43.1 What Is USP Chapter <797>?

Understanding the risks inherent in sterile compounding and incorporating established standards are essential for patient safety. Compounded drugs made without the guidance of standards may be subpotent, superpotent, or contaminated, exposing patients to significant risk of adverse events or even death.

United States Pharmacopeia (USP) develops standards for preparing compounded sterile drugs to help ensure patient benefit and reduce risks such as contamination, infection, or incorrect dosing.

USP General Chapter <797> describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations.

43.2 What Is Next Iteration of the USP Chapter <797> Draft?

In September 2015, the USP released a proposed updated Chapter 797 on procedures for sterile compounding. The existing chapter had provided procedures for allergen immunotherapy extracts as a separate element to processes applicable to three levels of risk for other sterile compounded products. The September 2015 draft collapsed those requirements into just two categories; treating all sterile compounds, including allergen extract, as equally and inherently dangerous. At the time of the writing of this chapter, the updated draft was open for public comment. The anticipated official date for < 797 > to go into effect will be December 1, 2019.

Allergen extract is restored as a separate section of the proposed draft chapter. The allergen extract compounding requirements address compounding personnel training and evaluation, hygiene and garbing, and updated documentation requirements, plus either installation of an ISO Class 5, Primary Engineering Control (PEC), or a dedicated Allergenic Extracts Compounding Area (AECA), with specifications and requirements provided for either option.

43.3 Who Does the Mixing?

The preparation of compounded sterile preparations (CSPs) is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication. There are minimum requirements that apply to all persons who prepare CSPs. This includes, but is not limited to, pharmacists, technicians, physicians, and nurses in all places including, but not limited to, hospitals and other health care institutions, patient treatment sites, infusion facilities, pharmacies, and physicians’ or practice sites.

Compounding staff will be required to be trained and regularly evaluated on aseptic and compounding technique, mostly reflecting existing requirements but with the addition of gloved fingertip testing and thumb sampling and appropriate incubation of samples to ensure proper sterile technique is being followed. These requirements will help maintain consistent attention to the foremost importance of ensuring patient safety. Documentation requirements for compounding procedures, temperature logs for refrigeration, and prescription set documentation reflect best practices.