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It means the FDA determined it doesn't meet the specific regulatory criteria for bulk compounding under current law

Biol Trace Elem Res 184:422435

The relationship among IL-13, GSTP1, and CYP1A1 polymorphisms and environmental tobacco smoke in a population of children with asthma in Northern Mexico

The changes in the incidence of these very different diseases at exactly the time acetaminophen use dropped for a significant period of time is remarkable and may indicate the same factor as causing the two diseases