An Overview of Nonsterile Compounding Regulations, Standards and Guidelines

Course overview

Compounding medications requires specialized training and knowledge. Changing a medication formulation can affect its stability and effectiveness. Compounded medications provide important treatment options for patients with specific clinical needs not met by existing products. Risks, such as bacterial or fungal contamination and calculation errors leading to under- or over-dosing, are possible with compounding. For quality and safety, several pieces of legislation define the oversight of compounding. State boards of pharmacy and the Food and Drug Administration share oversight of compounding with several additional federal agencies. The United States Pharmacopeia (USP) publishes standards for compounding to ensure patient safety. USP Chapters 795 and 800 apply to the compounding of nonsterile preparations. Knowledge of these standards and adherence to them are crucial to minimizing common errors and improving patient safety.