Regulation of Compounding by the Food and Drug Administration: A Tale of 2 Circuits

Federal regulation of the traditional art of pharmacy practice compounding is an unsettled area of the law and the profession. For many years, the Food and Drug Administration (FDA) was not interested in compounding. Attempts to regulate by FDA and Congress have caused difficulty within the profession, litigation with inconsistent results, and an unsettled state of affairs. There are a number of possible resolutions