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United States Pharmacopeia (USP) standards can be confusing, with nuances that are hard to understand.
Next year, hospitals and pharmacies will need to adjust to revised standards. Fortunately, ESD understands these revised standards as they apply to the required clean room environments and is already providing cost-effective engineering designs to Chicago-area hospitals to lead them toward compliance.
According to the USP website, USP 797 is widely agreed to improve the safety of the compounding environment and the drugs produced in that environment. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies.
Though it’s been in effect for a decade, it really hasn’t been enforced. A revision will be adopted in December 2019 which will do a better job of defining in engineering terms what’s necessary for the pharmaceutical clean rooms. At the same time, USP 800 will be implemented, which looks to minimize pharmacists’ exposure to hazardous drugs when the drugs are being compounded in addition to creating a sterile environment in which to work.
As a result, hospitals will have to evaluate their clean rooms for compliance and may have to retrofit/upgrade their rooms to be in compliance with the soon-to-be-adopted guidelines. We have started to evaluate the existing pharmaceutical clean rooms at the various Northwestern Memorial Hospital and Presence Health Hospital sites, and have either developed or started to develop construction drawings for the necessary mechanical, electrical, plumbing, fire protection and technology work to steer hospitals toward compliance. Hospitals will need to comply with the USP 797 and 800 standards or they risk reimbursement funding from Medicare and Medicaid along with losing their pharmacy license.
ESD enjoys long-term relationships with many Chicagoland hospitals and knows their infrastructure well. We are pleased to help them comply with these important revised standards.