WHAT IS USP?
USP sets standards for the identity, strength, quality and purity of medicines.
United States Pharmacopeia (USP) is a nonprofit science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards.These standards are enforced by the U.S. Food & Drug Administration (FDA).
WHAT ARE USP 797 and USP 800?
Two essential USP standards related to cleanrooms are USP 797 and USP 800. USP 797 standards are enforced for the general protection of sterile compounds and to keep spaces free of contamination. USP 797 was first enforced in 2004, with the latest revision being published in 2008. Future revisions will harmonize USP 797 with USP 800.
USP 800 standards include controls for the protection of workers and environments against hazardous drug compounds. USP 800 was developed in response to reports of adverse effects in healthcare personnel from exposure to hazardous drugs. According to the Centers for Disease Control and Prevention (CDC), an estimated 8 million US healthcare workers are exposed to hazardous drugs each year.
USP 800 standards became official on December 1, 2019. The latest revision was published in June 2020.
USP 800 is informational only and does not contain any mandatory testing or assays unless otherwise specified by regulatory and enforcement bodies. USP 800 applies only to the handling of hazardous drugs and is intended to be referenced within USP 797 for application to compounding. When this occurs, USP 800 is applicable only during compounding and not during administering and dispensing final dosage forms.
Subzero Engineering can make your cleanroom compliant
USP 800 Updates from June 2020
Several upgrades to existing and new compounding spaces are required to meet the latest version of USP 800. Our team of engineers understands the newest regulations and can assist in making your cleanroom meet these important requirements.