Detailed definition
United States Pharmacopeia chapter <795> establishes minimum standards for non-sterile compounding in pharmacy practice. It covers facility design, equipment cleanliness, personnel training and competency, quality of starting components, water quality, master and compounding records, and beyond-use dating. State boards of pharmacy generally require 503A compounding pharmacies to comply with USP <795>. The chapter was significantly updated in 2022 to tighten requirements for documentation, beyond-use dating, and personnel training.
Why it matters in menopause
For patients receiving compounded HRT, USP <795> compliance by the dispensing pharmacy is a baseline quality marker. It does not equal FDA-approved product testing but is the closest analog in the compounding world.