Millions of prescriptions are compounded by pharmacists, nurses and doctors each year in the United States to meet the unique needs of patients who otherwise may not have access to the required medicine in the right concentration or dosage. Understanding of the inherent risks of compounding and incorporating established USP standards into everyday practices is essential for patient and staff safety.
New regulations set forth by the United States Pharmacopeia’s USP 797 and USP 800 were recently established and adopted to include workroom air pressure requirements, specialized work flows, isolation measures and sterility conditions related to compounding. What do these new standards involve and what do they mean for healthcare organizations?
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 preparation.
USP 800 provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. USP 800 deals with product transport, product storage, compounding, preparation, and administration of products.
The regulations exact enforcement fluctuates by state, however current USP mandates require that compliant facilities and practices must be implemented by December 31, 2019. These new statutes affect public and private sector pharmacies and will require, in many cases, substantial capital investments in infrastructure and personnel to meet the new regulations.