Chapter <797> in the United States Pharmacopeia 27/NF 22 "applies to health care institutions, pharmacies, physicians practice facilities in which compounded sterile preparations (CSPs) are prepared, stored and dispensed. The purpose of these regulations is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in strength or correct ingredients, and incorrect ingredients in CSPs."

The choice of appropriate cleanroom (buffer zone) consumables is necessary for USP <797> compliance. Please contact your Regional Technical Representative to schedule an audit of your processes. The audit can take place on-site, by phone interview or electronic survey.