Will your Pharmacy be USP 800 Ready?

The U.S. Pharmacopeial Convention (USP) Chapter 800 related to handling of hazardous drugs in healthcare settings will officially take effect on December 1, 2019. Chapter 800 will supersede the current Chapter 797 requirements for compounding of hazardous drugs. Several of the requirements in Chapter 800 may prove challenging to meet for facilities with aging mechanical infrastructures.

Applicability to Healthcare Facilities

While the state requirements for compliance with both USP Chapters 797 and 800 vary from state to state, federal regulations require healthcare facilities to comply with Chapter 797 currently and Chapter 800 by July 1, 2018. The Center for Medicare & Medicaid Services (CMS) issued an updated State Operations Manual on October 30, 2015 instructing CMS field inspectors to enforce the USP requirements. Furthermore, the Joint Commission currently reviews for conformance to Chapter 797 and has agreed to enforce Chapter 800 on December 1, 2019.

Impact to Facility HVAC Infrastructure

The HVAC requirements for Chapter 800 are similar to those of Chapter 797 however requirements that used words such as “should” in Chapter 797 now read “shall” in Chapter 800 providing no flexibility in meeting the requirements. One significant impact to HVAC infrastructure is that all Primary Engineering Controls (PEC) used for sterile compounding of hazardous drugs must be vented to the outside. Previously, PEC’s could be recirculated in the sterile compounding prep room if HEPA filtration was utilized.

Steps to Ensure Compliance

Many healthcare facility pharmacies are currently undergoing “gap analysis” studies to identify compliance issues with both USP Chapters 797 and 800. These studies are focusing on both facilities and the actual processes implemented by the pharmacy team in compounding drugs. While these gap analysis studies typically identify HVAC deficiencies, they rarely go as far as recommending an engineering solution to remedy the gaps into compliance. We recommend completion of an engineering assessment, in conjunction with the pharmacy’s gap analysis, to identify solutions to bring HVAC systems into compliance. This allows facility departments to budget and schedule any required modifications prior to the December 1, 2019 deadline.

If you need assistance reviewing your HVAC infrastructure for compliance with USP Chapters 797 and 800, Barton Associates can help you. Please contact Michael Jacobs, PE at (717) 845-7654 or maj@ba-inc.com.