Pharmacy Compounding Regulationin the United Kingdom

Рharmaceutical practice of advanced regulatory healthcare systems places high demands on the quality and safety of medicines, especially on compounding drugs by pharmacies. The United Kingdom is one of the countries with a developed system of legal regulation of drug treatment, which is based on the principles of effective management and is aimed not only at following formal procedures, but also at ensuring the ultimate goals, namely patient safety, quality of manufactured drugs and effectiveness of pharmaceutical processes.

The aim. To identify the key elements of the British system of regulation of drugs compounding by pharmacies, to assess their applicability in other legal systems and to form promising directions for improving Russian legislation.

Materials and methods. The study based on analysis of the UK regulatory framework governing circulation of medicines, as well as documents from government agencies and regulatory agencies. Comparative legal, content analysis, a systematic approach, analytical and empirical methods were used.

Results. Pharmaceutical activity is regulated by the General Pharmaceutical Council, which develops standards and guidelines that are binding. The production of medicines is carried out within the framework of a licensing system and is subject to the principles of good practices. The British system is based on a model of effective regulation, where the emphasis is on achieving targeted results rather than strictly following procedures. There is a separate license for the production of special drugs designed for a specific patient.

Conclusion. Legal and regulatory systems for manufacturing of medicines in the UK demonstrates high degree of harmonization with international standards, including GMP and PIC/S recommendations. It can serve as a model for improving legislation in other countries, including the Russian Federation, in terms of developing and implementing a unified system of regulatory support for manufacturing of medicines, including introduction of adapted GMP requirements into of pharmaceutical medicine manufacturing practice — good practices for the preparation of medicinal products.

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