Problems of Social Hygiene, Public Health and History of MedicineProblems of Social Hygiene, Public Health and History of Medicine0869-866X2412-2106Joint-Stock Company Chicot153410.32687/0869-866X-2024-32-5-892-896НеопределенThe legal status of off-label preparations and legal aspects of their application in The Russian FederationSimonyanRimma Zorikovnarimmasimonyan@mail.ruKarapetyanAlina Slavikovnanot@provid.edBrechkaEgor Alekseevichnot@provid.edThe Federal State Budget Educational Institution of Higher Education “The Kursk State Medical University” of Minzdrav of Russia, 305041, Kursk, Russia271020243252604202526042025Copyright © 2025,2025<p>For many years, the medications outside of instruction (the so-called off-label ones) had no single-valued legal status in the Russian Federation and other countries that entailed number of problems. Most of them had to do with schemes and tactics of treatment of patient, impossibility of proper medical care support, legal responsibility of physician for applying medications outside of attached instruction. The important move in resolving mentioned problem became adoption of the Federal Law On entering changes in the Federal Law On Fundamentals of Health Care of Citizen in The Russian Federation that became first step on the path leading to acquisition by off-label its legal status. The analysis of relevant normative legal acts, the Criminal code of the Russian Federation was carried out. The basic conclusions related to application of medications in medical institutions in Russia, to physician strategy in cases requiring application of of medications outside of instruction were formulated. In case of applying medications outside of instruction without informed voluntary agreement of patient, without utmost necessity, single-handed instead of decision of medical commission or in situations which could be managed without this kind of medications i.e. under unfounded risk the physician can be prosecuted since treatment with off-label medications is considered as insecure according to legislative base currently in force.</p>medication“off-label” medicationlegal liabilitymedical commissionvalid riskemergencyлекарственные препаратыофф-лейбл препаратыюридическая ответственностьврачебная комиссияобоснованный рисккрайняя необходимость1.Shakhzadova A. O., Starinsky V. V., Lisichnikova I. V. Cancer care to the population of Russia in 2022. Siberian Journal of Oncology. 2023;22(5):5–13. doi: 10.21294/1814-4861-2023-22-5-5-13 (in Russian).2.Tucker K., Günther K. P., Kjaersgaard-Andersen P., Lützner J., Kretzer J. P., Nelissen R. G. H. H., Lange T., Zagra L. EFORT recommendations for off-label use, mix & match and mismatch in hip and knee arthroplasty. EFORT Open Rev. 2021;6:985. doi: 10.1302/2058-5241.6.2100803.Somova M. N., Batishcheva G. A. Legal aspects of prescribing off-label drugs. Applied Information Aspects of Medicine. 2016;19:152 (in Russian).4.Agarwal V. Off-label Medication Use: A Double-edged Sword. Indian J. Crit. Care Med. 2021;25:845. doi: 10.5005/jp-journals-10071-239515.Gabay P. G., Bagmet N. A. Use of off-label medicines: responsibility of the medical worker and medical organization. Russian Investigator. 2017;17:21-2 (in Russian).6.Agamov Z. Kh., Burtsev A. K., Moskvicheva L. I. The normative legal regulation of expertise of medical care quality in the Russian Federation. Problemi socialnoi gigieni, zdravookhranenia i istorii meditsini. 2021;29(1):139–43. doi: 10.32687/0869-866X-2021-29-1-139-143 (in Russian).