USP-Compliant Outpatient Center Renovation Part III

November 2017 - Vol.14 No. 11 - Page #34
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.

The Valley Health System renovated its pharmacy and built a new cleanroom to achieve USP <797> and <800> compliance; this process was described in the July and September issues of Pharmacy Purchasing & Products. USP-Compliant Outpatient Center Renovation Parts I and II focus on important construction elements of The Valley Health System’s Luckow Pavilion outpatient center, including the anteroom, hazardous and nonhazardous cleanrooms, and drug storage areas. As part of the renovation process, it is also important to consider pharmacy logistics, including proper documentation, cleaning requirements, and drug disposal.

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.

¬ĀPharmacy and Cleanroom Humidifier
Although the current iteration of <797> does not specify humidity parameters for the cleanroom, this may be clarified in the next revision. Garbed personnel working in the cleanroom must be comfortable and work in temperatures that do not facilitate perspiration, since more particles and microorganisms are shed when sweating occurs. Higher humidity supports microbial growth, while too little humidity causes problems with static. Either extreme can affect the comfort of health care workers and impact their ability to work effectively.2


  • Consultant: Erik Kastango, Clinical IQ, LLC
  • Casework: R.C. Smith/MMI Systems
  • CSTDs: ICU Medical, Inc
  • BSCs: The Baker Company
  • Cleanroom Controls: Designed by Rodney B. Strohl, Associate AIA, r4 Architects
  • Intercom: Aiphone Corporation
  • Medical-Grade Refrigerators: Follett LLC
  • Wireless Temperature Monitoring System: Primex Wireless, Inc
  • Documentation Software: Pharmacy OneSource's Simplifi 797
  • Pharmaceutical Waste Management Services: Stericycle, Inc


  1. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. Accessed October 5, 2017.
  2. Comment by Eric Kastango. Pharmacy OneSource. Accessed October 5, 2017.

Ronald J. Krych, RPh, MPA, is the director of pharmacy at The Valley Hospital in Ridgewood, New Jersey.

Carlo Lupano, RPh, MBA, CCP, FASHP, is the pharmacy manager for ambulatory services at The Valley Hospital in Ridgewood, New Jersey.


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