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Learn about the 100-year history of collaboration between USP and the FDA.

USP History

1820
U.S. Pharmacopeia founded; all state societies of medicine invited to send delegates; 11 attended. USP created a system of standards, a system of quality control (formulae), and a national formulary. Only 217 drugs that met the criteria of "most fully established and best understood" were admitted.

1830
Committee of Revision created (seven members); first revision of the USP published; revisions continue at 10-year intervals. Surgeons General of U.S. Army and Navy became first federal agencies to participate in USP revision.

1848
Drug Import Act–Federal legislation recognizes the USP as an official compendium.

1850
Colleges of pharmacy invited to participate in revision of the USP.

1880s–1890s
State Boards of Pharmacy formed; USP becomes a state board requirement.

1900
USP incorporated in D.C. as not-for-profit corporation. U.S. Pharmacopeial Convention and Board of Trustees created.

1906
Federal Food & Drugs Act: USP and NF strength, quality, and purity recognized as official standards.

1938
Federal Food & Cosmetic Act: USP, NF, and Homeopathic Pharmacopeia standards of strength, quality, purity, packaging, and labeling recognized as official and enforced by FDA. "New Drug" concept established. FDA approves drugs for safety before marketing.

1942
USP revision cycle changed; USP published every 5 years.

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1950
USP establishes its first permanent office in New York City. Lloyd C. Miller, Ph.D., becomes first employed director of revision.

1963
United States Adopted Names Council formed. Representatives from American Medical Association (AMA), American Pharmacists Association (APhA), USP, and FDA establish drug nomenclature.

1968
USP moves its headquarters from New York City, eventually locating in Rockville, Maryland, USA.

1970
USP adopts resolution calling for information to be provided to dispensers of drugs in United States. Position of executive director created, filled by William M. Heller, Ph.D.

1975
USP acquires National Formulary and Drug Standards Laboratory from APhA.

1977
USP and NF scope redefined: USP standards for drug substances and dosage forms; NF standards for excipients.

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1980
USP XX and the NF XV published under same cover; USP Dispensing Information, 1st Edition.

1990
Jerome A. Halperin becomes USP executive director (title later changed to executive vice president and CEO) at the 1990 USP Convention. USP members adopt a resolution to explore establishing standards for vitamins and minerals.

1990, 1993
Federal Omnibus Budget Reconciliation Acts (OBRA '90 and '93) name the USP Drug Information as a source of information that state Medicaid agencies could use for drug utilization review, patient counseling, and medically accepted off-label uses of medicines.

1994
USP signs an agreement with the American Medical Association to combine the information in AMA's Drug Evaluations database with the USP DI database to develop a single product that contains drug and therapeutic information.

1995
USP members adopt a resolution to explore establishing standards for botanical dietary supplements.

1997
The management consulting firm, McKinsey & Company, recommended new USP focus, including divestiture of print and electronic drug information products.

1998
USP sells USP DI and associated products to The Thomson Company and USP DI is published by their MICROMEDEX subsidiary. The new Reference Standard Center opens. MEDMARX®, an Internet-accessible medication errors reporting program for hospitals, is launched.

1999
USP publishes final USP DI in three-volume format; publishes USP 24–NF 19; initiated modernization project for developing e-commerce capabilities and establishing electronic communications with constituents.

2000
At the USP Convention in April 2000, Roger L. Williams, M.D., becomes USP executive vice president and CEO; members vote to change name of Committee of Revision to Council of Experts and elect chairpersons for 62 Expert Committees.

2002
USP–NF published annually.

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