Compounding pharmacy regulations: experience of the North American pharmaceutical market

Abstract

In order to improve regulation of socially significant type of activity in the field of compounding pharmacy production, the review summarizes the technological, organizational and regulatory requirements for ensuring quality and safety of compounding drugs, as well as historical and technical analysis of the compounding pharmacy regulation in North American pharmaceutical market. The main imperatives are identified and the best practices recommended for implementation into the current state of the pharmaceutical market in the Russian Federation.

Keywords

• drugs compounding
• compounding pharmacy
• extemporaneous drugs
• outsourcing faculties
• 503а
• 503в
• personalized medicine
• regulatory practice