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Pharmacy compounding
Traditional pharmacy compounding involves the act of combining, mixing or altering ingredients to prepare a customized medication for an individual patient with a prescription. By definition, pharmacy compounding involves making a new drug for which safety and efficacy have not been demonstrated with the kind of data that the U.S. Food and Drug Administration requires to approve a new drug. Even though the FDA often regards compounded drugs as “unapproved new drugs,” the agency has long recognized that traditional pharmacy compounding serves an important public health function.
Sources: U.S. Food and Drug Administration; Regulatory Science at the University of Southern California
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