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As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the statement “Approved by FDA” must appear on the labeling of approved animal drugs in the marketplace. This statement is intended to clearly identify approved animal drugs and distinguish them from drugs that do not have the benefit of FDA approval. The FDA’s approval ensures that the drug is safe and effective for its intended use, properly manufactured, and adequately labeled and packaged.
The FDA considers approved animal drugs that don’t carry the statement on the labeling to be misbranded, and distributing such drugs violates the law.
The “Approved by FDA” statement on medicated feeds
The labeling for Type A medicated articles (animal drugs that are used to manufacture medicated feeds) is required to have the “Approved by FDA” statement. While the statement is not required on representative labeling (also known as “Blue Bird” labeling) for medicated feeds manufactured from Type A medicated articles, the FDA recommends that drug sponsors include it. If the statement is included on the Blue Bird labeling, then the final printed label for the medicated feed must also include the statement and this will reassure end users (for example, veterinarians and food animal producers) that the medicated feed was manufactured according to FDA-approved Blue Bird labeling.
The labeling of proprietary medicated feeds must also include the “Approved by FDA” statement. Proprietary feeds have formulas that are not publicly available and can only be manufactured by the licensed feed mills that are referenced in the NADA of the Type A medicated article.
April 1, 2024/ FDA/ United States.
https://www.fda.gov
