USP <797> Sterile Compounding: A Plain-English Overview

What USP <797> is

USP <797>

A General Chapter published by the United States Pharmacopeia that describes the minimum standards for preparing compounded sterile preparations, with the goal of protecting patients from contamination, errors, and variation in strength. ¹

The United States Pharmacopeia is a standards-setting organization, not a government agency. Its compounding chapters, including <795> for nonsterile work and <797> for sterile work, are widely referenced by state boards of pharmacy and others. ¹ When people say a sterile preparation was made "to USP <797>," they mean it was prepared under the conditions and practices the chapter describes.

Why sterile work needs its own rules

A sterile preparation is one that must be free of living microorganisms, because it may be injected, infused, or used in the eye, where contamination can cause real harm. ¹ Nonsterile work, like many creams and oral suspensions, carries different risks. Because the stakes for sterile preparations are higher, the standards governing how they are made are more demanding. ²

The main areas the chapter covers

At a plain-English level, <797> organizes its requirements around a few themes. The exact details are in the official text and are updated over time, so the list below is an orientation, not a checklist. ¹

• People. Training, competency checks, hand hygiene, and proper garbing for anyone who compounds sterile preparations. ¹
• Place. A controlled compounding environment, often described as a cleanroom, with air quality and surface controls designed to limit contamination. ¹
• Process. Procedures for compounding, plus environmental monitoring and quality checks appropriate to the risk level of the work. ¹
• Product. Labeling, documentation, and the beyond-use date assigned to each preparation. ¹

The beyond-use date

Beyond-use date (BUD)

The date or time after which a compounded preparation should not be used, based on factors such as the type of preparation, how it was made, and how it is stored. It is not the same as a manufacturer expiration date. ¹

The beyond-use date is one of the most practical ideas in the chapter. Compounded sterile preparations do not carry the extensive stability testing behind a mass-manufactured product, so the BUD is a conservative limit meant to keep patients safe. ¹ How a BUD is assigned depends on the specifics of the preparation and on the current chapter.

How <797> relates to FDA oversight

USP standards and FDA oversight are related but distinct. The FDA describes how compounding fits into federal law and notes that compounded preparations are not FDA-approved. ² USP provides the technical standards that practitioners and boards reference. ¹ A 503B outsourcing facility additionally operates under Current Good Manufacturing Practice, a separate and more extensive manufacturing standard. ²

Because USP chapters are revised and because state adoption varies, a pharmacy should rely on the current official chapter and its own state board guidance rather than on any summary. ¹²