March 9, 2018
The U.S. Food and Drug Administration today issued draft guidance to provide recommendations to assist sponsors in developing proprietary names for new animal drugs in order to avoid contributing to medication errors,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Draft Guidance for Industry #240, entitled "Proprietary Names for New Animal Drugs," proposes a framework for evaluating proposed proprietary names before submitting them for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 The draft guidance also explains how new animal drug sponsors can request agency evaluation of a proposed proprietary name.
The 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.
The FDA is accepting public comments beginning on March 12, 2018. While comments are welcome at any time, you should submit them by May 11, 2018, for the FDA to consider your comments in drafting the final guidance.
To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2018-D-0626 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2018-D-0626 on each page of your written comments.
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
For more information:
- Notice of Availability of Draft Guidance for Industry; Proprietary Names for New Animal Drugs
- Regulations.gov: please note that the public comment period opens on March 12, 2018.
- Draft Guidance for Industry #240 Proprietary Names for New Animal Drugs
For questions, Contact CVM.