
FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs
FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination. In the
According to FDA, penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people. FDA, therefore, points out that implementing methods for preventing cross-contamination of other drugs with penicillin is a key element of manufacturing penicillin and CGMP regulations require the use of such methods.
FDA also states that non-penicillin beta-lactam drugs also may be sensitizing agents and cross-contamination with non-penicillin beta-lactam drugs can initiate the same types of drug-induced hypersensitivity reactions that penicillin can trigger, including life-threatening allergic reactions. Manufacturers of non-penicillin beta-lactam drugs, therefore, should use similar control strategies to prevent cross-contamination.
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