Introduction
Introduction
This edition of the British Pharmacopoeia supersedes the British Pharmacopoeia 2002. It has been prepared by the British Pharmacopoeia Commission with the collaboration and support of its advisory Committees and experts, and contains nearly 2900 monographs for substances and articles used in the practice of medicine. Some of these monographs are of national origin while others have been reproduced from the 4th edition of the European Pharmacopoeia. This new edition, together with its companion edition, the British Pharmacopoeia (Veterinary) 2003, contains all monographs of the 4th edition of the European Pharmacopoeia as amended by Supplements 4.1, 4.2, 4.3, 4.4 and 4.5. 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 six volumes as follows:-
Effective Date
The effective date for this edition is 1st December 2003 unless otherwise stated.
Where a monograph which appeared previously in an earlier edition of the British Pharmacopoeia has not been included in this new edition, it remains effective in accordance with Section 65(4) of the Medicines Act 1968.
Additions
A list of monographs included within the Pharmacopoeia for the first time is given at the end of this introduction. It includes 12 new monographs of national origin and 68 new monographs reproduced from Supplements 4.3, 4.4 and 4.5 of the European Pharmacopoeia.
Revisions
National monographs which have been amended technically by means of this edition are also listed at the end of this introduction. For the benefit of the reader this list indicates the section, or sections, of each monograph which has/have been revised.
The list is as comprehensive as possible. However, to ensure that the reader uses the current standard it is essential to refer to the full text of each individual monograph.
Title changes
Monographs for medicinal substances and formulated preparations that were dual-labelled with both the recommended International Nonproprietary Name and the British Approved Name in the British Pharmacopoeia 2002 have been amended in this edition so that only the recommended International Nonproprietary Names are used. This is in accordance with the implementation of Directive 92/27/EEC. The two exceptions to the changes are Adrenaline and Noradrenaline for which the British Approved Names are retained. These are the names used in European Pharmacopoeia monographs and their associated formulation monographs. The changes are explained fully in Supplementary Chapter II A and the list of title changes is also included at the end of the Introduction. The list of Approved Synonyms has also been amended to reflect the changes. The former names used in the United Kingdom are included in a statement at the beginning of the relevant monograph for information.
The statement 'When [former title] is prescribed or demanded, [current title] shall be dispensed or supplied', previously included in monographs to provide continuity, has been deleted from monographs in this edition.
All those involved in the provision of medicines to the public are being alerted to the changes through an extensive communication strategy developed by the Medicines and Healthcare products Regulatory Agency and the Department of Health.
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