SC II A. Changes in Monograph Titles

1. Certain changes in monograph titles were made in the British Pharmacopoeia 1998 in order to bring the titles in the British Pharmacopoeia in line with the names (recommended International Nonproprietary Names [rINNs]) that manufacturers are now required to use on product labels and leaflets in accordance with EC Directive 92/27/EEC.

2. Normal practice within the British Pharmacopoeia when changing the title of a monograph is to retain the former title as a subsidiary title for a period of at least five years. This was not possible for these changes since use of the former name would no longer be permitted on product labels, etc. In order to provide continuity, a statement was therefore included in all affected monographs in the British Pharmacopoeia 1998 in the form ‘When [former title] is prescribed or demanded, [current title] shall be dispensed or supplied.’. These statements were deleted from the British Pharmacopoeia 2003.

3. For substances for which there was a rINN, it was necessary to omit any subsidiary titles from the British Pharmacopoeia 1998. For example, the ‘Vitamin C’ subsidiary titles were omitted from the monographs for Ascorbic Acid, Ascorbic Acid Injection and Ascorbic Acid Tablets. Statements of the type described above (incorporating the name used in the former subsidiary title) were included and have been retained in subsequent editions, where appropriate, to provide continuity.

4. With the exception of Adrenaline and Noradrenaline, the practice of ‘dual-labelling’ (two names presented on separate lines) was discontinued in the British Pharmacopoeia 2003. In order to comply with EC Directive 92/27/EEC, the titles of all such affected monographs were replaced by the rINNs. A statement in the form ‘The name [former title] was formerly used in the United Kingdom’ was included in all affected monographs in the British Pharmacopoeia 2003 and subsequent publications. These statements have been deleted from the British Pharmacopoeia 2009.

5. Adrenaline and Noradrenaline are the terms used in the titles of monographs in the European Pharmacopoeia and are thus the official names in use in the 37 Member States party to the Convention on the Elaboration of a European Pharmacopoeia.