Complying with <797> and <800>

Attaining compliance with United States Pharmacopeia (USP) Chapters is of great concern within the practice of sterile compounding, as the process can be quite daunting and also expensive. This is especially true in small and/or rural facilities.

Having more than one large project occurring at a given time requires a division of focus, and there is a risk that this division can have a deleterious effect on the respective end goals.

Before undertaking any upgrade planning, hold meetings to assess the facility’s current state. Consider the responsibilities for each of the individuals involved in the project and define end product that is desired. This is the time to identify any logistical issues that will require attention, such as which staff members will need to be trained in cleaning to maintain the upgraded space, who will be responsible for evaluating the project to ensure regulatory compliance is attained, who will conduct the terminal cleaning before commencing use of the new space, etc. It is strongly recommended that you have copies of USP <797> ready for reading and discussion at this stage, and be prepared to explain the general details of the chapter. Many individuals at our facility, in addition to the contractors chosen for the construction, did not have a full grasp of USP <797>, which contributed to several of the challenges we faced during the renovation.

he team must be familiar with both federal and state requirements. It is important to recognize that states require varying levels of compliance with the USP chapters. To begin, determine if your state requires full compliance with USP Chapter <797> and review whether any of the state requirements are more stringent than those of USP. For example, Connecticut takes a stricter approach with certain aspects of sterile processing, including defined requirements for temperature and humidity control.

Select architects and contractors wisely; do not choose an architect or contractor based simply on the premise that “We have worked with them in the past.” Pharmacy management must be involved in the selection process. If possible, evaluate other facilities in which the contractor and/or architect has completed a sterile processing suite; investigate whether that facility had issues. For example, did the contractors and/or architects understand the legal ramifications for both the state and federal enforcement of the USP chapters? Were they cognizant of the approvals that were required at both the state and federal levels?

It’s common and totally understandable if you have doubts and/or struggles when considering compliance service providers. Get in touch with us now and we will make sure to provide the most comprehensive compliance assistance. Call 1.800.418.9289 today and let us know how we can help.

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