Have You Herd? AABP PodCasts

What do Veterinarians Need to Know about FDA Guidance for Industry #263?

April 17, 2023 AABP
Have You Herd? AABP PodCasts
What do Veterinarians Need to Know about FDA Guidance for Industry #263?
Show Notes

AABP Executive Director Dr. Fred Gingrich is joined by Dr. Eric Moore, an AABP member who is Director of Technical Services at Norbrook. Guidance for Industry (GFI) #263 is part of the FDA’s five-year plan which will move the remaining medically important antimicrobials under veterinary oversight. This means that all medically important antimicrobials that are currently marketed as over-the-counter (OTC) medications will be moved to prescription (Rx) status. About 95% of antimicrobials sold in the U.S. are administered by feed or water. The remaining 5% of dosage forms include both OTC and Rx products and this move will ensure that all medically important antimicrobials are under the oversight of the veterinarian who has a valid veterinarian-client-patient relationship with the producer. Moore discusses the products that will be affected that cattle veterinarians and producers use, as well as discuss what will happen as these products have a change in marketing status. This implementation will be different than the implementation of the Veterinary Feed Directive where on that date, no products could be used that did not have an associated authorization VFD from the veterinarian. OTC products will have their labels changed to Rx; however, those products currently in commerce after June 11, 2023, will be able to be exhausted and newly labeled products will require a prescription from the veterinarian. Moore suggests that veterinarians familiarize themselves with the regulation and make sure to communicate these changes to producers in their communities. Producers should make sure they have a valid VCPR prior to the need for the medications and that veterinarians continue to implement antimicrobial stewardship plans on their clients' operations. This includes the question “why are you using this antimicrobial?” as the first step in stewardship is preventing disease. 

 Relevant links:

FDA Frequently Asked Questions on GFI #263

 GFI #263 Recommendations for Sponsors of Medically Important Antimicrobials

 FDA GFI #263 Text

 AABP Guidelines for Establishing and Maintaining the VCPR in Bovine Practice

 AABP Key Elements for Implementing Antimicrobial Stewardship Plans in Bovine Veterinary Practices Working with Beef and Dairy Operations

 AVMA Resources on GFI #263