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Basics of Compounding: Summary of the Official United States Pharmacopeia Monographs for Compounded Preparations

Author(s):  Allen Loyd V Jr

Issue:  Mar/Apr 2019 - Volume 23, Number 2
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Abstract:  The USP has financially supported a number of stability studies for formulations that are being prepared to become official in the United States Pharmacopeia–National Formulary. The United States Pharmacopeia compounded formulation monographs contain the Official Name and Definition of the preparation, along with other information including, but not limited to, tests for Identification, Assay, Limits, Impurities, Specific Tests (pH), Packaging, and Storage requirements. There are currently 214 official compounded preparation monographs, of which 178 contain active pharmaceutical ingredients and 36 are monographs for excipients and vehicles. Some of the monographs are carryovers from previous editions, especially those used for flavoring and as vehicles. Most of these official compounded preparation monographs have validated beyond-use dates. This article provides a summary of the monograph names along with information including dosage form, pH, alcohol content, and beyond-use dates at refrigerated and/or room temperature.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, United States Pharmacopeia, USP Compounding Compendium, monographs

Related Categories: EXCIPIENTS, LEGAL, UNITED STATES PHARMACOPEIA CONVENTIONS

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