British Pharmacopoeia 2009

The British Pharmacopoeia 2009 is published for the Health Ministers on the recommendation of the Commission on Human Medicines in accordance with section 99(6) of the Medicines Act 1968. The Commission on Human Medicines believes that the British Pharmacopoeia contributes significantly to the overall control of the quality of medicinal products by providing an authoritative statement of the quality that a product, material or article is expected to meet at any time during its period of use. The Pharmacopoeial standards, which are publicly available and legally enforceable, are designed to complement and assist the licensing and inspection processes and are part of the system for safeguarding purchasers and users of medicinal products. 

The Commission on Human Medicines wishes to record its appreciation of the services of all those who have contributed to this important work.

Notices

Monographs of the European Pharmacopoeia are distinguished by a chaplet of stars against the title. The term European Pharmacopoeia, used without qualification, means the sixth edition of the European Pharmacopoeia comprising, unless otherwise stated, the main volume, published in 2007 as amended by any subsequent supplements and revisions. 

Patents

In this Pharmacopoeia certain drugs and preparations have been included notwithstanding the existence of actual or potential patent rights. In so far as such substances are protected by Letters Patent their inclusion in this Pharmacopoeia neither conveys, nor implies, licence to manufacture.

Effective dates

New and revised monographs of national origin enter into force on 1 January 2009. Monographs of the European Pharmacopoeia have previously been published by the Council of Europe and have been brought into effect by means of Notices published in the Belfast, Edinburgh and London Gazettes.

The British Pharmacopoeia 2009 supersedes the British Pharmacopoeia 2008. It has been

prepared by the British Pharmacopoeia Commission, with the collaboration and support of its

Expert Advisory Groups and Panels of Experts, and contains approximately 3200 monographs

for substances, preparations and articles used in the practice of medicine. Some of these monographs are of national origin while others have been reproduced from the 6th edition of the European Pharmacopoeia. This edition, together with its companion edition, the British Pharmacopoeia (Veterinary) 2009, incorporates all the monographs of the 6th edition of the European Pharmacopoeia as amended by Supplements 6.1 and 6.2. The user of the British Pharmacopoeia thereby benefits by finding within this one, comprehensively indexed, compendium all current United Kingdom pharmacopoeial standards for medicines for human use. The new edition comprises five volumes as follows. 

Volumes I and II Medicinal Substances

Volume III Formulated Preparations, Blood-related Products, Immunological Products, Radiopharmaceutical Preparations, Surgical Materials, Herbal Drugs and Herbal

Drug Preparations and Materials for use in the Manufacture of Homoeopathic Preparations 

Volume IV Infrared Reference Spectra, Appendices, Supplementary

Chapters and Index

Volume V British Pharmacopoeia (Veterinary) 2009

Effective Date

The effective date for this edition is 1 January 2009.

Where a monograph which appeared previously in an earlier edition of the British Pharmacopoeia has not been included in this edition, it remains effective in accordance with Section 65(4) of the Medicines Act 1968.