The Food and Drug Administration (FDA or Agency) is withdrawing the proposed rule to list bulk drug substances used in pharmacy compounding and preparing to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products, although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. To identify candidates for this bulk drugs list, interested groups and individuals may nominate specific bulk drug substances, and FDA is describing the information that should be provided to the Agency in support of each nomination.
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2 comments:
Sue, does this mean that I can no longer nominate a drug such as Estriol (the one used in a lot of bHRT compounds) to be "allowed to be used"?
Ironically, if Estriol was "off the table", all the grass roots support for the compounding pharmacies would evaporate.
Kenneth Woliner, MD
www.holisticfamilymed.com
That is a good question. Let me see what I can find out and I will get back with you.
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