The purpose of USP General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations, released on June 1st, 2019, in alignment with USP <797> and <800>, is to provide minimum standards for compounded nonsterile preparations (CNSPs). Like USP <797>, USP <795> aims to ensure that pharmacy is producing the best quality products for the patient while minimizing contamination risks. The scope of USP <795> encompasses pharmacists and technicians, as well as any providers, including physicians and nurses, who manipulate CNSPs.

USP <795> Section 4, Buildings and Facilities, provides guidance regarding compliant design for the compounding space, storage area, and water sources. Ensuring that the space where CNSPs are produced is safe and compliant is the responsibility of the health-system pharmacist.

Designing the Compounding Space

USP <795> compliant CNSP compounding facilities must have a space that is specifically designed for compounding these preparations. Moreover, a visible perimeter must be in place and described in the facility’s standard operating procedure (SOP). The visible perimeter could be a different color of flooring (not carpet, which is prohibited) that underscores that this space is designated for CNSP compounding. The space must display signage that specifies that the area is for nonsterile compounding only; other activities must not occur in this space at the same time.

This location may be a separate room or simply a designated countertop. See pppmag.com/795compoundingroom for an example of a dedicated room for USP <795> compounding, separate from the USP <800> compounding room. The nonsterile compounding room may be used to produce topicals, capsules, pediatric medications, dermatological drugs, etc.

Describing the space in the SOP is critical. For example, specify if the designated USP <795> compounding space is a designated countertop with signage, or a separate room with signage. In addition, delineate where the visible perimeter is located.

When designing a compliant area, multiple issues must be considered, including workflow, surfaces, sinks and plumbing, storage, and containment.

• Workflow. Workflow must be specifically considered and designed to fit the designated compounding space. Consider the flow of product into and out of the CNSP space when implementing a workflow. The workflow must facilitate orderly placement of equipment and materials to prevent mix-ups among the components, containers, labels, in-process material, and completed CNSPs. Consider the following: If compounding records are being printed, is there a chance that they could become disorganized? Proper workflow should guard against this possibility.
  

   
  The space must also be arranged in such a way to minimize cross-contamination from non-compounding areas. For example, if the CNSP compounding space is a specific countertop, and active pharmaceutical ingredients are being handled nearby, is there a chance that the aerosolized and micronized powders could cross-contaminate other areas? When designing a space, be cognizant of the flow of product into and out of the area to prevent errors and enable a smooth workflow.

• Surfaces. Surfaces in the compounding space should be well lighted; maintained in a clean, orderly, and sanitary condition; and in a good state of repair. Surfaces should be resistant to damage by cleaning and sanitizing agents. Best practice is for surfaces to be smooth, impervious, easy to clean, non-shedding, and resistant to sanitizing agents, and for walls to be epoxy-painted.
  
  
• Sinks and Plumbing. An easily accessible sink, with hot and cold water, must be available for compounding. The sink may be located inside or outside the nonsterile compounding space. Ensure that the sink is emptied of all items unrelated to compounding and cleaned when visibly soiled before being used to clean any equipment used in nonsterile compounding. Plumbing must be free of defects that could contribute to the contamination of any CNSP.
  
  
• Storage. All nonsterile preparations, components, equipment, and containers must be stored off the floor and in a manner that prevents contamination and permits inspection and cleaning of the storage area.
  
  
• Containment. Weighing, measuring, or otherwise manipulating components that could generate airborne chemical particles (eg, active pharmaceutical ingredients, added substances, conventionally manufactured products) must be assessed to determine if these activities must be performed in a closed system processing device to reduce the potential exposure to personnel or contamination of the facility or CNSPs. Examples of closed system processing devices include containment ventilated enclosures (CVEs), biological safety cabinets (BSCs), or single-use containment glove bags.

Conclusion

Like USP <797> compliance, <795> compliance is necessary to ensure compounded preparations are safe and effective for patients. Ensuring the compounding space, storage area, and sink are compliant with USP <795> is critical to this pursuit.

Bryan’s webinar, USP Compliance: USP <795> Facility Requirements, is available at: pppmag.com/webinars

Bryan Prince, MBA, is a compounding workflow and lab designer, and the owner of Lab•Red Pharmacy Consultants. He has published numerous articles on compounding pharmacy workflow design and has been invited to speak at conferences on workflow and USP <800> throughout the United States and Canada.