Past, current and future of legal regulation of drugs compounding in the Russian Federation

Today the activities of compounding pharmacies in terms of the drug compounding and in-pharmacy packaging of approval drugs is considered as a priority social task of the Russian Federation, due to the need to solve problems that are aimed at ensuring the strategic independence of the state from external and internal challenges, as well as threats, widespread introduction of personalized pharmacotherapy methods, opportunities in the field of optimizing the costs of the healthcare system.

The aim of the study was to conduct a historical analysis and comprehensive review of the current state of legal and regulatory framework of the Russian pharmaceutical market in the field of compounding drugs, as well as to develop proposals for improving the regulatory field.

Materials and methods. The following methodological tools – empirical, theoretical, quantitative ones – have been used in the work. In particular, an analysis of a wide range of relevant sources of information was carried out and information was obtained from legal and regulatory framework for the activities of compounding pharmacies in the Russian Federation, which was implemented using a bibliometric method of analysis.

Results. The main elements of the Russian legislation in the field of drug circulation with the aim of a comprehensive understanding of the classification and determination of the role of extemporaneous drugs in the Russian healthcare system, are presented in the article. A historical and technical analysis of the regulatory practice development is consistently presented. The key issues of organizing the pharmaceutical business in the field of compounding and dispensing of drugs on the territory of the Russian Federation have been considered, and current problems that need to be solved when improving the regulatory field, are presented.

Conclusion. The review conducted makes it possible to clarify further actions to improve federal legislation and delegated legislation in the field of circulation of compounded drugs by pharmacy organizations. The work presents recommendations that will contribute to the development of compounding pharmacies in the constituent entities of the Russian Federation.

1. Fundamentals of the formation of a unified harmonized system of legal regulation in the field of circulation of medicinal products manufactured by pharmacy organizations: Monograph / IA Narkevich, VS Fisenko, ZM Golant, DS Yurochkin, DD Mamedov, SE Erdni-Garyaev, AA Leshkevich. St. Petersburg: Media papir; 2023, 292 p. Russian

2. Mamedov DD, Yurochkin DS, Leshkevich AA, Erdni-Garyaev SE, Golant ZM, Narkevich IA. Compounding pharmacy regulations: experience of the North American pharmaceutical market. Farmakoekonomika. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(1):80–6. DOI: 10.17749/2070-4909/farmakoekonomika.2022.155. Russian

3. Petrishche TL. Israel Ionasovich Levinshtein (1883–1972) – pharmacy, pharmaceutical education and science organizer in 1920-s (to the 130th anniversary). Vestnik farmacii=Bulletin of Pharmacy. 2013;4(62):93–8. Russian

4. Higby GJ. The continuing evolution of American pharmacy practice, 1952-2002. J Am Pharm Assoc (Wash). 2002;42(1):12–5. DOI: 10.1331/108658002763538017

5. Minghetti P, Pantano D, Gennari CG, Casiraghi A. Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe. Health Policy. 2014;117(3):328–33. DOI: 10.1016/j.healthpol.2014.07.010

6. Fink JL 3rd. Compounding versus manufacturing in pharmacy practice: a regulatory challenge. J Pharm Pract. 1995;8(3):103–14. DOI: 10.1177/089719009500800304

7. Kudryashov KV, Sankova AA. Problems of the implementation of the constitutional right to receive free medical care for the Russian Federation citizens. Concept. 2019;(9):1–9. DOI: 10.24411/2304-120X-2019-13056. Russian

8. Manturov DV. Industrial policy in the pharmaceutical industry of the Russian Federation. Ekonomicheskaya Politika. 2018;13(2):64–77. Russian

9. Fisenko VS, Farrakhov AZ, Solomatina TV, Alekhin AV, Yurochkin DS, Erdni-Garyaev SE, Mamedov DD, Golant ZM. Monitoring of compounding pharmacies in the Russian Federation. Vestnik Roszdravnadzora. 2023;(3):22–33. Russian

10. Fisenko VS, Solomatina TV, Farrakhov AZ, Yurochkin DS, Mamedov DD, Golant ZM. Analysis of the conditions and development of ways to improve the system of training of pharmaceutical and medical workers aimed at developing the potential of compounding pharmacies in the Russian Federation. Vestnik Roszdravnadzora. 2023;(4):29–42. Russian

11. Narkevich IA, Golant ZM, Yurochkin DS, Leshkevich AA, Erdni-Garyaev SE. Development of proposals for improving the processes of circulation of extemporal drugs and regulation of prescription and production activities of pharmaceutical organizations in the Russian Federation. Remedium. 2021;(4):14–29. DOI: 10.32687/1561-5936-2021-25-4-14-29. Russian

12. Fisenko VS, Farrakhov AZ, Mamedov DD, Yurochkin DS, Golant ZM, Narkevich IA. Review of judicial practice in relation to public procurement of extemporal drugs for 2012–2022. Vestnik Roszdravnadzora. 2023;(5):19–30. Russian

13. Semenov VI, Gavrilova EB, Lyskov NB. Pitfalls of patenting and state authorization of medicines. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(4):43–6. Russian

14. Nesterenko IA. Administrative procedure of state registration of medical products for medical application: concept and structure. Issues of modern jurisprudence: Proceedings of the XXX International Scientific and Practical Conference, No. 10(30). Novosibirsk: SibAK; 2013, p. 6–12. Russian

15. Mironov AN, Digtyar AV, Sakaeva IV, Koshechkin KA. The State registry of medicinal products for medical use — retrospective analysis, current state, and improvement of requirements (analytical review of legislation). Farmakoekonomika. Modern Pharmacoeconomics and Pharmacoepidemiology. 2011;4(2):13–7. Russian

16. Soloviev KS. Differentiation of the production of medicines and pharmaceutical activities. Actual Problems of Russian Law. 2019;(3):134–41. DOI: 10.17803/1994-1471.2019.100.3.134-141. Russian

17. Zhdanova KV. Problems of Russia’s import substitution program of drugs. Russian Foreign Economic Journal. 2015;(10):126–32. Russian

18. Meshkovskiy AP. The role of inspections of pharmaceutical manufacturers for the compliance with Good Manufacturing Practice in the quality assurance of medicinal products. medical technologies. Assessment and Choice. 2016;1(23):81–8. Russian

19. Yakovleva EV. Good Distribution Practice: modernization of the medicines distribution system in Russia. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2018;8(1):36–43. DOI: 10.30895/1991-2919-2018-8-1-36-43. Russian

20. Kovalev VA. The role of Roszdravnadzor in ensuring quality control of medical products and drugs at the federal level during the implementation of the national project “Health”. Problems of healthcare management. 2009;(3):10–3. Russian

21. Gunba AM. Regulation of Distance Sales of Medicinal Products in the Russian Federation. Novelty. Experiment. Traditions (N.Ex.T). 2023;9(1(21):6–12. Russian

22. Drigo AE, Lavrenteva LI, Zheltkevich OV, Korchkova NV. Topical issues of pharmaceutical organization systematization. Remedium. 2020;(11-12):55–60. DOI: 10.21518/1561-5936-2020-10-55-60

23. Koshida I, Kubota K, Yamashita M, Katayanagi H, Noda K, Terada H, Yoshioka S, Sekine N, Kameda T, Terada K. [Role of pharmaceutical company pharmacist in provision of drug information for cancer chemotherapy]. Gan To Kagaku Ryoho. 2009;36(4):687–91. Japanese

24. Titov DS, Yakusheva EN, Novikova YuE, Maystrenko MA, Uliteonok EE. Changes in the Procedure of Issuing and Circulation of Prescriptions in the Russian Federation. I.P. Pavlov Russian Medical Biological Herald. 2022;30(3):423–30. DOI: 10.17816/PAVLOVJ89996. Russian

25. Kabanova IA, Lebedev DA. The procedure for prescribing medications: all changes. Modern problems of natural sciences and pharmacy: Proceedings of the All-Russian Scientific Conference; May 16–20, 2022). Yoshkar-Ola: Mari State University; 2022. Issue. 11, pp. 318–21. Russian

26. Vasilyeva AV, Filippova TL. Changes in the procedure for dispensing medicines in 2022. Modern problems of natural sciences and pharmacy: Proceedings of the All-Russian Scientific Conference; May 16–20, 2022). Yoshkar-Ola: Mari State University; 2022. Issue. 11, p. 292–5. Russian

27. Gavrilyuk RV, Nosanenko GYu, Gavrilyuk AR. The right of citizens to health care. Intellectual potential of an educational organization and social and economic development of the region: Proceedings of the international scientific-practical conference of the Academy of MUBiNT. Yaroslavl: Educational organization of higher education (private institution) “International Academy of Business and New Technologies (MUBiNT)”, 2018;30–32. Russian

28. Kapralova EV, Sergeeva ES. Constitutional right of citizens to health care: its content and legislative provision. Vestnik of Lobachevsky University of Nizhni Novgorod. 2011;(1):295–302. Russian

29. Rudenkov IV. Nikolay Semashko the first soviet people’s commissar of health – the founder of health care system of obraztsov. Experimental and Clinical Gastroenterology. 2015;2 (114):119–23. Russian

30. Kopytin DA. State regulation of prices on medicines: search for balance. Remedium. 2018;(1-2):8–14. DOI: 10.21518/1561-5936-2017-12-8-14. Russian

31. Kuryaseva YuS. Fond obyazatel’nogo medicinskogo strahovaniya-garant polucheniya medicinskoj pomoshchi naseleniem Rossii [The Compulsory Medical Insurance Fund is a guarantor of medical care for the population of Russia]. Derzhavin Readings: Proceedings of the XXIV All-Russian Scientific Conference (Tambov, April 24, 2019). YaYu Radyukova editor. State University named after G.R. Derzhavina (Tambov); 2019, pp. 52–61. Russian

32. Lazarova LB, Dadyanova MS. Compulsory medical insurance funds, their role in the financing of health care costs. Modern problems of science and education. 2015;(2-2):457–7. Russian

33. Akafeva T.I., Zemlyanova M.A. Pharmaceutical market analysis of the Russian Federation. Bulletin of Perm University. Biology. 2013;(1):63–6. Russian

34. Karpov OE, Nikitenko DN, Tretjakov VV, Nushtaeva EM. Drug provision. Procurement of drugs. Examination of contract performance results. Claim work. Execution of the contract. Bulletin of Pirogov National Medical & Surgical Center. 2019;14(2):75–81. DOI: 10.25881/BPNMSC.2019.40.15.017. Russian

35. Mokrysheva NG, Melnichenko GA. Personalized medicine – stages of concept formation and ways of its practical implementation. Russian Journal for Personalized Medicine. 2021;1(1):43–58.

36. Batchelor HK, Marriott JF. Paediatric pharmacokinetics: key considerations. Br J Clin Pharmacol. 2015;79(3):395–404. DOI: 10.1111/bcp.12267

37. Viergever RF, Rademaker CM, Ghersi D. Pharmacokinetic research in children: an analysis of registered records of clinical trials. BMJ Open. 2011;1(1):e000221. DOI: 10.1136/bmjopen-2011-000221

38. Kuhach VV. Pharmacy manufacture and quality control of medicinal preparations abroad. Vestnik farmacii=Bulletin of Pharmacy. 2021; 2 (92):64–79. DOI: 10.52540/2074-9457.2021.2.64. Russian

39. Meshkovskiy AP, Aladysheva GI, Piatigorskaya NV, Sapozhnikova EA, Pichugina VV. The 50th anniversary of GMP: The history of the GMP rule (first message). Remedium. 2013;(2): 32–9. Russian

40. Prepyalov A. Implementation of GMP standards in Russian enterprises: The other side of the medal. Remedium. 2010;(5):34–7. Russian

41. Fedotov AE. GMP v Rossii – byt’! [GMP in Russia – to be!]. Medical alphabet. 2012;4(22):32–4. Russian

42. Trofimova EO. Transition to GMP standards. Remedium. 2014;(3):25–7. Russian

43. Basevich AV, Kaukhova IE, Kodash AA, Bitkina TA, Smirnova EM, Stepchenkov VI. Comparison of requirements of Annex 1 to the rules of Good Manufacturing Practice of the Eurasian Economic Union and Requirements of the draft Annex 1 GMP PIC/S. Pharmacy Formulas. 2020;2(2):8–19. DOI: 10.17816/phf33976

44. Odabashyan A. The Federal Law “On circulation of medicines”: key points. Remedium. 2010;(6):44–7. Russian

45. Velts NYu, Alyautdin RN, Kazakov AS, Bukatina TM, Darmostukova MA. The rules of good laboratory practice. Safety and Risk of Pharmacotherapy. 2016;(1):28–32. Russian

46. Shevchenko A.B. The introduction of the GCP – Good Clinical Practice. J “Chief medical officer”. 2018;(1):33–6. Russian

47. Chernobrovkina AE. Features and benefits of centralized cytostatic dilution in oncological clinical research center. Medline.ru. 2018;(19): 1245–53. Russian

48. Ismagilov AKh, Sadygova SN, Kotkov PA, Mikhaylichenko VYu, Sigua BV. Treatment strategy for patients with decaying breast cancer. Oncology Bulletin of the Volga region. 2023;14(1(53):86–91. DOI: 10.32000/2078-1466-2023-1-86-91. Russian

49. Karimova AA, Chusovitina AO, Petkau VV. The possibilities of optimizing the costs of drug provision to patients due to the centralized dilution of antitumor drugs. Medical & pharmaceutical journal “Pulse”. 2023;25(7):26–32. DOI: 10.26787/nydha-2686-6838-2023-25-7-6-26-32. Russian

50. Mironov AN. Main areas of activity and development prospects of the federal state budgetary institution “Scientific center for expertise of medical application products” of the Ministry of Health and Social Development of the Russian Federation. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2011;(1):4–10. Russian