PREPARATION, TRANSFER, AND USE OF BYPRODUCT MATERIAL FOR MEDICAL USE APPROVED X '"/ ""*"* DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:
See attached corments.
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SIGNATURE CORRESPONDENCE PDR RELEASE VOTE
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April 6, 1993 DATE WITHHOLD VOTE
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I ENTERED ON "AS" YES NO
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CHAIRMAN BELIN'S COMMENTS ON SECY-93-050, PROPOSED AMENDMENTS ON PREPARATION, TRANSFER AND USE OF DYPRODUCT MATERIAL.FOR MEDICAL USE I approve the staff's recommendations in this paper, subject to the comments below, and commend the staff on a fine effort in resolving the many issues addressed in this proposed rule.
I endorse Commissioner Rogers' comment regarding the definition of
" patient" in the proposed rule.
Also, in subsection 35.49(b),
the words " manufactured or distributed" should be " manufactured and distributed."
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(NringthedevelopmentoftheACNP-SNMpetition,oneNRCstaffmember provided substantial assistance in the preparation of the petition, but has not carticipated in the NRC's resolution of the petition or in the development of this proposed rule. Another NRC staff member reviewed the petition prior 3o m e.
to its formal submittal to the Commission and participated, to a-44miteC extent at-an early sta in the NRC's resolution of the petition and in the development of the proposed rule.
The NRC reviewed the petition and identified the following issues:
A.
The petitioners requested that authorized users who are physicians (physician authorized users) be given greater flexibility regarding the i
medical use of radiopharmaceuticals containing byproduct material.
Specifically, the petitioners requested that these physicians be permitted to:
(1) uss '.diopharmaceuticals to treat diseases that are not listed in the U.S.
Food and Drug Administration (FDA) approved package insert; (2) use methods of administration of radiopharmaceuticals for therapy that are not listed in the package insert; (3) use radiopharmaceuticals other than those for which the FDA has accepted an Investigational New Drug (IND) or an approved New Drug Application (NDA); (4) prepare radiopharmaceuticals using radionuclide generators and reagent kits in a manner other than in accordance with the manufacturer's instructions; (5) compound radiopharmaceuticals as described in State or FDA regulations; and (6) compound radiopharmaceuticals whose i
manufacture and distribution are not regulated by the State or FDA.
B.
The petitioners regs ;ted that the NRC recognize the practice of i
nuclear pharmacy by nuclear pharmacists and the certification of nuclear pharmacists by the Board of Pharmaceutical Specialties.
Specifically, the petitioners requested that nuclear pharmacists be permitted to:
(1) compound 3
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