Drugs

Non-Penicillin Beta-Lactam Drug Guidance

FDA has published a draft guidance, Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination, describing methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with compounds containing a beta-lactam ring. The document also provides information about 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.

FDA says the guidance recommends complete and comprehensive separation of the manufacturing operations of non-penicillin beta-lactam antibacterial drugs from the manufacturing operations of other drugs. The guidance information is intended for finished drug manufacturers, active pharmaceutical ingredient manufacturers, repackagers, and outsourcing facilities with operations that include one or more beta-lactam compounds.

The guidance revises a 4/2013 guidance with these significant changes:

clarifying that the scope of the guidance also includes all compounds, including intermediates or derivatives, that are not a penicillin, have a chemical structure that includes one or more beta-lactam rings, and have a mechanism of action other than an antibacterial mechanism of action;
providing FDA’s interpretation of terms used in the guidance;
clarifying the distinction between non-penicillin beta-lactam antibacterial drugs and non-antibacterial beta-lactam compounds in terms of the cross-contamination and patient exposure risks and the strategies appropriate for manufacturing operations involving each category; and
providing recommendations for drug manufacturers that seek to justify alternative cross-contamination prevention strategies for non-antibacterial beta-lactam compounds.

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