U.S. Pharmacopeia history

Doctor Lyman Spalding, Doctor Samuel Mitchill and Doctor Jacob Bigelow credited with establishing the United States Pharmacopeia (USP) compendium.  1830 Committee of Revision created (seven members). First revision of the USP published; revisions continue at 10-year intervals.

The Edinburgh College published its first Pharmacopoeia, dedicated to William 111, in 1699, and subsequent editions were issued at intervals till 1841, when the fourteenth and last Edinburgh Pharmacopoeia appeared.

Explore our digital archive back to 1845, including articles by more than 150 Nobel Prize winners.

The Drug Importation Act of 1848 was the first such measure.

The third and last Dublin Pharmacopoeia was issued in 1850.

Subsequent editions appeared regularly, the tenth and last London Pharmacopoeia being published in 1851.

A subsequent publication in 1868 included not only the indigenous drugs used in India, but also the drugs of the British Pharmacopoeia.

However, from the earliest times, dating back to 1874, the objective had actually been to create a unified pharmacopoeia that could be used around the world-truly an international pharmacopoeia.

His efforts transformed the sixth revision, published in 1880, from a collection of recipes into a true chemistry resource, with formulae and purity tests based on the emergence of analytical chemistry. “It basically became a kind of standard scientific textbook,” Higby says.

But in 1901, the treatment turned deadly when 13 children were injected with diphtheria antitoxin contaminated with tetanus.

One such act in 1906 officially recognized USP standards for strength, purity and quality of medicines.

Beginning with the first translation of the USP into Spanish in 1908, USP's mission to improve public health through its standards has extended beyond United States borders.

Insulin was first used to treat diabetes in 1922.

The difficulty was resolved by a report prepared in 1928 by a subcommittee of the Committee on Civil Research under the chairmanship of the Right Hon.

Under these arrangements the Council published the 1932 Pharmacopoeia.

In response to public outcry, Congress declared in the 1938 Food, Drug and Cosmetic Act that all medicines sold in the United States must meet applicable USP quality standards.

In 1941, when the patent on insulin was about to expire, there was no public standard available.

In 1947, WHO took over the work begun under the League of Nations for the unification of pharmacopoeias.

After independence from Britain, the Indian Pharmacopoeia Commission was established in 1948, with its main function being the publication of IP as the national pharmacopoeia.

In 1949, the Board of Trustees appointed Doctor Lloyd Miller as the Director of Revision, making him USP's first salaried employee.

The first edition of the Chinese Pharmacopoeia was published in 1953, containing 531 monographs for drug substances and products, including chemical medicines and traditional medicines of plant and animal origin.

By 1969, 27 countries recognized USP standards.

As healthcare evolved over the years, USP adapted to the changes, including pivotal United States legislation in 1984 that increased people's access to generic drugs.

In 1994, federal legislation recognized USP as official standards for dietary supplements.

MedMarx®, an Internet-accessible medication errors reporting program for hospitals, is launched.  2000 Roger L. Williams, M.D., becomes USP executive vice president and CEO at the USP Convention in April.

13.  2006 USP and the Indian Pharmacopoeia Commission sign MOU to promote greater cooperation.

USP acquires the Food Chemicals Codex (FCC) from the Institute of Medicine.  2007 USP opens office and laboratory facility in Shanghai, China.

USP publishes USP–NF as a three-volume set.  2008 USP inaugurates newly expanded site in Rockville, MD, USA. USP opens office and laboratory facility in São Paulo, Brazil.

In 2009, USP introduced the Dietary Supplement Compendium, to provide methodologies to help ensure the quality of dietary supplements.

First Russian edition of USP–NF published.  2010 Pharmacopeial Forum transitions to a free online resource.

USP/PQM registers in Ethiopia as a nongovernmental organization.  2012 USP hosts the Pharmacopeial Discussion Group for the first time at USP–United States USP

USP–NF translated into Chinese.  2013 USP introduces a new logo and tagline to celebrate and emphasize the global scope of our work.

The Center for Pharmaceutical Advancement and Training (CePAT) opens in Accra, Ghana.  2014 USP–China site expands to a 95,000 sq. ft. facility with state-of-the-art laboratories.

C. Vielle, “The European Pharmacopoeia–Part 1,” Presentation at the Workshop The Chinese and European Pharmacopoeias–The New Editions, Strasbourg, France (October 17, 2016).

Eur., which became official in January 2017, has continued to add new and revised general chapters and monographs, including the publication of the first monograph for a finished product containing a chemically defined active substance.

Int. was published in 2018 and constitutes a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances and dosage forms.

PMDA, “JP History and Legal Status”, Japanese Pharmacopoeia–About JP, pmda.go.jp, Accessed June 26, 2019.