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GUIDANCE DOCUMENT

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination Draft Guidance for Industry June 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2011-D-0104
Issued by:
Guidance Issuing Office
Center 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0104.

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