SILVER SPRINGS, MD. — On March 8, the US Food and Drug Administration (FDA) proposed new regulations on animal drugs, aimed at providing animal drug sponsors with predictable requirements for labeling new prescriptions and over-the-counter (OTC) animal drugs, as well as those used in animal feed. According to the administration, the proposed regulations will not only benefit veterinarians, but also animal/pet owners and livestock producers by providing more consistent information on safe and effective use. of new drugs.
According to the FDA, it has followed certain practices for reviewing animal drug labels in the past. However, these practices are not codified in regulation.
“The lack of direction regarding the format and content for each part of the labeling has resulted in confusion for sponsors as they prepare the label for FDA review and sometimes results in poor quality label submissions, ” said the agency. “Submissions of poor quality labeling increase the time it takes sponsors to revise and resubmit adequate labeling, and they increase the time it takes the FDA to review and approve the labeling. , and consequently, the application.”
Additionally, the FDA is proposing to amend or delete some existing regulations to help ensure consistency with the new regulations on animal drug labeling. It will place all labeling requirements on the content and format of approved or conditionally approved new animal drugs in the Code of Federal Regulations under one location.
“The new animal drug label that presents information inconsistently may contribute to medication errors by making it difficult for veterinarians and animal owners to easily find and understand critical directions and safety information,” the agency added.
If the new regulations are finalized, future animal drug applications will have to comply, while previously approved new animal drugs will have to follow a staggered schedule for six years.
The FDA is currently accepting public comments on the new proposed animal drug regulations until June 10, before creating a final version of the new rules. Comments can be submitted through the Federal eRulemaking Portal or sent by mail.
“If finalized, the rule will create for the first time a comprehensive set of regulations that establish requirements for labeling content and format for approved and conditionally approved new animal drugs and will also help animal drug sponsor better prepare label for review,” claims the agency.
Read more about the new animal medicine regulations here.
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