New labeling statement on pet medicines becomes mandatory in the US

The FDA has mandated a new rule requiring an “Approved by FDA” statement on animal drug labels. This aims to simplify the process for veterinarians, pet owners and food animal producers to identify medications that have received government approval.

A label indicating FDA approval attests to the drug’s effectiveness, intended use, proper manufacturing, labeling and packaging. The requirement became mandatory on 1 April 2024 after being temporarily exercised from September 2023 to March 2024.

Under the new amendment to Section 502(w)(3) of the Federal Food, Drug and Cosmetic Act, approved animal drugs will be required to include their 6-digit New Animal Drug Application (NADA) number or an Abbreviated New Animal Drug Application (ANADA) identification number on their labels.

Approved drugs that fail to carry this statement will be considered misbranded and in violation of the law. 

Who does it apply to?

An FDA spokesperson confirms to GlobalPETS that the requirement applies to new animal drugs. 

The government body clarifies that the use of the “Approved by FDA” statement is not allowed to label individual ingredients for the manufacturing of approved animal drugs, conditionally approved animal drugs and indexed animal drugs for minor species—including zoo animals, ornamental fish, parrots, ferrets and guinea pigs. 

The label can be included on “Blue Bird labeling,” though it is not mandatory. Blue Bird labeling refers to representative labeling for medicated feeds manufactured from ‘Type A’ medicated articles. 

The inclusion of the label is exempt on small labeling components, such as ‘blister packs’ for tablets or the label on very small syringes, due to the lack of space. Officials inform GlobalPETS that the FDA will decide on a case-by-case basis whether the omission is acceptable.

According to official figures, 99% of approved and marketed animal drugs have already incorporated the labeling statement.