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British Pharmacopoeia

British Pharmacopoeia

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Encyclopedia
The British Pharmacopoeia (BP) is an annual published collection of quality standards for UK
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...

 medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing.

Pharmacopoeia
Pharmacopoeia
Pharmacopoeia, pharmacopeia, or pharmacopoea, , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.In a broader sense it is...

l 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
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....

 (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
Commission on Human Medicines
The Commission on Human Medicines is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005 by the amalgamation of the Medicines Commission and the Committee on Safety of Medicines....

 in accordance with section 99(6) of the Medicines Act 1968
Medicines Act 1968
The Medicines Act 1968 is an Act of Parliament of the United Kingdom. It governs the manufacture and supply of medicine.The act defines three categories of medicine: prescription only medicines , which are available only from a pharmacist if prescribed by an appropriate practitioner; pharmacy...

 and notified in draft to the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....

 in accordance with Directive 98/34/EEC.

The monographs of the European Pharmacopoeia
European Pharmacopoeia
The European Pharmacopoeia of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe...

 (as amended by Supplements published by the Council of Europe
Council of Europe
The Council of Europe is an international organisation promoting co-operation between all countries of Europe in the areas of legal standards, human rights, democratic development, the rule of law and cultural co-operation...

) 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
Letters patent
Letters patent are a type of legal instrument in the form of a published written order issued by a monarch or president, generally granting an office, right, monopoly, title, or status to a person or corporation...

 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
Henry VIII of England
Henry VIII was King of England from 21 April 1509 until his death. He was Lord, and later King, of Ireland, as well as continuing the nominal claim by the English monarchs to the Kingdom of France...

 (1491–1547). The Royal College of Physicians
Royal College of Physicians
The Royal College of Physicians of London was founded in 1518 as the College of Physicians by royal charter of King Henry VIII in 1518 - the first medical institution in England to receive a royal charter...

 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
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...

 (GMC) when the body was made statutorily responsible under the Medical Act 1858
Medical Act 1858
The Medical Act 1858 was a British Act of Parliament which created the General Medical Council to regulate doctors in the UK.Describing its purpose, the act notes that "it is expedient that Persons requiring Medical Aid should be enabled to distinguish qualified from unqualified Practitioners".The...

 for producing a British Pharmacopoeia on a national basis. In 1907 the British Pharmacopoeia was supplemented by the British Pharmaceutical Codex
British Pharmaceutical Codex
The British Pharmaceutical Codex was first published in 1907, to supplement the British Pharmacopoeia which although extensive, did not cover all the medicinal items that a pharmacist might require in daily work...

, 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 Name
British Approved Name
A British Approved Name is the official non-proprietary or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia...

s (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
Veterinary medicine
Veterinary Medicine is the branch of science that deals with the prevention, diagnosis and treatment of disease, disorder and injury in non-human animals...

 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


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:
  • Development of new pharmacopoeial monographs – the laboratory undertakes the development and validation of qualitative and quantitative test methods for new BP monograph specifications and refines and revalidates test methods for existing BP monographs.
  • British Pharmacopoeia Chemical Reference Substances (BPCRS) – the laboratory is responsible for the procurement, establishment, maintenance and sale of BPCRS. The catalog currently contains nearly 500 BPCRS, which are needed as standards for monograph tests in both the BP and the BP (Veterinary).
  • A new website for the British Pharmacopoeia Commission opened in 2008.

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



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
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 maintains "The International Pharmacopoeia
The International Pharmacopoeia
The aim of The International Pharmacopoeia , which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms.The information published in The International...

" http://www.who.int/medicines/publications/pharmacopoeia/overview/en/.

The British National Formulary
British National Formulary
The British National Formulary is a medical and pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about all medicines available on the National Health Service , including indication,...

 http://www.bnf.org contains information on prescribing, indications, side effects and costs of all medication drugs available on the National Health Service
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...

.

See also

  • British Approved Name
    British Approved Name
    A British Approved Name is the official non-proprietary or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia...

  • British Pharmaceutical Codex
    British Pharmaceutical Codex
    The British Pharmaceutical Codex was first published in 1907, to supplement the British Pharmacopoeia which although extensive, did not cover all the medicinal items that a pharmacist might require in daily work...

  • Pharmacopoeia
    Pharmacopoeia
    Pharmacopoeia, pharmacopeia, or pharmacopoea, , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.In a broader sense it is...

  • The International Pharmacopoeia
    The International Pharmacopoeia
    The aim of The International Pharmacopoeia , which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms.The information published in The International...


External links