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What is USP 797?

USP 797 is the set of standards pharmacies are to follow when compounding sterile drug products. It covers both nonhazardous and hazardous drugs and deals primarily with protecting staff, facilities, and sterile compounds from contamination. USP 797 helps ensure patient safety and minimizes the risks connected with compounding medications, including improper dosage, infection, and contamination. LicenseTrak’s compliance and accreditation modules can help you achieve and maintain compliance with current USP 797 and other USP standards.

Ensuring Drugs Are Free From Contaminates

The USP 797 standard, if followed properly, helps guarantee that patients do not receive contaminated drugs. It applies to all pharmacies that manufacture compounded sterile preparations. These pharmacies include nuclear or radio pharmacies; pharmacies inside hospitals, operating rooms, and chemotherapy units; and compounding pharmacies. The ultimate aim of USP 797 is to protect patients from harm resulting from variations in the strength of ingredients, physical and chemical contaminants, and microbial contamination.

Training Requirements

The personnel training required for producing compounded sterile preparations (CSPs) is one of the major focus areas covered in the USP 797 standard. In order to keep CSPs within an ISO Class V environment, pharmacy professionals must receive training in core competencies and best practices associated with CSPs.

For example, within an ISO Class V environment, the use of Personal Protective Equipment (PPE) is required at all times. Personnel must be trained on the rules and standards concerning PPE. This includes removing all cosmetics, personal outer garments, jewelry, and piercings before putting on PPE. Based on the particular environment, PPE may include facemasks, head and facial hair covers, shoe covers or dedicated shoes, and eye shields, with a gown worn by personnel after cleaning their hands. The last step in wearing PPE is putting on powder-free, sterile gloves.

Risk Determination

USP 797 gives the standards for the three risk levels for CSPs – low, medium, and high. These standards are designed to be a guide – and not necessarily comprehensive – for the determination of a CSP risk level in order to create the right procedures and practices for handling CSPs.

To learn about how LicenseTrak can help you achieve compliance with the USP 797 guidelines, call us today at (480) 500-6236 or fill out our contact form.