On June 23, 2022, the U.S. Food and Drug Administration (FDA) notified the pharmaceutical industry of an important update to Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination, published on April 17, 2013.1 This new draft guidance broadens the scope of the previously released guidance to include all compounds containing a beta-lactam ring in their structure (including intermediates and derivatives). For manufacturers of nonantibacterial beta-lactam compounds, this guidance also 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.
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