The new draft guidance also contains FDA recommendations for CGMP requirements on preventing cross-contamination of these products, including the separate manufacturing of non-penicillin beta-lactam antibacterial drugs from other drug manufacturing processes, as well as alternate recommendations when complete separation of manufacturing is not possible.

Public comment is open until 23 August 2022.

Sources:

RF Regulatory Focus: News

US Federal Register: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability