With the expected revision to USP Chapter <797> and the official release of USP <800>, many health systems are renovating their pharmacies or building new cleanrooms to ensure compliance. USP recently announced its intention to postpone the official date of Chapter <800> from July 1, 2018, to December 1, 2019, in order to align <800> with the upcoming date of the next revision of <797>. The purpose of this change is to provide a unified approach to quality compounding.¹ Although hospitals will undoubtedly welcome the additional time the postponement provides, it is critical that organizations maximize this window to bring their facilities into compliance.

Documentation Area
Maintaining proper documentation is essential to ensuring USP compliance. The Valley Health System utilizes a Web-based quality management and documentation software system to document our processes, including proper environmental monitoring and timely hood cleaning. Other types of documentation required by the state board of pharmacy, such as recording lot numbers and expiration dates, documenting original labels, and recording which staff members compounded medications, are manual processes. Ideally, these tasks will be automated as well sometime in the near future.

Performing Manual Documentation
The well-lit documentation area is located adjacent to the hazardous drug cleanroom pass-through. Here, Valley Health pharmacist Jennifer Lee, RPh, performs manual documentation required by the New Jersey State Board of Pharmacy.

Drug Disposal
USP <800> requires that all hazardous drug waste disposal comply with federal, state, and local regulations and that all personnel who perform routine custodial waste removal in hazardous drug areas be trained in appropriate procedures to protect themselves and the environment from contamination. Valley Health maintains robust drug disposal practices, including disposal of toxic chemotherapy drugs in proper containers. Pharmacy personnel receive training to ensure waste is disposed by waste stream in the correct color-coded bins provided by our waste vendor.

Dedicated Cleaning Product Storage Area
Cleaning products, mops, and other equipment used in the pharmacy should not be shared with other hospital departments. To ensure that pharmacy’s cleaning supplies are not used to clean other areas in the facility, >USP <797> requires that these items be stored in a separate, isolated area. Our renovation consultant helped design a designated cleaning product storage closet, which also houses a humidifier that maintains proper humidity in the pharmacy and cleanrooms.