Guidance for industry no. 263: Transition of remaining over-the-counter antibiotics to prescription status
Abstract
"In December of 2013, the Food and Drug Administration's (FDA) Guidance for Industry (GFI) #213 was published in the federal register. This led to two significant changes regarding the use of medically important antibiotics (see sidebar) in the feed and water of livestock beginning Jan. 1, 2017. One change that occurred was medically important antibiotics could no longer be used for production purposes such as growth promotion or increased feed efficiency. The other change was many of these antibiotics, which had been available over the counter (OTC), now required either a Veterinary Feed Directive if used in feed or aprescription if used in drinking water. This action brought the majority of antibiotic use in the livestock industry under veterinary supervision. However, a small percentage remained available OTC in the form of injectables, intramammary tubes, boluses, etc."--Page 1.
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