The United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, provides various regulations and recommendations for patient and healthcare personnel safety.
“Millions of medications are compounded each year in the US to meet the unique needs of patients. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine) (USP).”
USP General Chapter <797> outlines the procedures for compounding sterile preparations. USP <797> was designed with patient safety at the core. Following this standard helps reduce risk and adverse drug reactions that may occur. Failing to follow these guidelines could lead to harm, including death, to patients due to improperly made or contaminated compounded sterile preparations (CSPs). Patient safety is the number one driver for standards and regulation.
USP <797> applies to ALL settings in which sterile preparations are compounded. Consistency with procedures throughout the organization is essential. Whether it is the central pharmacy, satellite pharmacy, or outpatient areas, all locations need to be practicing safe and sterile compounding which complies with USP <797>.
In the video below, Patricia Kienle, BSPHARM, MPA, FASHP, mentions that one part of the health system that can often be overlooked is when private practices are brought into the health system. You can’t overlook clinics and physician’s offices where compounding is occurring.
Many of these locations do not have the controls in place that you would find in a clean room. It is imperative that these facilities be trained and educated on best sterile compounding practices. They also need to be using the correct controls to keep patients safe.
In this quick video, Kienle discusses how pharmacists are an essential piece of the puzzle when it comes to maintaining safe and sterile compounding standards outside of the pharmacy.
USP General Chapter <797> is currently under revision. The proposed changes were published on June 1, 2019 and are currently postponed until further notice. The currently official version of General Chapter <797> (last revised in 2008) remains official until further notice (USP).
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In conclusion, USP <797> applies to ALL areas which compound sterile preparations whether it is inpatient or outpatient. Following these standards is important for patient health and safety. Pharmacy is key to keeping the entire organization educated and updated on sterile compounding best practices and regulations. Pharmacists must step up and take on the leadership role when it comes to USP <797> standards throughout the health system.
This video was filmed by Pharmacy Times at the 2019 ASHP Summer Meeting.