Re: Good Manufacturing Practices

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

Short story, shorter:

I should have included that:

  - the authorizations of the Food and Drug Modernization Act of 1997
expires 4 years from the date of enactment of the Act or 2 years from
the date of the FDA publishing regulations which implement the Act
(whichever is longer).

  - the Act still requires adherence to Good Manufacturing Practices.

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