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USP Chapter 797 Compliance (Required): All sterile compounding must comply with USP Chapter 797: Key Requirements: ISO Class 5 or better cleanroom environment Primary engineering controls (laminar flow hoods) Personnel garbing and hand hygiene Environmental monitoring Media fill testing to demonstrate sterility Regular facility cleaning and disinfection Beyond-use date assignment based on stability Master formulation records Compounding records for every batch Pharmacies should document and be able to demonstrate Chapter 797 compliance

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AUCs of APAP metabolites for the five pregnant women of the longitudinal observational study and normalised UHPLC areas