Draft Guidance
June 2022
FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination." This guidance revises the final guidance of the same title issued on April 17, 2013, and expands the scope of the guidance to include all compounds containing a beta-lactam ring in their structure. All beta-lactam compounds, including non-penicillin beta-lactam antibacterial drugs as well as non-antibacterial beta-lactam compounds (including intermediates and derivatives), have the potential to cause allergic reactions and represent a life-threatening risk to certain patients.
This draft guidance describes methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with non-penicillin beta-lactam antibacterial drugs or non-antibacterial beta-lactam compounds and makes recommendations for how manufacturers can be compliant with current good manufacturing practice requirements for preventing cross-contamination. This guidance also provides information regarding the relative health risk of, and the potential for, allergic reactions due to cross-reactivity in the classes of non-penicillin beta-lactam antibacterial drugs and non-antibacterial beta-lactam compounds.
This guidance recommends manufacturers have complete and comprehensive separation between non-penicillin beta-lactam antibacterial drugs and 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.
Significant changes from the 2013 guidance include:
- 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, such as allergic reaction, cross-reactivity, and complete and comprehensive separation, used in this guidance
- Clarifying the distinction between non-penicillin beta-lactam antibacterial drug(s) and non-antibacterial beta-lactam compound(s)--in terms of the cross-contamination and patient exposure risks and the control strategies appropriate for manufacturing operations involving each category
- Providing recommendations for drug manufacturers that seek to justify alternative cross-contamination prevention strategies for non-antibacterial beta-lactam compounds
Download the Draft Guidance
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