An FDA program in which each batch of every antibiotic drug for human use is certified by FDA as possessing the necessary characteristics of identity, strength, quality, and purity to adequately insure safety and effectiveness in use. Before an antibiotic is eligible for certification, FDA must approve the drug as safe and effective under procedures that are substantially equivalent to those for approving new drugs. Similar procedures exist for batch certification of insulin. Both antibiotic and insulin certification services are supported by user fees.