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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance describes methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with compounds containing a beta-lactam ring. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of non-penicillin beta-lactam antibacterial drugs and non-antibacterial beta-lactam compounds.
This guidance recommends complete and comprehensive separation of the manufacturing operations of non-penicillin beta-lactam antibacterial drugs from the manufacturing operations of other drugs. For manufacturers of non-antibacterial beta-lactam compounds, this guidance provides recommendations on cross-contamination prevention strategies, including examples of relevant design features and control approaches for those seeking to justify a cross-contamination prevention strategy other than complete and comprehensive separation when appropriate.