FDA Finalizes Guidance on Defining Durations of Use for Approved Medically Important Antimicrobial D

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Today, the U.S. Food and Drug Administration finalized Guidance for Industry (GFI) #273: Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals. The guidance provides recommendations for how animal drug sponsors may voluntarily establish defined durations of use for certain antimicrobial drugs that are important in human medicine (medically important antimicrobial animal drugs) and have one or more indications that currently lack a defined duration of use. 

GFI #273 applies only to medically important antimicrobials given in or on the feed of food-producing animals. The FDA has identified more than 100 affected drugs: List of Approved Medically Important Antimicrobial Drugs Administered in the Feed of Food-Producing Animals that Lack a Defined Duration of Use. All other dosage forms of these drugs (injectable, intramammary, tablet, etc.) already have established durations of use. 

When animal drugs do not have a defined duration of use, it means the labeling on the products does not specify how long the products may be administered for an approved use. Many of the antimicrobial drugs affected by this GFI were approved decades ago.  At that time, sponsors were not required to determine how long a product may be administered because antimicrobial resistance was not yet a pressing public health concern

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