Simplifying environmental quality and control practices for pharmaceutical compounding

Issued by the nonprofit United States Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), USP Regulation 797 is the first enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest revision became official on June 1, 2008.

USP 797 is a broad regulation that covers a variety of pharmacy policies and procedures. It is designed to reduce the number of patient infections due to contaminated pharmaceutical preparations.

This article focuses on the quality and control aspects of USP 797 as they relate to the immediate environment in which compounded sterile preparations (CSPs) are prepared. USP 797 contains specific requirements for ongoing air and surface evaluations to ensure product sterility and safety. Increasingly, affected organizations are realizing the importance of USP 797 compliance.

THE RATIONALE FOR A STERILE COMPOUNDING STANDARD
USP 797 was developed in response to realworld situations where patients were sickened by contaminated CSPs. One of the most notable examples occurred in 2006 at Mary Washington Hospital in Fredericksburg, Va., where eleven cardiac surgery patients became ill over a ten month period, and three died. Health officials later identified the cause to be a CSP solution containing bacteria that was injected into patients’ hearts during surgery.

Since then, there have been multiple instances where similar contaminations have impacted patient health. USP 797 sets into place the proper procedures for compounding sterile preparations, in order to mitigate risks. The standard is enforceable primarily by state boards of pharmacy and boards of health, and in some cases by the Food & Drug Administration (FDA).

As part of USP 797, environmental quality and control practices—those relating to airborne and surface bacteria—are vital.

ORGANIZATIONAL SCOPE FOR COMPLIANCE
USP 797 applies to all personnel who prepare CSPs and all places where they are created—including hospitals, clinics, pharmacies, and physician offices. Such sites tend to have less formal procedures in place to safeguard sterility as compared to those that govern commercial drug manufacturers.

Pharmacy-made compounds account for about one to five percent of all prescriptions today. Common examples of CSPs include inhalants, injections, soaks for live organs and tissues, intravenous solutions, chemotherapy drugs, irrigation solutions, and ophthalmic drops and ointments. Such preparations are made on-site either because they are not made commercially, or because a custom mixture is required to meet patient needs.

It should be noted that the costs related to USP 797 compliance can vary greatly—from minimal outlays that support basic hygiene and environmental monitoring practices to, in some cases, larger investments in equipment required for sterile compounding, such as laminar airflow workbenches (LAFW), biological safety cabinets (BSCs), or other primary engineering control (PEC) devices. Your facility’s specific needs will depend on your current compounding environment, as well as the types of CSPs being prepared.