USP <797> Overview

At Innovation, we compound both sterile and non-sterile medications, each of which have their own guidelines and standards through USP. Sterile medications in particular refer to those that are “administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).”1

The specific regulation for sterile compounding, USP <797>, stipulates the kind of conditions under which sterile medications should be compounded as well as the proper documentation of compounding procedures, ensuring patients receive safe and beneficial sterile drugs with reduced risk of contamination, infection, or incorrect dosing.

USP <797> applies to various facilities that prepare sterile products; details the processes required for dosing, mixing, and storing sterile products; outlines training and evaluation procedures of personnel who prepare sterile products; and sets the standards for a formal audit program.

Innovation Compounding prioritizes patient safety above all and our own sterile lab—which exceeds USP <797> standards—reflects that. This means our patients are administered only the highest-quality medications. You can read here to learn more about USP <797> and the other USP guidelines for sterile and non-sterile compounding, all of which aim to protect patients using the safest compounding practices.

If you have questions about our sterile compounding facility, email us at!

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