Wednesday, November 26, 2014

Another Important Comment from a Reader Regarding the article Compounding Pharmacies Even nurses may not realize the important role compounded medications play in their everyday lives. By Elizabeth Rosto Sitko

Under 503A, the following are not considered "compounded drugs," requiring conditions be met for exemption to provisions of the FFDCA, if they are prepared/mixed according to a manufacturer's label:

"In fact, any time a nurse mixes two medicines to give to a patient on the floor, that's a compound [maybe, maybe not].
Even the act of splitting tablets [definitely not] or reconstituting antibiotic liquid for a child is considered compounding" [if an approved dosage form, definitely not].

And if "This article seeks to clear up some of the confusion," it should make these clarifications. But if the article is for the sole purpose of marketing the industry, game on!

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