Introduction

British Pharmacopoeia (Veterinary) 2018

The British Pharmacopoeia (Veterinary) 2018 supersedes the British Pharmacopoeia (Veterinary) 2017. The British Pharmacopoeia Commission has caused this edition to be prepared under regulation 317(3)(b) of the Human Medicines Regulations 2012 and, in accordance with regulation 317(4), the Ministers have arranged for it to be published. This empowers the British Pharmacopoeia Commission to prepare a compendium containing information relating to substances, combinations of substances and articles (whether veterinary medicinal products or not) which are or may be used in the practice of veterinary medicine or veterinary surgery. Under the terms of the Human Medicines Regulations 2012 it is an offence to sell or supply a medicinal product in the United Kingdom that is the subject of a monograph in the Pharmacopoeia if that product does not comply with the standards specified in the monograph.

The British Pharmacopoeia (Veterinary) 2018 is published as a companion volume to the British Pharmacopoeia 2018 and thus contains only those monographs for substances and preparations used exclusively or predominantly in veterinary medicine within the United Kingdom, together with such additional texts as are necessary to support them. It therefore follows that any reference to a monograph, appendix or reagent not contained within this edition is to be construed as a reference to the said monograph, appendix or reagent contained within the British Pharmacopoeia 2018.

This edition, together with the British Pharmacopoeia 2018, contains all the monographs reproduced from the 9th Edition of the European Pharmacopoeia as amended by Supplements 9.1 and 9.2. Users of the British Pharmacopoeia and British Pharmacopoeia (Veterinary) therefore benefit by finding within these two compendia all current pharmacopoeial standards for veterinary medicines used within the United Kingdom.

Effective Date

The effective date for this edition is 1 January 2018.

National monographs omitted from this or earlier editions of the British Pharmacopoeia remain effective in accordance with Regulation 252(2)(c) of the Human Medicines Regulations 2012.

Implementation dates regarding European Pharmacopoeia publications are provided in Supplementary Chapter IV B: Dates of Implementation. European Pharmacopoeia monographs are identified by a chaplet of stars alongside the title.

Additions

A list of monographs included for the first time in the British Pharmacopoeia (Veterinary) 2018 is given at the end of this introduction. It includes 6 new monographs of national origin and 2 new monographs reproduced from the 9^th Edition of the European Pharmacopoeia, as amended by Supplements 9.1 and 9.2.

Revisions

A number of national monographs have been amended by means of this edition. Of these monographs, those with major technical revisions (6 monographs) are 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 of revisions appended to this Introduction is as comprehensive as practicable. However, to ensure that the reader uses the current standard, it is essential to refer to the full text of each individual monograph.

For those texts reproduced from the European Pharmacopoeia, the European Directorate for the Quality of Medicines & HealthCare (EDQM) database (see below, under Websites) provides information on revisions of the monographs or other texts on a historical basis, beginning from the 5th Edition of the European Pharmacopoeia.

Infrared Reference Spectra

As with the previous edition, the reference spectra are placed in alphabetical order within this edition. One new spectrum has been added to the collection (Ketoprofen).

European Pharmacopoeia

Co-operation Agreement

As a consequence of the Co-operation Agreement with the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe, the British Pharmacopoeia Commission is pleased to note the integration of European Pharmacopoeia texts for the British Pharmacopoeia 2017 in-year online updates and for this edition of the British Pharmacopoeia (Veterinary).

All monographs of the 9th Edition of the European Pharmacopoeia, as amended by Supplements 9.1 and 9.2, which are used in veterinary practice but not normally in human medicine in the United Kingdom, are reproduced in this edition of the British Pharmacopoeia (Veterinary). Each of these monographs is signified by a chaplet of stars alongside its title. Additionally, reference to the European Pharmacopoeia monograph number is included immediately below the title in italics in the form ‘Ph. Eur. monograph xxxx’. Where the title in the British Pharmacopoeia (Veterinary) is different from that in the European Pharmacopoeia, an approved synonym has been created (see Appendix XXI B (Vet)) and the European Pharmacopoeia title is included before the monograph number. The entire European Pharmacopoeia text is delineated by two horizontal lines bearing the symbol ‘Ph. Eur.’.

The European Pharmacopoeia texts have been reproduced in their entirety but, where deemed appropriate, additional statements of relevance to UK usage have been added (e.g. action and use statement, a list of British Pharmacopoeia (Veterinary) preparations). It should be noted, however, that in the event of doubt of interpretation in any text of the European Pharmacopoeia, the text published in English under the direction of the Council of Europe should be consulted.

Correspondence between the general methods of the European Pharmacopoeia and the appendices of the British Pharmacopoeia (Veterinary) is indicated in each appendix. A list is also provided at the beginning of the appendices section. This provides a full listing of the European Pharmacopoeia method texts with their British Pharmacopoeia and British Pharmacopoeia (Veterinary) equivalents.

Pharmacopoeial Requirements

Pharmacopoeial requirements for articles used in veterinary medicine are established on the same basis as those used in human medicine. A proper understanding of the basis upon which these requirements are established is essential for their application and advice is provided within the General Notices of the British Pharmacopoeia (Veterinary) and the Supplementary Chapters of the British Pharmacopoeia. It should be noted that no requirement of the Pharmacopoeia can be taken in isolation. A valid interpretation of any particular requirement depends upon it being read in the context of (i) the monograph as a whole, (ii) the specified method of analysis, (iii) the relevant General Notices and (iv) where appropriate, the relevant General Monograph(s).

Where a preparation that is the subject of a monograph in the British Pharmacopoeia is supplied for use in veterinary medicine, the standards of the British Pharmacopoeia apply, unless otherwise justified and authorised. Attention is drawn to the Notice permitting the designation British Pharmacopoeia (Veterinary) [BP (Vet)] to be used in place of the designation British Pharmacopoeia [BP] where a preparation complying with the British Pharmacopoeia is supplied for use in veterinary medicine with the approval of the competent authority.

Code of Practice

Members of the British Pharmacopoeia Commission and its supporting Expert Advisory Groups, Panels of Experts and Working Parties are required to comply with a Code of Practice on Declaration of Interests in the pharmaceutical industry. Details of the Code are published on the website (www.pharmacopoeia.com).

Recommendations of the Triennial Review of the British Pharmacopoeia Commission

In 2015 the Department of Health conducted a Triennial Review of the British Pharmacopoeia Commission (BPC) to provide assurance to the Department and the public that the functions of the Commission are required and that it is operating effectively. The Triennial Review report, published in March 2015, made a number of minor recommendations. All of the recommendations made in the report have now been completed.

The full report of the Review can be found on the website at www.gov.uk/government/consultations/british-pharmacopoeia-commission-triennial-review.

Websites

British Pharmacopoeia Websites

The British Pharmacopoeia website, http://www.pharmacopoeia.com, contains information relating to the British Pharmacopoeia. It allows subscribers to access the British Pharmacopoeia 2018 and British Pharmacopoeia (Veterinary) 2018 online and British Approved Names publications. All users are also able to view and purchase BPCRS products through the website.

Chromatograms for information to support new monographs published in the British Pharmacopoeia 2018 have been added to the example test results gallery to aid users of British Pharmacopoeia monographs. This service will increase year-on-year to allow users to examine chromatograms obtained during the practical evaluation of new monographs by the British Pharmacopoeia Commission Laboratory.

A regular review schedule for draft texts is included on the website, with draft new and revised monographs being posted at the start of each quarter and available for comment for a period of three months thereafter. This free service allows greater visibility of the BP’s work programme and enables stakeholder contributions to monograph development.

Subscribers to the BP online will find that draft texts and example test results are also linked with relevant texts and directly accessible from the BP online content. Additionally, BPCRS products are also linked with relevant BP monographs and subscribers to the BP online will be able to purchase these directly from the BP online. BPCRS customers are able to make purchases through invoice or credit card orders.

An email subscription feature allows users to keep abreast with BP news. Additionally, users can subscribe to receive BPCRS updates, which are now posted monthly.

Access to previous editions of the BP is available as a BP archive product for purchase by new and existing BP online subscribers. The content of the archive starts from the BP 2014 onwards and grows year-on-year as superseded editions are added to the archive.

A policy of continuous improvement allows the BP website to keep up to date and respond to users. Customers are therefore invited to provide the Secretariat with feedback on their experience.

European Pharmacopoeia Websites

https://extranet.edqm.eu/publications/recherches_sw.shtml For those texts reproduced from the European Pharmacopoeia, the EDQM website provides access to a database (the Knowledge database) containing information of various sorts related to monographs and intended to facilitate their proper use. Information is provided on chromatographic columns used in monograph development, suppliers of reagents and equipment that may be difficult to find for some users, the status of monographs (in development, adopted, published, under revision), revisions of the monographs on a historical basis, beginning from the 5th Edition of the European Pharmacopoeia as well as other useful information.

https://pharmeuropa.edqm.eu/homeThe European Pharmacopoeia Forum, Pharmeuropa, is published quarterly as an aid for the elaboration of monographs and as a vehicle for information on pharmacopoeial and related matters. Pharmeuropa is available as a free on-line publication.

Forward Look

Electronic Updates The British Pharmacopoeia 2018 online updates will be published on the website, www.pharmacopoeia.com, to enable users to keep up to date with monographs published in the European Pharmacopoeia. These updates will be integrated annually with the publication of the main edition of the British Pharmacopoeia.

Monograph Development The British Pharmacopoeia Commission will continue to collaborate with stakeholders to develop BP monographs for veterinary medicines, to ensure that the British Pharmacopoeia (Veterinary) continues to provide authoritative quality standards for veterinary preparations.

Acknowledgements

The British Pharmacopoeia Commission is greatly indebted to the members of its Expert Advisory Groups, Panels of Experts, in particular, the Panel of Experts on Veterinary Medicines, and Working Parties for their dedicated enthusiasm and assistance in the preparation of this edition.

Close co-operation has continued with many organisations at home and overseas. These include the Veterinary Medicines Directorate, the Medicines and Healthcare products Regulatory Agency, the National Office of Animal Health, the Association of the British Pharmaceutical Industry, the European Pharmacopoeia Commission and the European Directorate for the Quality of Medicines & HealthCare, the Therapeutic Goods Administration (Australia), the Health Products and Food Branch of Health Canada, the United States Pharmacopeia, the Quality Assurance and Safety: Medicines Department of the World Health Organization (WHO) and the Health Sciences Authority of Singapore.

The British Pharmacopoeia Commission wishes to thank the European Directorate for the Quality of Medicines & HealthCare for their support and assistance in the reproduction of the European Pharmacopoeia texts and monographs. The British Pharmacopoeia Commission acknowledges the importance of the work of the European Pharmacopoeia (Ph. Eur.) Commission and its Groups of Experts and Working Parties. The British Pharmacopoeia Commission is also grateful for the generous contribution by the UK experts to the work of the Groups of Experts and Working Parties of the European Pharmacopoeia Commission.

The British Pharmacopoeia Commission also acknowledges and appreciates the advice of the publishing team at The Stationery Office, in particular, Ms Nichola Billington, Mr Colin Hackett, Mr Paul Allard, Mr Paul Relfe and Mr Ian Webb, in the production of this edition.

Additions

The following monographs of the British Pharmacopoeia (Veterinary) 2018 were not included in the British Pharmacopoeia (Veterinary) 2017.

Medicinal and Pharmaceutical Substances

Milbemyin Oxime^*

Formulated Preparations: Specific Monographs

Carprofen Injection

Carprofen Tablets

Ketoprofen Injection

Ketoprofen Solution for use in Drinking Water

Ketoprofen Tablets

Veterinary Immunological Products

Veterinary Vaccines for use in Emergency Situations

Infectious Bovine Rhinotracheitis Vaccine (Inactivated)^*

Technical Changes

The following monographs in the British Pharmacopoeia (Veterinary) 2018 have been technically amended since the publication of the British Pharmacopoeia (Veterinary) 2017, or have had a significant editorial change. This list does not include revised monographs of the European Pharmacopoeia. An indication of the nature of the change or the section of the monograph that has been changed is given in italic type in the right hand column.

Formulated Preparations: Specific Monographs

Formulated Preparations: Specific Monographs

Immunological Products