Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia
The aim of the work was to analyze the current regulatory legal framework governing the manufacture of drugs in pharmacies, and a comprehensive review of the current state of their manufacture; a disclosure of problems and search for the ways to improve the sphere of circulation of extemporaneously...
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| Format: | Article |
| Language: | Russian |
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Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute
2025-06-01
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| Series: | Фармация и фармакология (Пятигорск) |
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| Online Access: | https://www.pharmpharm.ru/jour/article/view/1664 |
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| author | V. V. Ryazhenov E. A. Maksimkina V. S. Fisenko A. V. Alekhin V. V. Tarasov M. G. Raisyan E. R. Zakharochkina K. A. Chizhov R. Yu. Garankina |
| author_facet | V. V. Ryazhenov E. A. Maksimkina V. S. Fisenko A. V. Alekhin V. V. Tarasov M. G. Raisyan E. R. Zakharochkina K. A. Chizhov R. Yu. Garankina |
| author_sort | V. V. Ryazhenov |
| collection | DOAJ |
| description | The aim of the work was to analyze the current regulatory legal framework governing the manufacture of drugs in pharmacies, and a comprehensive review of the current state of their manufacture; a disclosure of problems and search for the ways to improve the sphere of circulation of extemporaneously compounded medicines (ECMs).Materials and methods. The national legislation of the Russian Federation and the regulatory framework of the medicines common market of the Eurasian Economic Union in the field of an extemporaneous drugs circulation formed a regulatory base of the work. To collect and analyze the information data, the materials presented on the official websites of the Ministry of Health of Russia, the Ministry of Industry and Trade of Russia have been used. The results of the scientific publications for the previous 10 years (2014–2024) have also been analyzed.Results. The article deals with the current state issues of the drug products manufactured in pharmacies, in the sphere of circulation. The analysis of the legislative base on ECMs has been carried out, the problems of the normative legal regulation of the pharmacy drugs manufacturing have been identified. The introduction of new relevant concepts into Federal Law No. 61-FZ “On Circulation of Medicines” — “extemporaneous drug products”, “extemporaneous manufacturing”, “extemporaneous production” — has been proposed. The authors’ definition of the “pharmaceutical sovereignty” concept was given in the course of the study. Based on the results of the study, the possibilities and ways of improving the mechanisms of the state regulation of the drugs extemporaneous manufacturing in the current political and economic conditions have been identified.Conclusion. The operational management and systematization of the regulatory legal framework of the ECMs circulation sphere based on the regulatory science is the most important factor in increasing the affordable, effective, personalized pharmaceutical care. An important element of the mobilization model of the economy is strengthening of the state regulation, development of the domestic production capacities and technologies, including taking into account extemporaneous manufacturing of drugs and small-scale production. |
| format | Article |
| id | doaj-art-e4fd31d07217404abc41dce9594fc250 |
| institution | Kabale University |
| issn | 2307-9266 2413-2241 |
| language | Russian |
| publishDate | 2025-06-01 |
| publisher | Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute |
| record_format | Article |
| series | Фармация и фармакология (Пятигорск) |
| spelling | doaj-art-e4fd31d07217404abc41dce9594fc2502025-08-20T03:44:21ZrusVolgograd State Medical University, Pyatigorsk Medical and Pharmaceutical InstituteФармация и фармакология (Пятигорск)2307-92662413-22412025-06-0112532433710.19163/2307-9266-2024-12-5-324-337526Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of RussiaV. V. Ryazhenov0E. A. Maksimkina1V. S. Fisenko2A. V. Alekhin3V. V. Tarasov4M. G. Raisyan5E. R. Zakharochkina6K. A. Chizhov7R. Yu. Garankina8Sechenov First Moscow State Medical University (Sechenov University).Sechenov First Moscow State Medical University (Sechenov University).Ministry of Health of the Russian Federation1. Limited Liability Company “UK Pharmaclone Group”. 2. Bauman Moscow State Technical University.Sechenov First Moscow State Medical University (Sechenov University).Sechenov First Moscow State Medical University (Sechenov University).Sechenov First Moscow State Medical University (Sechenov University).Sechenov First Moscow State Medical University (Sechenov University).Sechenov First Moscow State Medical University (Sechenov University).The aim of the work was to analyze the current regulatory legal framework governing the manufacture of drugs in pharmacies, and a comprehensive review of the current state of their manufacture; a disclosure of problems and search for the ways to improve the sphere of circulation of extemporaneously compounded medicines (ECMs).Materials and methods. The national legislation of the Russian Federation and the regulatory framework of the medicines common market of the Eurasian Economic Union in the field of an extemporaneous drugs circulation formed a regulatory base of the work. To collect and analyze the information data, the materials presented on the official websites of the Ministry of Health of Russia, the Ministry of Industry and Trade of Russia have been used. The results of the scientific publications for the previous 10 years (2014–2024) have also been analyzed.Results. The article deals with the current state issues of the drug products manufactured in pharmacies, in the sphere of circulation. The analysis of the legislative base on ECMs has been carried out, the problems of the normative legal regulation of the pharmacy drugs manufacturing have been identified. The introduction of new relevant concepts into Federal Law No. 61-FZ “On Circulation of Medicines” — “extemporaneous drug products”, “extemporaneous manufacturing”, “extemporaneous production” — has been proposed. The authors’ definition of the “pharmaceutical sovereignty” concept was given in the course of the study. Based on the results of the study, the possibilities and ways of improving the mechanisms of the state regulation of the drugs extemporaneous manufacturing in the current political and economic conditions have been identified.Conclusion. The operational management and systematization of the regulatory legal framework of the ECMs circulation sphere based on the regulatory science is the most important factor in increasing the affordable, effective, personalized pharmaceutical care. An important element of the mobilization model of the economy is strengthening of the state regulation, development of the domestic production capacities and technologies, including taking into account extemporaneous manufacturing of drugs and small-scale production.https://www.pharmpharm.ru/jour/article/view/1664extemporaneously compounded medicinesdrugs manufacturingextemporaneous formulationsextemporal productionpharmacydrug supplypharmaceutical sovereigntydrug sovereignty. |
| spellingShingle | V. V. Ryazhenov E. A. Maksimkina V. S. Fisenko A. V. Alekhin V. V. Tarasov M. G. Raisyan E. R. Zakharochkina K. A. Chizhov R. Yu. Garankina Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia Фармация и фармакология (Пятигорск) extemporaneously compounded medicines drugs manufacturing extemporaneous formulations extemporal production pharmacy drug supply pharmaceutical sovereignty drug sovereignty. |
| title | Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia |
| title_full | Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia |
| title_fullStr | Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia |
| title_full_unstemmed | Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia |
| title_short | Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia |
| title_sort | regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of russia |
| topic | extemporaneously compounded medicines drugs manufacturing extemporaneous formulations extemporal production pharmacy drug supply pharmaceutical sovereignty drug sovereignty. |
| url | https://www.pharmpharm.ru/jour/article/view/1664 |
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