British Pharmacopoeia

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 what is now known as the British Pharmacopoeia was published in 1864, and was one of the first attempts to harmonise pharmaceutical standards, through the merger of the London, Edinburgh and Dublin Pharmacopoeias. The Neo-Latin name that had some currency at the time was Pharmacopoeia Britannica (Ph. Br.).

In 1844, concern about the dangers of unregulated manufacture and use led William Flockhart – who had provided chloroform to Doctor (later Sir) James Young Simpson for his experiment on anaesthesia – to recommend the creation of a 'Universal Phamacopoeia for Great Britain' in his inaugural speech as president of the Northern British branch of the Pharmaceutical Society.

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 Medicines Act 1968 established the legal status of the British Pharmacopoeia Commission, and of the British Pharmacopoeia, 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 Commission is also responsible for selecting and devising British Approved Names.

Since its first publication in 1864, the distribution of the British Pharmacopoeia has grown throughout the world and 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; in other countries, such as South Korea, the BP is recognised as an acceptable reference standard.

The British Pharmacopoeia is prepared by the Pharmacopoeial Secretariat, working in collaboration with the British Pharmacopoeia 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 British Pharmacopoeia 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 British Pharmacopoeia monographs.

British Pharmacopoeia Chemical Reference Substances (BPCRS): the laboratory is responsible for the procurement, establishment, maintenance and sale of BPCRS. The catalogue currently contains nearly 500 BPCRS, which are needed as standards for monograph tests in both the British Pharmacopoeia and the British Pharmacopoeia (Veterinary).

Legal basis

The British Pharmacopoeia is published on behalf of 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 (EC) 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, licence to manufacture.