Approval of Animal Antibiotics

Like antibiotics for humans, antibiotics for animals are heavily regulated. The FDA reviews and approves animal medicines using the same standards and processes as those used for human medicine.

Companies seeking approval of antibiotics for animals submit data to FDA demonstrating that the product meets three standards:

  • Ensure the product is safe. Safety, according to FDA, includes safety to the animals, safety of food products derived from the animals, safety to persons administering the drug or otherwise associated with the animals, and safety in terms of the drug’s impact on the environment.
  • Ensure the product is efficacious. A product sponsor provides data for FDA review and concurrence to demonstrate that the product is safe for the proposed claim or indication.
  • Ensure that a quality product is manufactured. Quality means the company adheres to the Good Manufacturing Principles and demonstrates an ability to consistently provide a stable product that is uniform in potency.

These requirements apply to all products approved by FDA. Antibiotics require an additional step, which is an evaluation of how use of the antibiotic might impact the prevalence of AMR.

Government oversight does not end with FDA approval. Three additional components to government monitoring of antibiotics used in food animals include:

  • Companies must report to the FDA any developments in what is known about the product, including new studies that are published, new data that comes to light or any problematic reactions that develop in treated animals.
  • The U.S. Department of Agriculture monitors meat for the occurrence of antibiotic residues. This monitoring program acts as a check to ensure antibiotics are being used properly and to ensure the FDA-mandated withdrawal times are followed.
  • The FDA operates the National Antimicrobial Resistance Monitoring System (NARMS), which tracks antibiotic resistant pathogens in samples collected from animals at slaughter, retail meats, and people. The findings, published annually, provide information to policymakers on potential emerging resistance.

The FDA approves all claims (what it is used for) and directions (how it is used) that are on the product label. FDA approves antibiotics with one of three claims:

  • Disease treatment. The administration of antibiotics to sick animals to resolve disease in the individual and (or) treatment of outbreaks within the entire herd or flock.
  • Disease Control. Administration to groups of animals to contain the spread of a disease when some animals in the flock or herd become ill and expose the rest of the animals to a bacterial pathogen.
  • Disease Prevention. Administration when animals are not sick but there is sufficient history or risk of disease to warrant therapy under the direction of a veterinarian.

Antibiotic Labels

Since the label lists a specific disease or pathogen against which the antibiotic works, FDA has stated they consider each of these claims to be prudent and judicious therapeutic claims for the use of antibiotics in food producing animals.

The label also contains information on the proper use of the product, such as the disease target, the dose needed for the specific animal according to its weight, and the route of administration. The label may contain restrictions or constraints on use. For example, the label will include withdrawal time, or period of time during which antibiotics may not be administered before the animal or animal products can enter the food supply. The withdrawal time is mandated to ensure the meat or milk does not contain residues above limits set by FDA.

The FDA & Judicious Use

Collaboration and continuous improvement contribute to strong animal health outcomes

Animal health companies and our trade associations worked collaboratively with the FDA to implement the agency’s Judicious Use Policy in 2017.  Under this policy, companies voluntarily removed growth promotion claims from medically important antibiotic compounds, leaving only therapeutic claims.  As a result, antibacterial agents medically important to humans are used in food animals only to fight disease.

Also, as part of Judicious Use policy, all the antibiotics products with therapeutic claims that are used in feed and water were brought under the supervision of a licensed veterinarian.  All medically important antibiotics added to feed must be approved by a veterinarian by providing a Veterinary Feed Directive (VFD), written instructions to a feed mill on how to properly mix antibiotics in the feed.  The veterinarian must have a Veterinary Client-Patient Relationship (VCPR) with the producer of the animals and must make the medical judgment that administration of the antibiotic is needed due to disease threats or outbreaks.

Animal health companies also worked successfully with FDA to bring all remaining medically important antibiotics that were marketed over-the-counter under prescription status.  As a result, all medically important antibiotics used in animals are used under the supervision of a licensed veterinarian to address disease threats.

We continue to demonstrate our commitment by working with the FDA on the agency’s Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings. This plan includes, among other things, ensuring labels on medically important compounds have appropriate duration of use instructions; collecting and analyzing data on the use of antibiotics in animals; and the development of a strategy to ensure antimicrobial stewardship in companion animals.

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