General Information Of Pharmacopoeias

GENERAL INFORMATION OF B.P AND U.S.P

 

DRUG STANDARDS

As the scientific basis for drugs and drug products developed, so did the need for uniform standards to ensure quality. This need led to the development and publications of monographs and reference books containing such drug standards to be utilized by those involved in the production of drugs and pharmaceutical products. Organized sets of monographs or books of these standards are referred to as “pharmacopoeias” or  ”formularies”.

The word, pharmacopoeia, is derived from the Greek Phramakon, a drug, and poieo, I make. Literally, it is a list of medical substances, crude drugs and formulae for making preparations from them. Such a list is complied by recognized authorities, usually appointed by the government of each country. Most of the principal countries of the world have their national pharmacopoeias.

 

THE BIRTH OF PHARMACOPOEIAS

The formulation of pharmacopoeia must be credited to the invention of printing in the fifteenth century, not so much because printing offered a means of publication, but because it had let to the production of numerous formularies and compilations based on current and earlier manuscripts works, with diversed formulae and methods of preparation.

The first book published by the authority of recognized public body was issued by the college of Florence in 1498. It contained the most important formulae form the work of Nicholas Praepositus and additional matter from ancient writers e.g., Meuse, Avicenna, and Galen. The book was issued to ensure constancy in the composition of preparations prescribed by the Florentine physicians, may therefore be considered as the first official pharmacopoeia.

The city of Nuremberg was apparently the first community to possess the pharmacopoeia which was legally binding on the apothecaries (pharmacists) of that city. In 1529 the senate of Nuremberg passed a law which required certain preparations to be prepared to the formulae of recipe book.

 

USP–NF

The United States Pharmacopeia–National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

 

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.

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.

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.

 

MONOGRAPHS AND GENERAL CHAPTERS

The USP–NF is a three volume combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipients monographs are in the NF.

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. These tests and procedures require the use of official USP Reference Standards. Medicinal ingredients and products will have the stipulated strength, quality, and purity if they conform to the requirements of the monograph and relevant general chapters.

BRITISH PHARMACOPOEIA

HISTORY

The regulation of medicinal products by officials in the United Kingdom dates back to the reign of King Henry VIII (1491–1547). The Royal College of Physicians of London had the power to inspect apothecaries’ products in the London area and to destroy defective stock. The first list of approved drugs with information on how they should be prepared was the London Pharmacopoeia published in 1618. The first edition of the British Pharmacopoeia was published in 1864 and was one of the first attempts to harmonize pharmaceutical standards between different countries, through the merger of the London, Edinburgh and Dublin Pharmacopoeias.

A Commission was first appointed by the General Medical Council (GMC) when the body was made statutorily responsible under the Medical Act 1858 for producing a British Pharmacopoeia on a national basis. In 1907 the British Pharmacopoeia was supplemented by the British Pharmaceutical Codex, which gave information on drugs and other pharmaceutical substances not included in the BP, and provided standards for these.

The 1968 Medicines Act established the legal status of the British Pharmacopoeia Commission and of the BP as the UK standard for medicinal products under section 4 of the Act. The British Pharmacopoeia Commission continues the work of the earlier Commissions appointed by the GMC and is responsible for preparing new editions of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary) and for keeping them up to date. Under Section 100 of the Medicines Act, the British Pharmacopoeia Commission is also responsible for selecting and devising British Approved Names.

Since its first publication back in 1864 the distribution of the British Pharmacopoeia has grown throughout the world. It is now used in over 100 countries. Australia and Canada are two of the countries that have adopted the BP as their national standard alongside the UK, and in other countries (e.g. Korea) it is recognized as an internationally acceptable standard.

CONTENT

The current edition of the British Pharmacopoeia comprises six volumes which contain nearly 3,000 monographs for drug substances, excipients and formulated preparation, together with supporting General Notices, Appendices (test methods, reagents etc) and Reference Spectra used in the practice of medicine, all comprehensively indexed and cross-referenced for easy reference. Items used exclusively in veterinary medicine in the UK are included in the BP (Veterinary).

Volumes I and II

• Medicinal Substances

Volume III

• Formulated Preparations
• Blood related Preparations,
• Immunological Products,
• 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)
• British Approved Names