British Pharmacopoeia Explained

Company Name:British Pharmacopoeia
Location City:London
Location Country:United Kingdom
Homepage:www.pharmacopoeia.co.uk
www.pharmacopoeia.gov.uk

The British Pharmacopoeia (BP) is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing.

Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The Pharmacopoeia is an important statutory component in the control of medicines which complements and assists the licensing and inspection processes of the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom.

Pharmacopoeial standards are compliance requirements; that is, they provide the means for an independent judgment as to the overall quality of an article and apply throughout the shelf-life of a product. Inclusion of a substance in a pharmacopoeia does not indicate that it is either safe or effective for the treatment of any disease.

Legal basis

The British Pharmacopoeia is published for the Health Ministers of the United Kingdom on the recommendation of the Commission on Human Medicines in accordance with section 99(6) of the Medicines Act 1968 and notified in draft to the European Commission in accordance with Directive 98/34/EEC.

The monographs of the European Pharmacopoeia (as amended by Supplements published by the Council of Europe) are reproduced either in the British Pharmacopoeia or in the associated edition of the British Pharmacopoeia (Veterinary).

In the Pharmacopoeia certain drugs and preparations are included regardless of the existence of actual or potential patent rights. Where substances are protected by Letters Patent their inclusion in the Pharmacopoeia neither conveys, nor implies, license to manufacture.

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, 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 (BANs – see below).

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
Volume III
Volume IV
Volume V
Volume VI: (CD-ROM version)

The BP is available as a printed volume and electronically in both on-line and CD-ROM versions, the electronic products use sophisticated search techniques to locate information quickly. For example, pharmacists referring to a monograph can immediately link to other related substances and appendices referenced in the content by using 130,000+ hypertext links within the text.

Production

The BP is prepared by the Pharmacopoeial Secretariat working in collaboration with the BP Laboratory, the British Pharmacopoeia Commission (BPC) and its Expert Advisory Groups (EAG) and Advisory Panels. The development of pharmacopoeial standards receives input from relevant industries, hospitals, academia, professional bodies and governmental sources, both within and outside the UK.

The BP Laboratory provides analytical and technical support to the British Pharmacopoeia. Its major functions are:

1st edition -1862 in latin 1st edition -1864 in english 2nd edition - 1867 3rd edition -1885 4th edition -1898 5th edition -1914 6th edition -1928 7th edition -1932 8th edition -1953 9th edition -1958 10th edition -1963 13th edition -1980 14th edition -1993 15th edition -1989 16th edition -1990

Guidance

Detailed information and guidance on various aspects of current pharmacopoeial policy and practice is provided in Supplementary Chapters of the BP. This includes explanation of the basis of pharmacopoeial specifications and information on the development of monographs including guidance to manufacturers.

Availability

The current edition of the British Pharmacopoeia is available from The Stationery Office Bookshop.

British Approved Names

See main article: British Approved Name. British Approved Names (BANs) are devised or selected by the British Pharmacopoeia Commission (BPC) and published by the Health Ministers on the recommendation of the Commission on Human Medicines to provide a list of names of substances or articles referred to in section 100 of the Medicines Act 1968. BANs are short, distinctive names, for substances where the systematic chemical or other scientific names are too complex for convenient general use.

As a consequence of Directive 2001/83/EC as amended, the BANs, since 2002, may be assumed to be the recommended International Non-proprietary Name (rINN) except where otherwise stated. An INN identifies a pharmaceutical substance or active pharmaceutical ingredient by a unique name that is globally recognized and in which no party can claim any proprietary rights. A non-proprietary name is also known as a generic name.

Related publications

There are equivalents in many other countries, such as the United States (USP)http://www.usp.org and Japan http://jpdb.nihs.go.jp/jp14e/, and the World Health Organization maintains "The International Pharmacopoeia" http://www.who.int/medicines/publications/pharmacopoeia/overview/en/.

The British National Formulary http://www.bnf.org contains information on prescribing, indications, side effects and costs of all medication drugs available on the National Health Service.

See also

External links