Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice.

Brian Kelley

International journal of pharmaceutical compounding 2021 Mar-Apr

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The United States Pharmacopeial Convention, Inc. recommends within the standards of the United States Pharmacopeia that compounding pharmacies have staff dedicated to quality assurance and quality control to ensure patients are receiving safe medications. The quality-control program must include testing. While compounding pharmacies have grown familiar with potency, sterility, and endotoxin testing, there are many more tests recommended within the United States Pharmacopeia that are critical for evaluating the quality of compounded preparations. This article discusses when a few of these tests should be utilized, how to assign acceptance criteria, and how test results are obtained. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Citation

Brian Kelley. Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice. International journal of pharmaceutical compounding. 2021 Mar-Apr;25(2):115-124