Capabilities
Sterile Compounding: USP <797> Explained
Sterile compounding is the preparation of medications that must be free of microorganisms — such as injectables, IV admixtures, and ophthalmic (eye) preparations — in a controlled, ISO-classified cleanroom environment. It is governed by USP General Chapter <797>, which sets requirements for facilities, air quality, personnel technique, and beyond-use dating to prevent contamination.
Key takeaways
- Sterile compounding is for medications that bypass the body's natural barriers (injectables, eye drops, IV).
- Governed by USP <797> — cleanroom design, air classification, gowning, and testing.
- Sterility and potency testing verify each preparation's safety.
- Logos RX operates a dedicated sterile compounding lab.
Why sterility matters
Medications injected into the body or applied to the eye bypass the natural defenses that protect us from contamination. If such a preparation carried microorganisms, the consequences could be serious. Sterile compounding exists to ensure these medications are prepared in an environment and with techniques that keep them free of contaminants.
What USP <797> requires
USP <797> is the standard governing sterile compounding in the United States. In practice it addresses:
- ISO-classified cleanroom environments with controlled airflow.
- Personnel training, gowning, and aseptic technique.
- Environmental monitoring and equipment certification.
- Beyond-use dating based on preparation risk level.
- Sterility and potency verification.
Examples of sterile preparations
Common sterile compounded preparations include injectable hormones and peptides, vitamin and nutrient injections, and ophthalmic solutions. At Logos RX, sterile preparations are made in our dedicated <797> lab and prepared to each prescription.
Frequently asked questions
What's the difference between sterile and non-sterile compounding?
Sterile compounding (USP <797>) prepares medications that must be contaminant-free, like injectables and eye preparations, in cleanrooms. Non-sterile compounding (USP <795>) prepares things like capsules, creams, and oral liquids in a controlled but non-cleanroom setting.
Related reading
Work with a 503A compounding pharmacy
Logos RX compounds personalized medications in Tampa and ships nationwide within our licensed states. Providers can prescribe through our portal.
Educational content. Compounded medications are not FDA-approved and require a prescription. Last reviewed June 2026.