Perez 1

Anthony Perez

Dr. Casas

Pharmacy 64

January 19, 2017

USP Chapter 797 Summary

The USP Chapter 797 is a section of the USP pertaining to sterile compounding practices

and preparations. The main objective of the chapter is to describe in detail how a practitioner can

prevent the contamination of medications that have the potential to harm or cause death to

patients. To achieve this objective, the USP sets a minimum standard of practice and quality of

compounded sterile preparations (CSPs) for medications that have a low-risk level, medium-risk

level, high-risk level, and those that require immediate use. This chapter also delineates the

differences between non-sterile compounding and sterile compounding by explaining the need

for extra precaution and care in aseptic technique to CSPs. For example, it is necessary for one to

take extra precaution in sterilizing his or her environment even when reconstituting medications

as often labels only explain how to maintain chemical stability and not purity. In addition, there

is a list of notable definitions that pertain to CSPs that a practitioner should have a knowledge of

to facilitate his or her understanding of sterile compounding as a practice. Some examples of

these terms are First Air which is, [the] air exiting the HEPA filter in a unidirectional air

stream that is essentially particle free and Negative Pressure Room which is, [a] room that is

at a lower pressure than the adjacent spaces and, therefore, the net flow of air is into the room.

Although there is much more to CSPs such as but not limited to storage and beyond use dating,

the general purpose of USP 797 is to take every precaution necessary to ensure the integrity of

the medication and the health of the patient receiving said medication.
Perez 2