An Overview of Nonsterile Compounding Regulations, Standards, and Guidelines

Course overview

Compounded nonsterile medications play a critical role in meeting patient-specific therapeutic needs. However, these processes also introduce risks related to contamination, dosing variability, and preparation quality. Such risks have led to the development of a complex regulatory framework involving federal and state agencies, as well as standardized guidance from organizations such as the United States Pharmacopeia (USP). This continuing education activity provides an overview of the key legislation, regulatory bodies, and standards governing nonsterile compounding, including the Federal Food, Drug, and Cosmetic Act, the Drug Quality and Security Act, and USP Chapters 795 and 800. It also reviews the roles of oversight organizations, including state boards of pharmacy, the FDA, OSHA, and NIOSH. Understanding these regulations and standards is essential to ensure compliance, minimize compounding-related risks, and promote patient safety in nonsterile compounding practice.