Wisconsin-Madison School of Pharmacy

Rennebohm Hall n University of Wisconsin-Madison School of Pharmacy
777 Highland Avenue n Madison, WI 53705-2222 n 608.262.5378 n [email protected]
This slide presentation was compiled and produced by Robert
McCarthy, Ph.D., Professor and Dean Emeritus at the University of
Connecticut School of Pharmacy for his class “The History of
American Pharmacy.” Prof. McCarthy created this version of the
slide talk for his class in the Spring of 2016.
This slide presentation was downloaded from the Teaching the
History of Pharmacy section of the website of the American Institute
of the History of Pharmacy (https://aihp.org/historicalresources/teaching-the-history-of-pharmacy/) where a copy of the
syllabus (.pdf) for Prof. McCarthy’s class is also available.
This .pdf copy of the slide presentation was shared with the permission
of Prof. Robert McCarthy for the personal and educational use of
interested readers.
PHRX 4001W-002
The History of American
Spring 2016
An American Pharmacopeia
• 1808: The Massachusetts Pharmacopoeia is published providing a
state guide to drug standards.
• The Massachusetts Pharmacopoeia was used by apothecaries to properly
fill prescriptions from physicians since it defined the identity of drugs and
• 1820: The U.S. Pharmacopeial Convention founded in Washington,
DC; although all state medical societies were invited to send
delegates, only 11 states attended; only about 200 drugs were
included in the first USP since they were the only ones deemed
“most fully established and best understood.”
United States Pharmacopoeia (USP)
• 1830: The first revision of the USP published; revisions continue at
an interval of every 10 years.
• 1848: Congress passes legislation making the USP an official
• 1888: First National Formulary (NF) published by the American
Pharmaceutical (now Pharmacists) Association.
• 1900: USP Convention and Board of Trustees created.
• 1906: USP and NF standards for strength, quality, and purity
recognized as official.

United States Pharmacopoeia (USP)
• 1938: USP and NF standards for 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 to every 5 years.
• 1971: USP moves headquarters to Rockville, MD.
• 1975: USP acquires NF from APhA.
• 1977: USP and NF scope redefined: USP specifies standards for drug
substances and dosage forms; NF specifies standards for excipients.
• 1980: USP and NF published under same cover; USP Dispensing
Information (USP DI) published.
• 1993: Federal Omnibus Budget Reconciliation Acts (OBRA ’90 and ’93)
name USP DI as source of information that state Medicaid agencies can
use for drug utilization review, patient counseling, and medically accepted
off-label uses of medicines.
United States Pharmacopoeia (USP)
• 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.
• 2002: USP-NF published annually.
• 2000s: USP develops offices/laboratories around the world and
collaborates with the pharmacopoeias of other nations in
developing drug standards.
Source: USP Web Site
National Formulary
• 1883: NY Pharmacist Samuel Bendiner and NY hospital pharmacist
Charles Rice led an effort to modernize the US Pharmacopoeia;
Bendiner inspired the creation of the New York and Brooklyn
Formulary (NYBF); Rice negotiated an agreement to share the
information in the NYBF to develop a national formulary, which it
was hoped would be used by physicians in prescribing rather than
recommending the use of proprietary medicines.
• 1886: APhA published a preliminary draft of the National Formulary
of Unofficinal Preparations, asking for feedback from the pharmacy
• 1888: The National Formulary (NF) is published for the first time by
• 1906: The second revision of the NF coincides with the passage of
the Food & Drug Act, which named the NF as one of the official
standards for pharmaceuticals, much to the surprise of APhA.

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National Formulary (NF)
• The first three editions of the NF provided practicing pharmacists with
formulas for small scale compounding, allowing for competition with
ready-made preparations.
• 1916: National Formulary IV set “definite standards.”
• 1935: The NF established a drug standards lab at the University of Illinois
College of Pharmacy.
• 1938: APhA established the Drug Standards Laboratory in Washington,
DC.; during the 1960s, this lab was revitalized through financial support
from USP (which was using this lab’s services) and the AMA.
• In 1960, there were discussion of merging the NF and USP; by 1966, formal
discussion of a merger was underway.
• 1975: USP purchased both the NF and Drug Standards Laboratory from
• 1998: USP licensed USP DI to The Thomson Company; USP DI is published
by their Micromedex subsidiary.

USP Today
• “USP is a unique organization whose activities are directed by three governing
bodies composed of more than 900 volunteers and whose day-to-day operations
are managed by an executive team and staff of more than 800 employees.”
• “Governance: USP is governed by the Convention membership, the Board of
Trustees, and the Council of Experts and its Expert Committees. These decisionmaking bodies guide USP’s activities in the best interest of quality public health.”
• “Executive Team: USP’s executive team helps manage all USP operations at its
five international locations in support of the governing bodies’ standards-setting
activities. USP staff provide support for volunteer and member activities, scientific
testing, quality assurance, standards acquisition, verification services, training in
developing regions, education programs, customer service, harmonization, and
outreach and communications efforts.”
Source: USP Web Site.
The United States Pharmacopeia and
the National Formulary (USP–NF)
Food Chemicals Codex
USP Dietary Supplements
USP Medicines Compendium (MC)
Reference Standards
Other Resources
– Pharmacopeial Forum
– FCC Forum
– USP Dictionary
– Chromatographic Columns
USP’s Compendial Activities
USP Today
USP Today
• United States Pharmacopeia 38 – National Formulary 33
• Published November 1, 2014; official May 1, 2015
• Supplement 1 to the United States Pharmacopeia 38 – National Formulary 33
• Published February 1, 2015; official August 1, 2015
• Supplement 2 to the United States Pharmacopeia 38 – National Formulary 33
• Published June 1, 2015; official December 1, 2015

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