The Compound

USP <797> provides a comprehensive framework for sterile compounding—but it does not function as an operational playbook. Most organizations are not struggling because they are unaware of the requirements. They struggle in the space between what the chapter says and what daily practice actually looks like.

Viable air and surface sampling are often treated as a second thought. Results are reviewed, levels are checked, and the program moves on until there’s exceeded an action level. But USP <797> never intended viable monitoring to be a passive exercise.

For many sterile compounding teams, hazardous drug (HD) wipe sampling is one of the most intimidating aspects of USP <800>. Even organizations with strong sterile compounding programs often delay implementation—not because they don’t care about safety, but because they’re unsure what wipe sampling will uncover, how results will be interpreted, or how regulators will respond.

Understand how to design effective media-fill tests that accurately simulate real-world sterile compounding workflows and verify personnel competency across both non-HD and HD environments. This article breaks down the key elements, testing schedules, and documentation practices needed to build a reliable, compliant, and sustainable MFT program.