Definition: USP 797 (written USP <797>) is the chapter of the United States Pharmacopeia that sets standards for compounding sterile drugs, such as injections. It describes the clean rooms and work areas where they are made. Pharmacies follow it under state and federal rules, but meeting it does not make a compounded drug FDA approved.
FDA guidance on insanitary conditions at compounding facilities refers to USP 797 for its descriptions of clean rooms, controlled areas, buffer rooms, anterooms and "segregated compounding areas." The guidance names conditions FDA treats as insanitary for drugs meant to be sterile, such as poor cleaning of rooms and surfaces.
For a segregated compounding area at a pharmacy that is not an outsourcing facility, FDA says it generally will not act on certain conditions if the pharmacy meets all USP 797 criteria for that area and gives its drugs a beyond-use date of no more than 12 hours at room temperature or 24 hours refrigerated or frozen.
USP 797 is a standard for how a pharmacy works, not a test result for your vial. FDA says compounded drugs are not FDA approved, so FDA does not check their safety, effectiveness or quality before sale. FDA also warns that poor compounding can lead to contamination or a drug with too much or too little active ingredient.
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