A Brief History of the United States Pharmacopeia

The first U.S. Pharmacopeial Convention assembled in Washington, DC, on January 1, 1820, and on December 15, 1820, the first U.S. Pharmacopeia was published. At this first convention, it was decided that a revised USP edition would be published every 10 years. In 1900 the decision was made to issue supplements to the USP in the interim between new editions, and in 1940 the period for new editions was changed from every 10 years to every 5 years. 

In the years that followed, the USP developed into an agency that established state-of-the-art standards to ensure the quality of pharmaceutical drug products. The primary objective of the USP is to compile a select list of pharmaceuticals every 5 years, including medicinal substances and preparations that are still covered under patent rights. 

The United States Pharmacopeia works closely in conjunction with the Food and Drug Administration (FDA), the pharmaceutical industry, and health professionals in establishing their standards, which are enforceable by the FDA and the governments of more than 35 countries. Failure to comply with USP-National Formulary (NF) standards and test methods can result in products that are adulterated, leading to a variety of negative outcomes including FDA recalls and warning letters. 

In addition to providing methods and specifications, the USP also provides reference standards that can be used to carry out the testing in the monographs. USP also holds various events throughout the year on topics of interest for the industry. These events are designed to unite experts who have interests in specific topics. Past topics from USP Open Conference Proceedings include Children and Medicines and Communicating Risk to Patients.  

The Pharmacopeial Forum provides the arena for proposed and forthcoming revisions to the USP-NE It is published six times per year by the USP, allowing public review to official pharmaceutical standards before they become effective. In doing this, the Pharmacopeial Forum encourages a free exchange of ideas and information among the scientists involved in the development of analytical test methods. It is divided into two main sections Pharmacopeial Previews and In-process Revision. 

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