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5.29.13  |  VOL 3  |  ISSUE 5

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Role of the United States Pharmacopeia in Pharmacy Practice

When did the United States Pharmacopeial Convention, Inc. (USP) begin having a role in pharmacy practice?

Beginning with the first meeting of physicians on January 1, 1820 and publication of the first edition of the United States Pharmacopeia later that year, the United States Pharmacopeia has had a role in pharmacy practice for over 190 years.

Why did the USP begin having a role in pharmacy practice?

The USP was formed to create a compendium of standards for the uniformity of formulations prescribed and prepared by physicians and pharmacists.

How has the USP had a role in pharmacy practice over the last 190 years?

The USP is a scientific nonprofit organization that has set quality standards for the identity, strength/potency, quality, and purity of medicines, food ingredients, and dietary supplements that are compounded, manufactured, distributed, and consumed worldwide. These standards have specific information on the environment, labeling, storage, transport, packaging, repackaging, and equipment used in pharmacy practice from procurement of active and inactive pharmaceutical ingredients to the finished product or preparation.

Where does the USP have a role in pharmacy practice?

With offices in five locations around the world, the USP drug standards are developed and relied upon in more than 140 countries, and are enforceable by regulatory agencies around the world. Over 850 volunteer scientist, practitioner, and regulator experts from all over the world work together to develop these standards.

What does the USP do to continue to have a role in pharmacy practice?

The USP Mission is to improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

Fast forward 190 years…. In the United States Pharmacopeia 35-National Formulary 30 there are 4,648 official small molecule substances and 114 biologic substance and product monographs; 99 compounding monographs assigned to the compounding expert committee; and 260 chapters used as the standard to perform microbiological, biological, chemical, and physical tests and assays on manufactured products and compounded preparations from start to finish.

USP's role in pharmacy practice is huge in order for us to have quality prescription and nonprescription human and veterinary drugs, food ingredients, and dietary supplements to treat our patients.

Lisa D. Ashworth, BS Pharm, RPh, FACA
Children's Medical Center of Dallas
Dallas, Texas


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Loyd V. Allen, Jr.; International Journal of Pharmaceutical Compounding, Edmond, OK

Lisa D. Ashworth; Children's Medical Center Dallas, Dallas TX

Ron Donnelly; Ottawa Hospital, Ottawa, Canada

Mark Klang; Sloan-Kettering Institute, New York, NY

Ken Latta; Duke University Hospital, Durham, NC

Linda McElhiney; Indiana University Health, Indianapolis, IN

Dave Newton; Bernard J. Dunn School of Pharmacy, Shenandoah University, Winchester, VA

Richard Osteen; Vanderbilt University Medical Center, Nashville, TN

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