Draft gives non-penicillin ops guidance

The FDA expects manufacturers to treat sensitizing non-penicillin beta lactam antibiotics the same way they treat penicillin: using production facilities that are separate or isolated from those used for other products. Good manufacturing practice dictates "appropriate separation and control systems to prevent cross contamination," according to new draft guidance.

The guidance aims to help manufacturers determine whether separate facilities should be used based on the risk of cross-reactivity.

Like penicillin, the non-penicillin beta lactam drugs may be sensitizing agents. Cross-contamination can cause drug-induced hypersensitivity reactions in patients, including life-threatening anaphylaxis.

- see the draft guidance

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