USP <797>

Deep dive

USP <797>: complete reference

USP General Chapter <797> is a United States Pharmacopeia standard establishing requirements для compounded sterile preparations (CSPs) — covering personnel training + qualifications, facility design (cleanrooms, ISO classifications), environmental monitoring, beyond-use dating, и quality assurance. USP <797> applies to all pharmacies preparing sterile injectable medications, including compounded GLP-1s (semaglutide, tirzepatide). Compliance levels: Category 1 (low-risk, ≤12 hour BUD), Category 2 (medium-risk, 1-9 day BUD depending on conditions), Category 3 (highest-risk, longest BUD with strictest controls). Compounding pharmacies preparing injectable GLP-1s typically operate under Category 2 standards with refrigerated storage. State boards of pharmacy enforce USP <797> compliance — pharmacies failing inspections face license suspension or loss. PCAB accreditation evaluates USP <797> compliance as part of certification. Patients evaluating compounded GLP-1 sources can ask pharmacy directly about USP <797> compliance + last inspection date as a quality indicator.

In practice

Compounded semaglutide must be prepared в a USP <797>-compliant cleanroom by trained pharmacy staff. The standard ensures sterility + consistent quality — без it, infection risk + dose variability increase.

Clinical context

USP <797> compliance is the baseline quality standard для compounded sterile preparations. Check pharmacy compliance as part of due diligence.