The British Pharmacopoeia 2019 supersedes the British Pharmacopoeia 2018. 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 approximately 4000 monographs for substances, preparations and articles used in the practice of medicine. Some of these monographs are of national origin and have been elaborated or revised under the auspices of the British Pharmacopoeia Commission whilst others (indicated to users by a chaplet of stars) have been elaborated, or revised, under the auspices of the European Pharmacopoeia Commission, supported by its Groups of Experts and Working Parties, and are reproduced from the European Pharmacopoeia. This edition, together with its companion volume, the British Pharmacopoeia (Veterinary) 2019, incorporates all the monographs of the 9th Edition of the European Pharmacopoeia, as amended by Supplements 9.1 to 9.5. Users of the British Pharmacopoeia thereby benefit by finding within this comprehensively indexed compendium all current United Kingdom pharmacopoeial standards for medicines for human use.

The BP 2019 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) 2019

Effective Date

The effective date for British Pharmacopoeia monographs in this edition is 1 January 2019.

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 2019 is given at the end of this introduction. It includes 27 new monographs of national origin and 34 new monographs reproduced from the 9th Edition of the European Pharmacopoeia, as amended by Supplements 9.1 to 9.5.

Pharmacopoeial public quality standards for biological medicines

In October 2017 the Medicines and Healthcare products Regulatory Agency (MHRA) published its strategy for pharmacopoeial public quality standards for biological medicines. This was in the form of an official response to a consultation held earlier in the same year. Development of the consultation and strategy reflected the increasing importance of biological medicines to global healthcare strategies, together with the need to consider how standards can act as enablers for innovation now and in the future. It also acknowledged and supported the MHRA’s wider work in this area, such as the role identified for standards in the Medicines Manufacturing Industry Partnership action plan on advanced therapies manufacturing: http://www.abpi.org.uk/our-work/mmip/documents/advanced-therapies-manufacturing-taskforce-report.pdf.

The consultation and responses emphasised the value of pharmacopoeial public quality standards and the powerful contribution the MHRA is able to make through its incorporation of regulatory, documentary (BP) and physical (NIBSC) standard setting functions. The strategy focussed on how the MHRA would continue to contribute effectively to the assurance of quality through pharmacopoeial standards and set out a work programme aimed at supporting unmet needs identified during the consultation. The strategy laid out collaborative and knowledge building approaches that would be used to achieve this and recognised the role and importance of users, industry and international regulatory and peer organisations.

The full response, including strategy and work programme was posted to the consultation webpage https://www.gov.uk/government/consultations/strategy-for-pharmacopoeial-public-quality-standards-for-biological-medicines.

Consultation on Dissolution Testing

A public consultation on dissolution testing in BP finished product monographs for solid oral dosage forms was undertaken in early 2017 https://www.pharmacopoeia.com/content/file/Consultation-Dissolution-testing.pdf

During late 2017 and early 2018 the feedback received has been considered by the Expert Advisory Group on Pharmacy and a consultation response will be published on the BP website in mid 2018 that will summarise the proposed actions that will be taken in response to the consultation.

Traditional Herbal Medicines; Homoeopathic Preparations

Work is continuing on the development of monographs for herbs used in traditional herbal medicines and homoeopathic medicines. The Latin scientific names cited in BP monographs for herbal drugs are consistent with the advice provided by the Medicinal Plant Names Services at the Royal Botanic Gardens, Kew. As stated in previous editions, the requirements for the quality of the material are provided in the monographs to set the standards for Traditional Herbal Medicines in the UK and to assist the UK Traditional Herbal Medicines Registration Scheme. The British Pharmacopoeia Commission, however, has not assessed the safety and efficacy of the materials 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.

Two new BP monographs for herbal medicines are included in this edition. They reflect a continued commitment to providing standards for herbal drugs commonly used in the UK and for those known to be used for the preparation of traditional medicines. We have continued to review the fitness-for-purpose of published BP monographs for herbal and complementary medicines, revising them as deemed necessary. We continue to work with our collaborative partners to ensure better understanding of the needs of our users, which in turn focuses attention on producing the standards needed for the future.

Three new reference sequences are included in the updated Supplementary Chapter VII D on DNA Barcoding as a tool for Botanical Identification of Herbal Drugs: Anethum graveolens Sowa, Glehnia littoralis F. Schmidt ex Miq and Myristica fragrans Houtt (Nutmeg). Appendix XI V has also been updated to include a worked example for the DNA-based identification of Anethum graveolens Sowa using the nuclear ITS2 region.

Unlicensed Medicines

With this new edition, a further 4 monographs for unlicensed formulations have been added. These individual monographs are characterised by a statement that the products 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.

The General Monograph on Unlicensed Medicines has been expanded to include general requirements for Intraocular Injections as many of these injections are available as unlicensed formulations. Additional guidance on Intraocular Injections has also been included within Supplementary Chapter V F: Aseptic Preparation of Unlicensed Medicines.

Analytical Quality by Design (AQbD)

The British Pharmacopoeia, working with the MHRA and stakeholders, is investigating the application of the Quality by Design concept to analytical methods and the pharmacopoeia. Several AQbD concepts have been practically assessed in conjunction with the British Pharmacopoeia Laboratory, including: risk analysis, Design of Experiments (DoE) and Analytical Target Profiles (ATPs). The Australian Therapeutic Goods Administration have also been a key collaborator in the project. It is anticipated that the outcomes of the work will be published shortly.

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