Re: Good Manufacturing Practices

["Pete Myers" <pmyers@brc1.tdh.state.tx.us>]

Long story, short:

Nov 21, 97, Pres Clinton signed the "Food and Drug Modernization Act 
of 1997."  Among other things, the Act authorizes the distribution of 
PET radiopharmaceuticals as Compounded Positron Emission Tomography 
Drugs to appropriately authorized/licensed users, without submission
of a new drug application (NDA).  We're principally talking about F-18
FDG, because only it has a long enough half-life (1.8 hrs) to realisti-
cally be distributed away from the site at which it's produced.

Distributors, obviously, cannot distribute the PET radiopharmaceuticals
except to Licensees who are appropriately licensed to receive/use them.
Licensees wishing authorization to receive/use PET radiopharmaceuticals
must apply to their licensing authority (NRC/Agreement State Agencies).

Although PET is a localization/imaging agent, some of us believe (our 
final policy is still being developed) that the characteristics of PET
radiopharmaceuticals are different enough from traditional localization/
imaging drugs to not include them as Group II drugs, but Licensees to
submit PET-specific handling/use procedures before line-iteming the PET
drug they wish to use.

Pete.

Date:          Thu, 18 Dec 1997 12:57:53 -0600 (CST)
Reply-to:      radsafe@romulus.ehs.uiuc.edu
From:          "Dale E. Boyce" <dale@radpro.uchicago.edu>
To:            Multiple recipients of list <radsafe@romulus.ehs.uiuc.edu>
Subject:       Good Manufacturing Practices

I heard a rumor today that Congress has done something or other to
alter the FDA's requirement to meet CGMP for PET radiopharmaceuticals.

Has anyone heard of anything along these lines?

Dale Boyce
dale@radpro.uchicago.edu

Pete Myers, Cf, Med & Acad Licensing
Bureau Rad Control, Texas Dept Hlth
Phone (512) 834-6688 (FAX 834-6690)
pmyers "at" brc1.tdh.state.tx.us