Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Non-Penicillin Beta- Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination." This guidance describes the importance of implementing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and non-penicillin beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates and derivatives. Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of non- penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.