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What is the Difference Between USP 797 and USP 800?

United States Pharmacopeia (USP) is a collection of drug information published on an annual basis that puts forth physical and written standards for food ingredients, medicines, dietary supplements, and other ingredients used by manufacturers and regulatory organizations. The USP information is intended to help ensure that these types of products are identified properly as to their purity, strength, consistency, and quality. We offer LicenseTrak compliant software that enables you to efficiently comply with the USP 797 and 800 standards.

USP 797

The USP 797 Pharmaceutical Compounding – Sterile Preparations standard was instituted in 2014 to help ensure safety and quality for compounded products. The standard covers various factors including humidity, HVAC systems, pressure and temperature factors, clean room requirements, gowning requirements, personal training, and additional equipment requirements. It also covers testing procedures, standard operating procedures, approved cleaning solutions, and equipment maintenance specifications.

If adhered to properly, the USP 797 helps ensure patients do not receive contaminated drugs. This standard applies to all pharmacies that produce compounded sterile preparations, pharmacies such as chemotherapy units, operating rooms, radio or nuclear pharmacies, and pharmacies inside hospitals. The goal the standard is to protect the health of patients from particular harms stemming from strength of ingredient variations, chemical and physical contaminants, microbial contamination, and bacterial endotoxins.

USP 800

While the patient is the focus of protection with the USP 797 standard related to sterile compounding concerns, the USP 800 focuses on protecting healthcare workers who interact with hazardous drugs.

Chemotherapy related drugs of the most hazardous, but other drugs of concern are those that pose a reproductive risk to women attempting to conceive, already pregnant, or breast-feeding. More than 260 drugs are considered hazardous. The USP 800 not only addresses pharmacy related issues, it also covers transporters, nurses, and others.

The USP 800 covers and explains the requirements for decontamination, spill control, cleaning, deactivation, facility and engineering controls, medical surveillance, and any medical personnel handling or contacting hazardous drugs.

For information about how our LicenseTrak software can enable you to effectively obtain and maintain compliance with the USP 797 and 800 standards, call us today at (480) 500-6236 or complete our contact form.