Reports of drug shortages surfaced in news outlets in 2010. By 2011, the number of drug shortages peaked. Of the 251 problem drugs published by the FDA, 183 involved sterile injectable products (FDA/ CDER Drug Shortage Program). While many of the shortages were related to the inherent manufacturing complexity and daunting quality requirements of parenteral products, the FDA has cited delays in receiving raw materials and components from suppliers as a siginificant contributing factor. Many of these supplier shortages are related to the challenges of producing high purity exipients which has resulted in an under capacity to the market. Due to efforts by FDA and CDER, reports of drug shortage reports started to wane by 2013, but drug shortages still persist today, particularly in the sterile injectable products sector.

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