Trends in Outsourced Compounding

June 2016 - Vol.13 No. 6 - Page #18
Category: Outsourced Compounding Services (503B)

Regulators have focused significant attention on outsourced compounding providers in recent years, with new FDA regulations and increasingly common inspections by both the FDA and state boards of pharmacy. The goal of this additional scrutiny is to ensure patients receive safe and effective products. While the number of pharmacy directors conducting visits to their outsourced compounders also has increased, this remains a minority practice. Likewise, a surprising number of pharmacy directors are unaware whether their outsourced compounder has been inspected, meaning they have not reviewed any resulting 483s or queried the vendor as to how they responded to inspection findings.

For more data on outsourced compounding trends, see


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