Preparing for Implications of USP 797 and USP 800

Dawn Holcombe, MBA, FACMPE, ACHE

June 2015, Vol 5, No 5 - From the Editor

If your practice or cancer center receives, handles, stores, compounds, dispenses, administers, or disposes of hazardous drugs, you may soon be affected by the US Pharmacopeial Convention’s General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings (USP 800). It will affect different practices in different ways, depending on how it is enforced as well as the agency or organization that may choose to enforce it.

A version of USP 800 that was published in 2014 was updated in response to public comments. This newer version was available for further public comment through May 31, and a final version that incorporates public feedback should be published in the near future. General Chapter 797 Pharmaceutical Compounding—Sterile Preparations (USP 797) also may have an impact on oncology practices and cancer centers. It was published in 2004 and was most recently revised in 2008. An expert panel was convened in April 2013 to review further changes to this chapter.

Both USP 797 and USP 800 are considered enforceable by entities, including the US Food and Drug Administration, Occupational Safety & Health Administration, state boards of pharmacy, and even state legislatures. Historically, USP 797 has not been applied to cancer centers and oncology practices because of the individual and short-term duration of their drug compounding. However, some clinical trial organizations are now seeking to restrict trial activity only to cancer centers that are compliant with USP 797. This could have widespread impact on private practices and cancer centers if it is expanded, as most clinical trials currently are taking place in the outpatient setting.

What would oncology practices and cancer centers need to become compliant with USP 797 and USP 800? Most oncology practices would need a clean room that complies with the individual requirements of these chapters, but would face a substantial capital expenditure to build one. An affordable alternative might be to lease a temporary or portable clean room, which would allow expenses to be paid from operating revenue; it is important to note, however, that clean rooms that comply with both chapters are expensive.

USP 797 and the proposed USP 800 do not actually require a clean room for medical practices if the practice can limit itself to starting the infusion of its compounded sterile products within 12 hours of completing the compound. If a practice can meet that stipulation, it can be compliant by limiting its compounding to a containment segregated compounding area (C-SCA). This can be an isolated, restricted-traffic room just large enough to house a containment primary engineering control and an operator wearing adequate gowning, garb, and personal protective equipment. The proposed USP 800 stipulates that a C-SCA must meet criteria specific to ventilation and airflow. If a cancer center cannot adhere to a 12-hour beyond-use date, however, then its only means to compliance will be to construct or gain the use of a fully functional clean room.

The physical facility requirement is just one aspect of USP 797 and proposed USP 800, and both chapters present myriad other requirements related to the communication and understanding of policies and procedures, training of team members, environmental certification requirements for a clean room, and effective quality management programs. The comment period for USP 800 just passed, and we are awaiting a final determination; however, we have seen individual state boards of pharmacy, state legislatures, the Occupational Safety & Health Administration, and clinical trial organizers start to mandate some degree of compliance with USP 797.

This is an issue that will continue to expand and will affect practices and cancer centers across the country in varying degrees. Compliance audits of clinics and practices have already started and revealed oversights even in the most conscientious facilities. Oncology practices and cancer centers should begin preparations now in anticipation of these regulations.