Detailed definition
USP chapter <797> establishes minimum standards for sterile compounding. It addresses primary engineering controls (laminar airflow, biological safety cabinets, isolators), clean-room design, personnel training and garbing, environmental monitoring (air and surface sampling), and shorter beyond-use dating than non-sterile preparations. Most HRT compounding is non-sterile and falls under USP <795>; injectable hormone preparations and certain sterile vaginal/intrauterine preparations require USP <797> compliance. The chapter was extensively revised in 2022.
Why it matters in menopause
Most outpatient compounded HRT (capsules, creams, troches) is governed by USP <795>, not <797>. The exceptions are injectables and rare sterile preparations. Patients should not need to think about USP standards directly, but the dispensing pharmacy should comply with whichever standard applies.