Many healthcare facilities have yet to complete the evaluation, planning, and construction process to ensure their pharmacy departments are compliant with the new United States Pharmacopeial General Chapter 800 “Hazardous Drugs – Handling in Healthcare Settings,” generally known as USP 800. The guideline goes into effect Dec. 1 and is intended to protect healthcare workers and patients from harm associated with exposure to hazardous drugs. Providers and their design partners still in the process of updating their pharmacy environments—or those still figuring out how to get started—can tap into the knowledge gained from completed projects to help ensure a smooth and timely completion. Here are some valuable lessons that design consulting firm IMEG Corp. (Rock Island, Ill.) has learned from its work on several recent USP 800 projects.

Lesson 1: Understand a facility’s processes and compounding techniques
It’s important for the design and construction team to engage with pharmacy staff early in the planning stages to understand how the staff receives, transfers, stores, delivers, and administers hazardous drugs (HDs) to patients. It’s critical that the project team also understands what techniques the pharmacy staff will use for hazardous drug compounding, including if they’ll be performing nonsterile compounding, sterile compounding, or both, and how soon medications are administered following this process.

Nonsterile compounding is a safe and common method that refers to the act of preparing a drug that’s intended to be administered orally or topically. Sterile compounding, however, is utilized for drugs that will be directly injected into the patient. These types of drugs carry a risk of infection because they’re administered through the skin, so the compounding process ensures they are fully sterile and free from contamination.

After the design team members identify which compounding methods are being utilized, they will need to address three major considerations, including hazardous drug storage, pharmacy layout, and current and future hood needs.

Storage. To prevent cross contamination and potential staff exposure to HDs, USP 800 mandates that hazardous drugs are stored in a negative pressure room with a minimum of 12 air changes per hour. Options to address this are storing the HDs within a hazardous drug compounding room or providing a dedicated storage room. Often, a dedicated storage room is the preferred solution because it allows for a location to unbox and store both HDs and non-HDs—but this does require space allocation and planning for an additional room.

However, within the new guidelines is another requirement that states that while sterile and nonsterile hazardous drugs may be stored together, drugs used for nonsterile compounding should not be stored in areas designated for sterile compounding (to minimize traffic into the sterile compounding area). This means that if a pharmacy will be conducting both nonsterile and sterile compounding, the pharmacy will need a dedicated hazardous drug storage room.

Compounding. USP 800 eliminates the low volume exemption found in USP 797, which allowed the placement of a biological safety cabinet in a non-negative pressure room for facilities that prepare a low volume of hazardous drugs. Instead, all hazardous drug compounding must now occur in a separate, designated compounding area.

The new guideline does allow for compounding to occur in a containment segregated compounding area, called a C-SCA, for applications where only low- and medium-risk preparations are compounded and the beyond use date (BUD), which is the time after which a compounded sterile preparation may not be stored or transported, is less than 12 hours for non-refrigerated compounds or less than 24 hours for refrigerated compounds.

The C-SCA area doesn’t need to open into an adjacent ante room, which allows for flexibility in design and renovation. Having a conversation early on with pharmacists about a facility’s compounding process will allow the design team to understand if this space is a potential solution for current and future operations.

Compounding hoods. USP currently allows for a single hood, or containment primary engineering control, to be utilized for both nonsterile and sterile compounding. The guideline states hood disinfecting shall occur at several intervals throughout the day and between batches of compounding.

There’s concern within the industry that as an additional precautionary step, future USP updates may not allow this process to occur within the same hood, even if disinfecting occurs. Therefore, if a pharmacy is currently doing both nonsterile and sterile compounding or might do so in the future, it may be beneficial to allocate space in the hazardous drug compounding room for an additional hood to avoid the need for future renovations.

Lesson 2: Establish a realistic construction budget
A common mistake made by facilities preparing for a pharmacy renovation is establishing a construction budget based upon traditional cost-per-square-foot values. Many variables can affect the construction cost and schedule for a pharmacy renovation project. For example, the airflow, air quality, pressurization, temperature, and humidity requirements in USP 800 make it risky to assume the existing infrastructure is adequate to comply with the guideline. Proceeding with a renovation project under this assumption only to discover post-construction that there isn’t enough capacity will lead to project delays and, depending on the deficiencies, substantial additional cost. Therefore, premeasurement and verification of the HVAC systems are highly recommended to identify all deficiencies prior to establishing a construction budget.

Another challenge is keeping the existing pharmacy operational while the spaces are being renovated. Some facilities have the luxury of soft space that allows for smoother construction and continued operations, but this isn’t always the case. Construction phasing should be evaluated during the design process so that the quantity of phases can be balanced between limiting staff disruption and construction cost.

Scope is another variable that must be considered. Pharmacies often focus only on the compounding rooms in their initial planning stages to achieve compliance with USP 800. This makes sense due to the emphasis given to these areas in the new guideline, but it’s important to remember other topics covered, as well, such as transporting, receiving, storing, disposal, waste management, and cleaning. Doing a thorough review of the pharmacy space and operations as they relate to these issues is critical. When establishing the construction scope, it’s recommended that the design team walk through the entire drug handling process—from receiving, unboxing, transporting, compounding, and distribution—to ensure the construction scope required is completed in these areas.

Lesson 3: Engage the certifier early
Certification of a pharmacy’s compounding rooms by an independent certifier is required every six months. Testing will include certification of hoods, environmental monitoring, and viable airborne and surface sampling and will conclude with a pass or fail designation. While the industry adjusts to the new USP 800 compliance, some certifiers and design teams have interpreted portions of the guideline differently, such as proper pharmacy surfaces and finishes or what constitutes an accessible, cleanable, and nondegradable material.

A worst-case scenario is when a pharmacy renovation has been completed and the certifier gives a failing grade due to the designer’s lack of understanding of the guideline. Engaging an experienced certifier who can provide recommendations on operational best practices and potential cost savings at the initial planning stages can help avoid this situation.

Achieving success
Overall, the new guideline is a significant step in the healthcare industry’s growing regulatory focus on compounding practices, which, when subpar, can result in preventable patient and staff incidents, penalties, and other risks for an organization. Teams working to bring existing facilities toward meeting the Dec. 1 deadline, along with those answering the requirement in future projects, need to have a comprehensive grasp of USP 800 and follow the guidance offered above. Together, these steps will lay the foundation for success in completing a USP 800 compliance project.

Mike Zorich, PE, LEED AP, is a principal and director of healthcare for IMEG Corp. (Rock Island, Ill). He can be reached at