Identification of the nomenclature of gases for medical use and justification of proposals for regulating their circulation

The most important medicinal gaseous forms include medical gases: medical oxygen, nitrous oxide, xenon, which are listed in the State Register of Medicinal Products of the Russian Federation. At the same time, other gases are used in domestic health care - carbon dioxide, nitrogen, argon, helium, nitric oxide, krypton, radon, air, etc. According to the requirements of the Federal Law «On Circulation of Medicines», the regulatory documentation for the drug should be based on the requirements a similar pharmacopoeial monograph to this medicinal product, as well as a general pharmacopoeial monograph on the dosage form in which the medicinal product is presented. The article presents data indicating that the requirements for the production and quality of most gases used in domestic medical and pharmaceutical practice are not properly regulated. Formulated proposals, the implementation of which will not only create the conditions to facilitate the introduction of new medical gases into health care and harmonize their quality indicators with leading world pharmacopoeias, but also update the standards and procedures of medical care.

medical gases, medicine, dosage form, pharmacopoeial monograph, regulatory documentation, algorithm for the introduction into circulation of new medical gases