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This General Chapter provides procedures and requirements for compounding sterile preparations. General Chapter <797> describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations.

Link: Download USP–NF General Chapter <797> Pharmaceutical Compounding—Sterile Preparations


2012 USP <797> Compliance Study Data 

FDA 483 issued to Ameridose on 11/9/2012

FDA 483 issued to New England Compounding Pharmacy on 10/26/12