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Executive Summary

OTC ANTIBIOTICS FOR HUMAN USE ARE EXEMPT FROM BATCH CERTIFICATION if they are generally recognized as safe and effective and not misbranded. FDA amended the antibiotic drug regulations to exempt OTC antibiotics in July and the rule became effective Aug. 14. In a July 15 Federal Register notice announcing the final rule, FDA explained that current regulations exempt antibiotic drugs for human use from batch certification only if they are approved under an antibiotic application or an abbreviated antibiotic application. "FDA did not intend to exclude OTC antibiotic drugs that are generally recognized as safe and effective from the exemption from batch certification," the notice states. Therefore, the agency said it proposed in July 1985 to amend the antibiotic drug regulations to exempt from batch certification OTC antibiotics that meet the conditions for GRAS/E status and conditions in an applicable final OTC antibiotic drug monograph. FDA noted that it did not receive any comments or requests for an informal conference in response to the proposal.

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