USP General Chapter <795> is the U.S. Pharmacopeia standard for non-sterile compounding — applicable to oral, topical, and other non-sterile compounded preparations.
USP <795> covers personnel training, facility design, equipment maintenance, ingredient selection, master formulation records, compounding records, and beyond-use dating applicable to non-sterile compounding.
The current revision became enforceable on November 1, 2023 alongside the <797> update. As with <797>, enforcement is by state boards of pharmacy.
As with <797>, USP <795> is a pharmacy obligation. APIs we ship can be incorporated into either sterile (<797>) or non-sterile (<795>) compounded preparations depending on the dosage form — in either case, the pharmacy is solely responsible for compounding compliance. We document identity and purity. The pharmacy documents everything that follows.