A Compounding Problem: Pharmaceutical Importation and Drug Production in the United States

Abstract Drug shortages are not a new phenomenon in the United States. Current policies and regulations can be improved to better utilize drug compounding facilities to ensure patient safety, provide practical standards for the interstate market, and focus on patient needs in the marketplace. Adjustments in regulation and incentives such as performance-based bonuses are necessary to encourage registration for 503B outsourcing facilities and address shortages for less profitable drugs. Diversity of drug supply sources is also of the utmost importance to secure the trade of essential medicines in times of drug shortages through a globally diverse supply chain along with a strong system for domestic drug manufacturing and compounding facilities.