What is USP<797>? What Does it Entail?
USP NF stands for ‘US Pharmacopeia National Formulary’. It is a publication (a very large book) put out by the US Pharmacopieal Convention. Prescription, over-the-counter and other health care products sold in the U.S. must follow the requirements set forth in the required chapters of this book. USP 797 is the 797th chapter of the USP NF and it is officially considered be one of the ‘enforceable’ chapters. However, actual enforcement has traditionally been left to the states with few states actually enforcing the requirements for sterile compounding. Even then, when enforced by the state, historically only certain state boards were found to be enforcing <797>. For example, in many states, the State Pharmacy Board may be actively enforcing <797>; however the state’s medical board (which typically oversees oncology offices and other private physician practice settings where sterile compounding may take place) is not. Unfortunately, in many states that declare to be enforcing <797>, the extent to which officials are surveying facilities for compliance may be reduced to simply checking to make sure that sterile compounding hoods located within the facility display a sticker indicating that they have recently been certified.
So what does USP chapter 797 entail? There seems to be this misunderstanding that USP<797> only outlines requirements for clean room operation and construction. Although these aspects are included, there is much more to the chapter. It also includes standards for staff training and competency, cleaning supplies and procedures, documentation standards, aseptic technique…etc. Therefore being in compliance with USP<797> does not just mean having a great clean room. It means being able to demonstrate that through policies, procedures, documentation and action plans that all aspects of USP <797> are being met or will soon be met. When a facility is being surveyed for compliance with <797>, the surveyor may end up going through HR files for documentation of training and competency. They will also likely look at each staff member’s HR file to make sure they have completed media fill testing and observational audits that look at gowning, compounding and hygiene techniques. They may check clean room records for documentation of temperature readings, pressure readings and documentation of viable and non-viable testing. Finally, they may look at aspects of clean room construction. If the facility is being surveyed by an accrediting body like the Joint Commission or the Accreditation Commission for Healthcare (ACHC) the surveyor will certainly conduct an extensive review of the facility’s policy and procedure manual.
Facilities that work with service providers who have given their clean room a ‘gold seal of approval’, so to speak, declaring the clean room ”USP<797> compliant” need to keep in mind that although the clean room may be compliant, there may still be certain policies, procedures and training/competency documentation put into place before the facility is considered compliant as a whole. In truth it may be said that documentation is NEVER done, therefore, it is also important to make sure processes are in place to ensure proper, ongoing documentation of efforts. Documentation is an ongoing process that involves the efforts of pharmacists, technicians, nurses, physicians, managers and HR staff. Depending on how the facility is set up it may even involve documentation by ancillary staff such as cleaning/maintenance personnel.
About the author: Christi Larson, Pharm. D. is the owner and Chief Consultant of I.V. Insights. Dr. Larson is committed to helping clients improve patient care through the implementation of best sterile compounding practices within the healthcare system.
