Соціально-історичні передумови криміналізації діянь, що посягають на встановлений порядок обігу лікарських засобів, за кримінальним правом США

The article analysis the codified legislation of the US from the end of the 19th century to the present period is conducted, and precedents that played a decisive role in the criminalization of acts that infringe on the established procedure for drugs circulation in the US are also considered. It has been proven that the adoption of the Pure Food and Drug Act (1906) and Federal Food, Drug, and Cosmetic Act (1938) in USA played an important role in the formation of the criminal law protection of drugs circulation. This law, among other norms, contains §331 «Prohibited acts», the commission of which is a criminal offense (misdemeanors or felonies), which leads to the onset of criminal liability. Along with regulatory legislation, attention of the author is focused on the US Criminal Code (Title 18 of the United States Code) and the Model Penal Code developed by the American Law Institute. The socio-historical prerequisites for the criminalization of acts that encroach on the established procedure for drugs circulation in the USA include the increase in the number of cases of harm to the life and health of consumers as a result of drugs use, as well as the absence until 1962 of the obligation of pharmaceutical manufacturers to prove the safety and effectiveness of their products; the emergence of large pharmaceutical companies that developed rapidly due to economic and technological progress, created and brought to the market a large number of new drugs, which required effective preventive measures to prevent adulterated and misbranded drugs from entering the circulation; the need for legal regulation of pharmaceutical marketing and the establishment of prohibitions against entities that unscrupulously promote drugs and mislead consumers; the absence of an obligation to conduct studies to assess drugs safety and efficacy for children before the entry into force of the Pediatric Regulation; the importance of determining the legal regime for the circulation of prescription and non-prescription drugs, etc.