USP Products and Programs for Quality Assurance
United States Pharmacopeia National Formulary (USP–NF)
USP–NF is the comprehensive, world-recognized compendia of standards and test methods for drugs, vitamins and minerals, dietary supplements, radiopharmaceuticals, and other health care products. It helps to ensure product quality and regulatory compliance. The drug standards are FDA-enforceable in the United States.
This single-volume combination of the USP and the NF provides more than 3,800 monographs for standards of identity, strength, quality, purity, packaging, labeling, and storage. USP–NF includes monographs for drug substances, drug products, excipients, inactive ingredients, and dietary and nutritional supplements.
Beginning in November 2001, the main volume of USP–NF will be published annually and updated through the USP–NF Supplement. USP–NF is available in hardcover, CD, intranet, and online versions.
Pharmacopeial Education program
USP's Pharmacopeial Education series enhances the knowledge, skills, and expertise of pharmaceutical scientists and professionals, chemists, technicians, and management personnel. Two interactive courses are currently offered. The Fundamentals of Dissolution course leads to proficiency in USP–NF-based dissolution equipment, calibration, tests, methods development, and validation. The USP–NF and Standards Development Overview course provides an in-depth understanding of the official, FDA-enforceable pharmaceutical standards and test methods in USP–NF. Participants will learn about the impact of the standards, how to interpret and best use them, and influence their development.
Courses include lectures, demonstrations, case studies, and hands-on laboratory sessions. They are conducted by senior USP staff experts. The courses are offered either at USP's headquarters in Rockville, Maryland or at the participating company's site. USP can also develop a customized education program for a company. For details on the Pharmacopeial Education program, call Diana Lenahan at 301-816-8530.
Pharmacopeial Forum (PF)
Proposed and official revisions to USP–NF standards are published in the bimonthly journal, PF. Readers have the opportunity to review and comment on additions and revisions to standards. Public comment received and the responses of USP's Expert Committees are also published in PF. In addition, PF features Interim Revision Announcements—changes to standards that are official and binding before they are published in the next USP–NF edition or supplement.
USP Reference Standards
USP Reference Standards help to ensure quality control in pharmaceutical production worldwide. They are highly defined chemical specimens used to test product identity, strength, quality, and purity as specified in the official USP–NF. USP has nearly 1,300 different Reference Standards, one of the largest collections in the world. These standards are established through a collaborative process that enhances accuracy and dependability.
Ordering information and official lot numbers are published in the Reference Standards Catalog, which is available in print and online ( ).
USP Dictionary
The USP Dictionary of USAN and International Drug Names is the FDA-recognized, official source for established drug names. It helps to ensure the accuracy of product labeling; reports, articles, and correspondence; NDAs, ANDAs, and INDs; and pharmaceutical package inserts. The latest edition was published in April 2001. It provides the most up-to-date United States Adopted Names (USANs) of drugs; official USP–NF names; nonproprietary, brand, and chemical names; graphic formulas; molecular formulas and weights; CAS registry numbers and code designations; drug manufacturers; pharmacologic and therapeutic categories—all in a cohesive format.
For current pricing and ordering information for all products, please contact the USP Customer Service Department.
Phone: 1-800-227-8772
Fax: 301-816-8148
Mail: U.S. Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
Website: (online ordering available)