Health and Me

Rachel V Thomas

US FDA Asks Drugmakers To Set Time Limits For Antibiotic Use In Livestock

The US Food and Drug Administration (FDA) has issued new guidance urging veterinary drug makers to define the duration of antibiotic use in livestock.

The February 2026 guidance, published by the FDA’s Center for Veterinary Medicine (CVM), aims to mitigate the development of antimicrobial resistance and protect public health. It is consistent with previous recommendations by the federal agency that promoted the judicious use of medically important antimicrobial drugs in animals.

The FDA said that the guidance is intended for sponsors of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) containing antimicrobial drugs.

The guidance provides recommendations on how to add duration limits to medically important antibiotics used in or on the medicated feed of food-producing animals.

"The framework outlined in this guidance is intended to facilitate voluntary changes to have all medically important antimicrobial new animal drugs administered in alignment with the principles of judicious use,” the FDA said.

"This guidance provides specific recommendations on how sponsors may facilitate changes to the approved conditions of use of affected products in support of ongoing efforts to mitigate the development of antimicrobial resistance,” it added. 

Currently, no limit has been set for the approved treatment in food-producing animals. As a result, farmers can use the antibiotics in animal feed for extended periods of time. 

The proposed guidelines for “appropriately defined duration of use” labelling will ensure that the drug is used only when animals need it. 

The regulator also called the industry to “revise the labeling to include appropriate criteria regarding when to begin and end feeding of the antimicrobial drug.” 

The nonbinding guidance also suggests sponsors avoid instructions like “feed until market weight” to define the duration of use. 

"The scope of this guidance is limited to those drugs that are approved for use in or on animal feed because all the approved uses of medically important antimicrobial drugs in other (non-feed) dosage forms already have appropriately defined durations of use," the FDA said.

<h2>Why Misuse of Antibiotics In Animals Is A Concern</h2>

Antibiotic use in livestock and poultry globally is intended to treat, control, and prevent bacterial infections.

However, their overuse and misuse in food-animal production threaten both animal and human health. It is because these promote the emergence and spread of antimicrobial resistance (AMR).

AMR in livestock is a major driver of the 700,000 to over 1 million annual human deaths linked to drug-resistant infections globally. 

With roughly 70 per cent of global antibiotics used in agriculture, this misuse contributes to food-borne resistant pathogens and is projected to drive up to 10 million annual human deaths by 2050, as per the World Organisation for Animal Health.

The 2017 guidance issued by the FDA limited the over-the-counter use of medically important antibiotics on livestock. 

It also required a prescription and veterinary oversight for all antibiotic use. 

Later in 2018, the CVM called for all antibiotics used in the feed and drinking water of food -producing animals to have “an appropriately targeted duration of use”.

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The US Food and Drug Administration (FDA) has issued new guidance urging veterinary drug makers to define the duration of antibiotic use in livestock. The February 2026 guidance, published by the FDA’s Center for Veterinary Medicine (CVM), aims to mitigate the development of antimicrobial resistance and protect public health. It is consistent with previous recommendations by the federal agency that promoted the judicious use of medically important antimicrobial drugs in animals. The FDA said that the guidance is intended for sponsors of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) containing antimicrobial drugs. The guidance provides recommendations on how to add duration limits to medically important antibiotics used in or on the medicated feed of food-producing animals.  "The framework outlined in this guidance is intended to facilitate voluntary changes to have all medically important antimicrobial new animal drugs administered in alignment with the principles of judicious use,” the FDA said. "This guidance provides specific recommendations on how sponsors may facilitate changes to the approved conditions of use of affected products in support of ongoing efforts to mitigate the development of antimicrobial resistance,” it added. The New FDA RecommendationsCurrently, no limit has been set for the approved treatment in food-producing animals. As a result, farmers can use the antibiotics in animal feed for extended periods of time. The proposed guidelines for “appropriately defined duration of use” labelling will ensure that the drug is used only when animals need it. The regulator also called the industry to “revise the labeling to include appropriate criteria regarding when to begin and end feeding of the antimicrobial drug.”  The nonbinding guidance also suggests sponsors avoid instructions like “feed until market weight” to define the duration of use. "The scope of this guidance is limited to those drugs that are approved for use in or on animal feed because all the approved uses of medically important antimicrobial drugs in other (non-feed) dosage forms already have appropriately defined durations of use," the FDA said.Why Misuse of Antibiotics In Animals Is A Concern Antibiotic use in livestock and poultry globally is intended to treat, control, and prevent bacterial infections. However, their overuse and misuse in food-animal production threaten both animal and human health. It is because these promote the emergence and spread of antimicrobial resistance (AMR).AMR in livestock is a major driver of the 700,000 to over 1 million annual human deaths linked to drug-resistant infections globally. With roughly 70 per cent of global antibiotics used in agriculture, this misuse contributes to food-borne resistant pathogens and is projected to drive up to 10 million annual human deaths by 2050, as per the World Organisation for Animal Health. FDA On Antibiotic Use In Livestock The 2017 guidance issued by the FDA limited the over-the-counter use of medically important antibiotics on livestock. It also required a prescription and veterinary oversight for all antibiotic use. Later in 2018, the CVM called for all antibiotics used in the feed and drinking water of food -producing animals to have “an appropriately targeted duration of use”.