USP General Information and USP Structure
A collection of public, published standards that has been given official status as quality standards for drugs, biologics, medical devices, active ingredients, dietary supplements, and excipients. The standards in the United States Pharmacopeia and the National Formulary (USP—NF) are enforceable under U.S. laws. The term “compendium” is generally used interchangeably with “pharmacopeia.”
New USP—NF volumes are published annually. USP30—NF25 was released on November 1, 2006, and became effective May 1.
Two supplements to the USP—NF are published annually. In 2007, Supplement 1 was released on February 1 and became official August 1. Supplement 2 was released on June 1 and becomes official on December 1. The contents of the two supplements will be integrated into the annual volumes of the following year.
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The Pharmacopeial Forum (PF) is a USP journal of standards development and revisions of official compendia. It is the working document of the USP Council of Experts and consists of public notices that are open for comment. Six issues are published annually.
Although most text in the PF consists of proposed changes, the Interim Revision Announcements (IRA) section describes adopted changes that become official in the interval between publication of the annual revision and supplements. IRAs are intended for urgent revisions that cannot wait for the next supplement or main volume. They are republished in a supplement (or main volume) as soon as possible.
The USP—NF is comprised of seven sections with mandatory requirements. Volume 1 contains:
- General notices and requirements as well as general definitions.
- General chapters, including information provided to correctly perform the tests in the individual monographs.
- Reagents, indicators, and solutions.
- Reference tables.
- Dietary supplements and quality standards for dietary supplements.
- National Formulary. Quality standards for excipients.
Volumes 2 and 3 contain:
- Official Monographs.
- Quality standards for active ingredients, drugs, and biologics.