USP Compounding Standards

USP Compounding Standards

There are many regulations for compounding because when managed improperly, pharmaceutical compounding can cause serious harm to patients. The United States Pharmacopeia (USP) sets standards for compounding which states and/or federal agencies may then choose to enforce. In Iowa, the Board of Pharmacy endorses USP within their regulations on compounding and handling of hazardous medications. Iowa regulations for handling hazardous drugs apply to all pharmacy settings, if your pharmacy supplies and handles even one hazardous drug.

Chapters of Interest:

Chapter <795> on Pharmaceutical Compounding of Nonsterile Preparations
USP <795> describes requirements for the compounding process, facilities, equipment, components, documentation quality controls and training to promote patient safety.

Chapter <797> on Pharmaceutical Compounding of Sterile Preparations
USP <797> helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. It describes a number of requirements,
including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations.

Chapter <800> on Hazardous Drugs, Handling in Healthcare Settings
USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

Chapter <825> on Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging
USP<825> provides the minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities.