BP & USP History, Editions, Volumes & Appendices by Dr. Ashfaq

Detailed note on British Pharmacopeia & United States Pharmacopeia

1. British Pharmacopeia &
United States Pharmacopeia

Dr. Ashfaq Afridi
7
th
August, 2017

Abstract
A detailed note on introduction, history, volumes, edition and appendices of BP and USP.

2. PHARMACOPEIA
A pharmacopoeia or pharmacopoea, in its modern sense, is a legally binding collection, prepared
by a national or regional authority, of standards and quality specifications for medicines used in
that country or region. A quality specification is composed of a set of appropriate tests that will
confirm the identity and purity of the product, ascertain the strength (or amount) of the active
substance and, when needed, its performance characteristics. Reference substances, i.e. highly-
characterized, physical specimens, are used in testing to help ensure the quality, such as identity,
strength and purity, of medicines. The texts cover pharmaceutical starting materials, excipients,
intermediates and finished pharmaceutical products (FPPs). General requirements may also be
given in the pharmacopoeia on important subjects related to medicines quality, such as analytical
methods, microbiological purity, dissolution testing, stability, etc.

Monograph
A monograph includes the name of the ingredient or preparation; the definition; packaging,
storage, and labeling requirements; and the specification. The specification consists of a series of
tests, procedures for the tests, and acceptance criteria.

BRITISH PHARMACOPIEA
Introduction
British pharmacopeia is a pharmacopeia (compendium of drug information) for the United
Kingdom published annually by the British Pharmacopeia commission, a nonprofit organization
that owns the trademark and copyright.

Latest edition
The British Pharmacopoeia (BP) 2017 supersedes the BP 2016 and becomes legally effective on
1 January 2017. This edition incorporates new BP and European Pharmacopoeia monographs

3. and a significant number of revised monographs. Also included is new information for
unlicensed medicines and DNA barcoding.

History
Descriptive catalogues of drugs claimed to be useful in the practice of medicine have been
compiled since the night of time, and a bibliography of them published in Germany in 1784
includes such classic names as Celsus, Pliny, Galen, Dioscorides, Avicenna, and Paracelsus. The
first work of this nature, however, with the imprint of authority was probably the
Dispensaworium Pharmacorum Omnium issued in 1546 with the sanction of the Senate of
Nuremberg. The title “pharmacopoeia” is said to have been applied for the first time to a book
published in Basle in 1561. In England the importance of ensuring the purity of drugs was
officially recognized as long ago as 1518. In that year the Letters Patent constituting the College
of Physicians granted by Henry Vill provided for the election of four persons appointed by the
College to have the supervision and scrutiny of every kind of medicine and the prescription
thereof by physicians practicing within a radius of seven miles of the City of London. A
subsequent Act of 1540 gave such persons power to enter the premises of all apothecaries and to
destroy any defective drugs found there. The first London Pharmacopoeia, dedicated to James I,
was published by the College in 1618, a century after its foundation. It included no fewer than
1.028 drugs and 932 compounds, often of a bizarre and even revolting character. Subsequent
editions appeared regularly, the tenth and last London Pharmacopoeia being published in 1851.
From the beginning the book had authoritative countenance and proceedings were authorized
against those compounding medicines in any other form than therein directed.
In Scotland the President and Censors of the College of Physicians of Edinburgh, which received
its Charter from Charles If in 1681, were likewise empowered to inspect drugs and medicaments
offered for sale within the city and suburbs and to throw into the street or destroy those found to
be insufficient or corrupt. Similar activities were undertaken in Glasgow by the Faculty of
Physicians and Surgeons. 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. The Censors of the College of
Physicians in Ireland, founded by Charles 11 in 1667 and reincorporated by William and Miary

4. in 1692, were similarly ordered to inspect medicines within the City of Dublin and its environs
and to destroy those which were defective. It was not, however, till 1807 that the first Dublin
Pharmacopoeia appeared, and a revised edition was published in 1826. The third and last Dublin
Pharmacopoeia was issued in 1850.

The First British Pharmacopoeia
The inconvenience resulting from the existence of three different pharmacopoeias in the United
Kingdom and Ireland was considerable, and when the Medical Act of 1858 established the
General Council of Medical Education and Registration it enjoined the Council among other
things to publish a single pharmacopoeia to supersede those of London, Edinburgh, and Dublin.
Immediately after its constitution, therefore, a committee of the Council was set up to take the
necessary steps for the preparation of a British Pharmacopoeia. This committee consisted of
members of the Council, and was divided into three subcommittees, meeting respectively in
London, Edinburgh, and Dublin. The task of reducing to one standard the processes and
descriptions of three pharmacopoeias and of reconciling the varying pharmaceutical customs and
prescribing idiosyncrasies of the three countries must have been formidable, and, perhaps not
surprisingly, the work which was published in 1864 was found to have many imperfections. Thus
more than half of the 28.000 copies published were destroyed and a loss of £1,206 was incurred
on the first edition. The Council issued a second and more successful pharmacopoeia in 1867, a
third in 1885, a fourth in 1898 (with an Indian edition in 1901), and a fifth in 1914. The
preparation of each volume was undertaken by a committee of members of the Council. It could
only be by a fortunate coincidence that there might be on the Council from time to time men who
possessed the specialized knowledge requisite for the compilation of such a work, for members
of the Council are selected not with a view to their fitness and capacity to prepare a
pharmacopoeia, but rather because of their general ability, their administrative gifts, and their
professional standing. Thus it was necessary for the committee in preparing each new
pharmacopoeia, especially the later editions, to make extensive use of outside technical
assistance by invoking the aid of pharmacists and other experts. Early in the present century it
became clear that these external authorities were dissatisfied with the status accorded to them in
relation to the work. They argued that if their co-operation was indispensable, as it was conceded
to be, their position should be recognized by giving them a right of participation in the work not

5. merely as consultants but as colleagues. 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. H. P. Macmillan- afterwards Lord Macmillan. As a result of its recommendations a British
Pharmacopoeia Commission was established with a permanent secretary and other officers
employed by the Council. The Commission consists of up to a dozen medical and non-medical
experts appointed from time to time by the Council, acting in accordance with recommendations
made by a selection committee, four members of which are nominated by the Council, two by
the Medical Research Council, and one each by the Pharmaceutical Society of Great Britain, the
Pharmaceutical Society of Ireland, and the Pharmaceutical Society of Northern Ireland. The
Commission, which maintains a laboratory, is financially self-supporting through the sales of the
Pharmacopoeia. Thus the Council accepts responsibility for the work of the Commission which it
calls into being. On questions of policy the Council retains the power not only to give general
directions to the Commission but to refer back to it for reconsideration any matters it may deem
proper. This does not involve any lessening of the Commission's responsibility on the technical
side, while the position of the Council resembles that of many other eminent bodies which rely
upon the work of expert committees and are prepared to accept responsibility for it. Under these
arrangements the Council published the 1932 Pharmacopoeia.

Volumes
BP has six volumes as given under:

Volumes I and II
 Medicinal Substances

Volume III
 Formulated Preparations
 Blood related Preparations
 Immunological Products

6.  Radiopharmaceutical Preparations
 Surgical Materials
 Homeopathic Preparations

Volume IV
 Appendices
 Infrared Reference Spectra
 Index

Volume V
 British Pharmacopoeia (Veterinary)

Volume VI
(CD-ROM version)
 British Pharmacopoeia
 British Pharmacopoeia (Veterinary)


Appendices and Indices

Appendix 1: Interactions
Appendix 2: Borderline substances
Appendix 3: Cautionary and advisory labels for dispensed medicines
Appendix 4: Wound management products and elasticated garments
Dental Practitioners' Formulary

7. Nurse Prescribers' Formulary
Non-medical prescribing
Index of proprietary manufacturers
Special-order manufacturers

8. UNITED STATES PHARMACOPEIA
Introduction
The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for
the United States published annually by the United States Pharmacopeial Convention (usually
also called the USP), a nonprofit organization that owns the trademark and copyright.
A monograph published in any USP compendium (in a book, CD-ROM, or on line) provides: the
name of a substance; its definition; package, storage, and labeling requirements; and information
on tests needed to ensure the substance is of the appropriate strength, quality, and purity.

Latest Edition
The current version of USP–NF standards deemed official by USP are enforceable by the U.S.
Food and Drug Administration for medicines manufactured and marketed in the United States. A
new edition with 2016 standards—USP 40–NF 35—becomes official August 1, 2017.

History
 1820
The U.S. Pharmacopeial Convention founded in Washington, DC. All state societies of
medicine invited to send delegates—11 attended. USP creates a system of standards, and
a national formulary. Only 217 drugs meeting the criteria of "most fully established and
best understood" admitted. Dr. Lyman Spalding, Dr. Samuel Mitchill and Dr. 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. Surgeons General of U.S. Army and Navy
became first federal agencies to participate in USP revision.

9.  1848
Drug Import Act passed. Federal legislation recognizes the USP as an official
compendium.

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

 1880
Charles Rice elected chairman of the Committee of Revision, and soon initiates efforts to
modernize USP monographs and methods. Clara Marshall appointed the first woman
member of the USP Convention.

 1888
First National Formulary (NF) published by the American Pharmacists Association.

 1820
The U.S. Pharmacopeial Convention founded in Washington, DC. All state societies of
medicine invited to send delegates—11 attended. USP creates a system of standards, and
a national formulary. Only 217 drugs meeting the criteria of "most fully established and
best understood" admitted. Dr. Lyman Spalding, Dr. Samuel Mitchill and Dr. 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. Surgeons General of U.S. Army and Navy
became first federal agencies to participate in USP revision.

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

10.  1850
Colleges of pharmacy invited to participate in revision of the USP.

 1880
Charles Rice elected chairman of the Committee of Revision, and soon initiates efforts to
modernize USP monographs and methods. Clara Marshall appointed the first woman
member of the USP Convention.

 1888
First National Formulary (NF) published by the American Pharmacists Association.

 1963
First United States Adopted Names (USAN) cumulative list published.

 1964
United States Adopted Names Council formed by American Medical Association, USP
and the American Pharmacists Association (APhA).

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

 1971
USP moves to Rockville, MD, USA.

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

11.  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.

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

 1992
USP begins long-term collaboration with USAID.

 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.

 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.

12.  1998
USP licensed 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.

 2000
Roger L. Williams, M.D., becomes USP executive vice president and CEO at the USP
Convention in April. Convention Members vote to change name of Committee of
Revision to Council of Experts. USP-USAID collaborative efforts evolve into DQI, a
program focused on improving the quality of medicines and their appropriate uses in
resource-limited countries.

 2001
USP launches the Dietary Supplement Verification Program.

 2002
USP–NF published annually.

 2004
USP and the Chinese Pharmacopoeia Commission collaborate on hosting first joint
symposium in China to discuss key scientific and pharmacopeial topics.

 2005
USP opens office in Basel, Switzerland. USP signs Memorandum of Understanding
(MOU) with Chinese Pharmacopoeia Commission.

13.  2006
USP and the Indian Pharmacopoeia Commission sign MOU to promote greater
cooperation. USP opens first international laboratory facility in Hyderabad, India. USP
launches the Pharmaceutical Ingredient Verification Program. 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. USP licenses MedMarx® to Quantros.

 2009
USP publishes the USP Dietary Supplements Compendium. First Russian edition of
USP–NF published.

 2010
Pharmacopeial Forum transitions to a free online resource. Dr. Margaret Hamburg, US
FDA Commissioner, and Dr. Francis Collins, Director of NIH, address attendees at the
2010 USP Convention.

 2011
USP completes a 100,000 sq. ft. expansion of its USP–India site. USP creates the
Medicines Compendium. First USP Expert Committee established outside of the United
States in India. USP/PQM registers in Ethiopia as a nongovernmental organization.

 2012
USP hosts the Pharmacopeial Discussion Group for the first time at USP–U.S. USP

14. granted observer status by Codex Alimentarius Commission. USP–NF translated into
Chinese.

 2013
USP introduces a new logo and tagline to celebrate and emphasize the global scope of
our work.
USP inaugurates the first satellite site of the USP Spectral Library Global Laboratory
Network. USP creates the Herbal Medicines Compendium. 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. FCC
translation into Chinese released. Ronald T. Piervincenzi, Ph.D., becomes new USP
CEO.

Volumes
USP is printed in three volumes.
 Volume 1
Contains general chapters

 VolumeII & III
Contain monographs


Appendices
Appendix I: Apparatus for Test and Assays.
Appendix II: Physical Tests and Determinations.
Appendix III: Chemical Tests and Determinations.
Appendix IV: Chewing Gum Base.
Appendix V: Enzyme Assays.

15. Appendix VI: Essential Oils and Flavors.
Appendix VII: Fats and Related Substances.
Appendix VIII: Oleoresins.
Appendix IX: Rosins and Related Substances.
Appendix X: Carbohydrates.
Appendix XI: Flavor Chemicals (Other Than Essential Oils).
Appendix XII: Microbiological Tests.
Appendix XIII: Adulterants and Contaminants in Food Ingredients.
Appendix XIV: Markers for Authenticity Testing.

16. REFERENCES
1. International Meeting of World Pharmacopoeias World Health Organization,
Geneva, Executive Board Room 29 February–2 March 2012
2. The History and Development of The "BRITISH PHARMACOPEIA" By D. M.
Dunlop, M.D., F.R.C.P., F.R.CP.Ed.(Chairman of the British Pharmacopoeia
Commission, 1948-58) AND T. C. Denston, B.Pharm., F.R.I.C., F.P.S. (Secretary
to the British Pharmacopoeia Commission)
3. Wikipedia
4. http://www.usp.org/about/history-information-center/usp-milestones-timeline
5. Kopp, S. The International Pharmacopoeia – a Myth or Reality? International
Pharmacy Journal. 2006, 20 (2).
6. US Pharmacopeial Convention Official Website