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Basics of Compounding: The "Negative" List

Author(s):  Allen Loyd V

Issue:  Jul/Aug 2015 - Volume 19, Number 4
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Abstract:  H.R. 3204 requires the formation of a Pharmacy Compounding Advisory Committee to address the following: The “Negative List”; The “Positive List of Active Pharmaceutical Ingredients”; and “Demonstrable Difficulties in Compounding.” At the first meeting of the Pharmacy Compounding Advisory Committee, the Committee addressed the drug products that have been withdrawn or removed from the market and cannot be compounded because they have been found to be unsafe or not effective. This article provides a current list of drugs that cannot be used in compounding, as well as a “kit” where the combination of ingredients/products cannot be compounded.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, do not compound list, U.S. Food and Drug Administration, FDA, Drug Quality and Security Act, Pharmacy Compounding Advisory Committee, drug safety

Related Categories: LEGAL, DISCONTINUED FORMULATIONS

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