Re: radiopharmaceutical purity - retraction

[carol marcus <csmarcus@ucla.edu>]

At 01:37 PM 1/26/00 -0600, you wrote:
>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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Dear Mr. Moroney:

Those standards are not set by the FDA.  They are set by the United States
Pharmacopeia (USP).  FDA is required, via the Food Drug and Cosmetic Act, to
enforce the standards of the USP.  The USP is a private organization, its
experts receive zero compensation, and the quality of its work is outstanding.

Ciao, Carol

Carol S. Marcus, Ph.D.
Chair, Radiopharmaceutical Drug Information, USP
Member, Radiopharmaceutical Standards, USP

<csmarcus@ucla.edu>

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