RE: radiopharmaceutical purity - retraction

["Perrero, Daren" <Perrero@idns.state.il.us>]

Roger,

For my own education, at what point does the USP enter into the picture with
regards to commercial production of compounds/radiopharmaceuticals?  Do the
specifications you mentioned in your posting only apply to instances where
an NDA is granted to an institution.  Are these then superceded by granting
of final FDA approval?

Daren Perrero
I'm with the government, I'm here to help you...
dperrero@earthlink.net


-----Original Message-----
From: Moroney, Roger W [mailto:Roger.Moroney@mkg.com]
Sent: Wednesday, January 26, 2000 1:37 PM
To: Multiple recipients of list
Subject: radiopharmaceutical purity - retraction


I made a mistake on stating that the _FDA_ has limits on radionulidic
impurities. The limits, for all aspects of a pharmaceutical, are submitted
to the FDA as part of a New Drug Application (NDA). The FDA then reviews the
specifications. If the NDA is approved, then those specifications must be
met for production of the radiopharmaceutical. Therefore, radionuclidic
impurity limits may differ between us (Mallinckrodt), DuPont and Amersham.

Sorry for any confusion. Next time I'll check before opening my mouth.

Roger Moroney
Health Physicist
Mallinckrodt, Inc.
314.654.7457 voice
314.654.7571 fax
roger.moroney@mkg.com
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