What is the Origin of USP Compounding Standards?

The United States Pharmacopeia is a non-governmental, non-profit organization that has been setting public standards for the quality of medicines, food ingredients, and dietary supplements since 1820. The formalization of specific compounding standards became necessary to regulate the specialized practice of preparing individualized medications outside of traditional commercial manufacturing.

What is the Mechanism of USP Compounding Standards?

The mechanism of the standards involves rigorous requirements for facility design, personnel training, equipment calibration, component selection, and quality assurance testing of the final compounded product. By mandating documented procedures and environmental controls, the standards minimize the risk of microbial contamination, pyrogen presence, and errors in calculating ingredient potency, thereby ensuring the compounded hormone preparation is safe and meets the exact specifications prescribed by the clinician.

USP Compounding Standards ∞ Area

USP Compounding Standards

Meaning

USP Compounding Standards are the official, legally recognized quality and practice standards for the preparation of compounded sterile and nonsterile medications, established by the United States Pharmacopeia (USP). These standards, which include USP for nonsterile preparations and USP for sterile preparations, ensure the quality, purity, strength, and consistency of compounded medications, including customized bioidentical hormone formulations. Adherence to these guidelines is mandatory for licensed compounding pharmacies to ensure patient safety and therapeutic efficacy.