New Draft Guidance Issued for Animal Drug Names

FDA's goal is to help sponsors avoid contributing to medication errors, encouraging public comment by May 11, 2018.

FDA's goal is to help sponsors avoid contributing to medication errors, encouraging public comment by May 11, 2018.
FDA's goal is to help sponsors avoid contributing to medication errors, encouraging public comment by May 11, 2018.

Animal lovers might especially appreciate FDA’s March 9, 2018 announcement pertaining to guidelines to “provide recommendations to assist sponsors in developing proprietary names for new animal drugs in order to avoid contributing to medication errors, negatively impacting safe use of the drug, or misbranding the drug.”

Draft Guidance for Industry #240, "Proprietary Names for New Animal Drugs," proposes a framework for evaluating proposed proprietary names before submitting them for review by the FDA’s Center for Veterinary Medicine.The agency will accept public comments beginning March 12, 2018, encouraging comment submissions byMay 11, 2018in order to consider them in drafting the final guidance.

The announcement notes, “FDA evaluates proprietary names as part of the new animal drug approval process. Selecting a proprietary name is a critical element in the design and development of animal drug product labeling because end users (the prescribing veterinarian, veterinary technician, food animal producers, animal owners, pharmacist or pharmacy technician) may rely, in part, on the proprietary name to identify which product, among thousands of available products, is intended for a given animal. If end users cannot readily distinguish among proprietary names, the animal might receive an incorrect product, or it might be difficult to correctly identify the product used. The FDA also considers whether the proprietary name can contribute to medication errors. Examples of medication errors include incorrect drug selection, incorrect dosage or route of administration, or use in unintended species or classes. These types of errors may cause animal injury or lead to a lack of drug effectiveness, which could contribute to outcomes like complication of a disease and possible death of an animal.”

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