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 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.

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