The British Pharmacopoeia 2013 supersedes the British Pharmacopoeia 2012. It has been prepared by the British Pharmacopoeia Commission, with the collaboration and support of its Expert Advisory Groups, Panels of Experts and Working Parties and contains almost 3400 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 7th Edition of the European Pharmacopoeia. This edition, together with its companion edition, the British Pharmacopoeia (Veterinary) 2013, incorporates all the monographs of the 7th Edition of the European Pharmacopoeia, as amended by Supplements 7.1 to 7.5. The user of the British Pharmacopoeia thereby benefits by finding within this comprehensively indexed compendium all current United Kingdom pharmacopoeial standards for medicines for human use.
The BP 2013 comprises six volumes as follows.
Volumes I and II
Medicinal Substances
Volume III
Formulated Preparations: General Monographs Formulated Preparations: Specific Monographs
Volume IV
Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Materials for use in the Manufacture of Homoeopathic Preparations Blood-related Products Immunological Products Radiopharmaceutical Preparations Surgical Materials
Volume V
Infrared Reference Spectra Appendices Supplementary Chapters Index
Volume VI
British Pharmacopoeia (Veterinary) 2013
Effective Date
The effective date for British Pharmacopoeia monographs in this edition is 1 January 2013.
National monographs omitted from this or earlier editions of the British Pharmacopoeia remain effective in accordance with Section 65(4) of the Medicines Act 1968.
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.
General Notices
Part II
The British Pharmacopoeia General Notices (Part II) have been amended as follows.
Crude Drugs; Traditional Herbal and Complementary Medicines
Monograph Title This General Notice has been amended to delete references to the acronyms THM and THMP.
Unlicensed Medicines
This General Notice has been editorially amended to harmonise the reference to Manufacturer's 'Specials' Licence throughout the Pharmacopoeia.
Part III
The British Pharmacopoeia General Notices (Part III) have been amended to harmonise with the changes published in Supplement 7.5 of the 7th edition of the European Pharmacopoeia.
Additions
A list of monographs included for the first time in the British Pharmacopoeia 2013 is given at the end of this introduction. It includes 41 new monographs of national origin and 40 new monographs reproduced from the 7th Edition of the European Pharmacopoeia as amended by Supplements 7.1 to 7.5.
Traditional Herbal Medicines; Homoeopathic Preparations
Work is continuing on the development of monographs for materials and processed materials used in Traditional Herbal Medicines with the addition of 2 new monographs in this edition. The requirements for the quality of the material are provided in the monograph to set the standards for Traditional Herbal Medicines in the UK and to assist the registration scheme by the UK Licensing Authority. The British Pharmacopoeia Commission, however, has not assessed the safety and efficacy of the material in traditional use.
Likewise, the British Pharmacopoeia Commission has not assessed the safety and efficacy of materials for use in homoeopathic preparations for which monographs are published.
Unlicensed Medicines
With this new edition, a further 9 monographs for unlicensed formulations have been added. These individual monographs are characterised by a statement that they are not currently licensed in the United Kingdom. The general and individual monographs are intended to apply to all types of Unlicensed Medicines, that is, those formulations prepared under a Manufacturer's 'Specials' Licence and those prepared extemporaneously under the supervision of a pharmacist.
Revisions
A significant number (619) of national monographs have been amended by means of this edition. Of these monographs, those with major technical revisions 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.
Title Changes
Parenteral Preparations Following a review by the British Pharmacopoeia Commission's Expert Advisory Group on Pharmacy, the term "Intravenous" has been removed from the title of 35 monographs for Intravenous Infusions in the BP 2013. In addition, the Definition statements have been revised for consistency and to ensure that they reflect currently marketed products.
Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products The titles of 15 monographs for Traditional Herbal Medicines have been amended to delete reference to 'THM' and 'THMP' extensions in the BP 2013.
Labelling Requirements
A phased revision of Labelling requirements in the British Pharmacopoeia was initiated with the publication of a revised General Notice for Labelling in the British Pharmacopoeia 2009 and revision of the Labelling statements in the General Monographs in the British Pharmacopoeia 2012.
Following a review by the British Pharmacopoeia Commission's Expert Advisory Group on Pharmacy and, in collaboration with the MHRA Licensing Authority, all statements required by the European Directive 2001/83/EC have been omitted from the specific monographs in this edition of the British Pharmacopoeia to avoid duplication.
Reference Substances
21 monographs for medicinal and pharmaceutical substances and formulated preparations of the BP have been amended to refer to new British Pharmacopoeia Chemical Reference Substances established by the British Pharmacopoeia Laboratory.
Pharmacopoeial Requirements
It should be noted that any article intended for medicinal use which is described by a name at the head of a monograph in the current edition of the Pharmacopoeia must comply with that monograph 'whether or not it is referred to as BP'.
It is also important to note 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). Familiarity with the General Notices of the Pharmacopoeia will facilitate the correct application of the requirements. Additional guidance and information on the basis of pharmacopoeial requirements is provided in Supplementary Chapter I. This non-mandatory text describes the general underlying philosophy and current approaches to particular aspects of pharmacopoeial control.
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.mhra.gov.uk/pharmacopoeia).
Chromatograms for information have been added to the Image Gallery to support new monographs published in the British Pharmacopoeia 2013 to aid users of British Pharmacopoeia monographs. This service will continue to increase year on year to allow users to examine chromatograms obtained during the practical evaluation of new monographs by the British Pharmacopoeia Commission Laboratory.
Representative micrographs and photographs to support, and to be used in conjunction with, the current British Pharmacopoeia monographs for Traditional Herbal Medicines have been added. They are provided as an example of what users might expect to see when examining powdered herbal drugs and processed herbal drugs microscopically and macroscopically.
International Collaboration
Chinese Pharmacopoeia Following the signing of a Collaboration Agreement in October 2010, the British Pharmacopoeia Commission is pleased to continue its collaboration with the Chinese Pharmacopoeia on the development of monographs for Traditional Chinese Herbal Medicines and mutually agreed projects.
World Health Organisation Following the signing of a Collaboration Agreement in October 2011, the British Pharmacopoeia Commission is pleased to exchange information with the International Pharmacopoeia and to collaborate on the development of monographs for formulated preparations.
Informal Harmonisation of Methods Following an informal harmonisation process between two major Pharmacopoeias throughout the consultative period and, with the co-operation of the manufacturer and simultaneous submissions of data to both the British Pharmacopoeia and the United States Pharmacopeia, the new monographs for Dorzolamide Eye Drops and Dorzolamide and Timolol Eye Drops have been evaluated and published in this new edition of the British Pharmacopoeia. The British Pharmacopoeia Commission is pleased to observe that analytical methods in these monographs are harmonised for the two Pharmacopoeias, thus lessening the regulatory burden for manufacturers.
Additions
The following monographs are new additions to the British Pharmacopoeia 2013.
Medicinal and Pharmaceutical Substances
Aluminium Stearate*
Bicalutamide*
Candesartan Cilexetil*
Celecoxib*
Cholesterol for Parenteral Use*
Anhydrous Docetaxel*
Duloxetine Hydrochloride*
Fulvestrant*
Glucosamine Hydrochloride*
Glucosamine Sulfate Sodium Chloride*
Glycerol Formal*
Melphalan*
Montelukast Sodium*
Nateglinide*
Nicorandil
Nicotine Ditartrate Dihydrate*
Olanzapine*
Olmesartan Medoxomil*
Rizatriptan Benzoate*
Tadalafil*
Vigabatrin*
Voriconazole*
Water for Preparation of Extracts*
Formulated Preparations: Specific Monographs
Buprenorphine Injection
Buprenorphine Transdermal Patches
Buprenorphine Sublingual Tablets
Cefuroxime Axetil Oral Suspension
Cefuroxime Intracameral Injection
Clarithromycin for Infusion
Clonazepam Oral Suspension
Cyclophosphamide Oral Solution
Diphenhydramine Tablets
Prolonged-release Dipyridamole Capsules
Dipyridamole Infusion
Dipyridamole Oral Suspension
Dorzolamide Eye Drops
Dorzolamide and Timolol Eye Drops
Dosulepin Oral Solution
Epirubicin Injection
Fexofenadine Tablets
Glycopyrronium Bromide Oral Solution
Hydrocortisone Acetate Oral Suspension
Lamotrigine Tablets
Lisinopril Oral Solution
Malathion Lotion
Malathion Shampoo
Mesalazine Foam Enema
Nicorandil Tablets
Prolonged-release Nifedipine Tablets
Oxycodone Capsules
Oxycodone Injection
Oxycodone Oral Solution
Prolonged-release Oxycodone Tablets
Potassium Ascorbate Eye Drops
Sodium Chloride Eye Ointment
Prolonged-release Tamsulosin Tablets
Triamcinolone Acetonide Nasal Spray
Vancomycin Capsules
Prolonged-release Venlafaxine Tablets
Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products
Acanthopanax Bark*
Angelica Dahurica Root*
Angelica Pubescens Root*
Processed Angelica Sinensis Root*
Atractylodes Lancea Rhizome*
Atractylodes Rhizome, Largehead*
Berberis Aristata
Black Cohosh*
Drynaria Rhizome*
Eclipta Prostrata Whole Plant
Isatis Root*
Kudzuvine Root*
Thomson Kudzuvine Root*
Niaouli Oil, Cineole Type*
Poria*
Materials for use in the Manufacture of Homoeopathic Preparations
Hydrastis Canadensis for Homoeopathic Preparations*
Impregnated Homoeopathic Pillules*
Pillules for Homoeopathic Preparations*
Immunological Products
Hepatitis A (Inactivated, Adsorbed) and Typhoid Polysaccharide Vaccine*
Radiopharmaceutical Preparations
Sodium Iodohippurate Dihydrate for Radiopharmaceutical Preparations*
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